Conservative Versus Operative - Frist Time Shoulder Dislocations
- Conditions
- Shoulder Dislocation
- Interventions
- Procedure: Physical therapyProcedure: Arthroscopic Bankart repair
- Registration Number
- NCT05532150
- Lead Sponsor
- Columbia University
- 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- patients 12 and older
- seen by the Columbia University Shoulder Elbow and Sports Medicine Service
- first time anterior shoulder dislocation diagnosis
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-operative group Physical therapy The non-operative group will undergo physical therapy following a specific rehabilitation schedule. Operative group Arthroscopic Bankart repair The operative group will undergo an arthroscopic Bankart repair, which is type of surgery used to repair a dislocated shoulder.
- Primary Outcome Measures
Name Time Method Change in PROMIS Depression CAT at 2 weeks Baseline and 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 PROMIS PI CAT at at 6 weeks Baseline and 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 3 months Baseline and 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 1 year Baseline and 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 Baseline and 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 Western-Ontario Shoulder instability Index Score at 2 weeks Baseline and 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 Western-Ontario Shoulder instability Index Score at 6 weeks Baseline and 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 Depression CAT at 6 weeks Baseline and 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 PROMIS PI CAT at 1 year Baseline and 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 PF CAT at 6 weeks Baseline and 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 Patient Reported Outcome Measure Information System (PROMIS) Physical function (PF) Computer Adaptive Test (CAT) at 2 weeks Baseline and 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 Baseline and 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 PI CAT at 2 years Baseline and 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 Western-Ontario Shoulder instability Index Score at 3 months Baseline and 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 Western-Ontario Shoulder instability Index Score at 6 months Baseline and 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 Depression CAT at 6 months Baseline and 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 PROMIS Depression CAT at 1 year Baseline and 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 PROMIS PF CAT at 2 years Baseline and 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 Western-Ontario Shoulder instability Index Score at 5 years Baseline and 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 3 months Baseline and 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 Baseline and 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 PF CAT at 6 months Baseline and 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 Baseline and 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 Western-Ontario Shoulder instability Index Score at 2 years Baseline and 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 5 years Baseline and 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 Baseline and 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 Baseline and 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 Baseline and 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 Baseline and 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 Depression CAT at 10 years Baseline and 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 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years Percentage of participants in each group that experience shoulder dislocation after treatment initiates will be measured at each timepoint.
Change in PROMIS Depression CAT at 2 years Baseline and 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 PROMIS PI CAT at 10 years Baseline and 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.
- Secondary Outcome Measures
Name Time Method Change in Constant-Murley Score at 6 months Baseline and 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 Subjective Shoulder Value Score at 2 weeks Baseline and 2 weeks Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Change in Rowe Score at 2 weeks Baseline and 2 weeks Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Change in Rowe Score at 2 years Baseline and 2 years Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Change in Constant-Murley Score at 2 weeks Baseline and 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 Subjective Shoulder Value Score at 6 months Baseline and 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 Baseline and 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 5 years Baseline and 5 years Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Change in Rowe Score at 6 weeks Baseline and 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 Baseline and 3 months Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Change in Rowe Score at 5 years Baseline and 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 Baseline and 10 years Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Change in Subjective Shoulder Value Score at 6 weeks Baseline and 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 Baseline and 3 months Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Change in Constant-Murley Score at 6 weeks Baseline and 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 2 years Baseline and 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 Baseline and 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 Subjective Shoulder Value Score at 2 years Baseline and 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 10 years Baseline and 10 years Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Change in Rowe Score at 6 months Baseline and 6 months Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Time to baseline functional status Measured once per patient, depending on the time required to return to full activity (up to 10 years Time required to return to full activity level or return to sports after the initial injury, expressed in weeks
Change in Constant-Murley Score at 3 months Baseline and 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 1 year Baseline and 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 10 years Baseline and 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 Rowe Score at 1 year Baseline and 1 year Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Trial Locations
- Locations (1)
Columbia University Irving Medical Center
🇺🇸New York, New York, United States