Back to resultsOnlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty
Primary Purpose
Arthritis Shoulder, Rotator Cuff Injuries
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tornier Ascend Flex stem
Tornier Perform Stem Reverse+
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis Shoulder focused on measuring shoulder function, shoulder pain, shoulder range of motion
Eligibility Criteria
Inclusion Criteria:
Patients undergoing primary reverse total shoulder arthroplasty with the following components:
- Onlay group: Ascend Flex stem, Perform Reversed standard +3 lateralized 25mm baseplate with standard 36 mm glenosphere
- Inlay group: Perform Stem Reverse, Perform Reversed +3 lateralized 25mm baseplate with standard 36mm glenosphere
- Diagnosis of cuff tear arthropathy, massive cuff tear, or primary osteoarthritis with cuff tear
- Negative external rotation lag sign, ability to externally rotate beyond neutral
- Age 18 years or older
Exclusion Criteria:
- Revision arthroplasty
- Prior open shoulder surgery
- Concomitant tendon transfer (Latissimus Dorsi, Pectoralis Tendon, Lower Trapezius)
- Diagnosis of rheumatoid arthritis, infection, acute trauma or instability
- Patients not undergoing a standardized physical therapy protocol
- Patient anatomy does not accommodate the study implants per surgeon discretion (e.g. excessive bone loss)
- Pregnant, patient-reported
- Minors (under 18 years of age)
- Cognitively impaired based on a diagnosis of dementia, psychiatric disorder, or any cognitive deficit that will not allow for proper informed consent or answering of study questionnaires
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Onlay Component-Tornier Ascend Flex stem
Inlay Component-Tornier Perform Stem Reverse+
Arm Description
Reverse Total Shoulder Arthroplasty using onlay component (tray placed at top of humerus)
Reverse Total Shoulder Arthroplasty using inlay component (tray placed in humerus)
Outcomes
Primary Outcome Measures
Active external rotation, 2 years
Range of motion of repaired shoulder, active external rotation. Measured with goniometer in degrees.
Secondary Outcome Measures
Active external rotation, 3 months
Range of motion of repaired shoulder, active external rotation. Measured with goniometer in degrees.
Active external rotation, 1 year
Range of motion of repaired shoulder, active external rotation. Measured with goniometer in degrees.
Strength during active external rotation, 3 months
Strength measurement during active external rotation of repaired shoulder. Measured with dynamometer in pounds.
Strength during active external rotation, 1 year
Strength measurement during active external rotation of repaired shoulder. Measured with dynamometer in pounds.
Strength during active external rotation, 2 years
Strength measurement during active external rotation of repaired shoulder. Measured with dynamometer in pounds
Active forward elevation, 3 months
Range of motion of repaired shoulder, active forward elevation. Measured with goniometer in degrees.
Active forward elevation, 1 year
Range of motion of repaired shoulder, active forward elevation. Measured with goniometer in degrees.
Active forward elevation, 2 years
Range of motion of repaired shoulder, active forward elevation. Measured with goniometer in degrees.
Strength during active forward elevation, 3 months
Strength measured during active forward elevation of repaired shoulder. Measured with dynamometer in pounds.
Strength during active forward elevation, 1 year
Strength measured during active forward elevation of repaired shoulder. Measured with dynamometer in pounds.
Strength during active forward elevation, 2 years
Strength measured during active forward elevation of repaired shoulder. Measured with dynamometer in pounds.
Abduction, 3 months
Range of motion of repaired shoulder, abduction. Measured with goniometer in degrees.
Abduction, 1 year
Range of motion of repaired shoulder, abduction. Measured with goniometer in degrees.
Abduction, 2 years
Range of motion of repaired shoulder, abduction. Measured with goniometer in degrees.
Strength during abduction, 3 months
Strength measured during abduction of repaired shoulder. Measured with dynamometer in pounds.
Strength during abduction, 1 year
Strength measured during abduction of repaired shoulder. Measured with dynamometer in pounds.
Strength during abduction, 2 years
Strength measured during abduction of repaired shoulder. Measured with dynamometer in pounds.
Internal rotation, 3 months
Range of motion of repaired shoulder, internal rotation. Measured with goniometer in degrees.
Internal rotation, 1 year
Range of motion of repaired shoulder, internal rotation. Measured with goniometer in degrees.
Internal rotation, 2 years
Range of motion of repaired shoulder, internal rotation. Measured with goniometer in degrees.
Strength during Internal rotation, 3 months
Strength measured during internal rotation of repaired shoulder. Measured with dynamometer in pounds.
Strength during Internal rotation, 1 year
Strength measured during internal rotation of repaired shoulder. Measured with dynamometer in pounds.
Strength during Internal rotation, 2 years
Strength measured during internal rotation of repaired shoulder. Measured with dynamometer in pounds.
External rotation lag sign test, 3 months
Number of patients with positive external rotation lag sign test. The test is performed with the elbow passively flexed and repaired shoulder abducted 90 degrees by the examiner. Next, the examiner passively takes the patient's shoulder into a position of maximal external rotation. The patient is then instructed to hold that position. A positive test is if the patient cannot maintain the position and the shoulder rotates internally. A positive test indicates supraspinatus and infraspinatus tendon weakness.
External rotation lag sign test, 1 year
Number of patients with positive external rotation lag sign test. The test is performed with the elbow passively flexed and repaired shoulder abducted 90 degrees by the examiner. Next, the examiner passively takes the patient's shoulder into a position of maximal external rotation. The patient is then instructed to hold that position. A positive test is if the patient cannot maintain the position and the shoulder rotates internally. A positive test indicates supraspinatus and infraspinatus tendon weakness.
External rotation lag sign test, 2 years
Number of patients with positive external rotation lag sign test. The test is performed with the elbow passively flexed and repaired shoulder abducted 90 degrees by the examiner. Next, the examiner passively takes the patient's shoulder into a position of maximal external rotation. The patient is then instructed to hold that position. A positive test is if the patient cannot maintain the position and the shoulder rotates internally A positive test indicates supraspinatus and infraspinatus tendon weakness.
Drop arm test, 3 months
Number of patients with positive drop arm test of repaired shoulder, performed by passively abducting the patient's shoulder and observing for arm drop as the patient slowly lowers the arm to the waist. A positive test indicates supraspinatus dysfunction.
Drop arm test, 1 year
Number of patients with positive drop arm test of repaired shoulder, performed by passively abducting the patient's shoulder and observing for arm drop as the patient slowly lowers the arm to the waist. A positive test indicates supraspinatus dysfunction.
Drop arm test, 2 years
Number of patients with positive drop arm test of repaired shoulder, performed by passively abducting the patient's shoulder and observing for arm drop as the patient slowly lowers the arm to the waist. A positive test indicates supraspinatus dysfunction.
Lift off test, 3 months
Number of patients with positive lift off test. The test is performed by the patient performing internal rotation of repaired shoulder, by lifting the hand off the back while the examiner places pressure on the hand. The test is considered to be positive if the patient cannot resist, lift the hand off the back or if the patient compensates by extending the elbow and shoulder. A positive test indicates subscapularis weakness.
Lift off test, 1 year
Number of patients with positive lift off test. The test is performed by the patient performing internal rotation of repaired shoulder, by lifting the hand off the back while the examiner places pressure on the hand. The test is considered to be positive if the patient cannot resist, lift the hand off the back or if the patient compensates by extending the elbow and shoulder. A positive test indicates subscapularis weakness.
Lift off test, 2 years
Number of patients with positive lift off test. The test is performed by the patient performing internal rotation of repaired shoulder, by lifting the hand off the back while the examiner places pressure on the hand. The test is considered to be positive if the patient cannot resist, lift the hand off the back or if the patient compensates by extending the elbow and shoulder. A positive test indicates subscapularis weakness.
Belly press test, 3 months
Number of patients with positive belly press test. The patient is asked to press the palm of the hand against the abdomen and bring the elbow forward. The test is positive if the patient is unable to maintain maximal internal rotation of repaired shoulder, demonstrates weakness or the elbow deviates posteriorly. A positive test indicates subscapularis muscle dysfunction.
Belly press test, 1 year
Number of patients with positive belly press test. The patient is asked to press the palm of the hand against the abdomen and bring the elbow forward. The test is positive if the patient is unable to maintain maximal internal rotation of repaired shoulder, demonstrates weakness or the elbow deviates posteriorly. A positive test indicates subscapularis muscle dysfunction.
Belly press test, 2 years
Number of patients with positive belly press test. The patient is asked to press the palm of the hand against the abdomen and bring the elbow forward. The test is positive if the patient is unable to maintain maximal internal rotation of repaired shoulder, demonstrates weakness or the elbow deviates posteriorly. A positive test indicates subscapularis muscle dysfunction.
Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 3 months
Patients will complete a questionnaire of the repaired shoulder function and pain, with 100 maximum points. A score of 0 indicates no impairment (best outcome), and 100 indicates maximum impairment (worst outcome).
Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 1 year
Patients will complete a questionnaire of the repaired shoulder function and pain, with 100 maximum points. A score of 0 indicates no impairment (best outcome), and 100 indicates maximum impairment (worst outcome).
Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 2 years
Patients will complete a questionnaire of shoulder function and pain, with 100 maximum points. A score of 0 indicates no impairment (best outcome), and 100 indicates maximum impairment (worst outcome).
Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 3 months
Patients complete a questionnaire comprising 4 domains of: physical symptoms; sports, recreation and work; lifestyle; and emotions. Each question is answered using a visual analog scale with a possible score ranging from 0 to 100. There are 19 questions, and the total score ranges from 0 to 1900. A score of 1900 signifies that the patient has an extreme decrease in the shoulder-related quality of life (worst outcome), whereas a score of 0 signifies that the patient has no decrease in shoulder-related quality of life (best outcome).
Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 1 year
Patients complete a questionnaire comprising 4 domains of: physical symptoms; sports, recreation and work; lifestyle; and emotions. Each question is answered using a visual analog scale with a possible score ranging from 0 to 100. There are 19 questions, and the total score ranges from 0 to 1900. A score of 1900 signifies that the patient has an extreme decrease in the shoulder-related quality of life (worst outcome), whereas a score of 0 signifies that the patient has no decrease in shoulder-related quality of life (best outcome).
Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 2 years
Patients complete a questionnaire comprising 4 domains of: physical symptoms; sports, recreation and work; lifestyle; and emotions. Each question is answered using a visual analog scale with a possible score ranging from 0 to 100. There are 19 questions, and the total score ranges from 0 to 1900. A score of 1900 signifies that the patient has an extreme decrease in the shoulder-related quality of life (worst outcome), whereas a score of 0 signifies that the patient has no decrease in shoulder-related quality of life (best outcome).
Global Health, by Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) score, 3 months
Patients will complete the PROMIS-10 assessment of global health for the previous 7 days, a 10-question assessment where each statement is scored from 1 (poor health) to 5 (excellent health) on a Likert scale. A total score is summed from the 10 questions, resulting in a minimum of 10 and maximum of 50 points. Higher scores indicate better health (best outcome).
Global Health, by Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) score, 1 year
Patients will complete the PROMIS-10 assessment of global health for the previous 7 days, a 10-question assessment where each statement is scored from 1 (poor health) to 5 (excellent health) on a Likert scale. A total score is summed from the 10 questions, resulting in a minimum of 10 and maximum of 50 points. Higher scores indicate better health (best outcome).
Global Health, by Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) score, 2 years
Patients will complete the PROMIS-10 assessment of global health for the previous 7 days, a 10-question assessment where each statement is scored from 1 (poor health) to 5 (excellent health) on a Likert scale. A total score is summed from the 10 questions, resulting in a minimum of 10 and maximum of 50 points. Higher scores indicate better health (best outcome).
Visual Analog Scale measure of pain, 3 months
Shoulder-related pain reported by the patient for the repaired shoulder as a score on a visual analog scale from 0 to 10, where 0=no pain at all (best outcome), and 10=pain as bad as it can be (worst outcome).
Visual Analog Scale measure of pain, 1 year
Shoulder-related pain reported by the patient for the repaired shoulder as a score on a visual analog scale from 0 to 10, where 0=no pain at all (best outcome), and 10=pain as bad as it can be (worst outcome).
Visual Analog Scale measure of pain, 2 years
Shoulder-related pain reported by the patient for the repaired shoulder as a score on a visual analog scale from 0 to 10, where 0=no pain at all (best outcome), and 10=pain as bad as it can be (worst outcome).
Scapular notching, 3 months
Scapular notching of the repaired shoulder. Measured from radiographic evaluation and scored on the Sirveaux classification scale as Grade 1-4, where grade 1 indicates a defect that only involves the inferior pillar of the scapular neck (best outcome). In Grade 2, the notch contacts the lower screw. In Grade 3, erosion of the bone extends over the lower screw. In Grade 4, the notch extends under the baseplate (worst outcome).
Scapular notching, 1 year
Scapular notching of the repaired shoulder. Measured from radiographic evaluation and scored on the Sirveaux classification scale as Grade 1-4, where grade 1 indicates a defect that only involves the inferior pillar of the scapular neck (best outcome). In Grade 2, the notch contacts the lower screw. In Grade 3, erosion of the bone extends over the lower screw. In Grade 4, the notch extends under the baseplate (worst outcome).
Scapular notching, 2 years
Scapular notching of the repaired shoulder. Measured from radiographic evaluation and scored on the Sirveaux classification scale as Grade 1-4, where grade 1 indicates a defect that only involves the inferior pillar of the scapular neck (best outcome). In Grade 2, the notch contacts the lower screw. In Grade 3, erosion of the bone extends over the lower screw. In Grade 4, the notch extends under the baseplate (worst outcome).
Reoperation
Number of patients requiring reoperation of the same shoulder within 2 years.
Study-related adverse events
All adverse events determined by the PI to be probably or definitely related to study interventions (surgery or device).
Full Information
NCT ID
NCT05297305
First Posted
March 16, 2022
Last Updated
September 21, 2023
Sponsor
William Beaumont Hospitals
Collaborators
Stryker Nordic
1. Study Identification
Unique Protocol Identification Number
NCT05297305
Brief Title
Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty
Official Title
Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty: A Prospective, Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
William Beaumont Hospitals
Collaborators
Stryker Nordic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to compare the effect of different ways to place the component that goes at the top of the humerus (upper arm) in reverse total shoulder replacement. Some surgeons place the humeral tray component sitting on the bone while others place it in the bone. Changing the way that the humeral component is placed may change how much the arm can raise up or turn out/in after surgery for some patients. This study compares patients with inlay humeral component (tray sits in the upper arm bone) versus onlay humeral component (tray sits on top of the upper arm bone) to see if there are differences in range of motion or function after surgery.
Detailed Description
This study aims to determine if active external rotation two years postoperatively varies based on whether an inlay or onlay humeral component is used in reverse shoulder arthroplasty (RTSA). The study also aims to determine whether active forward elevation, abduction, scapular notching, and functional outcomes two years postoperatively vary based on whether an inlay or onlay humeral component is used in reverse shoulder arthroplasty. Patients undergoing primary RTSA by Dr. J. Michael Wiater, Dr. Brett Wiater, or Dr. Alexander Martusiewicz at Beaumont Health will be screened for eligibility. Following informed consent, participants will be randomised (1:1) to one of the following groups: 1) RTSA with inlay humeral component (Tornier Perform Stem Reverse+) or 2) RTSA with onlay humeral component (Tornier Ascend Flex stem). At baseline, participants will complete study questionnaires, receive a range-of-motion (ROM) exam, and standard of care x-rays and computed tomography (CT) scans. These evaluations will be repeated at 3 months, 12 months and 24 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis Shoulder, Rotator Cuff Injuries
Keywords
shoulder function, shoulder pain, shoulder range of motion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized double-blind trial of two active comparators.
Masking
ParticipantOutcomes Assessor
Masking Description
Key personnel not collecting data will perform randomization and inform surgeon of the group assignment, keeping data collection blinded. The participant will also remain blinded to their assignment.
Allocation
Randomized
Enrollment
154 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Onlay Component-Tornier Ascend Flex stem
Arm Type
Active Comparator
Arm Description
Reverse Total Shoulder Arthroplasty using onlay component (tray placed at top of humerus)
Arm Title
Inlay Component-Tornier Perform Stem Reverse+
Arm Type
Active Comparator
Arm Description
Reverse Total Shoulder Arthroplasty using inlay component (tray placed in humerus)
Intervention Type
Device
Intervention Name(s)
Tornier Ascend Flex stem
Intervention Description
Reverse Total Shoulder Arthroplasty using onlay component (tray placed at top of humerus)
Intervention Type
Device
Intervention Name(s)
Tornier Perform Stem Reverse+
Intervention Description
Reverse Total Shoulder Arthroplasty using inlay component (tray placed in humerus)
Primary Outcome Measure Information:
Title
Active external rotation, 2 years
Description
Range of motion of repaired shoulder, active external rotation. Measured with goniometer in degrees.
Time Frame
2 years postoperative
Secondary Outcome Measure Information:
Title
Active external rotation, 3 months
Description
Range of motion of repaired shoulder, active external rotation. Measured with goniometer in degrees.
Time Frame
3 months postoperative
Title
Active external rotation, 1 year
Description
Range of motion of repaired shoulder, active external rotation. Measured with goniometer in degrees.
Time Frame
1 year postoperative
Title
Strength during active external rotation, 3 months
Description
Strength measurement during active external rotation of repaired shoulder. Measured with dynamometer in pounds.
Time Frame
3 months postoperative
Title
Strength during active external rotation, 1 year
Description
Strength measurement during active external rotation of repaired shoulder. Measured with dynamometer in pounds.
Time Frame
1 year postoperative
Title
Strength during active external rotation, 2 years
Description
Strength measurement during active external rotation of repaired shoulder. Measured with dynamometer in pounds
Time Frame
2 years postoperative
Title
Active forward elevation, 3 months
Description
Range of motion of repaired shoulder, active forward elevation. Measured with goniometer in degrees.
Time Frame
3 months postoperative
Title
Active forward elevation, 1 year
Description
Range of motion of repaired shoulder, active forward elevation. Measured with goniometer in degrees.
Time Frame
1 year postoperative
Title
Active forward elevation, 2 years
Description
Range of motion of repaired shoulder, active forward elevation. Measured with goniometer in degrees.
Time Frame
2 years postoperative
Title
Strength during active forward elevation, 3 months
Description
Strength measured during active forward elevation of repaired shoulder. Measured with dynamometer in pounds.
Time Frame
3 months postoperative
Title
Strength during active forward elevation, 1 year
Description
Strength measured during active forward elevation of repaired shoulder. Measured with dynamometer in pounds.
Time Frame
1 year postoperative
Title
Strength during active forward elevation, 2 years
Description
Strength measured during active forward elevation of repaired shoulder. Measured with dynamometer in pounds.
Time Frame
2 years postoperative
Title
Abduction, 3 months
Description
Range of motion of repaired shoulder, abduction. Measured with goniometer in degrees.
Time Frame
3 months postoperative
Title
Abduction, 1 year
Description
Range of motion of repaired shoulder, abduction. Measured with goniometer in degrees.
Time Frame
1 year postoperative
Title
Abduction, 2 years
Description
Range of motion of repaired shoulder, abduction. Measured with goniometer in degrees.
Time Frame
2 years postoperative
Title
Strength during abduction, 3 months
Description
Strength measured during abduction of repaired shoulder. Measured with dynamometer in pounds.
Time Frame
3 months postoperative
Title
Strength during abduction, 1 year
Description
Strength measured during abduction of repaired shoulder. Measured with dynamometer in pounds.
Time Frame
1 year postoperative
Title
Strength during abduction, 2 years
Description
Strength measured during abduction of repaired shoulder. Measured with dynamometer in pounds.
Time Frame
2 years postoperative
Title
Internal rotation, 3 months
Description
Range of motion of repaired shoulder, internal rotation. Measured with goniometer in degrees.
Time Frame
3 months postoperative
Title
Internal rotation, 1 year
Description
Range of motion of repaired shoulder, internal rotation. Measured with goniometer in degrees.
Time Frame
1 year postoperative
Title
Internal rotation, 2 years
Description
Range of motion of repaired shoulder, internal rotation. Measured with goniometer in degrees.
Time Frame
2 years postoperative
Title
Strength during Internal rotation, 3 months
Description
Strength measured during internal rotation of repaired shoulder. Measured with dynamometer in pounds.
Time Frame
3 months postoperative
Title
Strength during Internal rotation, 1 year
Description
Strength measured during internal rotation of repaired shoulder. Measured with dynamometer in pounds.
Time Frame
1 year postoperative
Title
Strength during Internal rotation, 2 years
Description
Strength measured during internal rotation of repaired shoulder. Measured with dynamometer in pounds.
Time Frame
2 years postoperative
Title
External rotation lag sign test, 3 months
Description
Number of patients with positive external rotation lag sign test. The test is performed with the elbow passively flexed and repaired shoulder abducted 90 degrees by the examiner. Next, the examiner passively takes the patient's shoulder into a position of maximal external rotation. The patient is then instructed to hold that position. A positive test is if the patient cannot maintain the position and the shoulder rotates internally. A positive test indicates supraspinatus and infraspinatus tendon weakness.
Time Frame
3 months postoperative
Title
External rotation lag sign test, 1 year
Description
Number of patients with positive external rotation lag sign test. The test is performed with the elbow passively flexed and repaired shoulder abducted 90 degrees by the examiner. Next, the examiner passively takes the patient's shoulder into a position of maximal external rotation. The patient is then instructed to hold that position. A positive test is if the patient cannot maintain the position and the shoulder rotates internally. A positive test indicates supraspinatus and infraspinatus tendon weakness.
Time Frame
1 year postoperative
Title
External rotation lag sign test, 2 years
Description
Number of patients with positive external rotation lag sign test. The test is performed with the elbow passively flexed and repaired shoulder abducted 90 degrees by the examiner. Next, the examiner passively takes the patient's shoulder into a position of maximal external rotation. The patient is then instructed to hold that position. A positive test is if the patient cannot maintain the position and the shoulder rotates internally A positive test indicates supraspinatus and infraspinatus tendon weakness.
Time Frame
2 years postoperative
Title
Drop arm test, 3 months
Description
Number of patients with positive drop arm test of repaired shoulder, performed by passively abducting the patient's shoulder and observing for arm drop as the patient slowly lowers the arm to the waist. A positive test indicates supraspinatus dysfunction.
Time Frame
3 months postoperative
Title
Drop arm test, 1 year
Description
Number of patients with positive drop arm test of repaired shoulder, performed by passively abducting the patient's shoulder and observing for arm drop as the patient slowly lowers the arm to the waist. A positive test indicates supraspinatus dysfunction.
Time Frame
1 year postoperative
Title
Drop arm test, 2 years
Description
Number of patients with positive drop arm test of repaired shoulder, performed by passively abducting the patient's shoulder and observing for arm drop as the patient slowly lowers the arm to the waist. A positive test indicates supraspinatus dysfunction.
Time Frame
2 years postoperative
Title
Lift off test, 3 months
Description
Number of patients with positive lift off test. The test is performed by the patient performing internal rotation of repaired shoulder, by lifting the hand off the back while the examiner places pressure on the hand. The test is considered to be positive if the patient cannot resist, lift the hand off the back or if the patient compensates by extending the elbow and shoulder. A positive test indicates subscapularis weakness.
Time Frame
3 months postoperative
Title
Lift off test, 1 year
Description
Number of patients with positive lift off test. The test is performed by the patient performing internal rotation of repaired shoulder, by lifting the hand off the back while the examiner places pressure on the hand. The test is considered to be positive if the patient cannot resist, lift the hand off the back or if the patient compensates by extending the elbow and shoulder. A positive test indicates subscapularis weakness.
Time Frame
1 year postoperative
Title
Lift off test, 2 years
Description
Number of patients with positive lift off test. The test is performed by the patient performing internal rotation of repaired shoulder, by lifting the hand off the back while the examiner places pressure on the hand. The test is considered to be positive if the patient cannot resist, lift the hand off the back or if the patient compensates by extending the elbow and shoulder. A positive test indicates subscapularis weakness.
Time Frame
2 years postoperative
Title
Belly press test, 3 months
Description
Number of patients with positive belly press test. The patient is asked to press the palm of the hand against the abdomen and bring the elbow forward. The test is positive if the patient is unable to maintain maximal internal rotation of repaired shoulder, demonstrates weakness or the elbow deviates posteriorly. A positive test indicates subscapularis muscle dysfunction.
Time Frame
3 months postoperative
Title
Belly press test, 1 year
Description
Number of patients with positive belly press test. The patient is asked to press the palm of the hand against the abdomen and bring the elbow forward. The test is positive if the patient is unable to maintain maximal internal rotation of repaired shoulder, demonstrates weakness or the elbow deviates posteriorly. A positive test indicates subscapularis muscle dysfunction.
Time Frame
1 year postoperative
Title
Belly press test, 2 years
Description
Number of patients with positive belly press test. The patient is asked to press the palm of the hand against the abdomen and bring the elbow forward. The test is positive if the patient is unable to maintain maximal internal rotation of repaired shoulder, demonstrates weakness or the elbow deviates posteriorly. A positive test indicates subscapularis muscle dysfunction.
Time Frame
2 years postoperative
Title
Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 3 months
Description
Patients will complete a questionnaire of the repaired shoulder function and pain, with 100 maximum points. A score of 0 indicates no impairment (best outcome), and 100 indicates maximum impairment (worst outcome).
Time Frame
3 months postoperative
Title
Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 1 year
Description
Patients will complete a questionnaire of the repaired shoulder function and pain, with 100 maximum points. A score of 0 indicates no impairment (best outcome), and 100 indicates maximum impairment (worst outcome).
Time Frame
1 year postoperative
Title
Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 2 years
Description
Patients will complete a questionnaire of shoulder function and pain, with 100 maximum points. A score of 0 indicates no impairment (best outcome), and 100 indicates maximum impairment (worst outcome).
Time Frame
2 years postoperative
Title
Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 3 months
Description
Patients complete a questionnaire comprising 4 domains of: physical symptoms; sports, recreation and work; lifestyle; and emotions. Each question is answered using a visual analog scale with a possible score ranging from 0 to 100. There are 19 questions, and the total score ranges from 0 to 1900. A score of 1900 signifies that the patient has an extreme decrease in the shoulder-related quality of life (worst outcome), whereas a score of 0 signifies that the patient has no decrease in shoulder-related quality of life (best outcome).
Time Frame
3 months postoperative
Title
Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 1 year
Description
Patients complete a questionnaire comprising 4 domains of: physical symptoms; sports, recreation and work; lifestyle; and emotions. Each question is answered using a visual analog scale with a possible score ranging from 0 to 100. There are 19 questions, and the total score ranges from 0 to 1900. A score of 1900 signifies that the patient has an extreme decrease in the shoulder-related quality of life (worst outcome), whereas a score of 0 signifies that the patient has no decrease in shoulder-related quality of life (best outcome).
Time Frame
1 year postoperative
Title
Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 2 years
Description
Patients complete a questionnaire comprising 4 domains of: physical symptoms; sports, recreation and work; lifestyle; and emotions. Each question is answered using a visual analog scale with a possible score ranging from 0 to 100. There are 19 questions, and the total score ranges from 0 to 1900. A score of 1900 signifies that the patient has an extreme decrease in the shoulder-related quality of life (worst outcome), whereas a score of 0 signifies that the patient has no decrease in shoulder-related quality of life (best outcome).
Time Frame
2 years postoperative
Title
Global Health, by Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) score, 3 months
Description
Patients will complete the PROMIS-10 assessment of global health for the previous 7 days, a 10-question assessment where each statement is scored from 1 (poor health) to 5 (excellent health) on a Likert scale. A total score is summed from the 10 questions, resulting in a minimum of 10 and maximum of 50 points. Higher scores indicate better health (best outcome).
Time Frame
3 months postoperative
Title
Global Health, by Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) score, 1 year
Description
Patients will complete the PROMIS-10 assessment of global health for the previous 7 days, a 10-question assessment where each statement is scored from 1 (poor health) to 5 (excellent health) on a Likert scale. A total score is summed from the 10 questions, resulting in a minimum of 10 and maximum of 50 points. Higher scores indicate better health (best outcome).
Time Frame
1 year postoperative
Title
Global Health, by Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) score, 2 years
Description
Patients will complete the PROMIS-10 assessment of global health for the previous 7 days, a 10-question assessment where each statement is scored from 1 (poor health) to 5 (excellent health) on a Likert scale. A total score is summed from the 10 questions, resulting in a minimum of 10 and maximum of 50 points. Higher scores indicate better health (best outcome).
Time Frame
2 years postoperative
Title
Visual Analog Scale measure of pain, 3 months
Description
Shoulder-related pain reported by the patient for the repaired shoulder as a score on a visual analog scale from 0 to 10, where 0=no pain at all (best outcome), and 10=pain as bad as it can be (worst outcome).
Time Frame
3 months postoperative
Title
Visual Analog Scale measure of pain, 1 year
Description
Shoulder-related pain reported by the patient for the repaired shoulder as a score on a visual analog scale from 0 to 10, where 0=no pain at all (best outcome), and 10=pain as bad as it can be (worst outcome).
Time Frame
1 year postoperative
Title
Visual Analog Scale measure of pain, 2 years
Description
Shoulder-related pain reported by the patient for the repaired shoulder as a score on a visual analog scale from 0 to 10, where 0=no pain at all (best outcome), and 10=pain as bad as it can be (worst outcome).
Time Frame
2 years postoperative
Title
Scapular notching, 3 months
Description
Scapular notching of the repaired shoulder. Measured from radiographic evaluation and scored on the Sirveaux classification scale as Grade 1-4, where grade 1 indicates a defect that only involves the inferior pillar of the scapular neck (best outcome). In Grade 2, the notch contacts the lower screw. In Grade 3, erosion of the bone extends over the lower screw. In Grade 4, the notch extends under the baseplate (worst outcome).
Time Frame
3 months postoperative
Title
Scapular notching, 1 year
Description
Scapular notching of the repaired shoulder. Measured from radiographic evaluation and scored on the Sirveaux classification scale as Grade 1-4, where grade 1 indicates a defect that only involves the inferior pillar of the scapular neck (best outcome). In Grade 2, the notch contacts the lower screw. In Grade 3, erosion of the bone extends over the lower screw. In Grade 4, the notch extends under the baseplate (worst outcome).
Time Frame
1 year postoperative
Title
Scapular notching, 2 years
Description
Scapular notching of the repaired shoulder. Measured from radiographic evaluation and scored on the Sirveaux classification scale as Grade 1-4, where grade 1 indicates a defect that only involves the inferior pillar of the scapular neck (best outcome). In Grade 2, the notch contacts the lower screw. In Grade 3, erosion of the bone extends over the lower screw. In Grade 4, the notch extends under the baseplate (worst outcome).
Time Frame
2 years postoperative
Title
Reoperation
Description
Number of patients requiring reoperation of the same shoulder within 2 years.
Time Frame
2 years postoperative
Title
Study-related adverse events
Description
All adverse events determined by the PI to be probably or definitely related to study interventions (surgery or device).
Time Frame
2 years postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing primary reverse total shoulder arthroplasty with the following components:
Onlay group: Ascend Flex stem, Perform Reversed standard +3 lateralized 25mm baseplate with standard 36 mm glenosphere or +6 lateralized 25mm baseplate with 39mm glenosphere
Inlay group: Perform Stem Reverse, Perform Reversed +3 lateralized 25mm baseplate with standard 36mm glenosphere or +6 lateralized 25mm baseplate with 39mm glenosphere
Diagnosis of cuff tear arthropathy, massive cuff tear, or primary osteoarthritis with cuff tear
Negative external rotation lag sign, ability to externally rotate beyond neutral
Age 18 years or older
Exclusion Criteria:
Revision arthroplasty
Prior open shoulder surgery
Concomitant tendon transfer (Latissimus Dorsi, Pectoralis Tendon, Lower Trapezius)
Diagnosis of rheumatoid arthritis, infection, acute trauma or instability
Patients not undergoing a standardized physical therapy protocol
Patient anatomy does not accommodate the study implants per surgeon discretion
Pregnant, patient-reported
Minors (under 18 years of age)
Cognitively impaired based on a diagnosis of dementia, psychiatric disorder, or any cognitive deficit that will not allow for proper informed consent or answering of study questionnaires
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grace SanAgustin, BSN
Phone
248-551-6679
Email
Grace.SanAgustin@beaumont.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Martusiewicz, MD
Organizational Affiliation
Beaumont Health
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty
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