RCT Evaluating First Time Shoulder Dislocation

NCT05715021 | Recruiting

• 1 other identifier: REDUCE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the pilot study is to assess the feasibility of a definitive trial to determine the effect of arthroscopic soft tissue stabilization vs. non-operative management on the risk of recurrent anterior dislocation rates and functional outcomes following in patients presenting with a first-time dislocation (FTD) over a 24-month period.

Conditions

Shoulder Dislocation; Sport Injury; Anterior Dislocation

Outcome Measures

Primary Outcomes (4)

• Recruitment Feasibility

  Number of patients recruited

  10 months

• Follow-up

  Proportion of participants followed at two years

  2 years

• Surgery within 3 months of enrollment

  Ability to operate on patients within 3 months following enrollment

  3 months

• Crossovers

  Assessment of crossovers between groups

  2 years

Secondary Outcomes (13)

• Rate of Recurrence Dislocation

  2 years

• Rate of Instability

  2 years

• Clinical Outcome - shoulder function

  2 years

• Clinical Outcome

  2 years

• Clinical Outcome - Quality of Life

  2 years

Study Arms (4)

Bankart repair + Remplissage (randomized cohort)

EXPERIMENTAL

Arthroscopic repair of anterior capsulo-labral structures

Procedure: Bankart + Remplissage Procedure

Conservative treatment (randomized cohort)

NO INTERVENTION

Non surgical intervention

Bankart repair + Remplissage (non-randomized cohort)

EXPERIMENTAL

Arthroscopic repair of anterior capsulo-labral structures

Procedure: Bankart + Remplissage Procedure

Conservative treatment (non-randomized cohort)

NO INTERVENTION

Non surgical intervention

Interventions

Bankart + Remplissage Procedure PROCEDURE

Participants will undergo arthroscopic stabilization.

Bankart repair + Remplissage (non-randomized cohort); Bankart repair + Remplissage (randomized cohort)

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients ages 14-40 years;
• Diagnosis of first-time shoulder anterior dislocation having occurred within the past 3 months confirmed either by radiographic evidence or documented reduction of anterior shoulder dislocation as well as physical examination eliciting unwanted glenohumeral translation with reproduction of symptoms;
• Provision of informed consent.

You may not qualify if:

• Patients that cannot undergo surgery or anesthesia;
• Patients with concomitant injuries (rotator cuff tear, fracture)
• Previous shoulder surgery;
• Patients that will likely have problems with maintaining follow-up or are incarcerated;
• Epilepsy/seizure disorder;
• Pregnancy;
• Diagnosis of multidirectional instability;
• Bony glenoid defect (bony Bankart) \>10% as measured on preop imaging;
• Dislocation without trauma, in a context of hyper laxity or atraumatic instability;
• Cases involving litigation or workplace insurance claims (e.g., WSIB).

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

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

Study Officials

• Moin Khan, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Dagher, MSc

CONTACT

905-522-1155; ddagher@stjoes.ca

Moin Khan, MD

CONTACT

905-522-1155; khanmm2@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Orthopaedic Surgeon

Model Details: Randomized Controlled Trial with Embedded Non-randomized Cohort

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 6, 2023
• Study Start: July 12, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)