Arthroscopic Stabilization vs Latarjet Procedure for Shoulder Dislocation (STABLE-2 Trial)

N/A

Recruiting

Led By Moin Khan, MD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if two shoulder repair surgeries have different effects on recovery time and function 24 months later.

Who is the study for?

This trial is for men and women aged 18-50 with recurrent shoulder dislocations, specifically those who've had at least two documented episodes. They should have mild bone loss in the shoulder joint but can't be pregnant, have other shoulder injuries, a history of seizures, or any legal or insurance claims related to their injury.

What is being tested?

The STABLE trial is comparing two surgical procedures for recurrent shoulder dislocation: the arthroscopic Bankart Procedure (with or without Remplissage) versus the Latarjet procedure. The goal is to see which one gives better functional recovery after 24 months.

What are the potential side effects?

Potential side effects from these surgeries may include pain at the surgery site, infection risk, limited range of motion, nerve damage around the operated area, and possible re-dislocation or instability of the shoulder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Outcome - Shoulder function

Secondary study objectives

Clinical Outcome

Clinical Outcome - Quality of Life

Clinical Outcome - Shoulder activity

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Latarjet ProcedureExperimental Treatment1 Intervention

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.

Group II: Bankart + Remplissage ProcedureExperimental Treatment1 Intervention

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.

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