Recurrent Anterior Shoulder InstabilitySCIFI-LNCT07756827
Surgical Stabilization of Anterior Shoulder Instability Using the Open Latarjet Procedure, With or Without Anterior Capsuloplasty Using the Coracoacromial Ligament.
A study testing Capsuloplasty and No capsuloplasty in people with Recurrent Anterior Shoulder Instability, run by Clinique Générale dAnnecy at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Anterior Shoulder Instability
- What is being tested?
- Capsuloplasty and No capsuloplasty
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2026to 1 Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique Générale d'Annecy
Annecy, 74000
Marion Mandon, PhD, +33678277672, drc@vivalto-sante.com
About this study
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.
- Conditions
- Recurrent Anterior Shoulder Instability
- Being tested
- Capsuloplasty, No capsuloplasty
- Keywords
- Anterior shoulder instability, Latarjet procedure, Pilot randomized controlled trial, Return to sport, Functional outcomes, Coracoacromial ligament, Kinesiophobia
- Medical subject headings
- Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsuloplastyProcedure or surgery
Capsuloplasty consists of an augmentation via transfer of the acromiocoracoid ligament attached to the native capsule following coracoid fixation
No capsuloplastyProcedure or surgery
Capsular closure will be performed without any additional procedure
| Study group | Role | What they receive |
|---|---|---|
| Open Latarjet procedure without capsuloplasty using the coracoacromial ligament | Sham comparator | No capsuloplasty Receives: Procedure: No capsuloplasty |
| Open Latarjet procedure with capsuloplasty using the coracoacromial ligament | Experimental | capsuloplasty Receives: Procedure: Capsuloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start3 Sep 2026
- Primary completion1 Feb 2031 (estimated)
- Study completion1 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Anterior Shoulder InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Générale dAnnecy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756827
- Sponsor's protocol ID
- 2026-18-CGA
- Acronym
- SCIFI-L
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Stabilization of Anterior Shoulder Instability Using the Open Latarjet Procedure, With or Without Anterior Capsuloplasty Using the Coracoacromial Ligament.
- ClinicalTrials.gov ID
- NCT07756827
- Acronym / sponsor ID
- SCIFI-L / 2026-18-CGA
- Conditions
- Recurrent Anterior Shoulder Instability
- Keywords
- Anterior shoulder instability, Latarjet procedure, Pilot randomized controlled trial, Return to sport, Functional outcomes, Coracoacromial ligament, Kinesiophobia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Clinique Générale dAnnecyUniversity, hospital or other
- Study start
- 3 Sep 2026 (actual)
- Primary completion
- 1 Feb 2031 (estimated)
- Study completion
- 1 Feb 2031 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Latarjet procedure without capsuloplasty using the coracoacromial ligament | Sham comparator | Procedure: No capsuloplastyNo capsuloplasty |
| Open Latarjet procedure with capsuloplasty using the coracoacromial ligament | Experimental | Procedure: Capsuloplastycapsuloplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapsuloplastyCapsuloplasty consists of an augmentation via transfer of the acromiocoracoid ligament attached to the native capsule following coracoid fixation | Procedure or surgery | Open Latarjet procedure with capsuloplasty using the coracoacromial ligament |
| No capsuloplastyCapsular closure will be performed without any additional procedure | Procedure or surgery | Open Latarjet procedure without capsuloplasty using the coracoacromial ligament |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
Related trials for Recurrent Anterior Shoulder Instability
Active, not recruiting
Remplissage Versus Latarjet Coracoid Transfer for Recurrent Shoulder Instability
Shoulder Dislocation
Recruiting
Surgical Treatment of Recurrent Shoulder Dislocations
Shoulder Instability
Recruiting
Labroplasty in Cases of Anterior Shoulder Instability With Subcritical Glenoid Bone Loss
Recurrent Anterior Shoulder Instability
Not yet recruitingObservational study
Shoulder Dislocation: Assessment of Lesions, Trajectories and Outcomes (SALTO)
Anterior Shoulder Dislocation, Shoulder Dislocation Closed Traumatic
Active, not recruiting
The Arthroscopic Treatment of Recurrent Anterior Shoulder Instability
Shoulder Dislocation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsuloplasty and No capsuloplasty in people with Recurrent Anterior Shoulder Instability, run by Clinique Générale dAnnecy at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geert Alexander BUIJZE, Dr (0450330950, gabuijze@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the feasibility of the protocol by estimating participant recruitment and retention rates (time frame: 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.