Biceps Tenodesis With 360 Suture Anchor Versus Self Locking Tenodesis In the Absence of Rotator Cuff Tears

Официальное название

Biceps Tenodesis With 360 Suture Anchor Versus Self-Locking Tenodesis in the Absence of Full-thickness Rotator Cuff Tears: Protocol for a Non-inferiority Randomized Controlled Trial (BLAST-2)

Обзор

This is a prospective randomized controlled trial. The aim of this study is to compare the clinical results and complications of self-locking biceps tenodesis and double-loop 360 lasso biceps tenodesis for the treatment of pathology of the long head of the biceps or superior labrum anterior-posterior (SLAP) during shoulder arthroscopy in patients without arthroscopic rotator cuff tears. 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. However, these studies were carried out on patients with rotator cuff tears, and so it has not been possible to directly compare the two procedures. 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 in patients without rotator cuff tears. Given its potential advantages, autobloc biceps tenodesis could become 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 choose the most appropriate treatment for their patients with long biceps tendon pathology.

Вмешательства

• Процедура self-locking biceps tenodesis
  The LHB tendon is detached from its origin at the level of 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 subsequent localization of the LHB tendon during imaging (3-0 stainless steel, ethicon).
• Процедура Biceps Tenodesis with 360 Suture anchor
  The LHB tendon is detached from its origin and sutured. Next, the LHB tendon is fixed in the bicipital groove using a 360-loop tenodesis technique with the Knotless FiberTak® biceps implant system. 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 [Срок оценки: 1 year after surgery]

Вторичные конечные точки (7)

• American Shoulder and Elbow Surgeons Score (ASES) [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

• Pathology of the LHBT or SLAP-type lesion based on clinical symptoms
• Partial-thickness rupture or absence of full-thickness rupture of the rotator cuff of the subscapular, supraspinatus and/or infraspinatus tendons, diagnosed preoperatively on ultrasound, arthro-CT or MRI

Критерии исключения

• Full-thickness tears of the rotator cuff diagnosed preoperatively on ultrasound, arthro-CT or MRI.
• Osteoarthritis of the glenohumeral joint, defined by narrowing of the glenohumeral joint space or osteophytes, using AP radiography of the affected shoulder.
• Previous surgery on the affected shoulder
• Patients presenting with motor paralysis of the shoulder
• Preoperative presence of the Popeye sign or documented LHBT rupture
• Dementia or inability to complete questionnaires and assessments in French or English.
• Pregnant or breast-feeding patient
• Protected adult patient
• Patient not covered by social security.

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

• Boulidam D, Shirinskiy IJ, Macken AA, Van Den Bekerom MPJ, Lafosse T, Buijze GA. Biceps tenodesis with 360 degrees 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). BMJ Open. 2026 Aug 4;16(8):e120296. doi: 10.1136/bmjopen-2026-120296. PMID 42552012

Идентификаторы

NCT: NCT06772103 · 2024-43-CGA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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