Actively Recruiting

Phase Not Applicable
Age: 14Years - 40Years
All Genders
ID05715021

Randomized Trial Evaluating First Time Shoulder Dislocation: Surgery vs Conservative Care

Led by McMaster University · Updated on 2025-09-26

100

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients aged 14 to 40 years who have experienced a first-time anterior shoulder dislocation within the past 3 months. The study aims to evaluate whether arthroscopic soft tissue stabilization surgery compared to non-operative management affects the risk of recurrent dislocations and functional outcomes over a 24-month period. This pilot trial will also assess feasibility factors such as recruitment, adherence to protocols, and participant follow-up. Participants who agree to randomization will be assigned to either arthroscopic capsuloligamentous repair (including Bankart and possibly Remplissage procedures) or non-operative management involving physical therapy. Additionally, a non-randomized group will include patients who choose their preferred treatment. Both groups will be followed for two years with outcomes measured at 6 weeks, 6 months, 12 months, and 24 months. This design allows inclusion of patient preferences and enhances the study's real-world relevance. During the study, participants will undergo baseline assessments including medical history, physical examination, and completion of shoulder function and quality of life questionnaires such as the Western Ontario Shoulder Instability Index and American Shoulder and Elbow Society score. Researchers will monitor recurrence of dislocations, symptoms of instability, range of motion, return to activity and work, pain, satisfaction, and adverse events. Safety and treatment adherence will be closely tracked throughout the 24-month follow-up period.

CONDITIONS

Brief Title

RCT Evaluating First Time Shoulder Dislocation

Who Can Participate

Age: 14Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 14 to 40 years
  • First-time anterior shoulder dislocation within the past 3 months confirmed by imaging or documented reduction and physical exam
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Unable to undergo surgery or anesthesia
  • Other shoulder injuries such as rotator cuff tear or fracture
  • Previous shoulder surgery
  • Likely to have difficulty maintaining follow-up or incarcerated
  • Epilepsy or seizure disorder
  • Pregnancy
  • Multidirectional shoulder instability
  • Bony glenoid defect greater than 10% on imaging
  • Dislocations without trauma or with hyper laxity or atraumatic instability
  • Involvement in litigation or workplace insurance claims

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 3 months

Participants receive either arthroscopic capsuloligamentous repair (Bankart +/- Remplissage Procedure) or non-operative physical therapy to manage their first-time anterior shoulder dislocation.

1 to 2 visits for surgery scheduling and treatment initiation

Follow-up

Duration - 24 months

Participants are followed for 24 months after treatment to monitor shoulder stability, function, pain, and return to activity, with assessments including questionnaires and physical exams.

Visits at 6 weeks, 6 months, 12 months, and 24 months post-treatment

Trial Site Locations

Total: 1 location

1

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada, L8N 4A6

Actively Recruiting

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Research Team

D

Danielle Dagher, MSc

M

Moin Khan, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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