Biceps lasso loop and self-locking tenodesis alongside repair of rotator cuff tears: randomised controlled trial study protocol (BLAST 1).
Igor J Shirinskiy, Dries Boulidam, Arno A Macken...
https://pubmed.ncbi.nlm.nih.gov/41263857/Actively Recruiting
Led by Clinique Générale dAnnecy · Updated on 2026-07-07
100
Participants Needed
1
Research Sites
8 weeks
Total Duration
This research aims to compare the clinical outcomes and complications of two surgical techniques, self-locking biceps tenodesis and double 360 lasso loop biceps tenodesis, for treating long head of biceps or superior labrum anterior-posterior SLAP tendon problems during shoulder arthroscopy in patients undergoing rotator cuff repair. There is currently no agreement on whether tenodesis or tenotomy is better for treating long head of biceps pathology during rotator cuff repair. The study investigates a new method called autobloc tenodesis, which may offer advantages and potentially reduce differences in outcomes like Popeye deformity. Participants will receive either the self-locking tenodesis procedure, where the long head of the biceps tendon is detached and self-locked in the bicipital groove with a radiographically visible suture for imaging, or the arthroscopic tenodesis procedure, where the tendon is detached, sutured, and fixed using a 360-lasso loop technique with a similar visible suture. Both procedures are performed during arthroscopic rotator cuff repair. This is a randomized controlled trial comparing these two surgical approaches. During the study, participants will be assessed with various outcome measures including the Constant score at 1 year post-surgery as the primary measure. Secondary assessments include shoulder function scores, pain ratings, cosmetic appearance, and imaging such as radiographs and MRI or ultrasound at specified intervals up to one year after surgery. These evaluations will help monitor clinical results and complications over time to guide future surgical choices.
CONDITIONS
Biceps Lasso Loop and Self- Locking Tenodesis Alongside Repair of Rotator Cuff Tears: Randomised Controlled Trial Study Protocol (BLAST 1)
G
Geert Alexander Buijze, MD
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Clinique Générale dAnnecy
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single surgery event
Participants undergo rotator cuff repair surgery along with either self-locking biceps tenodesis or arthroscopic 360 lasso loop tenodesis.
Follow-up visits at 6 weeks, 3 months, 6 months, and 1 year post-surgery
Duration - 1 year after surgery
Participants are assessed for shoulder function, pain, cosmetic outcome, and imaging results at multiple time points up to one year after surgery.
Regular visits at 6 weeks, 3 months, 6 months, and 1 year
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Igor J Shirinskiy, Dries Boulidam, Arno A Macken...
https://pubmed.ncbi.nlm.nih.gov/41263857/Clinique Générale dAnnecy
Lead Sponsor