Biceps Lasso Loop and Self- Locking Tenodesis Alongside Repair of Rotator Cuff Tears: Randomised Controlled Trial Study Protocol (BLAST 1)

NCT06774820 · tracked via the Priya Life Science France tracker

Sponsor

Clinique Générale dAnnecy

Phase

Not applicable

Started

2025-01-22

Last updated

2026-09-11

Condition(s) studied

Rotator Cuff Injury

Investigational drug(s) / intervention(s)

self-blocking tenodesisarthroscopic tenodesis

self-blocking tenodesis: the LHB tendon is detached from its origin in 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 later localization of the LHB tendon during imaging (3-0 stainless steel, ethicon).

arthroscopic tenodesis: LHB tendon is detached from its origin, and sutured. Next, the LHB tendon is fixed in the bicipital groove using a 360-lasso loop tenodesis technique. 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

The aim of this study is to compare the clinical results and complications of self-locking biceps tenodesis and double 360 lasso loop biceps tenodesis for the treatment of long chief of biceps or superior labrum anterior-posterior (SLAP) tendon pathology during shoulder arthroscopy in patients undergoing arthroscopic rotator cuff repair. 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. 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. Given its potential advantages, self-locking biceps tenodesis could emerge as 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 to choose the most appropriate treatment for their patients suffering from long biceps tendon pathology.

Eligibility

Sex

ALL

Min age

40 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Rotator cuff tear: confirmed preoperative diagnosis of a non- traumatic, full- thickness tear of the supraspinatus and/or infraspinatus and/or subscapularis tendon, as evidenced by ultrasound, arthro- CT or MRI. * Language proficiency: sufficient to allow for communication during the informed consent process and for the completion of the study questionnaires. Exclusion Criteria: * Tear type: partial thickness rotator cuff tears are excluded. * Tear severity: individuals with massive or irreparable rotator cuff tears are excluded. * Fatty degeneration: presence of rotator cuff muscle fatty degeneration classified as Grade 4 according to the Goutallier system will result in exclusion. * Glenohumeral osteoarthritis: patients exhibiting glenohumeral osteoarthritis, defined radiographically by the presence of joint space narrowing or osteophytes on anteroposterior (radiographs of the affected shoulder) will be excluded. * Prior shoulder surgery: history of previous surgical intervention on the affected shoulder will result in exclusion. * Popeye sign: preoperative presence of the Popeye sign will result in exclusion. * Cognitive impairment: pre- existing dementia or any condition that impairs the ability to understand study procedures and complete questionnaires and assessments is an exclusion criterion. * 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

Primary outcome measure(s)

Constant score (CMS) — 1 year after surgery
The CMS is a 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, there 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 NCT06774820 on ClinicalTrials.gov ↗ ← All trials in France