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

NCT ID: NCT07257081

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Shoulder Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Arthroscopic coracoid process resection

Arthroscopic coracoid process resection

Group Type NO_INTERVENTION

No interventions assigned to this group

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

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

Group Type EXPERIMENTAL

Filling of the posterior superior notch of the humerus

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique Saint Jean, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique St Jean Sud de France

Saint-Jean-de-Védas, , France

Site Status

Countries

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France

Other Identifiers

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2024-A02276-41

Identifier Type: -

Identifier Source: org_study_id