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)
Dries Boulidam, Igor Jurievich Shirinskiy, Arno Alexander Macken, M P.J Van Den Bekerom, Thibault Lafosse, Geert Alexander BuijzeIntroduction
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 (
Trial registration number