Actively Recruiting
Biceps Tenodesis with 360 Suture Anchor Versus Self Locking Tenodesis in the Absence of Rotator Cuff Tears
Led by Clinique Générale dAnnecy · Updated on 2025-02-12
100
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two surgical techniques for treating pathology of the long head of the biceps or superior labrum anterior-posterior (SLAP) lesions in patients without rotator cuff tears. This prospective randomized controlled trial aims to compare the clinical outcomes and complications of self-locking biceps tenodesis versus a double-loop 360 lasso biceps tenodesis. The study addresses a gap in knowledge since previous research focused on patients with rotator cuff tears and no consensus exists on the best treatment approach for those without such tears. The study compares two procedures performed during shoulder arthroscopy. In the self-locking biceps tenodesis, the long head of the biceps (LHB) tendon is detached and secured by its self-locking mechanism in the bicipital groove, with a radiographically visible suture attached for imaging. The 360 suture anchor tenodesis involves detaching the LHB tendon, suturing it, and fixing it in the bicipital groove using a Knotless FiberTak® biceps implant system, also with a visible suture for imaging. Both procedures are evaluated to determine which may better reduce complications like the Popeye deformity. Participants will be followed for at least one year after surgery, during which their shoulder function will be assessed using the Constant score as the primary outcome measure. Clinical results, complications, and imaging will be monitored to compare the two surgical techniques. This trial may help guide surgeons in choosing the most suitable tenodesis method for patients with biceps tendon pathology but no rotator cuff tear, potentially improving treatment decisions and patient outcomes.
CONDITIONS
Brief Title
Biceps Tenodesis with 360 Suture Anchor Versus Self Locking Tenodesis in the Absence of Rotator Cuff Tears
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Age between 40 and 80 years
You will not qualify if you...
- Osteoarthritis of the glenohumeral joint, defined by narrowing of the joint space or osteophytes on shoulder X-ray
- Distance between acromion and humeral head 6 mm or less
- Previous shoulder surgery
- Dementia or inability to complete questionnaires and assessments
- Pregnant or breast-feeding
- Protected adult status
- Not covered by social security
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and immediate recovery period
Participants undergo biceps tenodesis surgery using either the self-locking technique or the 360 suture anchor technique, followed by immediate post-operative care.
1 visit (surgery and immediate post-operative)
Duration - Up to 1 year after surgery
Participants are monitored during recovery to assess healing and shoulder function after surgery.
Approximately 6 post-operative visits
Trial Site Locations
Total: 1 location
1
Clinique Générale
Annecy, France, 74000
Actively Recruiting
Research Team
G
Geert Alexander Buijze, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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