Comparing two techniques for biceps tendon treatment during shoulder surgery
Self-locking Tenodesis of the Long Chief of the Biceps Vs. Lasso 360 Tenodesis in Arthroscopic Rotator Cuff Repair Rotator Cuff Repair
NA · Clinique Générale dAnnecy · NCT06774820
This study is testing two different surgical methods for treating a tendon in the shoulder during rotator cuff repair to see which one works better and has fewer complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Clinique Générale dAnnecy (other) |
| Locations | 1 site (Annecy) |
| Trial ID | NCT06774820 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the clinical outcomes and complications of two surgical techniques for treating the long head of the biceps tendon during arthroscopic rotator cuff repair. The techniques being evaluated are self-locking biceps tenodesis and double 360 lasso loop biceps tenodesis. The research addresses the lack of consensus on the best approach to manage biceps tendon pathology in conjunction with rotator cuff repairs. By utilizing innovative methods, the study seeks to determine if one technique offers superior results over the other.
Who should consider this trial
Good fit: Ideal candidates are patients with a full-thickness rotator cuff tear of the supraspinatus or infraspinatus tendon.
Not a fit: Patients with partial or massive irreparable rotator cuff tears, or those with significant biceps tendon issues, 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 rotator cuff repair.
How similar studies have performed: While there have been numerous studies on biceps tenotomy versus tenodesis, this specific comparison of autobloc tenodesis against traditional methods is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Full-thickness rotator cuff tear of the supraspinatus/infraspinatus tendon, diagnosed preoperatively by ultrasound, arthro-CT or MRI. * Patients must be able to read and write in French in order to complete the questionnaires and sign the informed consent form. Exclusion Criteria: * Partial rotator cuff tear * Massive and irreparable rotator cuff tear * Grade 4 according to Goutallier classification of fatty degeneration of rotator cuff muscles * Rupture of the long biceps * Hourglass deformity of biceps tendon origin * 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, defined by Hamada classification as grade 2 or higher. * Previous shoulder surgery. * Dementia or inability to complete questionnaires and assessments. * Pregnant, parturient or breast-feeding patients. * Persons under legal protection (curatorship, guardianship, safeguard of justice). * Persons deprived of their liberty by judicial or administrative measure * Persons under psychiatric care * Persons not affiliated to a social security scheme
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 6 69 96 27 33
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: Rotator Cuff Injury, rotator cuff, biceps, long biceps tendon