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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique Générale dAnnecy

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Capsuloplasty

    Procedure/Surgery

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

  • No capsuloplasty

    Procedure/Surgery

    Capsular closure will be performed without any additional procedure

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Open Latarjet procedure without capsuloplasty using the coracoacromial ligamentSham comparator 1 intervention
Group B: Open Latarjet procedure with capsuloplasty using the coracoacromial ligamentExperimental treatment 1 intervention

Trial outcomes

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

Time frame
12 months post-surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

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