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

NCT03585491 | Active Not Recruiting

• 1 other identifier: STABLE
• Study Type: interventional
• Target: 86
• 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 capsuloligamentous repair (Bankart + Remplissage) vs. coracoid transfer (Latarjet procedure) on recurrent dislocation rates and functional outcomes over a 24-month period.

Conditions

Shoulder Dislocation; Sport Injuries; Shoulder; Anterior Dislocation

Outcome Measures

Primary Outcomes (3)

• Recruitment Feasibility

  Number of patients recruited

  10 months

• Protocol Adherence

  Number of errors in randomization

  2 years

• Follow-up

  Proportion of participants followed at two years

  2 years

Secondary Outcomes (3)

• Rate of Recurrence

  2 years

• Clinical Outcome

  2 years

• Clinical Outcome

  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

Latarjet Procedure PROCEDURE

Participants will undergo open or arthroscopic Latarjet procedure.

Latarjet Procedure

Bankart + Remplissage Procedure PROCEDURE

Participants will undergo arthroscopic stabilization.

Bankart + Remplissage Procedure

Eligibility Criteria

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

You may qualify if:

• Men and women 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;
• Mild 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 (cuff tear);
• Previous shoulder surgery;
• Patients that will likely have problems, in the judgment of the investigators, with maintaining follow-up;
• Epilepsy;
• Patients who are or at risk of being 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

• Moin Khan: lead
• St. Joseph's Healthcare Hamilton: collaborator
• University of Western Ontario, Canada: collaborator
• The Ottawa Hospital: collaborator
• Pan Am Clinic: collaborator
• University of Colorado, Denver: collaborator
• Queen's University: collaborator
• Sunnybrook Health Sciences Centre: collaborator
• Boston University: collaborator
• Deventer Ziekenhuis: collaborator
• Banff Sport Medicine Foundation: collaborator
• McMaster University: collaborator
• Brantford General Hospital: collaborator
• London Health Sciences Centre: collaborator
• Parc de Salut Mar: collaborator
• Hospital Universitari de Bellvitge: collaborator
• Hospital de Terrassa: collaborator
• Hospital Mutua de Terrassa: collaborator
• Pontificia Universidad Catolica de Chile: collaborator
• Endeavor Health: collaborator
• Medstar Health Research Institute: collaborator
• Hospital Universitari Vall d'Hebron Research Institute: collaborator

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. A pilot multicenter randomized controlled trial comparing Bankart repair and remplissage with the Latarjet procedure in patients with subcritical bone loss (STABLE): study protocol. Pilot Feasibility Stud. 2022 Jan 31;8(1):20. doi: 10.1186/s40814-022-00987-4.

  PMID: 35101120 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: SPONSOR INVESTIGATOR
• PI Title: MD, MSc, FRCSC

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 13, 2018
• Study Start: July 1, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)