Surgical Stabilization of Anterior Shoulder Instability Using the Open Latarjet Procedure, With or Without Anterior Capsuloplasty Using the Coracoacromial Ligament.

NCT07756827 | Not Yet Recruiting

• 1 other identifier: 2026-18-CGA
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

This pilot study aims to explore the feasibility and relevance of comparing the open Latarjet procedure performed with and without capsular repair (via coracoacromial ligament transfer) in patients with recurrent anterior shoulder instability. It will also generate preliminary data on potential differences between the two techniques regarding stability, complications, range of motion, and functional outcomes-from an exploratory standpoint, without aiming to formally demonstrate efficacy. The study results could generate hypotheses to better define the role of capsular repair in the Latarjet procedure and guide the design of a future, adequately powered randomized controlled trial, taking into account not only mechanical outcomes but also functional and psychological dimensions.

Conditions

Recurrent Anterior Shoulder Instability

Keywords

Anterior shoulder instability; Latarjet procedure; Pilot randomized controlled trial; Return to sport; Functional outcomes; Coracoacromial ligament; Kinesiophobia

Outcome Measures

Primary Outcomes (1)

• Evaluate the feasibility of the protocol by estimating participant recruitment and retention rates

  The feasibility of the study will be assessed via participant recruitment and retention rates

  12 months post-surgery

Study Arms (2)

Open Latarjet procedure without capsuloplasty using the coracoacromial ligament

SHAM COMPARATOR

No capsuloplasty

Procedure: No capsuloplasty

Open Latarjet procedure with capsuloplasty using the coracoacromial ligament

EXPERIMENTAL

capsuloplasty

Procedure: Capsuloplasty

Interventions

Capsuloplasty PROCEDURE

Capsuloplasty consists of an augmentation via transfer of the acromiocoracoid ligament attached to the native capsule following coracoid fixation

Open Latarjet procedure with capsuloplasty using the coracoacromial ligament

No capsuloplasty PROCEDURE

Capsular closure will be performed without any additional procedure

Open Latarjet procedure without capsuloplasty using the coracoacromial ligament

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recurrent anterior shoulder instability with critical glenoid bone loss and a potential concomitant Hill-Sachs lesion requiring surgical management.
• Patients must be able to provide written informed consent and be willing to adhere to the postoperative rehabilitation protocol and the scheduled follow-up.

You may not qualify if:

• History of bone stabilization procedures on the affected shoulder
• Multidirectional shoulder instability
• Full-thickness rotator cuff tear
• Neuromuscular disorder affecting shoulder function and range of motion
• Active infection, inflammatory arthritis, or tumor affecting the shoulder region
• Patients unable or unwilling to participate in the study or to undergo follow-up assessments
• Individuals deprived of liberty, in pre-trial detention, or under guardianship, curatorship, or judicial protection
• Individuals undergoing psychiatric care
• Individuals not affiliated with a social security scheme

Sponsors & Collaborators

• Clinique Générale dAnnecy: lead

MeSH Terms

Conditions

Kinesiophobia

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Central Study Contacts

Geert Alexander BUIJZE, Dr

CONTACT

0450330950; gabuijze@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): February 1, 2031
• Study Completion (Estimated): February 1, 2031
• Last Updated: August 11, 2026

Record last verified: 2026-08