Status:
ACTIVE_NOT_RECRUITING
Tenotomy of Biceps' Long Head by Mini-optics in Consultation (Hyperambulatory): What Advantage Compared to the Operating Room?
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Shoulder Pain
Biceps Tendon Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Mini-optics has been used in orthopedics for a short time. The Nanoscope used in this study is marketed by Arthrex. Its main indications concern knee, elbow, wrist, carp and small joints of long finge...
Eligibility Criteria
Inclusion
- patient over 18 years-old,
- With shoulder pain associated to massive irreparable rotator cuff and a biceps still presents (premature Hamada's stages, 1 to 3); Or with an isolated pathology of biceps with intact rotator cuff (in particular bicipital instability, subluxation, tenosynovitis, pre-rupture)
- Indication for tenotomy according orthopedic surgeon
- having given written consent after written and oral information,
- member of the social security system.
Exclusion
- patient protected by law or under guardianship r curatorship, or not able to participae in a clinical trial under L.1121-16 article of French Public Health Regulations
- pregnant or nursing patient,
- Allergies to local anesthetics
- Athletes
- Capsulitis in progress
- history of shoulder surgery
- Medical history of infection
- fracture of proximal end of the humerus
- Patient refusal to take part
Key Trial Info
Start Date :
November 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2026
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05370183
Start Date
November 29 2022
End Date
May 5 2026
Last Update
December 4 2025
Active Locations (1)
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1
CHU de Nice
Nice, Alpes Maritimes, France, 06000