ESTABLE: A Randomized Control Trial of Shoulder Instability Using the Latarjet Procedure With Suture Tape Cerclage Versus Screw Fixation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- WOSI score
Study Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Screw fixation
Latarjet technique with screw fixation
Intervention: Metal screw fixation of the coracoid graft during the Latarjet procedure. (Procedure)
Tape cerclage fixation
Latarjet technique fixed with cerclage fixation
Intervention: High-strength suture tape cerclage fixation of the coracoid graft during the Latarjet procedure. (Procedure)
Outcomes
Primary Outcomes
WOSI score
Time Frame: 12 months postoperative
The primary outcome of this study is shoulder-specific functional outcome at 12 months following surgery, measured using the Western Ontario Shoulder Instability Index (WOSI). The WOSI is a validated, disease-specific patient-reported outcome measure designed to assess quality of life and functional impairment in patients with shoulder instability. It consists of 21 items grouped into four domains: physical symptoms, sport/recreation/work function, lifestyle function, and emotional well-being. Each item is scored on a visual analog scale, and the total score ranges from 0 to 2100 points, where lower scores indicate better shoulder function and fewer symptoms. The primary analysis will compare the total WOSI score at 12 months postoperatively between the two study groups: high-strength suture tape cerclage fixation and metal screw fixation of the coracoid graft in the Latarjet procedure.
Secondary Outcomes
- ROWE score(12 months)
- VAS score(12 months)
- Return to sports(12 months)
- Radiological graft union(3 months and 12 months)
- Postoperative complications(12 months)
Investigators
Juan Ameztoy
Medical Doctor
Hospital Universitario La Paz