Minimally invasive biceps tendon surgery in an office setting
Tenotomy of Biceps' Long Head by Mini-optics in Consultation (Hyperambulatory): What Advantage Compared to the Operating Room?
NA · Centre Hospitalier Universitaire de Nice · NCT05370183
This study is testing a new way to perform biceps tendon surgery in a doctor's office using special mini-optics technology to see if it works better and is easier for people with shoulder pain.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice (other) |
| Locations | 1 site (Nice, Alpes Maritimes) |
| Trial ID | NCT05370183 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of performing a tenotomy of the biceps' long head using mini-optics technology in an office environment compared to traditional operating room procedures. The Nanoscope device allows for minimally invasive surgery, potentially reducing costs and improving accessibility for patients with shoulder pain and biceps tendon disorders. The study aims to assess the feasibility and advantages of this approach, particularly for patients with specific shoulder conditions. It builds on previous research that has explored the use of mini-optics in orthopedic procedures.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with shoulder pain related to massive irreparable rotator cuff injuries or isolated biceps pathologies.
Not a fit: Patients who may not benefit include those with a history of shoulder surgery, ongoing capsulitis, or those who are pregnant or nursing.
Why it matters
Potential benefit: If successful, this approach could provide patients with a less invasive option for treating shoulder pain, leading to quicker recovery times and reduced healthcare costs.
How similar studies have performed: While the use of mini-optics in orthopedic procedures is relatively novel, previous studies have shown promising results in similar minimally invasive techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Nice, Alpes Maritimes
- CHU de Nice — Nice, Alpes Maritimes, France (RECRUITING)
Study contacts
- Study coordinator: Marc-Olivier GAUCI
- Email: gauci.mo@chu-nice.fr
- Phone: 04 92 03 69 04
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Shoulder Pain, Biceps Tendon Disorder