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

NCT07457931 | Active Not Recruiting

• 1 other identifier: EC2025.639
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Latarjet; Anterior Shoulder Instability; Anterior Shoulder Dislocation; Shoulder Instability; Shoulder

Keywords

latarjet; cerclage; screws; shoulder; instability; anterior

Outcome Measures

Primary Outcomes (1)

• WOSI score

  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 Outcomes (5)

• 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

Study Arms (2)

Screw fixation

ACTIVE COMPARATOR

Latarjet technique with screw fixation

Procedure: Metal screw fixation of the coracoid graft during the Latarjet procedure.

Tape cerclage fixation

ACTIVE COMPARATOR

Latarjet technique fixed with cerclage fixation

Procedure: High-strength suture tape cerclage fixation of the coracoid graft during the Latarjet procedure.

Interventions

Metal screw fixation of the coracoid graft during the Latarjet procedure. PROCEDURE

This intervation is based on coracoid fixation using screws

Also known as: Latarjet, screw, fixation

Screw fixation

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

Latarjet procedure with coracoid fixation using a metal free technique with suture tape cerclage

Also known as: suture tape, cerclage, latarjet

Tape cerclage fixation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Juan Ameztoy: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Related Publications (8)

• 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.

  PMID: 37138684 BACKGROUND

• 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.

  PMID: 35936836 BACKGROUND

• 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.

  PMID: 29977940 BACKGROUND

• 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.

  PMID: 38145219 BACKGROUND

• 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.

  PMID: 38173830 BACKGROUND

• 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.

  PMID: 21035007 BACKGROUND

• 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.

  PMID: 23352473 BACKGROUND

• 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.

  PMID: 25644052 BACKGROUND

MeSH Terms

Interventions

Cerclage, Cervical

Intervention Hierarchy (Ancestors)

Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 9, 2026
• Study Start: March 3, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)