Latarjet vs Anatomic Glenoid Reconstruction

NCT05658289 | Recruiting

• 1 other identifier: LatarjetAGR
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Complication reporting

  Complications reported any time from surgery to post-surgery will be compared.

  2 years

Secondary Outcomes (7)

• Recurrent Instability

  2 years

• American Shoulder and Elbow Surgeon (ASES) Assessment Form

  1 and 2 years

• Western Ontario Shoulder Instability (WOSI) Index

  1 and 2 years

• EQ5D-5L

  1 and 2 years

• Radiographic measure - subscapularis muscle volume

  1 year

Study Arms (2)

Latarjet

ACTIVE COMPARATOR

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.

Procedure: Coracoid Transfer

Anatomic Glenoid Reconstruction

EXPERIMENTAL

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.

Procedure: Distal Tibia Allograft with Bankart repair

Interventions

Coracoid Transfer 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.

Latarjet

Distal Tibia Allograft with Bankart repair 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.

Anatomic Glenoid Reconstruction

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Nova Scotia Health QEII Halifax Infirmary

Halifax, Nova Scotia, B3H 2E1, Canada

RECRUITING

MeSH Terms

Conditions

Shoulder Dislocation; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries; Bone Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ivan Wong, MD

  Nova Scotia Health Authority, Orthopaedic Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan Wong, MD

CONTACT

9024737626; research@drivanwong.com

Sarah Remedios, MSc

CONTACT

9024737626; research@drivanwong.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant will be unaware of the procedure they were randomized to until the 1-year time point.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients that have consented to the study have a 50% chance of being randomized to 1 of 2 surgical procedures.

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 20, 2022
• Study Start: April 24, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)