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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07756827

Acronym

SCIFI-L

Enrollment

Registered

2026-08-11

Start date

2026-09-03

Completion date

2031-02-01

Last updated

2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Anterior Shoulder Instability

Keywords

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

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.

Interventions

PROCEDURECapsuloplasty

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

PROCEDURENo capsuloplasty

Capsular closure will be performed without any additional procedure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

France

Contacts

CONTACTGeert Alexander BUIJZE, Dr

gabuijze@hotmail.com0450330950

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026