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NCT Number: NCT05532150

Conservative Versus Operative - 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.

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Key information

Conditions

Shoulder Dislocation Joint Diseases Joint Dislocations Musculoskeletal Diseases Shoulder Injuries Wounds and Injuries

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

Location contact

David P Trofa, MD

CONTACT

[email protected]

212-305-5974

David P Trofa, MD

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic Bankart repair

Procedure

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

physical therapy

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

Secondary outcomes

  1. Change in Constant-Murley Score at 2 weeks

    Time frame: 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.

  2. Change in Constant-Murley Score at 6 weeks

    Time frame: 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.

  3. Change in Constant-Murley Score at 3 months

    Time frame: 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.

  4. Change in Constant-Murley Score at 6 months

    Time frame: 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.

  5. Change in Constant-Murley Score at 1 year

    Time frame: 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.

  6. Change in Constant-Murley Score at 2 years

    Time frame: 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.

  7. Change in Constant-Murley Score at 5 years

    Time frame: 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.

  8. Change in Constant-Murley Score at 10 years

    Time frame: 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.

  9. Change in Subjective Shoulder Value Score at 2 weeks

    Time frame: Baseline and 2 weeks

    Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline

  10. Change in Subjective Shoulder Value Score at 6 weeks

    Time frame: Baseline and 6 weeks

    Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline

  11. Change in Subjective Shoulder Value Score at 3 months

    Time frame: Baseline and 3 months

    Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline

  12. Change in Subjective Shoulder Value Score at 6 months

    Time frame: Baseline and 6 months

    Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline

  13. Change in Subjective Shoulder Value Score at 1 year

    Time frame: Baseline and 1 year

    Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline

  14. Change in Subjective Shoulder Value Score at 2 years

    Time frame: Baseline and 2 years

    Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline

  15. Change in Subjective Shoulder Value Score at 5 years

    Time frame: Baseline and 5 years

    Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline

  16. Change in Subjective Shoulder Value Score at 10 years

    Time frame: Baseline and 10 years

    Single item question where participant's grade their shoulder as a percentage of their pre-injury baseline

  17. Change in Rowe Score at 2 weeks

    Time frame: Baseline and 2 weeks

    Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function

  18. Change in Rowe Score at 6 weeks

    Time frame: Baseline and 6 weeks

    Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function

  19. Change in Rowe Score at 3 months

    Time frame: Baseline and 3 months

    Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function

  20. Change in Rowe Score at 6 months

    Time frame: Baseline and 6 months

    Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function

  21. Change in Rowe Score at 1 year

    Time frame: Baseline and 1 year

    Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function

  22. Change in Rowe Score at 2 years

    Time frame: Baseline and 2 years

    Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function

  23. Change in Rowe Score at 5 years

    Time frame: Baseline and 5 years

    Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function

  24. Change in Rowe Score at 10 years

    Time frame: Baseline and 10 years

    Questionnaire that ranges from 0 (worst) of 100 (best) points that assesses stability, mobility, and function

  25. 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

    Time required to return to full activity level or return to sports after the initial injury, expressed in weeks

Study contacts

Contact information is provided by the study sponsor or research team.

David P Trofa, MD

CONTACT

[email protected]

212 305 5974

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Conservative Versus Operative Management of First Time Shoulder Dislocations

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Sep 8, 2022
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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