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

Обзор

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 tenodesis. Given its potential advantages, self-locking biceps tenodesis could emerge as the new technique of choice for treating biceps longus tendon pathology, potentially reducing differences in outcomes such as Popeye deformity. The information provided by this study could potentially guide future clinical practice, helping surgeons to choose the most appropriate treatment for their patients suffering from long biceps tendon pathology.

Вмешательства

• Процедура self-blocking tenodesis
  the LHB tendon is detached from its origin in the superior labrum. This technique supports the self-locking mechanism of the LHB tendon in the bicipital groove by detaching the tendon from the Y-shaped superior glenoid, including the superior labrum. A radiographically visible suture will be attached to the proximal part of the LHB tendon to facilitate later localization of the LHB tendon during imaging (3-0 stainless steel, ethicon).
• Процедура arthroscopic tenodesis
  LHB tendon is detached from its origin, and sutured. Next, the LHB tendon is fixed in the bicipital groove using a 360-lasso loop tenodesis technique. A radiographically visible suture will be attached to the proximal part of the LHB tendon to facilitate subsequent localization of the LHB tendon during imaging (3-0 stainless steel, ethicon).

Первичные конечные точки

• Constant score (CMS) [Срок оценки: 1 year after surgery]

Вторичные конечные точки (7)

• American Shoulder and Elbow Surgeons Score [Срок оценки: 6 weeks, 3 months, 6 months, 1 year after surgery]
• Subjective Shoulder Value (SSV) [Срок оценки: 6 weeks, 3 months, 6 months, 1 year after surgery]
• LHB score [Срок оценки: 6 months, 1 year after surgery]
• Cosmetic appearance [Срок оценки: 6 weeks, 3 months, 6 months, 1 year after surgery]
• VAS pain score [Срок оценки: 6 weeks, 3 months, 6 months, 1 year after surgery]
• Radiograph [Срок оценки: Direct post-op, 6 weeks, 3 months, 6 months after surgery]
• MRI or Ultra-sound [Срок оценки: 1 year after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Clinique Générale — Annecy

Публикации

• Shirinskiy IJ, Boulidam D, Macken AA, van den Bekerom MPJ, Lafosse T, Buijze GA. Biceps lasso loop and self-locking tenodesis alongside repair of rotator cuff tears: randomised controlled trial study protocol (BLAST 1). BMJ Open. 2025 Nov 19;15(11):e106475. doi: 10.1136/bmjopen-2025-106475. PMID 41263857

Идентификаторы

NCT: NCT06774820 · 2024-45-CGA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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