Arthroscopic Stabilization vs Latarjet Procedure for Shoulder Dislocation

Recruiting in Palo Alto (17 mi)

Overseen by Moin Khan, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Moin Khan

No Placebo Group

Trial Summary

What is the purpose of this trial?

The primary objective of the pilot study is to assess the feasibility of a definitive trial to determine the effect of arthroscopic capsuloligamentous repair (Bankart + Remplissage) vs. coracoid transfer (Latarjet procedure) on recurrent dislocation rates and functional outcomes over a 24-month period.

Research Team

Moin Khan, MD

Principal Investigator

McMaster University

Eligibility Criteria

This trial is for adults aged 18-50 with a history of recurrent shoulder dislocation, specifically anterior dislocation confirmed by physical exam or imaging. Candidates should have mild glenoid bone loss and be able to give informed consent. It's not for those with previous shoulder surgery, epilepsy, other shoulder injuries like cuff tears, multidirectional instability, pregnancy, or certain connective tissue disorders.

Inclusion Criteria

My shoulder has dislocated at least twice due to an injury.

I am between 18 and 50 years old.

I have mild shoulder socket bone loss (10-20%).

Exclusion Criteria

Cases involving litigation or workplace insurance claims (e.g. WSIB)

Patients who are or at risk of being incarcerated

You are pregnant.

Treatment Details

Interventions

• Bankart + Remplissage Procedure (Procedure)
• Latarjet Procedure (Procedure)

Trial Overview The study compares two surgical procedures for recurrent shoulder dislocations over a period of 24 months: the Latarjet procedure (coracoid transfer) versus arthroscopic capsuloligamentous repair (Bankart + Remplissage). The goal is to see which one better prevents future dislocations and improves function.

Participant Groups

Group I: Latarjet Procedure Experimental Treatment 1 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 Procedure Experimental Treatment 1 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.

Bankart + Remplissage Procedure is already approved in Canada for the following indications:

Approved in Canada as Bankart Procedure with Remplissage for:

• Recurrent shoulder dislocations
• Anterior shoulder instability

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

St. Joseph's Healthcare Hamilton Hamilton, Canada

Who Is Running the Clinical Trial?

Moin Khan

Lead Sponsor

Trials

1

Patients Recruited

90+

University of Michigan

Collaborator

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1891

Patients Recruited

6,458,000+

Campus Bio-Medico University

Collaborator

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118

Patients Recruited

58,800+

OLVG

Collaborator

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25

Patients Recruited

166,000+

Hospital Universitario La Paz

Collaborator

Trials

127

Patients Recruited

37,900+

Endeavor Health

Collaborator

Trials

135

Patients Recruited

742,000+

Kingston Health Sciences Centre

Collaborator

Trials

312

Patients Recruited

112,000+

University of Western Ontario, Canada

Collaborator

Trials

168

Patients Recruited

320,000+

The Ottawa Hospital

Collaborator

Trials

97

Patients Recruited

64,000+

Pan Am Clinic

Collaborator

Trials

3

Patients Recruited

190+