Comparing two techniques for biceps tendon repair in patients without rotator cuff tears
Biceps Tenodesis with 360 Suture Anchor Versus Self Locking Tenodesis in the Absence of Rotator Cuff Tears
This study is testing two different surgical methods for fixing biceps tendon problems in patients who don’t have rotator cuff tears to see which one works better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Clinique Générale dAnnecy Academic / other |
| Locations | 1 site (Annecy) |
| Trial ID | NCT06772103 on ClinicalTrials.gov |
What this trial studies
This prospective randomized controlled trial aims to evaluate the clinical outcomes and complications associated with self-locking biceps tenodesis versus double-loop 360 lasso biceps tenodesis for treating SLAP lesions in patients who do not have rotator cuff tears. The study seeks to address the lack of consensus on the optimal surgical approach for biceps pathology during shoulder arthroscopy. By comparing these two techniques, the trial hopes to provide clearer guidance on the best treatment options for affected patients.
Who should consider this trial
Good fit: Ideal candidates include individuals with tendinopathy of the long head of the biceps or SLAP lesions without rotator cuff tears.
Not a fit: Patients with osteoarthritis of the glenohumeral joint, previous shoulder surgeries, or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing biceps tendon repair.
How similar studies have performed: While previous studies have compared biceps tenotomy and tenodesis in patients with rotator cuff tears, this trial is novel as it focuses specifically on patients without such tears.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Tendinopathy of the Long Head of the Biceps based on clinical symptoms or SLAP-type lesion * Partial thickness rupture or absence of rupture of the rotator cuff of the subscapular, supraspinatus and/or infraspinatus tendons, diagnosed preoperatively on ultrasound, arthro-CT or MRI. Exclusion Criteria: * Osteoarthritis of the glenohumeral joint, defined by narrowing of the glenohumeral joint space or osteophytes, using AP radiography of the affected shoulder. * Distance between acromion and humeral head measuring 6 mm or less * Previous shoulder surgery. * Dementia or inability to complete questionnaires and assessments. * Pregnant or breast-feeding patient * Protected adult patient * Patient not covered by social security.
Where this trial is running
Annecy
- Clinique Générale — Annecy, France (Recruiting)
Study contacts
- Study coordinator: Geert Alexander Buijze, MD
- Email: gabuijze@hotmail.com
- Phone: +33 669962733
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.