Remplissage Versus Latarjet Coracoid Transfer for Recurrent Shoulder Instability

NCT03453710 | Recruiting

• 1 other identifier: 111328
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This is a pilot study designed as a prospective, randomized controlled trial comparing arthroscopic Bankart repair and Remplissage with an open Latarjet coracoid transfer for the treatment of recurrent anterior glenohumeral instability with subcritical bone loss.

Conditions

Shoulder Dislocation

Keywords

Bankart Repair; Remplissage; Latarjet coracoid transfer

Outcome Measures

Primary Outcomes (1)

• Western Ontario Shoulder Instability (WOSI) Score

  Western Ontario Shoulder Instability (WOSI) questionnaire is a tool designed for self-assessment of shoulder function for patients with instability problems. Difference between study arm outcomes will be assessed using pre-op and post-op WOSI score as a covariate. This questionnaire has 21 questions, each scored on a scale from 0 to 100, with 0 being the best score (no limitations related to the shoulder) and 100 representing the worst score. Overall, the questionnaire is scored as a percentage of the maximum score of 2100 points. There are subscale components reporting on: physical symptoms (questions 1 through 10; maximum score of 1000); sports/recreation/work (questions 11 through 14; maximum score 400); lifestyle (questions 15 through 18; maximum score 400); and emotion (questions 19-21; maximum score 300). Subscale scores are added to determine the total score out of a possible 2100 points, with 2100, or 100%, representing the worst possible score.

  24 months

Secondary Outcomes (5)

• Pain numeric rating scale (NRS)

  24 months

• Simple Shoulder Test (SST)

  24 months

• American Shoulder and Elbow Society (ASES) assessment

  24 months

• Range of motion

  24 months

• Post-operative complications

  24 months

Study Arms (2)

Bankart Repair and Remplissage

ACTIVE COMPARATOR

Patients randomized to the all-arthroscopic group (Bankart repair and remplissage) will undergo a standard arthroscopic anterior labral repair with a minimum of 3 suture anchors, followed by remplissage with 1 or 2 anchors, at the discretion of the treating surgeon.

Procedure: Bankart Repair plus Remplissage

Latarjet Coracoid Transfer

ACTIVE COMPARATOR

Patients randomized to the open Latarjet coracoid transfer will undergo a Latarjet coracoid transfer through a deltopectoral approach and horizontal split in the subscapularis at the superior 2/3, inferior 1/3 junction. The coracoid process will be oriented in the conventional manner, with the inferior surface against the glenoid vault, secured with two cannulated screws

Procedure: Latarjet coracoid transfer

Interventions

Bankart Repair plus Remplissage PROCEDURE

Arthroscopic Bankart repair with a minimum of 3 anchors 1 or 2 anchor Remplissage subsequently performed with percutaneous anchor insertion in the base of the Hill-Sachs defect, and sutures passed in a horizontal mattress configuration 1 cm apart, tied in the subacromial space.

Bankart Repair and Remplissage

Latarjet coracoid transfer PROCEDURE

Coracoid transfer performed via deltopectoral approach with horizontal subscapularis split. Graft placed in the conventional orientation, secured with 2 screws, ensuring the graft is not lateral to the glenoid rim.

Latarjet Coracoid Transfer

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• anterior shoulder instability (\>1 dislocation)
• age \>14 years
• evidence of a Hill-Sachs defect on MRI or CT,
• \< 20% anteroposterior glenoid bone loss

You may not qualify if:

• \>20% anteroposterior glenoid bone loss
• significant shoulder comorbidities (i.e., osteoarthritis, previous surgery other than previous instability), active joint or systemic infection, significant muscle paralysis, rotator cuff or Charcot's arthropathy,
• significant medical comorbidity that may alter effectiveness of surgical intervention
• major medical illness,
• unable to speak French or English,
• psychiatric illness that precludes informed consent,
• unwilling to be followed for 2 years

Sponsors & Collaborators

• Western University, Canada: lead
• Panam Clinic: collaborator

Study Sites (2)

Pan Am Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

RECRUITING

Fowler Kennedy Sport Medicine Clinic

London, Ontario, N6A 3K7, Canada

RECRUITING

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Stacey Wanlin

CONTACT

519-661-3111; swanlin@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients will be evaluated by a blinded study nurse, unaware of treatment allocation, for administration of baseline questionnaires, as well as subsequent post-operative questionnaires.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized controlled trial

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 5, 2018
• Study Start: October 1, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)