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Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial (OASIS)

Primary Purpose

Shoulder Dislocation, Glenohumeral Dislocation, Anterior Shoulder Dislocation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arthroscopic Bankart repair procedure
Open Bankart
Latarjet
Post-Operative Rehabilitation
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Dislocation focused on measuring Anterior Shoulder Instability, Glenoid Bone Loss, Stabilization Surgery, Return to Duty or Sport, Rehabilitation

Eligibility Criteria

17 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Civilians and military personnel ages 17 to 50
  • Traumatic anterior shoulder dislocation
  • Associated subcritical bone loss between 10-20% less the glenoid width quantified by standard of care CT scan

Exclusion Criteria:

  • Chronic, non-traumatic multi-directional instability based on clinical exam.
  • Concurrent shoulder injury (e.g. rotator cuff tears, motor nerve pathologies, osteoarthritis of a Samilson-Prieto grade >2).
  • Prior instability or rotator cuff procedure on involved shoulder (including intra-articular soft tissue surgery).
  • Humeral sided bone lesion (Hill-Sachs lesion) that is sufficiently large enough to render the lesion "off-track" even after a bony augmentation procedure would be performed.
  • Neuromuscular and other movement control pathologies including seizures.
  • Vascular injury associated with the shoulder trauma.
  • Traumatic brain injury or any condition that would preclude the ability to comply with post-operative guidelines.
  • Does not plan to return to pre-injury levels of work, sports or military duty.

Sites / Locations

  • Naval Medical Center
  • Evans Army Community Hospital
  • Steadman ClinicRecruiting
  • University of Connecticut Health CenterRecruiting
  • US Naval Health Clinic (Academy)
  • Walter Reed National Military Medical Center
  • Naval Medical Center Camp Lejeune
  • University of North Carolina at Chapel HillRecruiting
  • Duke UniversityRecruiting
  • Wake Forest UniversityRecruiting
  • University of PittsburghRecruiting
  • Rhode Island Hospital- University OrthopedicsRecruiting
  • San Antonio Military Medical Center
  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arthroscopic Bankart repair with remplissage of Hill-Sachs lesion/rehabilitation

Open Bankart/rehabilitation

Latarjet/rehabilitation

Arm Description

Arthroscopic Bankart repair surgery with remplissage of Hill-Sachs lesion and post-operative rehabilitation.

Open Bankart surgery and post-operative rehabilitation.

Latarjet surgical procedure and post-operative rehabilitation.

Outcomes

Primary Outcome Measures

Western Ontario Shoulder Instability Index (WOSI)
The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
Western Ontario Shoulder Instability Index (WOSI)
The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
Western Ontario Shoulder Instability Index (WOSI)
The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
Western Ontario Shoulder Instability Index (WOSI)
The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
Time to Return to Pre-Injury Level of Activity
Time to return to pre-injury level military duty, work and sports.
Recurrent Instability / Re-injury
Recurrent instability will consist of any of the following events: dislocation, subluxation, revision stabilization procedure.
Recurrent Instability / Re-injury
Recurrent instability will consist of any of the following events: dislocation, subluxation, revision stabilization procedure.
Recurrent Instability / Re-injury
Recurrent instability will consist of any of the following events: dislocation, subluxation, revision stabilization procedure.
Recurrent Instability / Re-injury
Recurrent instability will consist of any of the following events: dislocation, subluxation, revision stabilization procedure.

Secondary Outcome Measures

Single Assessment Numerical Evaluation (SANE)
The SANE is a single-item, global, patient-reported outcome measure, where the participant provides a whole number response to the question "On a scale from 0 to 100, how would you rate your injured shoulder today, with 100 being normal?" SANE scale reliability is excellent (ICC greater or equal to 0.80) and Standard Error of Measurement ranges from 4.23 to 7.82 points. Validity of the SANE displays correlations of 0.50 - 0.88 (moderate to very strong correlations) between the SANE scale and other partient-reported outcome measures.
Single Assessment Numerical Evaluation (SANE)
The SANE is a single-item, global, patient-reported outcome measure, where the participant provides a whole number response to the question "On a scale from 0 to 100, how would you rate your injured shoulder today, with 100 being normal?" SANE scale reliability is excellent (ICC greater or equal to 0.80) and Standard Error of Measurement ranges from 4.23 to 7.82 points. Validity of the SANE displays correlations of 0.50 - 0.88 (moderate to very strong correlations) between the SANE scale and other partient-reported outcome measures.
Single Assessment Numerical Evaluation (SANE)
The SANE is a single-item, global, patient-reported outcome measure, where the participant provides a whole number response to the question "On a scale from 0 to 100, how would you rate your injured shoulder today, with 100 being normal?" SANE scale reliability is excellent (ICC greater or equal to 0.80) and Standard Error of Measurement ranges from 4.23 to 7.82 points. Validity of the SANE displays correlations of 0.50 - 0.88 (moderate to very strong correlations) between the SANE scale and other partient-reported outcome measures.
Single Assessment Numerical Evaluation (SANE)
The SANE is a single-item, global, patient-reported outcome measure, where the participant provides a whole number response to the question "On a scale from 0 to 100, how would you rate your injured shoulder today, with 100 being normal?" SANE scale reliability is excellent (ICC greater or equal to 0.80) and Standard Error of Measurement ranges from 4.23 to 7.82 points. Validity of the SANE displays correlations of 0.50 - 0.88 (moderate to very strong correlations) between the SANE scale and other partient-reported outcome measures.
Brophy Shoulder Activity Level
The Brophy Shoulder Activity Level is a patient-reported measure of participant's level of sports activity. It consists of 5 items that are rated in a 5-point scale (0-4), where higher scores indicate greater activity engagement. Possible scores on the scale range from 0 - 20.
Brophy Shoulder Activity Level
The Brophy Shoulder Activity Level is a patient-reported measure of participant's level of sports activity. It consists of 5 items that are rated in a 5-point scale (0-4), where higher scores indicate greater activity engagement. Possible scores on the scale range from 0 - 20.
Brophy Shoulder Activity Level
The Brophy Shoulder Activity Level is a patient-reported measure of participant's level of sports activity. It consists of 5 items that are rated in a 5-point scale (0-4), where higher scores indicate greater activity engagement. Possible scores on the scale range from 0 - 20.
Brophy Shoulder Activity Level
The Brophy Shoulder Activity Level is a patient-reported measure of participant's level of sports activity. It consists of 5 items that are rated in a 5-point scale (0-4), where higher scores indicate greater activity engagement. Possible scores on the scale range from 0 - 20.
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE)
The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Scale - Upper Extremity (UE) consists of an item bank of 121 items that assesses physical function regardless of the health condition present that can be administered as a computer adaptive test (CAT) or through the use of short forms. The Physical Function scale scores transformed to a T-score in which a score of 50 represents the US population average with a standard deviation of 10 indicating the population standard deviation.
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE)
The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Scale - Upper Extremity (UE) consists of an item bank of 121 items that assesses physical function regardless of the health condition present that can be administered as a computer adaptive test (CAT) or through the use of short forms. The Physical Function scale scores transformed to a T-score in which a score of 50 represents the US population average with a standard deviation of 10 indicating the population standard deviation.
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE)
The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Scale - Upper Extremity (UE) consists of an item bank of 121 items that assesses physical function regardless of the health condition present that can be administered as a computer adaptive test (CAT) or through the use of short forms. The Physical Function scale scores transformed to a T-score in which a score of 50 represents the US population average with a standard deviation of 10 indicating the population standard deviation.
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE)
The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Scale - Upper Extremity (UE) consists of an item bank of 121 items that assesses physical function regardless of the health condition present that can be administered as a computer adaptive test (CAT) or through the use of short forms. The Physical Function scale scores transformed to a T-score in which a score of 50 represents the US population average with a standard deviation of 10 indicating the population standard deviation.
Patient-Reported Outcome Measurement Information System (PROMIS) Global-10
The PROMIS-10 Global Health also measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. It includes physical and mental health component scores that can be transformed to t score distributions with a mean of 50 and standard deviation of 10. A higher score indicates better health.
Patient-Reported Outcome Measurement Information System (PROMIS) Global-10
The PROMIS-10 Global Health also measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. It includes physical and mental health component scores that can be transformed to t score distributions with a mean of 50 and standard deviation of 10. A higher score indicates better health.
Patient-Reported Outcome Measurement Information System (PROMIS) Global-10
The PROMIS Global-10 is a 10-item patient reported global measure of physical and emotional health. The PROMIS-10 Global Health also measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. It includes physical and mental health component scores that can be transformed to t score distributions with a mean of 50 and standard deviation of 10. A higher score indicates better health.
Patient-Reported Outcome Measurement Information System (PROMIS) Global-10
The PROMIS Global-10 is a 10-item patient reported global measure of physical and emotional health. The PROMIS-10 Global Health also measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. It includes physical and mental health component scores that can be transformed to t score distributions with a mean of 50 and standard deviation of 10. A higher score indicates better health.
Tampa Scale for Kinesiophobia-11 (TSK-11)
The Tampa Scale for Kinesiophobia-11 quantifies fear of re-injury due to movement and physical activity. Items are scored from 1 (strongly disagree) to 4 (strongly agree). Total TSK-11 scores range from 11 - 44, with higher scores indicating greater fear of pain, movement, and injury.
Tampa Scale for Kinesiophobia-11 (TSK-11)
The Tampa Scale for Kinesiophobia-11 quantifies fear of re-injury due to movement and physical activity. Items are scored from 1 (strongly disagree) to 4 (strongly agree). Total TSK-11 scores range from 11 - 44, with higher scores indicating greater fear of pain, movement, and injury.
Tampa Scale for Kinesiophobia-11 (TSK-11)
The Tampa Scale for Kinesiophobia-11 quantifies fear of re-injury due to movement and physical activity. Items are scored from 1 (strongly disagree) to 4 (strongly agree). Total TSK-11 scores range from 11 - 44, with higher scores indicating greater fear of pain, movement, and injury.
Tampa Scale for Kinesiophobia-11 (TSK-11)
The Tampa Scale for Kinesiophobia-11 quantifies fear of re-injury due to movement and physical activity. Items are scored from 1 (strongly disagree) to 4 (strongly agree). Total TSK-11 scores range from 11 - 44, with higher scores indicating greater fear of pain, movement, and injury.
Brief Resilience Scale
The Brief Resilience Scale is a 6-item questionnaire that measures an individual's ability to recover from an ongoing health related stress. It uses a 5-point Likert scale that ranges from "strongly disagree" to "strongly agree." Totally, the individual responses creates a range of possible scores from 6 - 30. The total score is then divided by the total number of questions answered for the final score. The scores range from 1 to 5, where higher scores indicate positive resilience capabilities.
Brief Resilience Scale
The Brief Resilience Scale is a 6-item questionnaire that measures an individual's ability to recover from an ongoing health related stress. It uses a 5-point Likert scale that ranges from "strongly disagree" to "strongly agree." Totally, the individual responses creates a range of possible scores from 6 - 30. The total score is then divided by the total number of questions answered for the final score. The scores range from 1 to 5, where higher scores indicate positive resilience capabilities.
Brief Resilience Scale
The Brief Resilience Scale is a 6-item questionnaire that measures an individual's ability to recover from an ongoing health related stress. It uses a 5-point Likert scale that ranges from "strongly disagree" to "strongly agree." Totally, the individual responses creates a range of possible scores from 6 - 30. The total score is then divided by the total number of questions answered for the final score. The scores range from 1 to 5, where higher scores indicate positive resilience capabilities.
Brief Resilience Scale
The Brief Resilience Scale is a 6-item questionnaire that measures an individual's ability to recover from an ongoing health related stress. It uses a 5-point Likert scale that ranges from "strongly disagree" to "strongly agree." Totally, the individual responses creates a range of possible scores from 6 - 30. The total score is then divided by the total number of questions answered for the final score. The scores range from 1 to 5, where higher scores indicate positive resilience capabilities.
Patient Acceptable Symptom State (PASS)
The Patient Acceptable Symptom State is assessed by asking the participant the question: Taking into account all the activity you have during your daily life, your level of pain and also activity limitations and participation restrictions, do you consider the current state of your shoulder satisfactory?" The PSS question is answered "Yes" or "No". A response of "Yes" indicates that the individual is satisfied with his/her current symptom state. The PASS question has show to have sufficient rest re-test reliability in patients after orthopaedic surgery, with a reported kappa coefficient of 0.78.
Patient Acceptable Symptom State (PASS)
The Patient Acceptable Symptom State is assessed by asking the participant the question: Taking into account all the activity you have during your daily life, your level of pain and also activity limitations and participation restrictions, do you consider the current state of your shoulder satisfactory?" The PSS question is answered "Yes" or "No". A response of "Yes" indicates that the individual is satisfied with his/her current symptom state. The PASS question has show to have sufficient rest re-test reliability in patients after orthopaedic surgery, with a reported kappa coefficient of 0.78.
Patient Acceptable Symptom State (PASS)
The Patient Acceptable Symptom State is assessed by asking the participant the question: Taking into account all the activity you have during your daily life, your level of pain and also activity limitations and participation restrictions, do you consider the current state of your shoulder satisfactory?" The PSS question is answered "Yes" or "No". A response of "Yes" indicates that the individual is satisfied with his/her current symptom state. The PASS question has show to have sufficient rest re-test reliability in patients after orthopaedic surgery, with a reported kappa coefficient of 0.78.
Patient Acceptable Symptom State (PASS)
The Patient Acceptable Symptom State is assessed by asking the participant the question: Taking into account all the activity you have during your daily life, your level of pain and also activity limitations and participation restrictions, do you consider the current state of your shoulder satisfactory?" The PSS question is answered "Yes" or "No". A response of "Yes" indicates that the individual is satisfied with his/her current symptom state. The PASS question has show to have sufficient rest re-test reliability in patients after orthopaedic surgery, with a reported kappa coefficient of 0.78.
Functional Comorbidity Index
The Functional Comorbidity Index (FCI) is an 18-item measure assessing the presence of medical comorbidities. The FCI is a self-administered report of medical comorbidities associated with physicla function. Using medical comorbidities is an important factor in creating risk adjustment models for orthopaedic trauma. The FCI was found to demonstrate a stronger association with the SF-36 physical function subscale (R2 = 0.29) than the Charleston (R2 = 0.18) and Kaplan-Feinstein (R2 = 0.17) indices. When individuals were classified into high and low function based ont he SF-36, the FCI correctly classified 77% of the cases.
Functional Comorbidity Index
The Functional Comorbidity Index (FCI) is an 18-item measure assessing the presence of medical comorbidities. The FCI is a self-administered report of medical comorbidities associated with physicla function. Using medical comorbidities is an important factor in creating risk adjustment models for orthopaedic trauma. The FCI was found to demonstrate a stronger association with the SF-36 physical function subscale (R2 = 0.29) than the Charleston (R2 = 0.18) and Kaplan-Feinstein (R2 = 0.17) indices. When individuals were classified into high and low function based ont he SF-36, the FCI correctly classified 77% of the cases.
Functional Comorbidity Index
The Functional Comorbidity Index (FCI) is an 18-item measure assessing the presence of medical comorbidities. The FCI is a self-administered report of medical comorbidities associated with physicla function. Using medical comorbidities is an important factor in creating risk adjustment models for orthopaedic trauma. The FCI was found to demonstrate a stronger association with the SF-36 physical function subscale (R2 = 0.29) than the Charleston (R2 = 0.18) and Kaplan-Feinstein (R2 = 0.17) indices. When individuals were classified into high and low function based ont he SF-36, the FCI correctly classified 77% of the cases.
Functional Comorbidity Index
The Functional Comorbidity Index (FCI) is an 18-item measure assessing the presence of medical comorbidities. The FCI is a self-administered report of medical comorbidities associated with physicla function. Using medical comorbidities is an important factor in creating risk adjustment models for orthopaedic trauma. The FCI was found to demonstrate a stronger association with the SF-36 physical function subscale (R2 = 0.29) than the Charleston (R2 = 0.18) and Kaplan-Feinstein (R2 = 0.17) indices. When individuals were classified into high and low function based ont he SF-36, the FCI correctly classified 77% of the cases.
Passive Range of Motion of the Shoulder
The range of passive elevation and external rotation and internal rotation of both shoulders will be measured with a goniometer. Range of motion measurements to the nearest 1 degree will be made with a large clear plastic gonionometer marked in 1 degree increments.
Passive Range of Motion of the Shoulder
The range of passive elevation and external rotation and internal rotation of both shoulders will be measured with a goniometer. Range of motion measurements to the nearest 1 degree will be made with a large clear plastic gonionometer marked in 1 degree increments.
Passive Range of Motion of the Shoulder
The range of passive elevation and external rotation and internal rotation of both shoulders will be measured with a goniometer. Range of motion measurements to the nearest 1 degree will be made with a large clear plastic gonionometer marked in 1 degree increments.
Isometric Muscle Strength of the Shoulder
Isometric muscle strength of shoulder will be assessed in 5 positions (external rotation at 0 degrees, external rotation at 90 degrees, internal rotation at 0 degrees, internal rotation at 90 degrees and scapular plane abduction at 90 degrees) using a hand-held dynamometer.
Isometric Muscle Strength of the Shoulder
Isometric muscle strength of shoulder will be assessed in 5 positions (external rotation at 0 degrees, external rotation at 90 degrees, internal rotation at 0 degrees, internal rotation at 90 degrees and scapular plane abduction at 90 degrees) using a hand-held dynamometer.
Isometric Muscle Strength of the Shoulder
Isometric muscle strength of shoulder will be assessed in 5 positions (external rotation at 0 degrees, external rotation at 90 degrees, internal rotation at 0 degrees, internal rotation at 90 degrees and scapular plane abduction at 90 degrees) using a hand-held dynamometer.
Performance on Functional Tests of the Upper Extremity - Closed Kinetic Chain Upper Extremity Stability test
Closed Kinetic Chain Upper Extremity Stability test: Participants take a full pushup position. They alternatingly touch each hand with the other, as fast as they can, for 15 seconds. Number of touches in 15 seconds.Three trials will be performed and the average value will be calculated.
Performance on Functional Tests of the Upper Extremity - Closed Kinetic Chain Upper Extremity Stability test
Closed Kinetic Chain Upper Extremity Stability test: Participants take a full pushup position. They alternatingly touch each hand with the other, as fast as they can, for 15 seconds. Number of touches in 15 seconds.Three trials will be performed and the average value will be calculated.
Performance on Functional Tests of the Upper Extremity - Unilateral Seated Shot-Put test
Unilateral Seated Shot-Put test: Distance of shot-put recorded in centimeters. The distance a 2.72 kg medicine ball is pushed, from block against participant's back to the site of ball contact on the floor. The participant will complete three trials for each arm, with the average of 3 trials being used for analysis.
Performance on Functional Tests of the Upper Extremity - Unilateral Seated Shot-Put test
Unilateral Seated Shot-Put test: Distance of shot-put recorded in centimeters. The distance a 2.72 kg medicine ball is pushed, from block against participant's back to the site of ball contact on the floor. The participant will complete three trials for each arm, with the average of 3 trials being used for analysis.
Performance on Functional Tests of the Upper Extremity - Push-ups
Push-ups: Number of push-ups that can be completed in 60 seconds is counted. The test is performed twice and the higher number of repetitions achieved is recorded.
Performance on Functional Tests of the Upper Extremity - Push-ups
Push-ups: Number of push-ups that can be completed in 60 seconds is counted. The test is performed twice and the higher number of repetitions achieved is recorded.
Performance on Functional Tests of the Upper Extremity - Weighted Overhead Ball Throw
Weighted Overhead Ball Throw: Participant will throw a 9.07 kg medicine ball overhead, with both hands. Distance of throw recorded in centimeters. Three trials will be performed.
Performance on Functional Tests of the Upper Extremity - Weighted Overhead Ball Throw
Weighted Overhead Ball Throw: Participant will throw a 9.07 kg medicine ball overhead, with both hands. Distance of throw recorded in centimeters. Three trials will be performed.
Performance on Functional Tests of the Upper Extremity - Upper Quarter Y-Balance test
Upper Quarter Y-Balance test: Maximum reach in 3 directions (medial, inferolateral, and superolateral), recorded in centimeters. Subjects stand in a three-point plank position with the tested shoulder perpendicular to the hand and the feet shoulder-width apart. Three test trials will be performed on each side with 30 seconds of rest in between each trial. A normalized composite score is the mean of the average distance in all three reach directions.
Performance on Functional Tests of the Upper Extremity - Upper Quarter Y-Balance test
Upper Quarter Y-Balance test: Maximum reach in 3 directions (medial, inferolateral, and superolateral), recorded in centimeters. Subjects stand in a three-point plank position with the tested shoulder perpendicular to the hand and the feet shoulder-width apart. Three test trials will be performed on each side with 30 seconds of rest in between each trial. A normalized composite score is the mean of the average distance in all three reach directions.
Clinical Measures after Surgical Stabilization - Pain
Pain: Pain intensity will be recorded utilizing an 11-point numeric pain scale (NPRS) that ranges from 0 (no pain) to 10 (worst imaginable pain). Th current, least, and worst pain intensity in the past 24 hours will be recorded and summed to create a pain score that ranges from 0 to 30.
Clinical Measures after Surgical Stabilization - Pain
Pain: Pain intensity will be recorded utilizing an 11-point numeric pain scale (NPRS) that ranges from 0 (no pain) to 10 (worst imaginable pain). Th current, least, and worst pain intensity in the past 24 hours will be recorded and summed to create a pain score that ranges from 0 to 30.
Clinical Measures after Surgical Stabilization - Pain
Pain: Pain intensity will be recorded utilizing an 11-point numeric pain scale (NPRS) that ranges from 0 (no pain) to 10 (worst imaginable pain). Th current, least, and worst pain intensity in the past 24 hours will be recorded and summed to create a pain score that ranges from 0 to 30.
Clinical Measures after Surgical Stabilization - Pain
Pain: Pain intensity will be recorded utilizing an 11-point numeric pain scale (NPRS) that ranges from 0 (no pain) to 10 (worst imaginable pain). Th current, least, and worst pain intensity in the past 24 hours will be recorded and summed to create a pain score that ranges from 0 to 30.
Clinical Measures after Surgical Stabilization - Pain
Pain: Pain intensity will be recorded utilizing an 11-point numeric pain scale (NPRS) that ranges from 0 (no pain) to 10 (worst imaginable pain). Th current, least, and worst pain intensity in the past 24 hours will be recorded and summed to create a pain score that ranges from 0 to 30.
Clinical Measures after Surgical Stabilization - Pain Medication Usage
Pain Medication Usage: At follow-up visit, current narcotic pain medication usage is recorded. Usage (Yes/No): If "Yes," name of medication, dose, frequency of use, and indication is noted.
Clinical Measures after Surgical Stabilization - Pain Medication Usage
Pain Medication Usage: At follow-up visit, current narcotic pain medication usage is recorded. Usage (Yes/No): If "Yes," name of medication, dose, frequency of use, and indication is noted.
Clinical Measures after Surgical Stabilization - Pain Medication Usage
Pain Medication Usage: At follow-up visit, current narcotic pain medication usage is recorded. Usage (Yes/No): If "Yes," name of medication, dose, frequency of use, and indication is noted.
Clinical Measures after Surgical Stabilization - Pain Medication Usage
Pain Medication Usage: At follow-up visit, current narcotic pain medication usage is recorded. Usage (Yes/No): If "Yes," name of medication, dose, frequency of use, and indication is noted.
Clinical Measures after Surgical Stabilization - Pain Medication Usage
Pain Medication Usage: At follow-up visit, current narcotic pain medication usage is recorded. Usage (Yes/No): If "Yes," name of medication, dose, frequency of use, and indication is noted.
Clinical Measures after Surgical Stabilization - Use of Post-op Brace
Use of Post-op Brace: Usage (Yes/No): If "No," date brace was discontinued will be recorded.
Clinical Measures after Surgical Stabilization - Use of Post-op Brace
Use of Post-op Brace: Usage (Yes/No): If "No," date brace was discontinued will be recorded.
Clinical Measures after Surgical Stabilization - Use of Post-op Brace
Use of Post-op Brace: Usage (Yes/No): If "No," date brace was discontinued will be recorded.
Clinical Measures after Surgical Stabilization - Use of Post-op Brace
Use of Post-op Brace: Usage (Yes/No): If "No," date brace was discontinued will be recorded.
Clinical Measures after Surgical Stabilization - Use of Post-op Brace
Use of Post-op Brace: Usage (Yes/No): If "No," date brace was discontinued will be recorded.
Clinical Measures after Surgical Stabilization - Wound Status
Wound Status: At follow-up visit, wound status recorded as healed, healing, draining, open, erythema or presence of a superficial wound infection.
Clinical Measures after Surgical Stabilization - Wound Status
Wound Status: At follow-up visit, wound status recorded as healed, healing, draining, open, erythema or presence of a superficial wound infection.
Clinical Measures after Surgical Stabilization - Wound Status
Wound Status: At follow-up visit, wound status recorded as healed, healing, draining, open, erythema or presence of a superficial wound infection.
Clinical Measures after Surgical Stabilization - Wound Status
Wound Status: At follow-up visit, wound status recorded as healed, healing, draining, open, erythema or presence of a superficial wound infection.
Clinical Measures after Surgical Stabilization - Wound Status
Wound Status: At follow-up visit, wound status recorded as healed, healing, draining, open, erythema or presence of a superficial wound infection.
Clinical Measures after Surgical Stabilization - Neurovascular status
Neurovascular status: Assessment of neurovascular status will include assessment of pulses, sensation to pain, and distal motor function. Brachial pulses will be recorded as symmetrical, diminished, or absent. Sensation to pain will be recorded as normal, diminished or absent. Distal motor function of the wrist will be recorded as strong/symmetrical to the contralateral arm, diminished, or absent.
Clinical Measures after Surgical Stabilization - Neurovascular status
Neurovascular status: Assessment of neurovascular status will include assessment of pulses, sensation to pain, and distal motor function. Brachial pulses will be recorded as symmetrical, diminished, or absent. Sensation to pain will be recorded as normal, diminished or absent. Distal motor function of the wrist will be recorded as strong/symmetrical to the contralateral arm, diminished, or absent.
Clinical Measures after Surgical Stabilization - Neurovascular status
Neurovascular status: Assessment of neurovascular status will include assessment of pulses, sensation to pain, and distal motor function. Brachial pulses will be recorded as symmetrical, diminished, or absent. Sensation to pain will be recorded as normal, diminished or absent. Distal motor function of the wrist will be recorded as strong/symmetrical to the contralateral arm, diminished, or absent.
Clinical Measures after Surgical Stabilization - Neurovascular status
Neurovascular status: Assessment of neurovascular status will include assessment of pulses, sensation to pain, and distal motor function. Brachial pulses will be recorded as symmetrical, diminished, or absent. Sensation to pain will be recorded as normal, diminished or absent. Distal motor function of the wrist will be recorded as strong/symmetrical to the contralateral arm, diminished, or absent.
Clinical Measures after Surgical Stabilization - Neurovascular status
Neurovascular status: Assessment of neurovascular status will include assessment of pulses, sensation to pain, and distal motor function. Brachial pulses will be recorded as symmetrical, diminished, or absent. Sensation to pain will be recorded as normal, diminished or absent. Distal motor function of the wrist will be recorded as strong/symmetrical to the contralateral arm, diminished, or absent.
Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests
Additional Diagnostic Tests: At follow-up visit, any additional diagnostic tests will be recorded. (Yes/No): If "Yes," the test, date and indication will be recorded.
Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests
Additional Diagnostic Tests: At follow-up visit, any additional diagnostic tests will be recorded. (Yes/No): If "Yes," the test, date and indication will be recorded.
Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests
Additional Diagnostic Tests: At follow-up visit, any additional diagnostic tests will be recorded. (Yes/No): If "Yes," the test, date and indication will be recorded.
Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests
Additional Diagnostic Tests: At follow-up visit, any additional diagnostic tests will be recorded. (Yes/No): If "Yes," the test, date and indication will be recorded

Full Information

First Posted
March 17, 2021
Last Updated
July 6, 2023
Sponsor
University of Pittsburgh
Collaborators
Walter Reed National Military Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04809064
Brief Title
Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial
Acronym
OASIS
Official Title
Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Walter Reed National Military Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical trial will investigate the effects of three surgical procedures and the associated post-operative rehabilitation to optimize time to return to military duty, work and sports, and patient-reported physical function for military personnel and civilians with traumatic anterior shoulder instability and 10-20% glenoid bone loss.
Detailed Description
The objective of this clinical trial is to determine the optimal surgical procedure and post-operative rehabilitation strategy for treatment of military personnel and civilians with shoulder instability and subcritical bone loss. Investigators will conduct a randomized, controlled trial comparing arthroscropic Bankart with remplissage/rehabilitation versus open Bankart/rehabilitation versus Latarjet/rehabilitation. Aim 1: The investigators will determine the effects of arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion versus open Bankart versus Latarjet on patient reported outcomes (Western Ontario Shoulder Instability score [WOSI]), time to Return to Duty/Activity (RTD/A) at pre-injury levels, and recurrent instability/re-injury at 6 months, 1 and 2 years. Aim 2: The investigators will determine if participation in rehabilitation that optimizes range of motion, strength, and functional performance predicts successful RTD/A, WOSI score, and recurrent instability at 6 months, 1, and 2 years. Subject Population: Male and female military personnel and civilians between the ages of 17 and 50 with a traumatic anterior shoulder dislocation with associated 10-20% glenoid bone loss and plans to return to physically demanding work or sports, without multi-directional instability, concomitant shoulder pathologies (e.g. rotator cuff tears, motor nerve lesion, fractures, osteoarthritis > Samilson Pietro grade 2), neuromuscular conditions including seizures, a history of shoulder surgery related to any intraarticular soft tissue, and vascular injury will be eligible to participate. Study / Experimental Design: Randomized controlled trial (Aim 1), Prospective cohort (Aim 2). Methodology: 400 individuals will be randomized to arthroscopic Bankart with remplissage of a Hill-Sachs lesion/rehabilitation vs. open Bankart/rehabilitation vs. open Latarjet/rehabilitation. To address Aim 1, individuals with traumatic anterior shoulder instability with subcritical bone loss will be randomized to arthroscopic Bankart repair with remplissageof a Hill-Sachs lesion, or open Bankart, or Latarjet. To address Aim 2, all individuals will enter into rehabilitation with specific instructions for the first 12 weeks dependent on the surgical arm to which they are randomized. After week 12, all rehabilitation programs will be similar and progressed based upon the results of interim testing at 3, 4, and 6 months. Participants will be followed for 24 months, with primary outcomes consisting of patient-reported physical function and time to return to pre-injury military duty, work and sports. Secondary outcomes will include shoulder-specific and generic patient-reported measures of physical function and health related quality of life and recurrent instability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation, Glenohumeral Dislocation, Anterior Shoulder Dislocation
Keywords
Anterior Shoulder Instability, Glenoid Bone Loss, Stabilization Surgery, Return to Duty or Sport, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arthroscopic Bankart repair with remplissage of Hill-Sachs lesion/rehabilitation
Arm Type
Experimental
Arm Description
Arthroscopic Bankart repair surgery with remplissage of Hill-Sachs lesion and post-operative rehabilitation.
Arm Title
Open Bankart/rehabilitation
Arm Type
Experimental
Arm Description
Open Bankart surgery and post-operative rehabilitation.
Arm Title
Latarjet/rehabilitation
Arm Type
Experimental
Arm Description
Latarjet surgical procedure and post-operative rehabilitation.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic Bankart repair procedure
Intervention Description
Bankart repair with remplissage consists of arthroscopic anterior inferior capsulolabral repair with arthroscopic infraspinatus tenodesis to the posterior humeral head.
Intervention Type
Procedure
Intervention Name(s)
Open Bankart
Intervention Description
Open Bankart repair consists of anterior capsulorrhaphy with labral repair.
Intervention Type
Procedure
Intervention Name(s)
Latarjet
Intervention Description
Latarjet consists of open transfer of the coracoid to the anterior glenoid bone deficiency.
Intervention Type
Other
Intervention Name(s)
Post-Operative Rehabilitation
Intervention Description
Post-operative rehabilitation will be conducted following surgical procedure-specific rehabilitation guidelines and will be progressed based on individual needs.
Primary Outcome Measure Information:
Title
Western Ontario Shoulder Instability Index (WOSI)
Description
The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
Time Frame
3 months after randomization
Title
Western Ontario Shoulder Instability Index (WOSI)
Description
The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
Time Frame
6 months after randomization
Title
Western Ontario Shoulder Instability Index (WOSI)
Description
The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
Time Frame
12 months after randomization
Title
Western Ontario Shoulder Instability Index (WOSI)
Description
The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
Time Frame
24 months after randomization
Title
Time to Return to Pre-Injury Level of Activity
Description
Time to return to pre-injury level military duty, work and sports.
Time Frame
Monthly starting at 3 months after randomization and continuing to 24 months
Title
Recurrent Instability / Re-injury
Description
Recurrent instability will consist of any of the following events: dislocation, subluxation, revision stabilization procedure.
Time Frame
3 months after randomization
Title
Recurrent Instability / Re-injury
Description
Recurrent instability will consist of any of the following events: dislocation, subluxation, revision stabilization procedure.
Time Frame
6 months after randomization
Title
Recurrent Instability / Re-injury
Description
Recurrent instability will consist of any of the following events: dislocation, subluxation, revision stabilization procedure.
Time Frame
12 months after randomization
Title
Recurrent Instability / Re-injury
Description
Recurrent instability will consist of any of the following events: dislocation, subluxation, revision stabilization procedure.
Time Frame
24 months after randomization
Secondary Outcome Measure Information:
Title
Single Assessment Numerical Evaluation (SANE)
Description
The SANE is a single-item, global, patient-reported outcome measure, where the participant provides a whole number response to the question "On a scale from 0 to 100, how would you rate your injured shoulder today, with 100 being normal?" SANE scale reliability is excellent (ICC greater or equal to 0.80) and Standard Error of Measurement ranges from 4.23 to 7.82 points. Validity of the SANE displays correlations of 0.50 - 0.88 (moderate to very strong correlations) between the SANE scale and other partient-reported outcome measures.
Time Frame
3 months after surgery
Title
Single Assessment Numerical Evaluation (SANE)
Description
The SANE is a single-item, global, patient-reported outcome measure, where the participant provides a whole number response to the question "On a scale from 0 to 100, how would you rate your injured shoulder today, with 100 being normal?" SANE scale reliability is excellent (ICC greater or equal to 0.80) and Standard Error of Measurement ranges from 4.23 to 7.82 points. Validity of the SANE displays correlations of 0.50 - 0.88 (moderate to very strong correlations) between the SANE scale and other partient-reported outcome measures.
Time Frame
6 months after surgery
Title
Single Assessment Numerical Evaluation (SANE)
Description
The SANE is a single-item, global, patient-reported outcome measure, where the participant provides a whole number response to the question "On a scale from 0 to 100, how would you rate your injured shoulder today, with 100 being normal?" SANE scale reliability is excellent (ICC greater or equal to 0.80) and Standard Error of Measurement ranges from 4.23 to 7.82 points. Validity of the SANE displays correlations of 0.50 - 0.88 (moderate to very strong correlations) between the SANE scale and other partient-reported outcome measures.
Time Frame
12 months after surgery
Title
Single Assessment Numerical Evaluation (SANE)
Description
The SANE is a single-item, global, patient-reported outcome measure, where the participant provides a whole number response to the question "On a scale from 0 to 100, how would you rate your injured shoulder today, with 100 being normal?" SANE scale reliability is excellent (ICC greater or equal to 0.80) and Standard Error of Measurement ranges from 4.23 to 7.82 points. Validity of the SANE displays correlations of 0.50 - 0.88 (moderate to very strong correlations) between the SANE scale and other partient-reported outcome measures.
Time Frame
24 months after surgery
Title
Brophy Shoulder Activity Level
Description
The Brophy Shoulder Activity Level is a patient-reported measure of participant's level of sports activity. It consists of 5 items that are rated in a 5-point scale (0-4), where higher scores indicate greater activity engagement. Possible scores on the scale range from 0 - 20.
Time Frame
3 months after randomization
Title
Brophy Shoulder Activity Level
Description
The Brophy Shoulder Activity Level is a patient-reported measure of participant's level of sports activity. It consists of 5 items that are rated in a 5-point scale (0-4), where higher scores indicate greater activity engagement. Possible scores on the scale range from 0 - 20.
Time Frame
6 months after randomization
Title
Brophy Shoulder Activity Level
Description
The Brophy Shoulder Activity Level is a patient-reported measure of participant's level of sports activity. It consists of 5 items that are rated in a 5-point scale (0-4), where higher scores indicate greater activity engagement. Possible scores on the scale range from 0 - 20.
Time Frame
12 months after randomization
Title
Brophy Shoulder Activity Level
Description
The Brophy Shoulder Activity Level is a patient-reported measure of participant's level of sports activity. It consists of 5 items that are rated in a 5-point scale (0-4), where higher scores indicate greater activity engagement. Possible scores on the scale range from 0 - 20.
Time Frame
24 months after randomization
Title
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE)
Description
The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Scale - Upper Extremity (UE) consists of an item bank of 121 items that assesses physical function regardless of the health condition present that can be administered as a computer adaptive test (CAT) or through the use of short forms. The Physical Function scale scores transformed to a T-score in which a score of 50 represents the US population average with a standard deviation of 10 indicating the population standard deviation.
Time Frame
3 months after randomization
Title
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE)
Description
The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Scale - Upper Extremity (UE) consists of an item bank of 121 items that assesses physical function regardless of the health condition present that can be administered as a computer adaptive test (CAT) or through the use of short forms. The Physical Function scale scores transformed to a T-score in which a score of 50 represents the US population average with a standard deviation of 10 indicating the population standard deviation.
Time Frame
6 months after randomization
Title
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE)
Description
The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Scale - Upper Extremity (UE) consists of an item bank of 121 items that assesses physical function regardless of the health condition present that can be administered as a computer adaptive test (CAT) or through the use of short forms. The Physical Function scale scores transformed to a T-score in which a score of 50 represents the US population average with a standard deviation of 10 indicating the population standard deviation.
Time Frame
12 months after randomization
Title
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE)
Description
The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Scale - Upper Extremity (UE) consists of an item bank of 121 items that assesses physical function regardless of the health condition present that can be administered as a computer adaptive test (CAT) or through the use of short forms. The Physical Function scale scores transformed to a T-score in which a score of 50 represents the US population average with a standard deviation of 10 indicating the population standard deviation.
Time Frame
24 months after randomization
Title
Patient-Reported Outcome Measurement Information System (PROMIS) Global-10
Description
The PROMIS-10 Global Health also measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. It includes physical and mental health component scores that can be transformed to t score distributions with a mean of 50 and standard deviation of 10. A higher score indicates better health.
Time Frame
3 months after surgery
Title
Patient-Reported Outcome Measurement Information System (PROMIS) Global-10
Description
The PROMIS-10 Global Health also measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. It includes physical and mental health component scores that can be transformed to t score distributions with a mean of 50 and standard deviation of 10. A higher score indicates better health.
Time Frame
6 months after surgery
Title
Patient-Reported Outcome Measurement Information System (PROMIS) Global-10
Description
The PROMIS Global-10 is a 10-item patient reported global measure of physical and emotional health. The PROMIS-10 Global Health also measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. It includes physical and mental health component scores that can be transformed to t score distributions with a mean of 50 and standard deviation of 10. A higher score indicates better health.
Time Frame
12 months after surgery
Title
Patient-Reported Outcome Measurement Information System (PROMIS) Global-10
Description
The PROMIS Global-10 is a 10-item patient reported global measure of physical and emotional health. The PROMIS-10 Global Health also measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. It includes physical and mental health component scores that can be transformed to t score distributions with a mean of 50 and standard deviation of 10. A higher score indicates better health.
Time Frame
24 months after surgery
Title
Tampa Scale for Kinesiophobia-11 (TSK-11)
Description
The Tampa Scale for Kinesiophobia-11 quantifies fear of re-injury due to movement and physical activity. Items are scored from 1 (strongly disagree) to 4 (strongly agree). Total TSK-11 scores range from 11 - 44, with higher scores indicating greater fear of pain, movement, and injury.
Time Frame
3 months after surgery
Title
Tampa Scale for Kinesiophobia-11 (TSK-11)
Description
The Tampa Scale for Kinesiophobia-11 quantifies fear of re-injury due to movement and physical activity. Items are scored from 1 (strongly disagree) to 4 (strongly agree). Total TSK-11 scores range from 11 - 44, with higher scores indicating greater fear of pain, movement, and injury.
Time Frame
6 months after surgery
Title
Tampa Scale for Kinesiophobia-11 (TSK-11)
Description
The Tampa Scale for Kinesiophobia-11 quantifies fear of re-injury due to movement and physical activity. Items are scored from 1 (strongly disagree) to 4 (strongly agree). Total TSK-11 scores range from 11 - 44, with higher scores indicating greater fear of pain, movement, and injury.
Time Frame
12 months after surgery
Title
Tampa Scale for Kinesiophobia-11 (TSK-11)
Description
The Tampa Scale for Kinesiophobia-11 quantifies fear of re-injury due to movement and physical activity. Items are scored from 1 (strongly disagree) to 4 (strongly agree). Total TSK-11 scores range from 11 - 44, with higher scores indicating greater fear of pain, movement, and injury.
Time Frame
24 months after surgery
Title
Brief Resilience Scale
Description
The Brief Resilience Scale is a 6-item questionnaire that measures an individual's ability to recover from an ongoing health related stress. It uses a 5-point Likert scale that ranges from "strongly disagree" to "strongly agree." Totally, the individual responses creates a range of possible scores from 6 - 30. The total score is then divided by the total number of questions answered for the final score. The scores range from 1 to 5, where higher scores indicate positive resilience capabilities.
Time Frame
3 months after randomization
Title
Brief Resilience Scale
Description
The Brief Resilience Scale is a 6-item questionnaire that measures an individual's ability to recover from an ongoing health related stress. It uses a 5-point Likert scale that ranges from "strongly disagree" to "strongly agree." Totally, the individual responses creates a range of possible scores from 6 - 30. The total score is then divided by the total number of questions answered for the final score. The scores range from 1 to 5, where higher scores indicate positive resilience capabilities.
Time Frame
6 months after randomization
Title
Brief Resilience Scale
Description
The Brief Resilience Scale is a 6-item questionnaire that measures an individual's ability to recover from an ongoing health related stress. It uses a 5-point Likert scale that ranges from "strongly disagree" to "strongly agree." Totally, the individual responses creates a range of possible scores from 6 - 30. The total score is then divided by the total number of questions answered for the final score. The scores range from 1 to 5, where higher scores indicate positive resilience capabilities.
Time Frame
12 months after randomization
Title
Brief Resilience Scale
Description
The Brief Resilience Scale is a 6-item questionnaire that measures an individual's ability to recover from an ongoing health related stress. It uses a 5-point Likert scale that ranges from "strongly disagree" to "strongly agree." Totally, the individual responses creates a range of possible scores from 6 - 30. The total score is then divided by the total number of questions answered for the final score. The scores range from 1 to 5, where higher scores indicate positive resilience capabilities.
Time Frame
24 months after randomization
Title
Patient Acceptable Symptom State (PASS)
Description
The Patient Acceptable Symptom State is assessed by asking the participant the question: Taking into account all the activity you have during your daily life, your level of pain and also activity limitations and participation restrictions, do you consider the current state of your shoulder satisfactory?" The PSS question is answered "Yes" or "No". A response of "Yes" indicates that the individual is satisfied with his/her current symptom state. The PASS question has show to have sufficient rest re-test reliability in patients after orthopaedic surgery, with a reported kappa coefficient of 0.78.
Time Frame
3 months after randomization
Title
Patient Acceptable Symptom State (PASS)
Description
The Patient Acceptable Symptom State is assessed by asking the participant the question: Taking into account all the activity you have during your daily life, your level of pain and also activity limitations and participation restrictions, do you consider the current state of your shoulder satisfactory?" The PSS question is answered "Yes" or "No". A response of "Yes" indicates that the individual is satisfied with his/her current symptom state. The PASS question has show to have sufficient rest re-test reliability in patients after orthopaedic surgery, with a reported kappa coefficient of 0.78.
Time Frame
6 months after randomization
Title
Patient Acceptable Symptom State (PASS)
Description
The Patient Acceptable Symptom State is assessed by asking the participant the question: Taking into account all the activity you have during your daily life, your level of pain and also activity limitations and participation restrictions, do you consider the current state of your shoulder satisfactory?" The PSS question is answered "Yes" or "No". A response of "Yes" indicates that the individual is satisfied with his/her current symptom state. The PASS question has show to have sufficient rest re-test reliability in patients after orthopaedic surgery, with a reported kappa coefficient of 0.78.
Time Frame
12 months after randomization
Title
Patient Acceptable Symptom State (PASS)
Description
The Patient Acceptable Symptom State is assessed by asking the participant the question: Taking into account all the activity you have during your daily life, your level of pain and also activity limitations and participation restrictions, do you consider the current state of your shoulder satisfactory?" The PSS question is answered "Yes" or "No". A response of "Yes" indicates that the individual is satisfied with his/her current symptom state. The PASS question has show to have sufficient rest re-test reliability in patients after orthopaedic surgery, with a reported kappa coefficient of 0.78.
Time Frame
24 months after randomization
Title
Functional Comorbidity Index
Description
The Functional Comorbidity Index (FCI) is an 18-item measure assessing the presence of medical comorbidities. The FCI is a self-administered report of medical comorbidities associated with physicla function. Using medical comorbidities is an important factor in creating risk adjustment models for orthopaedic trauma. The FCI was found to demonstrate a stronger association with the SF-36 physical function subscale (R2 = 0.29) than the Charleston (R2 = 0.18) and Kaplan-Feinstein (R2 = 0.17) indices. When individuals were classified into high and low function based ont he SF-36, the FCI correctly classified 77% of the cases.
Time Frame
3 months after surgery
Title
Functional Comorbidity Index
Description
The Functional Comorbidity Index (FCI) is an 18-item measure assessing the presence of medical comorbidities. The FCI is a self-administered report of medical comorbidities associated with physicla function. Using medical comorbidities is an important factor in creating risk adjustment models for orthopaedic trauma. The FCI was found to demonstrate a stronger association with the SF-36 physical function subscale (R2 = 0.29) than the Charleston (R2 = 0.18) and Kaplan-Feinstein (R2 = 0.17) indices. When individuals were classified into high and low function based ont he SF-36, the FCI correctly classified 77% of the cases.
Time Frame
6 months after surgery
Title
Functional Comorbidity Index
Description
The Functional Comorbidity Index (FCI) is an 18-item measure assessing the presence of medical comorbidities. The FCI is a self-administered report of medical comorbidities associated with physicla function. Using medical comorbidities is an important factor in creating risk adjustment models for orthopaedic trauma. The FCI was found to demonstrate a stronger association with the SF-36 physical function subscale (R2 = 0.29) than the Charleston (R2 = 0.18) and Kaplan-Feinstein (R2 = 0.17) indices. When individuals were classified into high and low function based ont he SF-36, the FCI correctly classified 77% of the cases.
Time Frame
12 months after surgery
Title
Functional Comorbidity Index
Description
The Functional Comorbidity Index (FCI) is an 18-item measure assessing the presence of medical comorbidities. The FCI is a self-administered report of medical comorbidities associated with physicla function. Using medical comorbidities is an important factor in creating risk adjustment models for orthopaedic trauma. The FCI was found to demonstrate a stronger association with the SF-36 physical function subscale (R2 = 0.29) than the Charleston (R2 = 0.18) and Kaplan-Feinstein (R2 = 0.17) indices. When individuals were classified into high and low function based ont he SF-36, the FCI correctly classified 77% of the cases.
Time Frame
24 months after surgery
Title
Passive Range of Motion of the Shoulder
Description
The range of passive elevation and external rotation and internal rotation of both shoulders will be measured with a goniometer. Range of motion measurements to the nearest 1 degree will be made with a large clear plastic gonionometer marked in 1 degree increments.
Time Frame
3 months after surgery
Title
Passive Range of Motion of the Shoulder
Description
The range of passive elevation and external rotation and internal rotation of both shoulders will be measured with a goniometer. Range of motion measurements to the nearest 1 degree will be made with a large clear plastic gonionometer marked in 1 degree increments.
Time Frame
4 months after surgery
Title
Passive Range of Motion of the Shoulder
Description
The range of passive elevation and external rotation and internal rotation of both shoulders will be measured with a goniometer. Range of motion measurements to the nearest 1 degree will be made with a large clear plastic gonionometer marked in 1 degree increments.
Time Frame
6 months after surgery
Title
Isometric Muscle Strength of the Shoulder
Description
Isometric muscle strength of shoulder will be assessed in 5 positions (external rotation at 0 degrees, external rotation at 90 degrees, internal rotation at 0 degrees, internal rotation at 90 degrees and scapular plane abduction at 90 degrees) using a hand-held dynamometer.
Time Frame
3 months after surgery
Title
Isometric Muscle Strength of the Shoulder
Description
Isometric muscle strength of shoulder will be assessed in 5 positions (external rotation at 0 degrees, external rotation at 90 degrees, internal rotation at 0 degrees, internal rotation at 90 degrees and scapular plane abduction at 90 degrees) using a hand-held dynamometer.
Time Frame
4 months after surgery
Title
Isometric Muscle Strength of the Shoulder
Description
Isometric muscle strength of shoulder will be assessed in 5 positions (external rotation at 0 degrees, external rotation at 90 degrees, internal rotation at 0 degrees, internal rotation at 90 degrees and scapular plane abduction at 90 degrees) using a hand-held dynamometer.
Time Frame
6 months after surgery
Title
Performance on Functional Tests of the Upper Extremity - Closed Kinetic Chain Upper Extremity Stability test
Description
Closed Kinetic Chain Upper Extremity Stability test: Participants take a full pushup position. They alternatingly touch each hand with the other, as fast as they can, for 15 seconds. Number of touches in 15 seconds.Three trials will be performed and the average value will be calculated.
Time Frame
4 months after surgery
Title
Performance on Functional Tests of the Upper Extremity - Closed Kinetic Chain Upper Extremity Stability test
Description
Closed Kinetic Chain Upper Extremity Stability test: Participants take a full pushup position. They alternatingly touch each hand with the other, as fast as they can, for 15 seconds. Number of touches in 15 seconds.Three trials will be performed and the average value will be calculated.
Time Frame
6 months after surgery
Title
Performance on Functional Tests of the Upper Extremity - Unilateral Seated Shot-Put test
Description
Unilateral Seated Shot-Put test: Distance of shot-put recorded in centimeters. The distance a 2.72 kg medicine ball is pushed, from block against participant's back to the site of ball contact on the floor. The participant will complete three trials for each arm, with the average of 3 trials being used for analysis.
Time Frame
4 months after surgery
Title
Performance on Functional Tests of the Upper Extremity - Unilateral Seated Shot-Put test
Description
Unilateral Seated Shot-Put test: Distance of shot-put recorded in centimeters. The distance a 2.72 kg medicine ball is pushed, from block against participant's back to the site of ball contact on the floor. The participant will complete three trials for each arm, with the average of 3 trials being used for analysis.
Time Frame
6 months after surgery
Title
Performance on Functional Tests of the Upper Extremity - Push-ups
Description
Push-ups: Number of push-ups that can be completed in 60 seconds is counted. The test is performed twice and the higher number of repetitions achieved is recorded.
Time Frame
4 months after surgery
Title
Performance on Functional Tests of the Upper Extremity - Push-ups
Description
Push-ups: Number of push-ups that can be completed in 60 seconds is counted. The test is performed twice and the higher number of repetitions achieved is recorded.
Time Frame
6 months after surgery
Title
Performance on Functional Tests of the Upper Extremity - Weighted Overhead Ball Throw
Description
Weighted Overhead Ball Throw: Participant will throw a 9.07 kg medicine ball overhead, with both hands. Distance of throw recorded in centimeters. Three trials will be performed.
Time Frame
4 months after surgery
Title
Performance on Functional Tests of the Upper Extremity - Weighted Overhead Ball Throw
Description
Weighted Overhead Ball Throw: Participant will throw a 9.07 kg medicine ball overhead, with both hands. Distance of throw recorded in centimeters. Three trials will be performed.
Time Frame
6 months after surgery
Title
Performance on Functional Tests of the Upper Extremity - Upper Quarter Y-Balance test
Description
Upper Quarter Y-Balance test: Maximum reach in 3 directions (medial, inferolateral, and superolateral), recorded in centimeters. Subjects stand in a three-point plank position with the tested shoulder perpendicular to the hand and the feet shoulder-width apart. Three test trials will be performed on each side with 30 seconds of rest in between each trial. A normalized composite score is the mean of the average distance in all three reach directions.
Time Frame
4 months after surgery
Title
Performance on Functional Tests of the Upper Extremity - Upper Quarter Y-Balance test
Description
Upper Quarter Y-Balance test: Maximum reach in 3 directions (medial, inferolateral, and superolateral), recorded in centimeters. Subjects stand in a three-point plank position with the tested shoulder perpendicular to the hand and the feet shoulder-width apart. Three test trials will be performed on each side with 30 seconds of rest in between each trial. A normalized composite score is the mean of the average distance in all three reach directions.
Time Frame
6 months after surgery
Title
Clinical Measures after Surgical Stabilization - Pain
Description
Pain: Pain intensity will be recorded utilizing an 11-point numeric pain scale (NPRS) that ranges from 0 (no pain) to 10 (worst imaginable pain). Th current, least, and worst pain intensity in the past 24 hours will be recorded and summed to create a pain score that ranges from 0 to 30.
Time Frame
2 weeks after surgery
Title
Clinical Measures after Surgical Stabilization - Pain
Description
Pain: Pain intensity will be recorded utilizing an 11-point numeric pain scale (NPRS) that ranges from 0 (no pain) to 10 (worst imaginable pain). Th current, least, and worst pain intensity in the past 24 hours will be recorded and summed to create a pain score that ranges from 0 to 30.
Time Frame
6 weeks +/- 2 weeks after surgery
Title
Clinical Measures after Surgical Stabilization - Pain
Description
Pain: Pain intensity will be recorded utilizing an 11-point numeric pain scale (NPRS) that ranges from 0 (no pain) to 10 (worst imaginable pain). Th current, least, and worst pain intensity in the past 24 hours will be recorded and summed to create a pain score that ranges from 0 to 30.
Time Frame
3 months after surgery
Title
Clinical Measures after Surgical Stabilization - Pain
Description
Pain: Pain intensity will be recorded utilizing an 11-point numeric pain scale (NPRS) that ranges from 0 (no pain) to 10 (worst imaginable pain). Th current, least, and worst pain intensity in the past 24 hours will be recorded and summed to create a pain score that ranges from 0 to 30.
Time Frame
5 months +/- month after surgery
Title
Clinical Measures after Surgical Stabilization - Pain
Description
Pain: Pain intensity will be recorded utilizing an 11-point numeric pain scale (NPRS) that ranges from 0 (no pain) to 10 (worst imaginable pain). Th current, least, and worst pain intensity in the past 24 hours will be recorded and summed to create a pain score that ranges from 0 to 30.
Time Frame
12 months after surgery
Title
Clinical Measures after Surgical Stabilization - Pain Medication Usage
Description
Pain Medication Usage: At follow-up visit, current narcotic pain medication usage is recorded. Usage (Yes/No): If "Yes," name of medication, dose, frequency of use, and indication is noted.
Time Frame
2 weeks after surgery
Title
Clinical Measures after Surgical Stabilization - Pain Medication Usage
Description
Pain Medication Usage: At follow-up visit, current narcotic pain medication usage is recorded. Usage (Yes/No): If "Yes," name of medication, dose, frequency of use, and indication is noted.
Time Frame
6 weeks +/- 2 weeks after surgery
Title
Clinical Measures after Surgical Stabilization - Pain Medication Usage
Description
Pain Medication Usage: At follow-up visit, current narcotic pain medication usage is recorded. Usage (Yes/No): If "Yes," name of medication, dose, frequency of use, and indication is noted.
Time Frame
3 months after surgery
Title
Clinical Measures after Surgical Stabilization - Pain Medication Usage
Description
Pain Medication Usage: At follow-up visit, current narcotic pain medication usage is recorded. Usage (Yes/No): If "Yes," name of medication, dose, frequency of use, and indication is noted.
Time Frame
5 months +/- month after surgery
Title
Clinical Measures after Surgical Stabilization - Pain Medication Usage
Description
Pain Medication Usage: At follow-up visit, current narcotic pain medication usage is recorded. Usage (Yes/No): If "Yes," name of medication, dose, frequency of use, and indication is noted.
Time Frame
12 months after surgery
Title
Clinical Measures after Surgical Stabilization - Use of Post-op Brace
Description
Use of Post-op Brace: Usage (Yes/No): If "No," date brace was discontinued will be recorded.
Time Frame
2 weeks after surgery
Title
Clinical Measures after Surgical Stabilization - Use of Post-op Brace
Description
Use of Post-op Brace: Usage (Yes/No): If "No," date brace was discontinued will be recorded.
Time Frame
6 weeks +/- 2 weeks after surgery
Title
Clinical Measures after Surgical Stabilization - Use of Post-op Brace
Description
Use of Post-op Brace: Usage (Yes/No): If "No," date brace was discontinued will be recorded.
Time Frame
3 months after surgery
Title
Clinical Measures after Surgical Stabilization - Use of Post-op Brace
Description
Use of Post-op Brace: Usage (Yes/No): If "No," date brace was discontinued will be recorded.
Time Frame
5 months +/- month after surgery
Title
Clinical Measures after Surgical Stabilization - Use of Post-op Brace
Description
Use of Post-op Brace: Usage (Yes/No): If "No," date brace was discontinued will be recorded.
Time Frame
12 months after surgery
Title
Clinical Measures after Surgical Stabilization - Wound Status
Description
Wound Status: At follow-up visit, wound status recorded as healed, healing, draining, open, erythema or presence of a superficial wound infection.
Time Frame
2 weeks after surgery
Title
Clinical Measures after Surgical Stabilization - Wound Status
Description
Wound Status: At follow-up visit, wound status recorded as healed, healing, draining, open, erythema or presence of a superficial wound infection.
Time Frame
6 weeks +/- 2 weeks after surgery
Title
Clinical Measures after Surgical Stabilization - Wound Status
Description
Wound Status: At follow-up visit, wound status recorded as healed, healing, draining, open, erythema or presence of a superficial wound infection.
Time Frame
3 months after surgery
Title
Clinical Measures after Surgical Stabilization - Wound Status
Description
Wound Status: At follow-up visit, wound status recorded as healed, healing, draining, open, erythema or presence of a superficial wound infection.
Time Frame
5 months +/- month after surgery
Title
Clinical Measures after Surgical Stabilization - Wound Status
Description
Wound Status: At follow-up visit, wound status recorded as healed, healing, draining, open, erythema or presence of a superficial wound infection.
Time Frame
12 months after surgery
Title
Clinical Measures after Surgical Stabilization - Neurovascular status
Description
Neurovascular status: Assessment of neurovascular status will include assessment of pulses, sensation to pain, and distal motor function. Brachial pulses will be recorded as symmetrical, diminished, or absent. Sensation to pain will be recorded as normal, diminished or absent. Distal motor function of the wrist will be recorded as strong/symmetrical to the contralateral arm, diminished, or absent.
Time Frame
2 weeks after surgery
Title
Clinical Measures after Surgical Stabilization - Neurovascular status
Description
Neurovascular status: Assessment of neurovascular status will include assessment of pulses, sensation to pain, and distal motor function. Brachial pulses will be recorded as symmetrical, diminished, or absent. Sensation to pain will be recorded as normal, diminished or absent. Distal motor function of the wrist will be recorded as strong/symmetrical to the contralateral arm, diminished, or absent.
Time Frame
6 weeks +/- 2 weeks after surgery
Title
Clinical Measures after Surgical Stabilization - Neurovascular status
Description
Neurovascular status: Assessment of neurovascular status will include assessment of pulses, sensation to pain, and distal motor function. Brachial pulses will be recorded as symmetrical, diminished, or absent. Sensation to pain will be recorded as normal, diminished or absent. Distal motor function of the wrist will be recorded as strong/symmetrical to the contralateral arm, diminished, or absent.
Time Frame
3 months after surgery
Title
Clinical Measures after Surgical Stabilization - Neurovascular status
Description
Neurovascular status: Assessment of neurovascular status will include assessment of pulses, sensation to pain, and distal motor function. Brachial pulses will be recorded as symmetrical, diminished, or absent. Sensation to pain will be recorded as normal, diminished or absent. Distal motor function of the wrist will be recorded as strong/symmetrical to the contralateral arm, diminished, or absent.
Time Frame
5 months +/- month after surgery
Title
Clinical Measures after Surgical Stabilization - Neurovascular status
Description
Neurovascular status: Assessment of neurovascular status will include assessment of pulses, sensation to pain, and distal motor function. Brachial pulses will be recorded as symmetrical, diminished, or absent. Sensation to pain will be recorded as normal, diminished or absent. Distal motor function of the wrist will be recorded as strong/symmetrical to the contralateral arm, diminished, or absent.
Time Frame
12 months after surgery
Title
Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests
Description
Additional Diagnostic Tests: At follow-up visit, any additional diagnostic tests will be recorded. (Yes/No): If "Yes," the test, date and indication will be recorded.
Time Frame
2 weeks after surgery
Title
Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests
Description
Additional Diagnostic Tests: At follow-up visit, any additional diagnostic tests will be recorded. (Yes/No): If "Yes," the test, date and indication will be recorded.
Time Frame
3 months after surgery
Title
Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests
Description
Additional Diagnostic Tests: At follow-up visit, any additional diagnostic tests will be recorded. (Yes/No): If "Yes," the test, date and indication will be recorded.
Time Frame
5 months +/- month after surgery
Title
Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests
Description
Additional Diagnostic Tests: At follow-up visit, any additional diagnostic tests will be recorded. (Yes/No): If "Yes," the test, date and indication will be recorded
Time Frame
12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Civilians and military personnel ages 17 to 50 Traumatic anterior shoulder dislocation Associated subcritical bone loss between 10-20% less the glenoid width quantified by standard of care CT scan Exclusion Criteria: Chronic, non-traumatic multi-directional instability based on clinical exam. Concurrent shoulder injury (e.g. rotator cuff tears, motor nerve pathologies, osteoarthritis of a Samilson-Prieto grade >2). Prior instability or rotator cuff procedure on involved shoulder (including intra-articular soft tissue surgery). Humeral sided bone lesion (Hill-Sachs lesion) that is sufficiently large enough to render the lesion "off-track" even after a bony augmentation procedure would be performed. Neuromuscular and other movement control pathologies including seizures. Vascular injury associated with the shoulder trauma. Traumatic brain injury or any condition that would preclude the ability to comply with post-operative guidelines. Does not plan to return to pre-injury levels of work, sports or military duty.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Popchak, PhD, PT
Phone
(412) 383-6627
Email
ajp64@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Dickens, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Popchak, PhD, PT
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan Dickens, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James J Irrgang, PhD, PT, ATC
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Chair
Facility Information:
Facility Name
Naval Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucas McDonald, MD
Email
lucas.s.mcdonald@gmail.com
First Name & Middle Initial & Last Name & Degree
Lucas McDonald, MD
Facility Name
Evans Army Community Hospital
City
Fort Carson
State/Province
Colorado
ZIP/Postal Code
80913
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Tennent, MD
Email
davidjtennent@gmail.com
First Name & Middle Initial & Last Name & Degree
David Tennent, MD
Facility Name
Steadman Clinic
City
Vail
State/Province
Colorado
ZIP/Postal Code
81657
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Provencher, MD
Email
mprovencher@thesteadmanclinic.com
First Name & Middle Initial & Last Name & Degree
Matthew Provencher, MD
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cory Edgar, MD, PhD
First Name & Middle Initial & Last Name & Degree
Cory Edgar, MD, PhD
Facility Name
US Naval Health Clinic (Academy)
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21402
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lance LeClere, MD
Email
lancend15@gmail.com
First Name & Middle Initial & Last Name & Degree
Lance LeClere, MD
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20089
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Kilcoyne, MD
First Name & Middle Initial & Last Name & Degree
Kelly Kilcoyne, MD
Facility Name
Naval Medical Center Camp Lejeune
City
Camp Lejeune
State/Province
North Carolina
ZIP/Postal Code
28547
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyle Nappo, MD
Email
kyle.nappo@gmail.com
First Name & Middle Initial & Last Name & Degree
Kyle Nappo, MD
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Creighton, MD
First Name & Middle Initial & Last Name & Degree
Alex Creighton, MD
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Dickens, MD
Email
jonathan.dickens@duke.edu
First Name & Middle Initial & Last Name & Degree
Jonathan Dickens, MD
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Waterman, MD
Email
bwaterma@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Brian Waterman, MD
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert Lin, MD
Email
alin2@upmc.edu
First Name & Middle Initial & Last Name & Degree
Albert Lin, MD
Facility Name
Rhode Island Hospital- University Orthopedics
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brett Owens, MD
Email
owensbrett@gmail.com
First Name & Middle Initial & Last Name & Degree
Brett Owens, MD
Facility Name
San Antonio Military Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Sheean, MD
Email
ajsheean@gmail.com
First Name & Middle Initial & Last Name & Degree
Andrew Sheean, MD
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22904
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Brockmeier, MD
Email
SFB2E@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Stephen Brockmeier, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A public-use version of the dataset will be constructed by the Data Coordinating Center (DCC) with contents to be determined jointly by the study PIs and the DCC Director. Copies of the public-use version of the dataset will be housed at the DCC on a secure server along with suitable documentation of this dataset. The public-use version of the dataset will be exported in one or more files in simple, widely-accessible formats, e.g., .xls, .csv, and/or Statistical Analysis Software (SAS) datasets. Documentation will be in .pdf files.
IPD Sharing Time Frame
The public-use version of the dataset will be made available 2 years after the study's main paper is published.
IPD Sharing Access Criteria
Outside investigators wishing to conduct analyses using the data will submit a request with objectives, methods, and analysis plan to the PI and the Director of the DCC. Once the request is approved, the public-use version of the dataset, with documentation, will be sent by secure email using e-mail, ftp, or other mutually agreeable transmission method.

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Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial

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