Remplissage vs Latarjet Procedure for Shoulder Dislocation

Recruiting at 1 trial location

Overseen By Stacey Wanlin

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Osteoarthritis, Previous surgery, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Surgical procedure with immediate post-operative care

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for individuals over 14 years old who have had more than one shoulder dislocation and show a Hill-Sachs defect on MRI or CT scans, with less than 20% bone loss in the glenoid. It's not suitable for those who don't meet these specific conditions.

Inclusion Criteria

anterior shoulder instability (>1 dislocation)

age >14 years

evidence of a Hill-Sachs defect on MRI or CT

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either arthroscopic Bankart repair and Remplissage or open Latarjet coracoid transfer for shoulder instability

Surgical procedure with immediate post-operative care

Follow-up

Participants are monitored for safety, effectiveness, and post-operative outcomes using various assessments

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Bankart Repair plus Remplissage
• Latarjet coracoid transfer

Trial Overview The study compares two surgical methods for recurrent shoulder instability: arthroscopic Bankart repair plus Remplissage versus open Latarjet coracoid transfer, to see which is more effective in patients with subcritical bone loss.

How Is the Trial Designed?

Group I: Bankart Repair and Remplissage Active Control 1 Intervention

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.

Group II: Latarjet Coracoid Transfer Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Panam Clinic

Collaborator

Trials

17

Recruited

1,500+