ClinicalTrials.gg
RecruitingNCT07756827SCIFI-LUpdated Sep 10, 2026

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

An interventional study of Capsuloplasty and No capsuloplasty in Recurrent Anterior Shoulder Instability, sponsored by Clinique Générale dAnnecy. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Clinique Générale dAnnecy · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Recurrent Anterior Shoulder Instability

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Keywords

  • Anterior shoulder instability
  • Latarjet procedure
  • Pilot randomized controlled trial
  • Return to sport
  • Functional outcomes
  • Coracoacromial ligament
  • Kinesiophobia
03

In context

Kinesiophobia

285 studies on the registry are indexed under Kinesiophobia; 91 are open to participants now.

This study's planned enrollment of 42 is below the median of 52 across 174 interventional studies indexed under Kinesiophobia.

Browse Kinesiophobia studies →

Lead sponsor

Clinique Générale dAnnecy is the lead sponsor of 8 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and be willing to adhere to the postoperative rehabilitation protocol and the scheduled follow-up.

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
42 participants (estimated)

Study arms

  • Sham comparator
    Open Latarjet procedure without capsuloplasty using the coracoacromial ligament

    No capsuloplasty

    Procedure: No capsuloplasty

  • Experimental
    Open Latarjet procedure with capsuloplasty using the coracoacromial ligament

    capsuloplasty

    Procedure: Capsuloplasty

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Feb 2031, 52 months after the start.

Of 132 non-industry interventional studies with no phase under Kinesiophobia, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 14. This study's planned 52 months is above that.

Counting every sponsor, half of 132 studies reached it within 8 months; a quarter within 4 and three quarters within 14.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2026
First posted
Aug 11, 2026
StartActual
Sep 3, 2026
Primary completionEst.
Feb 1, 2031
CompletionEst.
Feb 1, 2031
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07756827
Lead sponsor
Clinique Générale dAnnecy
Responsible party
Sponsor
First posted
Aug 11, 2026
Start date
Sep 3, 2026
Primary completion
Feb 1, 2031 (estimated)
Completion
Feb 1, 2031 (estimated)
Last update
Sep 10, 2026

Study contacts

Geert Alexander BUIJZE, Dr
Contact
gabuijze@hotmail.com
0450330950

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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