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Biceps Lasso Loop and Self- Locking Tenodesis Alongside Repair of Rotator Cuff Tears: Randomised Controlled Trial Study Protocol (BLAST 1)

RecruitingNAAges 40 Years - anyAllClinique Générale dAnnecy
NCT06774820 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aim of this study is to compare the clinical results and complications of self-locking biceps tenodesis and double 360 lasso loop biceps tenodesis for the treatment of long chief of biceps or superior labrum anterior-posterior (SLAP) tendon pathology during shoulder arthroscopy in patients undergoing arthroscopic rotator cuff repair. Currently, there is no consensus on the use of tenodesis versus tenotomy to treat pathology of the long head of the biceps during arthroscopic rotator cuff repair. Numerous studies have examined the clinical results of long biceps tenotomy versus long biceps tenodesis, and there is no evidence to date of superiority of either technique. At Clinique Générale, we use a new, innovative technique called autobloc tenodesis to treat pathologies of the long head of the biceps. There are no comparative studies between autobloc tenodesis of the biceps and biceps

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📋 Eligibility rules (as published)
Inclusion Criteria: * Rotator cuff tear: confirmed preoperative diagnosis of a non- traumatic, full- thickness tear of the supraspinatus and/or infraspinatus and/or subscapularis tendon, as evidenced by ultrasound, arthro- CT or MRI. * Language proficiency: sufficient to allow for communication during the informed consent process and for the completion of the study questionnaires. Exclusion Criteria: * Tear type: partial thickness rotator cuff tears are excluded. * Tear severity: individuals with massive or irreparable rotator cuff tears are excluded. * Fatty degeneration: presence of rotator cuff muscle fatty degeneration classified as Grade 4 according to the Goutallier system will result in exclusion. * Glenohumeral osteoarthritis: patients exhibiting glenohumeral osteoarthritis, defined radiographically by the presence of joint space narrowing or osteophytes on anteroposterior (radiographs of the affected shoulder) will be excluded. * Prior shoulder surgery: history of previous surgical intervention on the affected shoulder will result in exclusion. * Popeye sign: preoperative presence of the Popeye sign will result in exclusion. * Cognitive impairment: pre- existing dementia or any condition that impairs the ability to understand study procedures and complete questionnaires and assessments is an exclusion criterion. * Pregnant, parturient or breast-feeding patients. * Persons under legal protection (curatorship, guardianship, safeguard of justice). * Persons deprived of their liberty by judicial or administrative measure * Persons under psychiatric care * Persons not affiliated to a social security scheme
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What it tests

  • self-blocking tenodesis
  • arthroscopic tenodesis
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Where

1 site
Clinique Générale
Annecy, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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