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Conservative Versus Operative - Frist Time Shoulder Dislocations

Primary Purpose

Shoulder Dislocation

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arthroscopic Bankart repair
Physical therapy
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Dislocation

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients 12 and older
  • seen by the Columbia University Shoulder Elbow and Sports Medicine Service
  • first time anterior shoulder dislocation diagnosis

Exclusion Criteria:

  • humeral avulsion during arthroscopy
  • bony defect > 25% of glenoid surface
  • general anesthesia contraindication
  • previous shoulder surgery
  • inability or unwillingness to adhere to study participate
  • lost to follow up

Sites / Locations

  • Columbia University Irving Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Operative group

Non-operative group

Arm Description

The operative group will undergo an arthroscopic Bankart repair, which is type of surgery used to repair a dislocated shoulder.

The non-operative group will undergo physical therapy following a specific rehabilitation schedule.

Outcomes

Primary Outcome Measures

Change in Western-Ontario Shoulder instability Index Score at 2 weeks
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in Patient Reported Outcome Measure Information System (PROMIS) Physical function (PF) Computer Adaptive Test (CAT) at 2 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS Pain Interference (PI) CAT at 2 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 2 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in Western-Ontario Shoulder instability Index Score at 6 weeks
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PF CAT at 6 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PI CAT at at 6 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 6 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in Western-Ontario Shoulder instability Index Score at 3 months
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PF CAT at 3 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PI CAT at 3 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 3 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in Western-Ontario Shoulder instability Index Score at 6 months
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PF CAT at 6 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PI CAT at 6 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 6 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in Western-Ontario Shoulder instability Index Score at 1 year
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PF CAT at 1 year
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PI CAT at 1 year
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 1 year
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in Western-Ontario Shoulder instability Index Score at 2 years
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PF CAT at 2 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PI CAT at 2 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 2 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in Western-Ontario Shoulder instability Index Score at 5 years
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PF CAT at 5 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PI CAT at 5 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 5 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in Western-Ontario Shoulder instability Index Score at 10 years
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PF CAT at 10 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PI CAT at 10 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 10 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Percentage of Participants with Recurrent Instability
Percentage of participants in each group that experience shoulder dislocation after treatment initiates will be measured at each timepoint.

Secondary Outcome Measures

Change in Constant-Murley Score at 2 weeks
The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Change in Constant-Murley Score at 6 weeks
The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Change in Constant-Murley Score at 3 months
The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Change in Constant-Murley Score at 6 months
The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Change in Constant-Murley Score at 1 year
The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Change in Constant-Murley Score at 2 years
The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Change in Constant-Murley Score at 5 years
The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Change in Constant-Murley Score at 10 years
The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Change in Subjective Shoulder Value Score at 2 weeks
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Change in Subjective Shoulder Value Score at 6 weeks
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Change in Subjective Shoulder Value Score at 3 months
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Change in Subjective Shoulder Value Score at 6 months
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Change in Subjective Shoulder Value Score at 1 year
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Change in Subjective Shoulder Value Score at 2 years
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Change in Subjective Shoulder Value Score at 5 years
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Change in Subjective Shoulder Value Score at 10 years
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Change in Rowe Score at 2 weeks
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Change in Rowe Score at 6 weeks
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Change in Rowe Score at 3 months
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Change in Rowe Score at 6 months
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Change in Rowe Score at 1 year
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Change in Rowe Score at 2 years
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Change in Rowe Score at 5 years
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Change in Rowe Score at 10 years
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Time to baseline functional status
Time required to return to full activity level or return to sports after the initial injury, expressed in weeks

Full Information

First Posted
September 4, 2022
Last Updated
August 31, 2023
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT05532150
Brief Title
Conservative Versus Operative - Frist Time Shoulder Dislocations
Official Title
Conservative Versus Operative Management of First Time Shoulder Dislocations
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
September 2032 (Anticipated)
Study Completion Date
September 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

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

5. Study Description

Brief Summary
There is no consensus regarding whether rehabilitation or surgical stabilization leads to optimized outcomes for treatment of primary anterior shoulder dislocations. This prospective, randomized controlled trial therefore aims to compare arthroscopic Bankart repair versus physical therapy for the treatment of primary anterior shoulder dislocations.
Detailed Description
While primary anterior shoulder dislocations had been previously treated conservatively, growing concerns amidst recurrent shoulder instability have fueled interest in managing these injuries with surgery to mitigate the risk of future instability events. While the significant literature investigating the rates of shoulder instability with initial operative management suggests improvement outcomes, there is limited level 1 evidence to support these implications. A randomized-controlled trial (RCT) of 21 primary anterior shoulder dislocations undergoing arthroscopic Bankart repair or rehabilitation ( 9 operative vs 12 nonoperative; mean age: 22), found lower rates of recurrent shoulder instability (11% in operative vs 72% in non-operative; p=0.004) and higher Single Assessment Numeric Evaluation (SANE) scores (88 in operative vs 57 in non-operative; p<0.002) after 36 months of follow-up. Similarly, another RCT of 76 patients (37 operative vs 39 non-operative; mean age: 22), found lower rates of recurrent shoulder instability (2.7% in operative vs 53.8% in non-operative; p<0.01) and higher Oxford assessment scores (70% with either 'excellent' or 'good' scores in operative group vs 26% with either 'excellent' or 'good' scores in non-operative group) after 10 years of follow-up. A RCT of 31 patients (16 operative vs 15 non-operative; mean age: 22), found lower rates of recurrent instability ( 19% in operative vs 60% in non-operative; p=0.02) but no significantly different Western Ontario Score Indices (WOSI) (86% in operative vs 75% in non-operative; p=0.17) at a follow up of 79 months. A RCT of 91 patients (44 operative vs 47 non-operative; mean age: 22), found lower rates of recurrent instability (2.3% in operative vs 19.1% in non-operative; p=0.01) and no significantly difference in WOSI (92.7% in operative vs 91.5% in non-operative; p>0.05) at 2 years follow-up. A RCT of 40 patients (20 operative vs 20 non-operative; mean age: 21), found lower rates of recurrent shoulder instability (10% in operative vs 70% in non-operative; p=0.0001) and a higher WOSI (17.1 in operative vs 11.5 in non-operative; p=0.035) at 2 years follow-up. The previous 5 RCT's represent the only level 1 evidence amidst a much larger proportion of lower-level evidence upon which much of the discussion of surgical vs non-operative management has been formulated. Additionally, only 2 RCT's conducted power analyses to determine if their sample size was adequate, and they did not demonstrate unanimous results with patient reported outcomes as described above. It is therefore critical to increase the amount of level 1 evidence on the topic of operative vs non-operative management of primary shoulder dislocations to better inform this debate. This study aims to compare the incidence of recurrent shoulder instability and patient reported outcomes of patients with primary anterior shoulder dislocations managed with surgery (arthroscopic Bankart repair) compared to non-operative management (standardized rehabilitation protocol, control group).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to either the physical therapy (conservative) group or the operative (surgery) group if they agree to participate in the study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Operative group
Arm Type
Experimental
Arm Description
The operative group will undergo an arthroscopic Bankart repair, which is type of surgery used to repair a dislocated shoulder.
Arm Title
Non-operative group
Arm Type
Active Comparator
Arm Description
The non-operative group will undergo physical therapy following a specific rehabilitation schedule.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic Bankart repair
Intervention Description
Participants in this group will undergo minimally invasive surgery to repair their shoulder with a technique called a Bankart repair.
Intervention Type
Procedure
Intervention Name(s)
Physical therapy
Intervention Description
Participants in this group will follow a specific physical therapy rehabilitation protocol
Primary Outcome Measure Information:
Title
Change in Western-Ontario Shoulder instability Index Score at 2 weeks
Description
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 2 weeks
Title
Change in Patient Reported Outcome Measure Information System (PROMIS) Physical function (PF) Computer Adaptive Test (CAT) at 2 weeks
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 2 weeks
Title
Change in PROMIS Pain Interference (PI) CAT at 2 weeks
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 2 weeks
Title
Change in PROMIS Depression CAT at 2 weeks
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 2 weeks
Title
Change in Western-Ontario Shoulder instability Index Score at 6 weeks
Description
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 6 weeks
Title
Change in PROMIS PF CAT at 6 weeks
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 6 weeks
Title
Change in PROMIS PI CAT at at 6 weeks
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 6 weeks
Title
Change in PROMIS Depression CAT at 6 weeks
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 6 weeks
Title
Change in Western-Ontario Shoulder instability Index Score at 3 months
Description
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 3 months
Title
Change in PROMIS PF CAT at 3 months
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 3 months
Title
Change in PROMIS PI CAT at 3 months
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 3 months
Title
Change in PROMIS Depression CAT at 3 months
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 3 months
Title
Change in Western-Ontario Shoulder instability Index Score at 6 months
Description
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 6 months
Title
Change in PROMIS PF CAT at 6 months
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 6 months
Title
Change in PROMIS PI CAT at 6 months
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 6 months
Title
Change in PROMIS Depression CAT at 6 months
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 6 months
Title
Change in Western-Ontario Shoulder instability Index Score at 1 year
Description
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 1 year
Title
Change in PROMIS PF CAT at 1 year
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 1 year
Title
Change in PROMIS PI CAT at 1 year
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 1 year
Title
Change in PROMIS Depression CAT at 1 year
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 1 year
Title
Change in Western-Ontario Shoulder instability Index Score at 2 years
Description
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 2 years
Title
Change in PROMIS PF CAT at 2 years
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 2 years
Title
Change in PROMIS PI CAT at 2 years
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 2 years
Title
Change in PROMIS Depression CAT at 2 years
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 2 years
Title
Change in Western-Ontario Shoulder instability Index Score at 5 years
Description
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 5 years
Title
Change in PROMIS PF CAT at 5 years
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 5 years
Title
Change in PROMIS PI CAT at 5 years
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 5 years
Title
Change in PROMIS Depression CAT at 5 years
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 5 years
Title
Change in Western-Ontario Shoulder instability Index Score at 10 years
Description
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 10 years
Title
Change in PROMIS PF CAT at 10 years
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 10 years
Title
Change in PROMIS PI CAT at 10 years
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 10 years
Title
Change in PROMIS Depression CAT at 10 years
Description
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time Frame
Baseline and 10 years
Title
Percentage of Participants with Recurrent Instability
Description
Percentage of participants in each group that experience shoulder dislocation after treatment initiates will be measured at each timepoint.
Time Frame
2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
Secondary Outcome Measure Information:
Title
Change in Constant-Murley Score at 2 weeks
Description
The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Time Frame
Baseline and 2 weeks
Title
Change in Constant-Murley Score at 6 weeks
Description
The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Time Frame
Baseline and 6 weeks
Title
Change in Constant-Murley Score at 3 months
Description
The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Time Frame
Baseline and 3 months
Title
Change in Constant-Murley Score at 6 months
Description
The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Time Frame
Baseline and 6 months
Title
Change in Constant-Murley Score at 1 year
Description
The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Time Frame
Baseline and 1 year
Title
Change in Constant-Murley Score at 2 years
Description
The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Time Frame
Baseline and 2 years
Title
Change in Constant-Murley Score at 5 years
Description
The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Time Frame
Baseline and 5 years
Title
Change in Constant-Murley Score at 10 years
Description
The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Time Frame
Baseline and 10 years
Title
Change in Subjective Shoulder Value Score at 2 weeks
Description
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Time Frame
Baseline and 2 weeks
Title
Change in Subjective Shoulder Value Score at 6 weeks
Description
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Time Frame
Baseline and 6 weeks
Title
Change in Subjective Shoulder Value Score at 3 months
Description
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Time Frame
Baseline and 3 months
Title
Change in Subjective Shoulder Value Score at 6 months
Description
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Time Frame
Baseline and 6 months
Title
Change in Subjective Shoulder Value Score at 1 year
Description
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Time Frame
Baseline and 1 year
Title
Change in Subjective Shoulder Value Score at 2 years
Description
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Time Frame
Baseline and 2 years
Title
Change in Subjective Shoulder Value Score at 5 years
Description
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Time Frame
Baseline and 5 years
Title
Change in Subjective Shoulder Value Score at 10 years
Description
Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Time Frame
Baseline and 10 years
Title
Change in Rowe Score at 2 weeks
Description
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Time Frame
Baseline and 2 weeks
Title
Change in Rowe Score at 6 weeks
Description
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Time Frame
Baseline and 6 weeks
Title
Change in Rowe Score at 3 months
Description
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Time Frame
Baseline and 3 months
Title
Change in Rowe Score at 6 months
Description
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Time Frame
Baseline and 6 months
Title
Change in Rowe Score at 1 year
Description
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Time Frame
Baseline and 1 year
Title
Change in Rowe Score at 2 years
Description
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Time Frame
Baseline and 2 years
Title
Change in Rowe Score at 5 years
Description
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Time Frame
Baseline and 5 years
Title
Change in Rowe Score at 10 years
Description
Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Time Frame
Baseline and 10 years
Title
Time to baseline functional status
Description
Time required to return to full activity level or return to sports after the initial injury, expressed in weeks
Time Frame
Measured once per patient, depending on the time required to return to full activity (up to 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients 12 and older seen by the Columbia University Shoulder Elbow and Sports Medicine Service first time anterior shoulder dislocation diagnosis Exclusion Criteria: humeral avulsion during arthroscopy bony defect > 25% of glenoid surface general anesthesia contraindication previous shoulder surgery inability or unwillingness to adhere to study participate lost to follow up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian A Pearsall, BS, BA
Phone
251-377-6058
Email
cap2263@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Trofa, MD
Organizational Affiliation
Assistant Professor of Orthopedic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian A Pearsall, BS, BA
Phone
251-377-6058
Email
cap2263@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
David P Trofa, MD
Phone
914-787-2279
Email
dpt2103@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
David P Trofa, MD
First Name & Middle Initial & Last Name & Degree
Christian A Pearsall, BS, BA

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32389771
Citation
Hurley ET, Manjunath AK, Bloom DA, Pauzenberger L, Mullett H, Alaia MJ, Strauss EJ. Arthroscopic Bankart Repair Versus Conservative Management for First-Time Traumatic Anterior Shoulder Instability: A Systematic Review and Meta-analysis. Arthroscopy. 2020 Sep;36(9):2526-2532. doi: 10.1016/j.arthro.2020.04.046. Epub 2020 May 8.
Results Reference
background
PubMed Identifier
12130413
Citation
Bottoni CR, Wilckens JH, DeBerardino TM, D'Alleyrand JC, Rooney RC, Harpstrite JK, Arciero RA. A prospective, randomized evaluation of arthroscopic stabilization versus nonoperative treatment in patients with acute, traumatic, first-time shoulder dislocations. Am J Sports Med. 2002 Jul-Aug;30(4):576-80. doi: 10.1177/03635465020300041801.
Results Reference
background
PubMed Identifier
33705240
Citation
Pouges C, Hardy A, Vervoort T, Amouyel T, Duriez P, Lalanne C, Szymanski C, Deken V, Chantelot C, Upex P, Maynou C. Arthroscopic Bankart Repair Versus Immobilization for First Episode of Anterior Shoulder Dislocation Before the Age of 25: A Randomized Controlled Trial. Am J Sports Med. 2021 Apr;49(5):1166-1174. doi: 10.1177/0363546521996381. Epub 2021 Mar 11.
Results Reference
background
PubMed Identifier
33596092
Citation
Minkus M, Konigshausen M, Pauly S, Maier D, Mauch F, Stein T, Greiner S, Moursy M, Scheibel M. Immobilization in External Rotation and Abduction Versus Arthroscopic Stabilization After First-Time Anterior Shoulder Dislocation: A Multicenter Randomized Controlled Trial. Am J Sports Med. 2021 Mar;49(4):857-865. doi: 10.1177/0363546520987823. Epub 2021 Feb 17. Erratum In: Am J Sports Med. 2022 Aug 11;:3635465221119998.
Results Reference
background
PubMed Identifier
17276217
Citation
Jakobsen BW, Johannsen HV, Suder P, Sojbjerg JO. Primary repair versus conservative treatment of first-time traumatic anterior dislocation of the shoulder: a randomized study with 10-year follow-up. Arthroscopy. 2007 Feb;23(2):118-23. doi: 10.1016/j.arthro.2006.11.004.
Results Reference
background
PubMed Identifier
35148222
Citation
Belk JW, Wharton BR, Houck DA, Bravman JT, Kraeutler MJ, Mayer B, Noonan TJ, Seidl AJ, Frank RM, McCarty EC. Shoulder Stabilization Versus Immobilization for First-Time Anterior Shoulder Dislocation: A Systematic Review and Meta-analysis of Level 1 Randomized Controlled Trials. Am J Sports Med. 2023 May;51(6):1634-1643. doi: 10.1177/03635465211065403. Epub 2022 Feb 11.
Results Reference
background
PubMed Identifier
15650667
Citation
Kirkley A, Werstine R, Ratjek A, Griffin S. Prospective randomized clinical trial comparing the effectiveness of immediate arthroscopic stabilization versus immobilization and rehabilitation in first traumatic anterior dislocations of the shoulder: long-term evaluation. Arthroscopy. 2005 Jan;21(1):55-63. doi: 10.1016/j.arthro.2004.09.018.
Results Reference
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Learn more about this trial

Conservative Versus Operative - Frist Time Shoulder Dislocations

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