The Arthroscopic Treatment of Recurrent Anterior Shoulder Instability

NCT02510625 | Active Not Recruiting DMC

• 1 other identifier: 2016-035
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to investigate arthroscopic treatments of recurrent anterior shoulder instability. Functional outcomes of arthroscopic anatomic glenoid reconstruction with bone graft will be compared to the gold standard, arthroscopic Bankart repair. The investigators hypothesize that arthroscopic anatomic glenoid reconstruction with bone graft will provide better functional outcomes and decreased risk of recurrent dislocation/subluxation. This will be a single center, double blinded, randomized controlled trial performed in Halifax, Nova Scotia, Canada. The primary outcome measured will be the Western Ontario Shoulder Instability (WOSI) score. Secondary outcomes will be subluxation, re-dislocation, and range of motion. A minimum of 200 patients will be enrolled in the study as determined by sample size calculation. Routine radiographs as well as a pre-operative CT with 3D reconstruction and MRI are obtained for all patients. The patients will then undergo a clinical examination and complete a variety of functional and quality of life surveys. Randomization will be based on surgeon skill. Two groups (Bankart repair and anatomic glenoid reconstruction) will be selected with 100 subjects each. Postoperatively, patients in both groups will follow a standardized rehabilitation protocol. The patient will follow-up with the attending surgeon at 2 weeks post-operatively for a wound check. At the 3, 6, 12, and 24 month visits the patient will again undergo the structured clinical examination conducted by a physiotherapist who is blinded to the patients' treatment group. The patient will also complete the questionnaires at each of these follow-up appointments. Complications, and subluxation/dislocation events will be documented at each follow-up evaluation. On the basis of a clinical examination and patient history, the surgeon will diagnose recurrent instability and categorize it as a traumatic or atraumatic subluxation or dislocation.

Conditions

Shoulder Dislocation

Outcome Measures

Primary Outcomes (1)

• WOSI Score

  Western Ontario Shoulder Instability (WOSI) is being used as a disease-specific outcome measure.

  2 years

Secondary Outcomes (1)

• Recurrent Instability

  2 years

Study Arms (2)

Bankart repair

ACTIVE COMPARATOR

Arthroscopic bankart repair

Procedure: Arthroscopic bankart Repair

Anatomic Glenoid Reconstruction

EXPERIMENTAL

Arthroscopic distal tibia bone graft

Procedure: Anatomic Glenoid Reconstruction

Interventions

Anatomic Glenoid Reconstruction PROCEDURE

Distal tibia bone graft

Also known as: Cannulated Bristow-Latarjet Instability Shoulder System (Depuy-Mitek, MA, USA).

Anatomic Glenoid Reconstruction

Arthroscopic bankart Repair PROCEDURE

Arthroscopic bankart Repair

Bankart repair

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• or more documented incidences of anterior glenohumeral dislocation

You may not qualify if:

• Uncontrolled diabetes (Hgb A1C \>7%
• Prior surgery of affected shoulder
• Pregnancy
• Multidirectional instability
• Posterior instability
• Paralysis of the shoulder
• Cancer
• Severe systemic illness

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H2E1, Canada

Location

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

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

Study Officials

• Ivan H Wong, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Ivan Wong

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 29, 2015
• Study Start: September 1, 2015
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)