Shoulder Instability Surgery: Latarjet Technique With Surgical Tape Versus Screw Fixation (ESTABLE)
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Madrid
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Madrid, Madrid, Spain, 28046
- Hospital Universitario La Paz
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Screw fixation
Latarjet technique with screw fixation
|
This intervation is based on coracoid fixation using screws
Other Names:
|
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Active Comparator: Tape cerclage fixation
Latarjet technique fixed with cerclage fixation
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Latarjet procedure with coracoid fixation using a metal free technique with suture tape cerclage
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
12 months postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ROWE score
Time Frame: 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. |
12 months
|
|
VAS score
Time Frame: 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. |
12 months
|
|
Return to sports
Time Frame: 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). |
12 months
|
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Radiological graft union
Time Frame: 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 |
3 months and 12 months
|
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Postoperative complications
Time Frame: 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). |
12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Griesser MJ, Harris JD, McCoy BW, Hussain WM, Jones MH, Bishop JY, Miniaci A. Complications and re-operations after Bristow-Latarjet shoulder stabilization: a systematic review. J Shoulder Elbow Surg. 2013 Feb;22(2):286-92. doi: 10.1016/j.jse.2012.09.009.
- Hachem AI, Ahmed U, Ixtacuy LR, Molina-Creixell A, Campagnoli A, Rius X. Open Latarjet with Metal-Free Cerclage Fixation. Arthrosc Tech. 2023 Mar 3;12(4):e465-e475. doi: 10.1016/j.eats.2022.11.030. eCollection 2023 Apr.
- Jos S, Sanu S, J A, Thomas M L, Paulose B. Arthroscopic Latarjet Procedure Using FiberTape Cerclage With a Simplified Technique for Suture Passage and Coracoid Fixation. Arthrosc Tech. 2022 Jun 21;11(7):e1277-e1287. doi: 10.1016/j.eats.2022.03.011. eCollection 2022 Jul.
- Provencher MT, Aman ZS, LaPrade CM, Bernhardson AS, Moatshe G, Storaci HW, Chahla J, Turnbull TL, LaPrade RF. Biomechanical Comparison of Screw Fixation Versus a Cortical Button and Self-tensioning Suture for the Latarjet Procedure. Orthop J Sports Med. 2018 Jun 14;6(6):2325967118777842. doi: 10.1177/2325967118777842. eCollection 2018 Jun.
- Ganokroj P, Dey Hazra M, Dey Hazra RO, Brady AW, Brown JR, Rupp MC, Garcia AR, Whalen RJ, Millett PJ, Provencher MT. Biomechanical Evaluation of the 2 Different Levels of Coracoid Graft Positions in the Latarjet Procedure for Anterior Shoulder Instability. Orthop J Sports Med. 2023 Dec 22;11(12):23259671231202533. doi: 10.1177/23259671231202533. eCollection 2023 Dec.
- Vetoshkin AA, Mikhaylova KD. Learning curve in the arthroscopic Latarjet procedure: An analysis of the first 171 cases. J Orthop. 2023 Nov 30;50:58-64. doi: 10.1016/j.jor.2023.11.048. eCollection 2024 Apr.
- Boileau P, Mercier N, Roussanne Y, Thelu CE, Old J. Arthroscopic Bankart-Bristow-Latarjet procedure: the development and early results of a safe and reproducible technique. Arthroscopy. 2010 Nov;26(11):1434-50. doi: 10.1016/j.arthro.2010.07.011.
- Gupta A, Delaney R, Petkin K, Lafosse L. Complications of the Latarjet procedure. Curr Rev Musculoskelet Med. 2015 Mar;8(1):59-66. doi: 10.1007/s12178-015-9258-y.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC2025.639
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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