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Active, not recruiting Not applicable

Effect of Combining a Posterosuperior Humeral Notch Filling With a Coracoid Bone Block on the Rate of Return to Sport

NCT07257081 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-11-01
Last updated
2025-12-17

Condition(s) studied

Shoulder Injuries

Investigational drug(s) / intervention(s)

Filling of the posterior superior notch of the humerus

Filling of the posterior superior notch of the humerus: The intervention involves bringing part of the coracoid bone with the tendon attached to it onto the front of the glenoid cavity. The stop is secured with an endobutton. The additional procedure used in this study is filling the posterosuperior notch of the humerus. The filling technique involves placing two anchors, which causes tenodesis of the infraspinatus in the posterosuperior notch of the humerus.

Study summary

The goal of this interventional study is to demonstrate the benefit of combining filling of the posterosuperior notch of the humerus with a coracoid stop on the rate of return to sports at the same level as before at 12 months post-surgery.

The level of sport will be categorized as recreational, competitive, or professional.

This is a prospective, single-center, comparative study of two parallel randomized groups, using a single-blind design.

The patients included will be randomized into two groups with a 1:1 ratio: one group will undergo the filling technique, while the second group will not. The rest of the surgery will be similar.

Randomization will be stratified according to initial athletic level.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patient affiliated with or entitled to social security coverage * Patient who has received informed consent about the study and signed a consent form * Patient presenting with previous shoulder instability associated with a compromising humeral lesion determined by CT scan measurement Exclusion Criteria: * Patient non-compliant with follow-up over 1 year * Recurrence of a previously operated shoulder * Patient under judicial protection, guardianship, or trusteeship.

Primary outcome measure(s)

  • Number of Participants returning to sports at the same level after surgery, in each arms, at 12months — 12 months
    Difference between the two arms for returning to sports at the same level as before, categorized into three levels: recreational, competitive, or professional, 12 months after surgery.

Trial sites (1)

FacilityCityRegionStatus
Clinique St Jean Sud de France Saint-Jean-de-Védas France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07257081 on ClinicalTrials.gov ↗ ← All trials in France