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NCT Number: NCT07756827

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Générale d'Annecy

Annecy, 74000, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capsuloplasty

Procedure

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

No capsuloplasty

Procedure

Capsular closure will be performed without any additional procedure

Primary outcomes

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

    Time frame: 12 months post-surgery

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

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Clinique Générale dAnnecy

Other

Registry information

Acronym: SCIFI-L

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Aug 11, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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