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Recruiting Not applicable

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

NCT07756827 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-09-03
Last updated
2026-09-10

Condition(s) studied

Recurrent Anterior Shoulder Instability

Investigational drug(s) / intervention(s)

CapsuloplastyNo capsuloplasty

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

No capsuloplasty: Capsular closure will be performed without any additional procedure

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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

Primary outcome measure(s)

  • Evaluate the feasibility of the protocol by estimating participant recruitment and retention rates — 12 months post-surgery
    The feasibility of the study will be assessed via participant recruitment and retention rates

Trial sites (1)

FacilityCityRegionStatus
Clinique Générale d'Annecy Annecy France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07756827 on ClinicalTrials.gov ↗ ← All trials in France