Anterior Shoulder Dislocation, Anterior Shoulder Instability, Latarjet, Shoulder, Shoulder Instability
Conditions
Keywords
latarjet, cerclage, screws, shoulder, instability, anterior
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. 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.
Interventions
PROCEDUREMetal screw fixation of the coracoid graft during the Latarjet procedure.
This intervation is based on coracoid fixation using screws
PROCEDUREHigh-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
Sponsors
Juan Ameztoy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WOSI score | 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
| Measure | Time frame | Description |
|---|---|---|
| ROWE score | 12 months | A secondary outcome of this study is shoulder stability and functional outcome at 12 months following surgery, assessed using the ROWE Score. The ROWE Score is a validated clinical scoring system specifically developed to evaluate outcomes in patients with shoulder instability. It assesses three main components: stability (50 points), motion (20 points), and function (30 points), with a total possible score of 100 points. Higher scores indicate better shoulder stability and function. The total ROWE Score at 12 months postoperatively will be compared between the two study groups: high-strength suture tape cerclage fixation and metal screw fixation of the coracoid graft during the Latarjet procedure. |
| VAS score | 12 months | A secondary outcome of this study is postoperative shoulder pain at 12 months, assessed using the Visual Analog Scale (VAS). The VAS is a validated and widely used patient-reported measure of pain intensity. It consists of a 10-centimeter horizontal line anchored by two extremes: "no pain" (0) and "worst imaginable pain" (10). Patients are asked to indicate the point on the line that best represents their current level of shoulder pain. The score is recorded as a numerical value from 0 to 10, with higher scores indicating greater pain intensity. Pain levels at 12 months following surgery will be compared between the two study groups: high-strength suture tape cerclage fixation and metal screw fixation of the coracoid graft in the Latarjet procedure. |
| Return to sports | 12 months | A secondary outcome of this study is return to sport following surgery, evaluated at 12 months postoperatively. Return to sport will be defined as the patient's ability to resume participation in sports activities at the same or lower level compared to pre-injury status. Information will be collected regarding whether the patient has returned to sport (yes/no), the level of performance achieved (same level, lower level, or unable to return), and the time elapsed from surgery to return to sport (measured in months). |
| Radiological graft union | 3 months and 12 months | A secondary outcome of this study is radiological consolidation of the coracoid graft at 12 months following surgery. Graft union will be assessed using computed tomography (CT) scans performed at 3 and 12 months postoperatively. Radiological consolidation will be defined as the presence of continuous trabecular bone bridging between the coracoid graft and the native glenoid bone, without radiolucent lines suggestive of non-union |
| Postoperative complications | 12 months | A secondary outcome of this study is the incidence of postoperative complications within 12 months following surgery. Complications will include both early and late adverse events related to the surgical procedure or the fixation method. Specifically, the following events will be recorded: coracoid graft fracture, significant graft resorption, graft malposition, fixation device malposition or failure, non-union, recurrent instability, infection, neurovascular injury, and need for reoperation (including hardware removal or revision surgery). |
Countries
Spain
Outcome results
None listed