Biceps lasso loop and self-locking tenodesis alongside repair of rotator cuff tears: Randomised controlled trial study protocol (BLAST 1)

Introduction:

Pathology of the long head of the biceps tendon (LHBT) frequently accompanies rotator cuff tears, with tenotomy and tenodesis often being used to address this pathology. While meta-analyses report comparable functional outcomes between these techniques, tenotomy is linked to higher rates of Popeye deformity, whereas tenodesis is more technically demanding and might involve extra material. A novel self-locking tenodesis technique aims to reduce deformity risk while being a simpler alternative to the conventional tenodesis procedure; however, comparative evidence is currently limited. 

Methods and analysis:

This single-centre, patient-blinded randomised controlled trial will enrol 100 patients aged ≥40 years with reparable, non-traumatic, full-thickness supraspinatus and/or infraspinatus and/or subscapularis tendon tears undergoing arthroscopic repair from January 2025 until January 2027. Key exclusion criteria include massive or irreparable tears, advanced glenohumeral osteoarthritis and prior shoulder surgery. Participants will be randomised to either 360 double lasso loop tenodesis or self-locking tenodesis. The primary outcome is the Constant score at 1 year, with a predefined non-inferiority margin of 10 points. Secondary outcomes include American Shoulder and Elbow Surgeons score, simple shoulder value score, LHB score, cosmetic appearance, pain scores and radiographic tendon migration. Statistical non-inferiority will be assessed using a one-sided t-test. 

Ethics and dissemination: 

The study protocol received approval from the National Ethical Review Board in France (CPP Sud-Est V) and was registered at ClinicalTrials.gov. The results will be disseminated through publication in a peer-reviewed journal. Trial registration number NCT06774820.