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/41263857Actively Recruiting
Led by Clinique Générale dAnnecy · Updated on 2025-02-12
100
Participants Needed
1
Research Sites
8 weeks
Total Duration
This research aims to compare the 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 clear evidence favoring tenodesis or tenotomy for this condition, and the study evaluates a new technique called autobloc tenodesis developed at Clinique Générale, which may offer potential benefits such as reducing the occurrence of Popeye deformity. Participants will be randomly assigned to receive either the self-blocking tenodesis procedure or the arthroscopic tenodesis technique during their shoulder surgery. Both procedures involve detaching the long head of the biceps tendon from its origin and securing it in the bicipital groove, with a radiographically visible suture attached to the tendon to aid imaging. The study includes a single-blind design and focuses on comparing these two surgical approaches. During the study, participants' shoulder function and outcomes will be assessed using the Constant score (CMS) at one year after surgery and the American Shoulder and Elbow Surgeons Score at 3 months, 6 months, and 1 year post-surgery. Patients must be able to complete questionnaires in French, and the study excludes those with certain shoulder conditions or prior surgeries. The trial is set to begin in 2025 and continue through 2028, with thorough monitoring of clinical results and complications throughout the follow-up period.
CONDITIONS
Self-locking Tenodesis of the Long Chief of the Biceps Vs. Lasso 360 Tenodesis in Arthroscopic Rotator Cuff Repair Rotator Cuff Repair
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo arthroscopic rotator cuff repair with either self-locking tenodesis or lasso 360 tenodesis of the long head of the biceps tendon.
1 surgery visit
Duration - 1 year
Participants are followed to assess recovery and shoulder function after surgery.
Follow-up visits at 3 months, 6 months, and 1 year after surgery
Total: 1 location
1
Clinique Générale
Annecy, France, 74000
Actively Recruiting
G
Geert Alexander Buijze, MD
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