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

NCT07257081 | Active Not Recruiting

• 1 other identifier: 2024-A02276-41
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shoulder Injuries

Outcome Measures

Primary Outcomes (1)

• Number of Participants returning to sports at the same level after surgery, in each arms, at 12months

  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.

  12 months

Study Arms (2)

Arthroscopic coracoid process resection

NO INTERVENTION

Arthroscopic coracoid process resection

Arthroscopic coracoid process resection + filling of the posterosuperior notch of the humerus

EXPERIMENTAL

Arthroscopic coracoid process resection with filling of the posterosuperior notch of the humerus

Procedure: Filling of the posterior superior notch of the humerus

Interventions

Filling of the posterior superior notch of the humerus PROCEDURE

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.

Arthroscopic coracoid process resection + filling of the posterosuperior notch of the humerus

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Patient non-compliant with follow-up over 1 year
• Recurrence of a previously operated shoulder
• Patient under judicial protection, guardianship, or trusteeship.

Sponsors & Collaborators

• Clinique Saint Jean, France: lead

Study Sites (1)

Clinique St Jean Sud de France

Saint-Jean-de-Védas, 34430, France

Location

MeSH Terms

Conditions

Shoulder Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

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

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 2, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-11

Locations

FR (1)