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Conservative Versus Operative - First Time Shoulder Dislocations

Conservative Versus Operative Management of First Time Shoulder Dislocations

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05532150
Enrollment
200
Registered
2022-09-08
Start date
2026-09-30
Completion date
2032-09-30
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Dislocation

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).

Interventions

Participants in this group will undergo minimally invasive surgery to repair their shoulder with a technique called a Bankart repair.

PROCEDUREPhysical therapy

Participants in this group will follow a specific physical therapy rehabilitation protocol

Sponsors

Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants with Recurrent Instability2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 yearsPercentage of participants in each group that experience shoulder dislocation after treatment initiates will be measured at each timepoint.
Change in PROMIS Depression CAT at 6 weeksBaseline and 6 weeksA 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 monthsBaseline and 3 monthsA 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 monthsBaseline and 3 monthsA 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 monthsBaseline and 3 monthsA 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 monthsBaseline and 3 monthsA 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 monthsBaseline and 6 monthsA 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 monthsBaseline and 6 monthsA 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 monthsBaseline and 6 monthsA 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 monthsBaseline and 6 monthsA 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 yearBaseline and 1 yearA 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 yearBaseline and 1 yearA 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 yearBaseline and 1 yearA 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 yearBaseline and 1 yearA 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 yearsBaseline and 2 yearsA 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 yearsBaseline and 2 yearsA 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 yearsBaseline and 2 yearsA 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 yearsBaseline and 2 yearsA 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 yearsBaseline and 5 yearsA 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 yearsBaseline and 5 yearsA 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 yearsBaseline and 5 yearsA 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 yearsBaseline and 5 yearsA 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 yearsBaseline and 10 yearsA 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 yearsBaseline and 10 yearsA 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 yearsBaseline and 10 yearsA 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 yearsBaseline and 10 yearsA 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 weeksBaseline and 2 weeksA 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 weeksBaseline and 2 weeksA 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 weeksBaseline and 2 weeksA 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 weeksBaseline and 2 weeksA 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 weeksBaseline and 6 weeksA 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 weeksBaseline and 6 weeksA 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 weeksBaseline and 6 weeksA 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

MeasureTime frameDescription
Change in Constant-Murley Score at 6 weeksBaseline and 6 weeksThe Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Change in Constant-Murley Score at 3 monthsBaseline and 3 monthsThe Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Change in Constant-Murley Score at 6 monthsBaseline and 6 monthsThe 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 yearBaseline and 1 yearThe 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 yearsBaseline and 2 yearsThe 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 yearsBaseline and 5 yearsThe 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 yearsBaseline and 10 yearsThe 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 weeksBaseline and 2 weeksSingle item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Change in Subjective Shoulder Value Score at 6 weeksBaseline and 6 weeksSingle item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Change in Subjective Shoulder Value Score at 3 monthsBaseline and 3 monthsSingle item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Change in Subjective Shoulder Value Score at 6 monthsBaseline and 6 monthsSingle item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Change in Subjective Shoulder Value Score at 1 yearBaseline and 1 yearSingle item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Change in Subjective Shoulder Value Score at 2 yearsBaseline and 2 yearsSingle item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Change in Subjective Shoulder Value Score at 5 yearsBaseline and 5 yearsSingle item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Change in Subjective Shoulder Value Score at 10 yearsBaseline and 10 yearsSingle item question where participant's grade their shoulder as a percentage of their pre-injury baseline
Change in Rowe Score at 2 weeksBaseline and 2 weeksQuestionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Change in Rowe Score at 6 weeksBaseline and 6 weeksQuestionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Change in Rowe Score at 3 monthsBaseline and 3 monthsQuestionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Change in Rowe Score at 6 monthsBaseline and 6 monthsQuestionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Change in Rowe Score at 1 yearBaseline and 1 yearQuestionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Change in Rowe Score at 2 yearsBaseline and 2 yearsQuestionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Change in Rowe Score at 5 yearsBaseline and 5 yearsQuestionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Change in Rowe Score at 10 yearsBaseline and 10 yearsQuestionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function
Time to baseline functional statusMeasured once per patient, depending on the time required to return to full activity (up to 10 yearsTime required to return to full activity level or return to sports after the initial injury, expressed in weeks
Change in Constant-Murley Score at 2 weeksBaseline and 2 weeksThe 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.

Countries

United States

Contacts

Primary ContactDavid P Trofa, MD
dpt2103@cumc.columbia.edu212 305 5974

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026