Latarjet vs Anatomic Glenoid Reconstruction

NCT ID: NCT05658289

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-24
• Study Completion Date: 2026-12-31

Brief Summary

Anterior shoulder dislocations occur when the humeral head translates anterior to the glenoid cause pain, stiffness, and glenoid bone loss. If left untreated, the risk of recurrence can be up to or greater than 90%. The only surgically modifiable factor to reduce the risk of recurrence is the glenoid bone loss (GBL), where surgeons have the ability to recreate the shape of the glenoid and reduce the risk of recurrent shoulder dislocations.

Established boney procedures for shoulder instability include the Latarjet and free bone block procedures, such as the Anatomic Glenoid Reconstruction (AGR). The Latarjet is well known for its lower rate of recurrent instability, but raises concerns due to under-appreciated complications rates. The AGR is a newer surgical approach that has garnered attention for its low rate of recurrent instability and complication profile. Both treatments can reduce pain, increase function following surgery and reduce the risk of recurrent instability. However, these two established approaches have yet to be directly compared and studied on a larger scale.

The purpose of this randomized control trial is to compare clinical and radiographic outcomes pre- and post-operatively between the Latarjet to the AGR.

Detailed Description

Anterior shoulder dislocations are painful and highly prevalent. If left untreated, rates of recurrence can be up to and greater than 90%. The risk of recurrence room is increased with younger age (< 40), male sex, hyperlaxity, participation in contact sports, and GBL. From these factors, GBL is the only modifiable factor and surgical intervention is required. Managing the bone deficiency for instances of shoulder instability has proven to be a surgical challenge.

Established boney procedures for shoulder instability include the open and arthroscopic Latarjet and open and arthroscopic free bone block interventions. Latarjet is considered the gold standard for treating anterior shoulder instability with bone loss, where the coracoid process is cut and transferred with the conjoin tendon through the subscapularis. The coracoid process is then fixed to the anterior glenoid increasing glenohumeral surface area and stability by the addition of the sling effect. Latarjet has proven to result in low recurrent instability but raises concerns due to underappreciated complication rates (15-30%). The arthroscopic glenoid reconstruction (AGR) with distal tibia allograft is an arthroscopic bone block procedure that has recently garnered attention for its low rate of recurrent instability and complications, high levels of patient satisfaction and avoidance of splitting the subscapularis tendon. AGR with a distal tibia uses a new far medial portal, (i.e., Halifax portal) to avoid damaging the neurovascular or musculature while allowing for anatomic repair of the glenoid.

This randomized control trial will compare the gold standard Latarjet to the AGR. This study aims to randomize 68 individuals who experience anterior shoulder instability with GBL. Through a series of clinical and radiographic outcome measures, the study investigators hypothesize the AGR group will demonstrate smaller complication rates, but remain a similar post-operative recurrence rate, and patient reported outcomes. This trial will be the first multi-centre control trial evaluating the Latarjet to the AGR for patients with critical bone loss (>20%). This research has the potential to demonstrate clinical efficacy of a procedure that is safer, more anatomic, with less damage to the subscapular muscle, and an easier revision surgery.

Conditions

Shoulder Dislocation; Bone Loss; Arthroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Latarjet

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.

Group Type: ACTIVE_COMPARATOR

Coracoid Transfer

Intervention Type: PROCEDURE

For patients randomized to the active comparator group, the coracoid process and conjoined tendon will be cut and transferred to the anterior rim of the glenoid through an incision in the subscapularis muscle.

Anatomic Glenoid Reconstruction

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 Type: EXPERIMENTAL

Distal Tibia Allograft with Bankart repair

Intervention Type: PROCEDURE

For the experimental group, a distal tibia allograft will be prepped, cut (20mm x 10mm x 15mm), and inserted into the anterior aspect of the shoulder through a far medial portal. The distal tibia allograft will be attached to the anterior glenoid using cannulated screws. A soft tissue repair, Bankart repair, is performed above the graft.

Interventions

Coracoid Transfer

For patients randomized to the active comparator group, the coracoid process and conjoined tendon will be cut and transferred to the anterior rim of the glenoid through an incision in the subscapularis muscle.

Intervention Type: PROCEDURE

Distal Tibia Allograft with Bankart repair

For the experimental group, a distal tibia allograft will be prepped, cut (20mm x 10mm x 15mm), and inserted into the anterior aspect of the shoulder through a far medial portal. The distal tibia allograft will be attached to the anterior glenoid using cannulated screws. A soft tissue repair, Bankart repair, is performed above the graft.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with one or more instances of anterior shoulder dislocation; pre-operative CT scan illustrating >20% bone loss.

Exclusion Criteria

• posterior shoulder instability; multidirectional shoulder instability; massive rotator cuff teats (MRI proven); history of substance abuse, patients unable to provide informed consent, patients refusing randomization.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Ivan Wong, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ivan Wong, MD

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority, Orthopaedic Surgeon

Locations

Nova Scotia Health QEII Halifax Infirmary

Halifax, Nova Scotia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Ivan Wong, MD

Role: CONTACT

research@drivanwong.com

9024737626

Sarah Remedios, MSc

Role: CONTACT

research@drivanwong.com

9024737626

Facility Contacts

Sarah Remedios, MSc

Role: primary

Other Identifiers

LatarjetAGR

Identifier Type: -

Identifier Source: org_study_id