Arthroscopic Stabilization of Anterior Shoulder Instability With Subcritical Glenoid Bone Loss

NCT07715162 | Not Yet Recruiting

• 1 other identifier: 2026-19-CGA
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Anterior Shoulder Instability

Keywords

Anterior shoulder instability; arthroscopic Latarjet procedure; dynamic anterior stabilization (DAS); WOSI; subcritical glenoid bone loss; Hill-Sachs

Outcome Measures

Primary Outcomes (1)

• 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.

  Month 24

Study Arms (2)

Arthroscopic Treatment of Latarjet Syndrome

EXPERIMENTAL

Procedure: Arthroscopic Latarjet procedure

Treatment Using Dynamic Anterior Stabilization (DAS) via Arthroscopy

EXPERIMENTAL

Procedure: Dynamic anterior stabilization (DAS)

Interventions

Dynamic anterior stabilization (DAS) PROCEDURE

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.

Treatment Using Dynamic Anterior Stabilization (DAS) via Arthroscopy

Arthroscopic Latarjet procedure PROCEDURE

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

Arthroscopic Treatment of Latarjet Syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• deprived of liberty by judicial or administrative order
• receiving psychiatric care
• not enrolled in a social security program

Sponsors & Collaborators

• Clinique Générale dAnnecy: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 20, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: July 22, 2026

Record last verified: 2026-07