An interventional study of Arthroscopic Bankart repair and Physical therapy in Shoulder Dislocation, sponsored by Columbia University. Withdrawn. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Columbia University · Not applicable, Interventional, and Treatment
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.
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).
105 studies on the registry are indexed under Shoulder Dislocation; 22 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The operative group will undergo an arthroscopic Bankart repair, which is type of surgery used to repair a dislocated shoulder.
Procedure: Arthroscopic Bankart repair
The non-operative group will undergo physical therapy following a specific rehabilitation schedule.
Procedure: Physical therapy
Participants in this group will undergo minimally invasive surgery to repair their shoulder with a technique called a Bankart repair.
Participants in this group will follow a specific physical therapy rehabilitation protocol
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Measured once per patient, depending on the time required to return to full activity (up to 10 years
No study locations are listed for this record.
Plan to share: No
This study is withdrawn, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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