Biceps Tenodesis With 360 Suture Anchor Versus Self Locking Tenodesis In the Absence of Rotator Cuff Tears

NCT06772103 · tracked via the Priya Life Science France tracker

Sponsor

Clinique Générale dAnnecy

Phase

Not applicable

Started

2025-01-22

Last updated

2026-07-09

Condition(s) studied

SLAP Lesion

Investigational drug(s) / intervention(s)

self-locking biceps tenodesisBiceps Tenodesis with 360 Suture anchor

self-locking biceps tenodesis: The LHB tendon is detached from its origin at the level of the superior labrum. This technique supports the self-locking mechanism of the LHB tendon in the bicipital groove by detaching the tendon from the Y-shaped superior glenoid, including the superior labrum. A radiographically visible suture will be attached to the proximal part of the LHB tendon to facilitate subsequent localization of the LHB tendon during imaging (3-0 stainless steel, ethicon).

Biceps Tenodesis with 360 Suture anchor: The LHB tendon is detached from its origin and sutured. Next, the LHB tendon is fixed in the bicipital groove using a 360-loop tenodesis technique with the Knotless FiberTak® biceps implant system. A radiographically visible suture will be attached to the proximal part of the LHB tendon to facilitate subsequent localization of the LHB tendon during imaging (3-0 stainless steel, ethicon).

Study summary

This is a prospective randomized controlled trial. The aim of this study is to compare the clinical results and complications of self-locking biceps tenodesis and double-loop 360 lasso biceps tenodesis for the treatment of pathology of the long head of the biceps or superior labrum anterior-posterior (SLAP) during shoulder arthroscopy in patients without arthroscopic rotator cuff tears. Currently, there is no consensus on the use of tenodesis versus tenotomy to treat pathology of the long head of the biceps during arthroscopic rotator cuff repair. Numerous studies have examined the clinical results of long biceps tenotomy versus long biceps tenodesis, and there is no evidence to date of superiority of either technique. However, these studies were carried out on patients with rotator cuff tears, and so it has not been possible to directly compare the two procedures. At Clinique Générale, we use a new, innovative technique called autobloc tenodesis to treat pathologies of the long head of the biceps. There are no comparative studies between autobloc tenodesis of the biceps and biceps tenodesis in patients without rotator cuff tears. Given its potential advantages, autobloc biceps tenodesis could become the new technique of choice for treating biceps longus tendon pathology, potentially reducing differences in outcomes such as Popeye deformity. The information provided by this study could potentially guide future clinical practice, helping surgeons choose the most appropriate treatment for their patients with long biceps tendon pathology.

Eligibility

Sex

ALL

Min age

40 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Pathology of the LHBT or SLAP-type lesion based on clinical symptoms * Partial-thickness rupture or absence of full-thickness rupture of the rotator cuff of the subscapular, supraspinatus and/or infraspinatus tendons, diagnosed preoperatively on ultrasound, arthro-CT or MRI Exclusion Criteria: * Full-thickness tears of the rotator cuff diagnosed preoperatively on ultrasound, arthro-CT or MRI. * Osteoarthritis of the glenohumeral joint, defined by narrowing of the glenohumeral joint space or osteophytes, using AP radiography of the affected shoulder. * Previous surgery on the affected shoulder * Patients presenting with motor paralysis of the shoulder * Preoperative presence of the Popeye sign or documented LHBT rupture * Dementia or inability to complete questionnaires and assessments in French or English. * Pregnant or breast-feeding patient * Protected adult patient * Patient not covered by social security.

Primary outcome measure(s)

Constant score — 1 year after surgery
100-point scale comprising four components, including a patient-reported section (pain 15 points and activity level 20 points), for a total of 35 points. Alongside this is a doctor-reported section (shoulder strength 25 points, range of motion 40 points) for a total of 65 points.

Trial sites (1)

Facility	City	Region	Status
Clinique Générale	Annecy	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06772103 on ClinicalTrials.gov ↗ ← All trials in France