Effect of Combining a Posterosuperior Humeral Notch Filling With a Coracoid Bone Block on the Rate of Return to Sport (BUTEE2024)

Clinique Saint Jean, France

Status: Active, not recruiting

Conditions: Shoulder Injuries

Treatments: Procedure: Filling of the posterior superior notch of the humerus

Study type: Interventional

Funder types: Other

Identifiers

NCT07257081

2024-A02276-41

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Arthroscopic coracoid process resection

No Intervention group

Description:

Arthroscopic coracoid process resection

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

Experimental group

Description:

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

Treatment:

Procedure: Filling of the posterior superior notch of the humerus