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Clinical Trials in Canada / NCT05658289
Recruiting Not applicable

Latarjet vs Anatomic Glenoid Reconstruction

NCT05658289 · tracked via the Priya Life Science Canada tracker
Sponsor
Nova Scotia Health Authority
Phase
Not applicable
Started
2023-04-24
Last updated
2024-08-22

Condition(s) studied

Shoulder DislocationBone LossArthroscopy

Investigational drug(s) / intervention(s)

Coracoid TransferDistal Tibia Allograft with Bankart repair

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.

Study 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.

Eligibility

Sex
ALL
Min age
16 Years
Max age
40 Years
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Nova Scotia Health QEII Halifax Infirmary Halifax Nova Scotia Recruiting

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Other trials for the same condition

Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode. Starting soon
Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared With Latarjet Procedure Evaluation - STABLE Definitive Trial Active, not recruiting
Remplissage Versus Latarjet Coracoid Transfer for Recurrent Shoulder Instability Active, not recruiting
Strength Training for Osteoporosis Prevention During Early Menopause Active, not recruiting
RCT Evaluating First Time Shoulder Dislocation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05658289 on ClinicalTrials.gov ↗ ← All trials in Canada