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Clinical Trials in Spain / NCT07457931
Active, not recruiting Not applicable

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

NCT07457931 · tracked via the Priya Life Science Spain tracker
Sponsor
Juan Ameztoy
Phase
Not applicable
Started
2026-03-03
Last updated
2026-03-11

Condition(s) studied

Shoulder InstabilityShoulderLatarjetAnterior Shoulder InstabilityAnterior Shoulder Dislocation

Investigational drug(s) / intervention(s)

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

Metal screw fixation of the coracoid graft during the Latarjet procedure.: This intervation is based on coracoid fixation using screws

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: * Age between 18 and 50 years at the time of surgery. * Clinical and radiological diagnosis of anterior shoulder instability. * Indication for surgical treatment with the open Latarjet procedure, as determined by the treating surgeon. * Ability to understand the study procedures and provide written informed consent. * Willingness and ability to comply with the postoperative follow-up schedule. Exclusion Criteria: * Multidirectional or posterior shoulder instability. * Previous surgical procedures on the affected shoulder. * Concomitant shoulder pathology requiring additional surgical treatment, including rotator cuff tears, glenohumeral osteoarthritis, or pathology of the long head of the biceps tendon. * Systemic, neurological, or vascular conditions that could affect upper limb function or influence study outcomes. * Contraindication to surgery or general anesthesia. * Inability to complete follow-up assessments or comply with study procedures.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital Universitario La Paz Madrid Madrid

Other trials for the same condition

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 NCT07457931 on ClinicalTrials.gov ↗ ← All trials in Spain