Anterior Shoulder InstabilitySHIELDNCT07715162
Arthroscopic Stabilization of Anterior Shoulder Instability With Subcritical Glenoid Bone Loss
A study testing Arthroscopic Latarjet procedure and Dynamic anterior stabilization (DAS) in people with Anterior Shoulder Instability, run by Clinique Générale dAnnecy at 1 site in France.
Trial summary
Recurrent anterior shoulder instability is a common condition among young and active patients, with a significant impact on function and a high risk of recurrence in the absence of appropriate management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Shoulder Instability
- What is being tested?
- Arthroscopic Latarjet procedure and Dynamic anterior stabilization (DAS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2026to 1 Nov 2030
- 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
- aged 18 or older
- with symptomatic recurrent anterior shoulder instability indicating the need for surgical stabilization
- whose glenoid bone loss must be classified as subcritical, approximately between 13.5% and 20%, according to the criteria defined in the protocol
- with HAGL lesions
- with bone lesions
- capable of providing informed consent and complying with the planned 24-month follow-up
Who cannot join
- with glenoid bone loss exceeding 20%
- with a clear indication for another procedure not covered by the protocol (particularly if routine bone grafting is required and incompatible with the study)
- with a history of bone stabilization of the affected shoulder
- with a transfixing rotator cuff tear or a neurological condition impairing shoulder function
- unable to guarantee adequate follow-up
- under legal guardianship (curatorship, guardianship, or judicial protection)
Show all 9Show fewer
- deprived of liberty by judicial or administrative order
- receiving psychiatric care
- not enrolled in a social security program
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
Official title: Arthroscopic Stabilization of Anterior Shoulder Instability With Subcritical Glenoid Bone Loss: A Comparison Between Dynamic Anterior Stabilization and the Latarjet Procedure
Recurrent anterior shoulder instability is a common condition among young and active patients, with a significant impact on function and a high risk of recurrence in the absence of appropriate management. Quantifying glenoid bone loss has become a central component of the treatment strategy, with losses exceeding 20 % traditionally considered critical and requiring a coracoid transfer according to the Latarjet procedure. Recent data have, however, shown that so-called "subcritical" bone loss, ranging from 13.5 to 20%, may already be associated with unfavorable clinical outcomes, particularly in highly active patients. These patients most often present with associated humeral lesions, such as Hill-Sachs lesions, and sometimes other concomitant lesions such as Humeral Avulsion of the Glenohumeral Ligament, underscoring the need for a comprehensive therapeutic approach.
Two arthroscopic techniques are currently used for this indication. The arthroscopic Latarjet procedure restores glenoid bone stock and improves dynamic stability through the combined effect of the bone block and the sling, while offering reduced morbidity compared to the open approach. Dynamic anterior stabilization (DAS), on the other hand, involves transferring the long biceps tendon to the anterior glenoid rim to replicate the sling effect in a less invasive manner, while preserving the pectoralis minor and the thoracoacromial pedicle and reducing the risk of neurological complications.
Read more
Although both techniques have shown low recurrence rates and functional improvement in the short and medium term, no Level I randomized prospective study has directly compared their outcomes in patients with subcritical glenoid bone loss and combined lesions, as the available data are primarily derived from retrospective studies or case series.
Due to the biomechanical differences between the two techniques, the associated rehabilitation protocols also differ. Thus, this study compares not only the surgical procedures themselves, but two comprehensive therapeutic strategies that include both surgery and rehabilitation.
This project aims to determine whether, in these patients, treatment with DAS yields functional outcomes comparable to those of treatment with arthroscopic Latarjet surgery while reducing morbidity and the risk of overtreatment. The evaluation will be based on validated functional and quality-of-life scores. The primary outcome measure will be the WOSI score. The results of this study could help refine surgical indications and optimize care for a population that is predominantly young and active.
- Conditions
- Anterior Shoulder Instability
- Being tested
- Arthroscopic Latarjet procedure, Dynamic anterior stabilization (DAS)
- Keywords
- Anterior shoulder instability, arthroscopic Latarjet procedure, dynamic anterior stabilization (DAS), WOSI, subcritical glenoid bone loss, Hill-Sachs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic Latarjet procedureProcedure or surgery
The arthroscopic Latarjet procedure restores the glenoid bone stock and improves dynamic stability through the combined effect of the bone block and the band, while offering reduced morbidity compared to the open approach
Dynamic anterior stabilization (DAS)Procedure or surgery
Dynamic anterior stabilization (DAS), on the other hand, involves transferring the long biceps tendon to the anterior glenoid rim in order to replicate the sling effect in a less invasive manner, while preserving the pectoralis minor and the thoracoacromial pedicle and reducing the risk of neurological complications.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic Treatment of Latarjet Syndrome | Experimental | Not described Receives: Procedure: Arthroscopic Latarjet procedure |
| Treatment Using Dynamic Anterior Stabilization (DAS) via Arthroscopy | Experimental | Not described Receives: Procedure: Dynamic anterior stabilization (DAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOSI (Western Ontario Shoulder Instability Index) score. The WOSI is a validated score specific to shoulder instability that assesses the impact of the condition on quality of life and daily activities.
To compare the impact of recurrent anterior shoulder instability associated with subcritical glenoid bone loss on quality of life and activities of daily living between DAS and arthroscopic Latarjet procedure The total WOSI score ranges from 0, representing the best possible situation, to 2,100, indicating the highest level of discomfort.
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start3 Sep 2026
- Primary completion1 Nov 2030 (estimated)
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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, Outcomes assessor
- Enrolment
- 84 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
- NCT07715162
- Sponsor's protocol ID
- 2026-19-CGA
- Acronym
- SHIELD
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 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
- Arthroscopic Stabilization of Anterior Shoulder Instability With Subcritical Glenoid Bone Loss: A Comparison Between Dynamic Anterior Stabilization and the Latarjet Procedure
- ClinicalTrials.gov ID
- NCT07715162
- Acronym / sponsor ID
- SHIELD / 2026-19-CGA
- Conditions
- Anterior Shoulder Instability
- Keywords
- Anterior shoulder instability, arthroscopic Latarjet procedure, dynamic anterior stabilization (DAS), WOSI, subcritical glenoid bone loss, Hill-Sachs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Clinique Générale dAnnecyUniversity, hospital or other
- Study start
- 3 Sep 2026 (actual)
- Primary completion
- 1 Nov 2030 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 20 Jul 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.
Recurrent anterior shoulder instability is a common condition among young and active patients, with a significant impact on function and a high risk of recurrence in the absence of appropriate management. Quantifying glenoid bone loss has become a central component of the treatment strategy, with losses exceeding 20 % traditionally considered critical and requiring a coracoid transfer according to the Latarjet procedure. Recent data have, however, shown that so-called "subcritical" bone loss, ranging from 13.5 to 20%, may already be associated with unfavorable clinical outcomes, particularly in highly active patients. These patients most often present with associated humeral lesions, such as Hill-Sachs lesions, and sometimes other concomitant lesions such as Humeral Avulsion of the Glenohumeral Ligament, underscoring the need for a comprehensive therapeutic approach.
Two arthroscopic techniques are currently used for this indication. The arthroscopic Latarjet procedure restores glenoid bone stock and improves dynamic stability through the combined effect of the bone block and the sling, while offering reduced morbidity compared to the open approach. Dynamic anterior stabilization (DAS), on the other hand, involves transferring the long biceps tendon to the anterior glenoid rim to replicate the sling effect in a less invasive manner, while preserving the pectoralis minor and the thoracoacromial pedicle and reducing the risk of neurological complications.
Although both techniques have shown low recurrence rates and functional improvement in the short and medium term, no Level I randomized prospective study has directly compared their outcomes in patients with subcritical glenoid bone loss and combined lesions, as the available data are primarily derived from retrospective studies or case series.
Due to the biomechanical differences between the two techniques, the associated rehabilitation protocols also differ. Thus, this study compares not only the surgical procedures themselves, but two comprehensive therapeutic strategies that include both surgery and rehabilitation.
This project aims to determine whether, in these patients, treatment with DAS yields functional outcomes comparable to those of treatment with arthroscopic Latarjet surgery while reducing morbidity and the risk of overtreatment. The evaluation will be based on validated functional and quality-of-life scores. The primary outcome measure will be the WOSI score. The results of this study could help refine surgical indications and optimize care for a population that is predominantly young and active.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic Treatment of Latarjet Syndrome | Experimental | Procedure: Arthroscopic Latarjet procedure |
| Treatment Using Dynamic Anterior Stabilization (DAS) via Arthroscopy | Experimental | Procedure: Dynamic anterior stabilization (DAS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged 18 or older
- with symptomatic recurrent anterior shoulder instability indicating the need for surgical stabilization
- whose glenoid bone loss must be classified as subcritical, approximately between 13.5% and 20%, according to the criteria defined in the protocol
- with HAGL lesions
- with bone lesions
Key exclusion criteria (9 listed)
- with glenoid bone loss exceeding 20%
- with a clear indication for another procedure not covered by the protocol (particularly if routine bone grafting is required and incompatible with the study)
- with a history of bone stabilization of the affected shoulder
- with a transfixing rotator cuff tear or a neurological condition impairing shoulder function
- unable to guarantee adequate follow-up
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 |
|---|---|---|
| Arthroscopic Latarjet procedureThe arthroscopic Latarjet procedure restores the glenoid bone stock and improves dynamic stability through the combined effect of the bone block and the band, while offering reduced morbidity compared to the open approach | Procedure or surgery | Arthroscopic Treatment of Latarjet Syndrome |
| Dynamic anterior stabilization (DAS)Dynamic anterior stabilization (DAS), on the other hand, involves transferring the long biceps tendon to the anterior glenoid rim in order to replicate the sling effect in a less invasive manner, while preserving the pectoralis minor and the thoracoacromial pedicle and reducing the risk of neurological complications. | Procedure or surgery | Treatment Using Dynamic Anterior Stabilization (DAS) via Arthroscopy |
Primary outcome
WOSI (Western Ontario Shoulder Instability Index) score. The WOSI is a validated score specific to shoulder instability that assesses the impact of the condition on quality of life and daily activities.
Time frame: Month 24
To compare the impact of recurrent anterior shoulder instability associated with subcritical glenoid bone loss on quality of life and activities of daily living between DAS and arthroscopic Latarjet procedure The total WOSI score ranges from 0, representing the best possible situation, to 2,100, indicating the highest level of discomfort.
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.
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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 Arthroscopic Latarjet procedure and Dynamic anterior stabilization (DAS) in people with 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 6 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOSI (Western Ontario Shoulder Instability Index) score. The WOSI is a validated score specific to shoulder instability that assesses the impact of the condition on quality of life and daily activities. (time frame: Month 24). 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.