What is the mechanism of action of this treatment?

The Latarjet procedure and Anatomic Glenoid Reconstruction (AGR) are surgical treatments designed to address recurrent shoulder dislocations by reconstructing the glenoid, the socket part of the shoulder joint. The Latarjet procedure involves transferring a piece of bone with an attached tendon from the shoulder blade to the front of the glenoid, which increases the glenoid's surface area and provides a physical block to prevent dislocation. AGR, on the other hand, uses a bone graft to anatomically restore the original shape and size of the glenoid. Both procedures aim to reduce the risk of recurrent dislocations, improve shoulder stability, and enhance overall shoulder function. These treatments are crucial for patients as they address the underlying structural issues that contribute to recurrent dislocations, thereby reducing pain, improving function, and preventing further joint damage.

What side effects are associated with this type of intervention?

The Latarjet procedure, used to treat recurrent shoulder dislocations, is known for its effectiveness but also has a notable complication rate. Common side effects include infection, nerve injury, and issues related to the hardware used in the surgery. Additionally, there is a risk of nonunion or malunion of the bone graft. Anatomic Glenoid Reconstruction (AGR) is a newer approach with a lower rate of recurrent instability and fewer complications reported. However, as with any surgical procedure, potential side effects include infection, graft failure, and nerve damage. Both procedures aim to reduce pain and improve function but require careful consideration of the associated risks.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the surgical treatment of shoulder dislocation, such as the Latarjet or Anatomic Glenoid Reconstruction procedures. These treatments are surgical interventions aimed at reconstructing the glenoid to reduce the risk of recurrent shoulder dislocations. The focus of these procedures is on anatomical repair rather than pharmacological treatment. For non-surgical management, treatments may include physical therapy, immobilization, and pain management with NSAIDs or other analgesics, but these do not directly address the structural issues targeted by the Latarjet or Anatomic Glenoid Reconstruction.

What other types of research exist?

Promising novel alternatives to Latarjet and Anatomic Glenoid Reconstruction for shoulder dislocation patients include arthroscopic remplissage and the use of suture anchors for soft tissue repair. Arthroscopic remplissage involves filling the Hill-Sachs lesion with the infraspinatus tendon and posterior capsule, which can prevent engagement of the lesion with the glenoid rim. Suture anchors for soft tissue repair can provide a less invasive option with potentially fewer complications and quicker recovery times.

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Procedure

Latarjet Procedure vs Anatomic Glenoid Reconstruction for Shoulder Dislocation

N/A

Recruiting

Led By Ivan Wong, MD

Research Sponsored by Nova Scotia Health Authority

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 and 2 years

Awards & highlights

Summary

This trial compares two surgeries for stabilizing shoulders that frequently dislocate due to bone loss. One method moves a piece of bone and tendon, while the other uses a donor bone graft. The goal is to see which method is safer and more effective.

Who is the study for?

This trial is for individuals who have experienced one or more anterior shoulder dislocations and show over 20% bone loss on a pre-operative CT scan. It's not suitable for those with posterior or multidirectional instability, massive rotator cuff tears, substance abuse history, or inability to consent or accept random treatment assignment.

What is being tested?

The study compares two surgical methods for treating recurrent shoulder dislocation due to bone loss: Latarjet procedure (coracoid transfer) versus Anatomic Glenoid Reconstruction using distal tibia allograft with Bankart repair. The goal is to assess which surgery offers better clinical and radiographic outcomes post-operation.

What are the potential side effects?

Potential side effects of the surgeries may include pain, stiffness in the shoulder joint, infection risk at the surgical site, nerve damage around the operated area, and complications related to grafting such as graft failure or arthritis development.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 and 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 and 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 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

Complication reporting

Secondary study objectives

American Shoulder and Elbow Surgeon (ASES) Assessment Form

EQ5D-5L

Radiographic measure - glenoid size

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Anatomic Glenoid ReconstructionExperimental Treatment1 Intervention

An allograft will be used for the patients in this group, inserted through a new portal and fixed to the anterior rim of the glenoid to recreate the size of the glenoid.

Group II: LatarjetActive Control1 Intervention

The Latarjet involves the use of a auto-graft to be fixated to the anterior portion of the glenoid to recreate the size of the glenoid.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Latarjet procedure and Anatomic Glenoid Reconstruction (AGR) are surgical treatments designed to address recurrent shoulder dislocations by reconstructing the glenoid, the socket part of the shoulder joint. The Latarjet procedure involves transferring a piece of bone with an attached tendon from the shoulder blade to the front of the glenoid, which increases the glenoid's surface area and provides a physical block to prevent dislocation. AGR, on the other hand, uses a bone graft to anatomically restore the original shape and size of the glenoid. Both procedures aim to reduce the risk of recurrent dislocations, improve shoulder stability, and enhance overall shoulder function. These treatments are crucial for patients as they address the underlying structural issues that contribute to recurrent dislocations, thereby reducing pain, improving function, and preventing further joint damage.

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Who is running the clinical trial?

Nova Scotia Health AuthorityLead Sponsor

286 Previous Clinical Trials

94,196 Total Patients Enrolled

2 Trials studying Shoulder Dislocation

220 Patients Enrolled for Shoulder Dislocation

Ivan Wong, MDPrincipal InvestigatorNova Scotia Health Authority, Orthopaedic Surgeon

4 Previous Clinical Trials

142 Total Patients Enrolled

Media Library

Anatomic Glenoid Reconstruction (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05658289 — N/A

~32 spots leftby Jan 2026

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