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Procedure

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

STABLE-2 Trial 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.Check my eligibility

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.See study design

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.

STABLE-2 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical Outcome - Shoulder function

Secondary outcome measures

Clinical Outcome

Clinical Outcome - Quality of Life

Clinical Outcome - Shoulder activity

+5 more

STABLE-2 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

McMaster UniversityLead Sponsor

884 Previous Clinical Trials

2,598,190 Total Patients Enrolled

3 Trials studying Shoulder Dislocation

162 Patients Enrolled for Shoulder Dislocation

Moin Khan, MDPrincipal InvestigatorMcMaster University

4 Previous Clinical Trials

392 Total Patients Enrolled

2 Trials studying Shoulder Dislocation

132 Patients Enrolled for Shoulder Dislocation

Media Library

Bankart + Remplissage Procedure (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05705479 — N/A

Shoulder Dislocation Research Study Groups: Bankart + Remplissage Procedure, Latarjet Procedure

Shoulder Dislocation Clinical Trial 2023: Bankart + Remplissage Procedure Highlights & Side Effects. Trial Name: NCT05705479 — N/A

Bankart + Remplissage Procedure (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05705479 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment of elderly participants being welcomed in this experiment?

"The participants accepted into this study must fall between 18 to 50 years old. For those outside of this age range, there are 31 studies for minors and 30 trials catered towards older adults."

Answered by AI

Are there still opportunities available for individuals to enter this trial?

"According to clinicaltrials.gov, this medical trial is not actively recruiting new candidates at present. The study was initially posted on May 1st 2023 and the latest update occurred on January 27th of that same year. Despite this, there are still 61 other trials seeking participants currently listed online."

Answered by AI

Is there a possibility for me to participate in this experiment?

"This clinical trial is seeking 126 participants aged 18-50 with a diagnosis of recurrent anterior shoulder dislocation. To meet the eligibility requirements, male and female patients must have experienced at least two episodes of dislocations indicated by radiographic evidence or physical examination as well as CT showing mild glenoid bone loss (<20%). In addition, all individuals must provide written consent to participate in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Moin Khan 2023. "Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared With Latarjet Procedure Evaluation - STABLE Definitive Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05705479.