Conservative Versus Operative - Frist Time Shoulder Dislocations

Study Overview
=================
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).

Official Title
-----------------
Conservative Versus Operative Management of First Time Shoulder Dislocations

Conditions
-----------------
Shoulder Dislocation

Intervention / Treatment
-----------------
* Procedure: Arthroscopic Bankart repair
* Procedure: Physical therapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Operative group<br>The operative group will undergo an arthroscopic Bankart repair, which is type of surgery used to repair a dislocated shoulder. | Procedure: Arthroscopic Bankart repair<br>* Participants in this group will undergo minimally invasive surgery to repair their shoulder with a technique called a Bankart repair.<br>|
| Active Comparator: Non-operative group<br>The non-operative group will undergo physical therapy following a specific rehabilitation schedule. | Procedure: Physical therapy<br>* Participants in this group will follow a specific physical therapy rehabilitation protocol<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 2 weeks | 
| 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. | Baseline and 2 weeks | 
| 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. | Baseline and 2 weeks | 
| 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. | Baseline and 2 weeks | 
| 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. | Baseline and 6 weeks | 
| 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. | Baseline and 6 weeks | 
| 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. | Baseline and 6 weeks | 
| 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. | Baseline and 6 weeks | 
| 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. | Baseline and 3 months | 
| 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. | Baseline and 3 months | 
| 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. | Baseline and 3 months | 
| 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. | Baseline and 3 months | 
| 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. | Baseline and 6 months | 
| 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. | Baseline and 6 months | 
| 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. | Baseline and 6 months | 
| 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. | Baseline and 6 months | 
| 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. | Baseline and 1 year | 
| 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. | Baseline and 1 year | 
| 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. | Baseline and 1 year | 
| 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. | Baseline and 1 year | 
| 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. | Baseline and 2 years | 
| 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. | Baseline and 2 years | 
| 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. | Baseline and 2 years | 
| 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. | Baseline and 2 years | 
| 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. | Baseline and 5 years | 
| 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. | Baseline and 5 years | 
| 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. | Baseline and 5 years | 
| 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. | Baseline and 5 years | 
| 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. | Baseline and 10 years | 
| 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. | Baseline and 10 years | 
| 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. | Baseline and 10 years | 
| 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. | Baseline and 10 years | 
| 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. | 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 2 weeks | 
| 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. | Baseline and 6 weeks | 
| 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. | Baseline and 3 months | 
| 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. | Baseline and 6 months | 
| 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. | Baseline and 1 year | 
| 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. | Baseline and 2 years | 
| 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. | Baseline and 5 years | 
| 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. | Baseline and 10 years | 
| 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 | Baseline and 2 weeks | 
| 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 | Baseline and 6 weeks | 
| 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 | Baseline and 3 months | 
| 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 | Baseline and 6 months | 
| 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 | Baseline and 1 year | 
| 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 | Baseline and 2 years | 
| 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 | Baseline and 5 years | 
| 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 | Baseline and 10 years | 
| Change in Rowe Score at 2 weeks | Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function | Baseline and 2 weeks | 
| Change in Rowe Score at 6 weeks | Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function | Baseline and 6 weeks | 
| Change in Rowe Score at 3 months | Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function | Baseline and 3 months | 
| Change in Rowe Score at 6 months | Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function | Baseline and 6 months | 
| Change in Rowe Score at 1 year | Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function | Baseline and 1 year | 
| Change in Rowe Score at 2 years | Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function | Baseline and 2 years | 
| Change in Rowe Score at 5 years | Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function | Baseline and 5 years | 
| Change in Rowe Score at 10 years | Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function | Baseline and 10 years | 
| Time to baseline functional status | Time required to return to full activity level or return to sports after the initial injury, expressed in weeks | Measured once per patient, depending on the time required to return to full activity (up to 10 years |