Shoulder Injuries
Conditions
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.
Interventions
PROCEDUREFilling 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.
Sponsors
Clinique Saint Jean, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants returning to sports at the same level after surgery, in each arms, at 12months | 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. |
Countries
France
Outcome results
None listed