Recruiting

Latarjet vs. Anatomic Glenoid Reconstruction

Sponsor:

Nova Scotia Health Authority

Code:

NCT05658289

Conditions

Shoulder Dislocation

Bone Loss

Arthroscopy

Eligibility Criteria

Sex: All

Age: 16 - 40

Healthy Volunteers: Accepted

Interventions

Coracoid Transfer

Distal Tibia Allograft with Bankart repair

Study Details

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.

Conditions

Shoulder Dislocation

Bone Loss

Arthroscopy

Study ID

NCT05658289

Start date

Apr 24, 2023

Status verified date

Aug, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 40

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

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.

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.

Primary outcome measure

  • Complication reporting [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

Nova Scotia Health QEII Halifax Infirmary

Recruiting

Halifax, Nova Scotia, Canada, B3H 2E1

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Aug 22, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2024-08-22.