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ACTIVE NOT RECRUITING
NCT07457931
NA

Shoulder Instability Surgery: Latarjet Technique With Surgical Tape Versus Screw Fixation

Sponsor: Juan Ameztoy

View on ClinicalTrials.gov

Summary

Anterior shoulder instability is a common condition, particularly in young and active patients, and may lead to recurrente shoulder dislocations, pain, and functional limitations. The open Latarjet procedure is a widely used surgical technique to treat this condition, especially in patients with significant glenoid bone loss. In the traditional Latarjet procedure, the transferred coracoid bone graft is fixed to the anterior glenoid using metallic screws. Although screw fixation provides stable compression, implant-related complications have been reported, including hardware irritation, screw loosening, graft fracture and the need for hardware removal. High-strength suture tape cerclage has been proposed as an alternative fixation method that may reduce implant-related complications while maintaining adequate graft stability. This study aims to compare coracoid graft fixation using high-strength suture tape cerclage versus conventional metallic screw fixation in patients undergoing the Latarjet procedure for anterior shoulder instability. Participants will be randomly assigned in a 1:1 ratio to receive either screw fixation or suture tape cerclage fixation. Clinical and radiological outcomes will be evaluated during postoperative follow-up, including shoulder function, pain, return to sports activity, complications and graft healing. This study will be conducted at Hospital Universitario La Paz (Madrid, Spain), with a planned sample size of approximately 80 patients and a minimum follow-up of 12 months.

Official title: ESTABLE: A Randomized Control Trial of Shoulder Instability Using the Latarjet Procedure With Suture Tape Cerclage Versus Screw Fixation

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-03-03

Completion Date

2027-02-01

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

PROCEDURE

Metal screw fixation of the coracoid graft during the Latarjet procedure.

This intervation is based on coracoid fixation using screws

PROCEDURE

High-strength suture tape cerclage fixation of the coracoid graft during the Latarjet procedure.

Latarjet procedure with coracoid fixation using a metal free technique with suture tape cerclage

Locations (1)

Hospital Universitario La Paz

Madrid, Madrid, Spain