Biceps tenodesis with 360° suture anchor versus self-locking tenodesis in the absence of full-thickness rotator cuff tears: protocol for a non-inferiority randomised controlled trial (BLAST-2)

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INTRODUCTION: Pathology of the long head of the biceps tendon (LHBT) is commonly treated with either tenotomy or tenodesis, which provide comparable clinical outcomes but have distinct disadvantages. A novel self-locking biceps tenodesis aims to combine the benefits of both techniques. Comparative evidence in patients without full-thickness rotator cuff tears is limited. This study aims to compare the clinical outcomes and complications of self-locking biceps tenodesis and biceps tenodesis with 360° suture anchor in patients without full-thickness rotator cuff tears. METHODS AND ANALYSIS: This single-centre, double-blinded non-inferiority randomised controlled trial will include 98 patients aged≥40 years with symptomatic LHBT pathology in the absence of full-thickness rotator cuff tears. Participants will be recruited between January 2025 and January 2030 and randomly allocated to self-locking biceps tenodesis or biceps tenodesis with 360° suture anchor. The primary outcome is the Constant score at 1 year postoperatively, with a predefined non-inferiority margin of 10 points. ETHICS AND DISSEMINATION: This study received approval from the French Committee of Person Protection North-West II (national registration number 2024-A02217-40). Furthermore, the trial is registered at ClinicalTrials.gov (NCT06772103). Results will be disseminated through publication in peer-reviewed journals and presentation at scientific conferences. TRIAL REGISTRATION NUMBER: NCT06772103.