Shoulder DislocationNCT05532150
Conservative Versus Operative - First Time Shoulder Dislocations
A study testing Arthroscopic Bankart repair and Physical therapy in people with Shoulder Dislocation, run by Columbia University.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- Arthroscopic Bankart repair and Physical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2032
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients 12 and older
- seen by the Columbia University Shoulder Elbow and Sports Medicine Service
- first time anterior shoulder dislocation diagnosis
Who cannot join
- 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
About this study
Official title: Conservative Versus Operative Management of First Time Shoulder Dislocations
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.
Read the 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).
- Conditions
- Shoulder Dislocation
- Being tested
- Arthroscopic Bankart repair, Physical therapy
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic Bankart repairProcedure or surgery
Participants in this group will undergo minimally invasive surgery to repair their shoulder with a technique called a Bankart repair.
Physical therapyProcedure or surgery
Participants in this group will follow a specific physical therapy rehabilitation protocol
| Study group | Role | What they receive |
|---|---|---|
| Operative group | Experimental | The operative group will undergo an arthroscopic Bankart repair, which is type of surgery used to repair a dislocated shoulder. Receives: Procedure: Arthroscopic Bankart repair |
| Non-operative group | Active comparator | The non-operative group will undergo physical therapy following a specific rehabilitation schedule. Receives: Procedure: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
Secondary outcomes (25)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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: Measured once per patient, depending on the time required to return to full activity (up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study startSep 2026 (estimated)
- Primary completionSep 2032 (estimated)
- Study completionSep 2032 (estimated)
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Shoulder DislocationStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David P Trofa, MD, Principal investigator, Associate Professor of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532150
- Sponsor's protocol ID
- AAAU0965
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32389771Bottoni 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.
PubMed 12130413Pouges 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.
PubMed 33705240Minkus 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.
PubMed 33596092Jakobsen 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.
PubMed 17276217Belk 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.
PubMed 35148222Kirkley 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.
PubMed 15650667
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Versus Operative Management of First Time Shoulder Dislocations
- ClinicalTrials.gov ID
- NCT05532150
- Acronym / sponsor ID
- AAAU0965
- Conditions
- Shoulder Dislocation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2032 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Operative group | Experimental | Procedure: Arthroscopic Bankart repairThe operative group will undergo an arthroscopic Bankart repair, which is type of surgery used to repair a dislocated shoulder. |
| Non-operative group | Active comparator | Procedure: Physical therapyThe non-operative group will undergo physical therapy following a specific rehabilitation schedule. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients 12 and older
- seen by the Columbia University Shoulder Elbow and Sports Medicine Service
- first time anterior shoulder dislocation diagnosis
Key exclusion criteria (6 listed)
- humeral avulsion during arthroscopy
- bony defect > 25% of glenoid surface
- general anesthesia contraindication
- previous shoulder surgery
- inability or unwillingness to adhere to study participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic Bankart repairParticipants in this group will undergo minimally invasive surgery to repair their shoulder with a technique called a Bankart repair. | Procedure or surgery | Operative group |
| Physical therapyParticipants in this group will follow a specific physical therapy rehabilitation protocol | Procedure or surgery | Non-operative group |
Primary outcome
Change in Western-Ontario Shoulder instability Index Score at 2 weeks
Time frame: 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 Patient Reported Outcome Measure Information System (PROMIS) Physical function (PF) Computer Adaptive Test (CAT) at 2 weeks
Time frame: 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
Time frame: 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 Depression CAT at 2 weeks
Time frame: 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 Western-Ontario Shoulder instability Index Score at 6 weeks
Time frame: 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 PF CAT at 6 weeks
Time frame: 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 PROMIS PI CAT at at 6 weeks
Time frame: 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 6 weeks
Time frame: 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 Western-Ontario Shoulder instability Index Score at 3 months
Time frame: 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 PROMIS PF CAT at 3 months
Time frame: 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
Time frame: 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 Depression CAT at 3 months
Time frame: 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 6 months
Time frame: 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 PF CAT at 6 months
Time frame: 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
Time frame: 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 PROMIS Depression CAT at 6 months
Time frame: 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 Western-Ontario Shoulder instability Index Score at 1 year
Time frame: 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
Time frame: 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 PROMIS PI CAT at 1 year
Time frame: 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 Depression CAT at 1 year
Time frame: 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 Western-Ontario Shoulder instability Index Score at 2 years
Time frame: 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 2 years
Time frame: 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 PROMIS PI CAT at 2 years
Time frame: 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 PROMIS Depression CAT at 2 years
Time frame: 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 Western-Ontario Shoulder instability Index Score at 5 years
Time frame: 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 5 years
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 PI CAT at 10 years
Time frame: 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.
Change in PROMIS Depression CAT at 10 years
Time frame: 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
Time frame: 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.
25 secondary outcomes
Change in Constant-Murley Score at 2 weeks
Time frame: Baseline and 2 weeks
Change in Constant-Murley Score at 6 weeks
Time frame: Baseline and 6 weeks
Change in Constant-Murley Score at 3 months
Time frame: Baseline and 3 months
Change in Constant-Murley Score at 6 months
Time frame: Baseline and 6 months
Change in Constant-Murley Score at 1 year
Time frame: Baseline and 1 year
Change in Constant-Murley Score at 2 years
Time frame: Baseline and 2 years
Change in Constant-Murley Score at 5 years
Time frame: Baseline and 5 years
Change in Constant-Murley Score at 10 years
Time frame: Baseline and 10 years
Change in Subjective Shoulder Value Score at 2 weeks
Time frame: Baseline and 2 weeks
Change in Subjective Shoulder Value Score at 6 weeks
Time frame: Baseline and 6 weeks
Change in Subjective Shoulder Value Score at 3 months
Time frame: Baseline and 3 months
Change in Subjective Shoulder Value Score at 6 months
Time frame: Baseline and 6 months
Change in Subjective Shoulder Value Score at 1 year
Time frame: Baseline and 1 year
Change in Subjective Shoulder Value Score at 2 years
Time frame: Baseline and 2 years
Change in Subjective Shoulder Value Score at 5 years
Time frame: Baseline and 5 years
Change in Subjective Shoulder Value Score at 10 years
Time frame: Baseline and 10 years
Change in Rowe Score at 2 weeks
Time frame: Baseline and 2 weeks
Change in Rowe Score at 6 weeks
Time frame: Baseline and 6 weeks
Change in Rowe Score at 3 months
Time frame: Baseline and 3 months
Change in Rowe Score at 6 months
Time frame: Baseline and 6 months
Change in Rowe Score at 1 year
Time frame: Baseline and 1 year
Change in Rowe Score at 2 years
Time frame: Baseline and 2 years
Change in Rowe Score at 5 years
Time frame: Baseline and 5 years
Change in Rowe Score at 10 years
Time frame: Baseline and 10 years
Time to baseline functional status
Time frame: Measured once per patient, depending on the time required to return to full activity (up to 10 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 32389771Hurley 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.
- Background: PubMed 12130413Bottoni 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.
- Background: PubMed 33705240Pouges 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.
- Background: PubMed 33596092Minkus 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.
- Background: PubMed 17276217Jakobsen 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.
- Background: PubMed 35148222Belk 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.
- Background: PubMed 15650667Kirkley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David P Trofa, MD principal investigator
Associate Professor of Orthopaedic Surgery
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic Bankart repair and Physical therapy in people with Shoulder Dislocation, run by Columbia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Western-Ontario Shoulder instability Index Score at 2 weeks (time frame: Baseline and 2 weeks). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05532150, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.