Shoulder InjuriesBUTEE2024NCT07257081
Effect of Combining a Posterosuperior Humeral Notch Filling With a Coracoid Bone Block on the Rate of Return to Sport
A study testing Filling of the posterior superior notch of the humerus in people with Shoulder Injuries, run by Clinique Saint Jean, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Injuries
- What is being tested?
- Filling of the posterior superior notch of the humerus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient non-compliant with follow-up over 1 year
- Recurrence of a previously operated shoulder
- Patient under judicial protection, guardianship, or trusteeship.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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
- Being tested
- Filling of the posterior superior notch of the humerus
- Medical subject headings
- Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filling of the posterior superior notch of the humerusProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Filling of the posterior superior notch of the humerus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Nov 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Saint Jean, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257081
- Sponsor's protocol ID
- 2024-A02276-41
- Acronym
- BUTEE2024
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07257081
- Acronym / sponsor ID
- BUTEE2024 / 2024-A02276-41
- Conditions
- Shoulder Injuries
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Clinique Saint Jean, FranceUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic coracoid process resection | No intervention | –Arthroscopic coracoid process resection |
| Arthroscopic coracoid process resection + filling of the posterosuperior notch of the humerus | Experimental | Procedure: Filling of the posterior superior notch of the humerusArthroscopic coracoid process resection with filling of the posterosuperior notch of the humerus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patient non-compliant with follow-up over 1 year
- Recurrence of a previously operated shoulder
- Patient under judicial protection, guardianship, or trusteeship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filling of the posterior superior notch of the humerusThe 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. | Procedure or surgery | Arthroscopic coracoid process resection + filling of the posterosuperior notch of the humerus |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Filling of the posterior superior notch of the humerus in people with Shoulder Injuries, run by Clinique Saint Jean, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants returning to sports at the same level after surgery, in each arms, at 12months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.