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NCT Number: NCT07257081

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique St Jean Sud de France

Saint-Jean-de-Védas, 34430, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Clinique Saint Jean, France

Other

Registry information

Official study title

Effect of Combining Filling of the Posterior Superior Notch of the Humerus With a Coracoid Stop on the Rate of Return to Sports at the Same Level: a Randomized Study

Acronym: BUTEE2024

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 2, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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