ESTABLE: A Randomized Control Trial of Shoulder Instability Using the Latarjet Procedure With Suture Tape Cerclage Versus Screw Fixation
ESTABLE: A Randomized Control Trial of Shoulder Instability Using the Latarjet Procedure With Suture Tape Cerclage Versus Screw Fixation
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.
This study is designed as a prospective, single-center, randomized clinical trial comparing two methods of coracoid bone graft fixation in the open Latarjet procedure for the treatment of anterior shoulder instability.
Participants will be randomly assigned in a 1:1 ratio to one of two treatment groups. The experimental group will undergo coracoid graft fixation using high-strength suture tape cerclage, while the control group will receive conventional fixation using two metallic screws. Randomization will be performed using permuted blocks.
All surgical procedures will be performed at Hospital Universitario La Paz (Madrid, Spain) by surgeons experienced in shoulder surgery. The surgical approach and operative steps of the Latarjet procedure will be standardized across both groups. The only difference between groups will be the fixation method used to secure the transferred coracoid graft to the anterior glenoid.
In the suture tape cerclage group, fixation will be achieved using interconnected high-strength suture tapes passed through bone tunnel to compress the graft against the glenoid. In the control group, the graft will be fixed using two metallic screws, which represents the conventional fixation technique.
Because of the nature of the surgical intervention, surgeons cannot be blinded to the fixation technique used during the procedure.
Postoperative care and rehabilitation protocols will be standardized for all participants. Clinical follow-up visits will include assessment of shoulder function, pain, return to sports activity, and postoperative complications. Radiological evaluation will be performed using computed tomography to assess graft healing and position.
Inclusion Criteria:
Exclusion Criteria: