Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared With Latarjet Procedure Evaluation - STABLE Definitive Trial

NCT05705479 | Active Not Recruiting

• 1 other identifier: STABLE-2
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to evaluate the functional shoulder recovery of patients with recurrent shoulder dislocations at 24 months when treated with either arthroscopic capsuloligamentous repair (Bankart Procedure +/- Remplissage) or coracoid transfer (Latarjet procedure).

Conditions

Shoulder Dislocation; Sport Injuries; Anterior Dislocation

Outcome Measures

Primary Outcomes (1)

• Clinical Outcome - Shoulder function

  The change from baseline to 24 months post-intervention difference in Western Ontario Shoulder Instability Index (WOSI) scores between patients with recurrent dislocations treated with Bankart Procedure + Remplissage versus Latarjet procedure.

  2 years

Secondary Outcomes (8)

• Rate of Recurrence

  2 years

• Clinical Outcome

  2 years

• Clinical Outcome - Quality of Life

  2 years

• Clinical Outcome - Shoulder activity

  2 years

• Rate of participants with anterior shoulder instability

  2 years

Study Arms (2)

Bankart + Remplissage Procedure

EXPERIMENTAL

Bankart Procedure: the participant will be placed in the lateral decubitus or beach chair position. Standard diagnostic arthroscopy will be performed. The anterior capsulolabral complex will be freed from the anterior aspect of the scapular neck. The anterior aspect of the scapular neck will be decorticated using a motorized burr. A capsuloligamentous repair will be performed with the capsule shifted from inferior to superior and repaired on the glenoid face. The number of anchors used for the repair will be left to the discretion of the surgeon. Patients will be given a sling for 4 weeks, and participation in sports will not be allowed for 6 months.

Procedure: Bankart + Remplissage Procedure

Latarjet Procedure

EXPERIMENTAL

Open or Arthroscopic coracoid transfer (Latarjet Procedure): This procedure may be performed through small incisions (minimally invasive) but may require a larger incision in some cases. It involves the transfer of a nearby bony structure (the coracoid process) to the front of the shoulder joint (glenoid). This bone will then provide support to prevent the shoulder joint from dislocating.

Procedure: Latarjet Procedure

Interventions

Bankart + Remplissage Procedure PROCEDURE

Participants will undergo arthroscopic stabilization.

Bankart + Remplissage Procedure

Latarjet Procedure PROCEDURE

Participants will undergo open or arthroscopic Latarjet procedure.

Latarjet Procedure

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults ages 18-50 years;
• Diagnosis of post-traumatic recurrent anterior dislocation. This will require a minimum of 2 episodes of documented dislocations either by radiographic evidence or documented reduction of anterior shoulder dislocation as well as physical examination eliciting unwanted glenohumeral translation with reproduction of symptoms;
• Subcritical glenoid bone loss as defined on CT by standardized and reproducible best-fit circle technique (\>10% but \<20%);
• Provision of informed consent.

You may not qualify if:

• Patients with concomitant injuries of the index shoulder (cuff tear, greater tuberosity fracture);
• Previous shoulder surgery;
• Patients that will likely have problems, in the judgment of the investigators, with maintaining follow-up;
• Epilepsy/seizure disorder;
• Patients who are currently incarcerated;
• Diagnosis of multidirectional instability;
• Cases involving litigation or workplace insurance claims (e.g. WSIB);
• Confirmed connective tissue disorder (Ehlers-Danlos, Marfans) or Beighton hypermobility score \> 6.
• Pregnancy.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (1)

• Khan M, Bedi A, Degen R, Warner J, Bhandari M; STABLE Investigators. Multicentre randomised controlled trial comparing Bankart repair with remplissage and Latarjet procedure in shoulder instability with subcritical bone loss (STABLE): study protocol. BMJ Open. 2024 Nov 14;14(11):e089831. doi: 10.1136/bmjopen-2024-089831.

  PMID: 39542469 DERIVED

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

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

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 30, 2023
• Study Start: October 17, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)