SINEFIX-2022 Comparative Phase

Официальное название

Pre-market Clinical Investigation Inovedis SINEFIX

Обзор

Shoulder pain is one of the most commonly reported musculoskeletal complaints, which negatively affects upper limb use, night rest, daily life activities, work, sports performance and autonomy. Rotator cuff disease represents the most common cause of shoulder pain and it is responsible for up to 70% of all shoulder related visits to clinicians. Its incidence furthermore is expected to grow as the population ages. A wide range of conditions are included under the umbrella term of rotator cuff disease, including rotator cuff tendinopathy, subacromial bursal pathology, and partial-thickness or full- thickness rotator cuff tears (RCTs). The latter ones, i.e. rotator cuff tears, form the indications for which the test devices, the SINEFIX implant and instruments, are intended. Despite the high prevalence of this condition, the pathophysiology and healing potential are not well understood, making the condition challenging to predictably treat in some patient populations. RCTs may occur in young people as a consequence of trauma (e.g. acute shoulder dislocation), however RCTs typically present in middle-aged or elderly people and cannot always be attributed to precipitating events or trauma. Instead, they can be attributed to degenerative processes, and are therefore referred to as degenerative RCTs. For RCTs, treatment options include both surgical and non-surgical (conservative) procedures. In this context, the SINEFIX implant and instruments were developed to treat adult patients with rotator cuff lesions of size up to 2 cm through arthroscopic reconstruction. A pilot study phase investigating the SINEFIX implant and instruments was conducted and showed adequate performance, usability and preliminary safety. Hence, the device is now being tested on a larger number of participants as part of the comparative study phase.

Вмешательства

• Устройство Rotator cuff repair with the SINEFIX
  Treatment of rotator cuff lesions of size up to 2 cm using the SINEFIX implant and instruments
• Устройство Rotator cuff repair with comparator device
  Treatment of rotator cuff lesions with the conventional surgical technique (comparator device)

Первичные конечные точки

• Functional and clinical outcome after rotator cuff repair as compared with baseline [Срок оценки: 1 year post operation]

Вторичные конечные точки (12)

• Surgery time [Срок оценки: Immediately post procedure]
• Functional and clinical outcome after rotator cuff repair [Срок оценки: At 6 months, 1 and 2 years follow-up]
• Functional and clinical outcome after rotator cuff repair as compared with baseline [Срок оценки: At 6 months and 2 years follow-up]
• Shoulder function after rotator cuff repair (subjective evaluation) [Срок оценки: At 10 weeks, 6, 12, and 24 months]
• Shoulder function after rotator cuff repair (physical examination-active external rotation) [Срок оценки: At 10 weeks, 6, 12, and 24 months]
• Shoulder function after rotator cuff repair (physical examination-active anteversion) [Срок оценки: At 10 weeks, 6, 12, and 24 months]
• Healing integrity [Срок оценки: At 6, 12, and 24 months]
• Re-tear rate [Срок оценки: At 6, 12, and 24 months]
• Dislocation of the implant [Срок оценки: At 6, 12, and 24 months]
• Bursitis [Срок оценки: At 6, 12, and 24 months]
• Complications [Срок оценки: During the follow up time (up to 24 months)]
• Patient satisfaction [Срок оценки: At 10 weeks, 6, 12, 24 months]

Критерии участия

Критерии включения

• Patient indicated for surgical repair of the rotator cuff tear according to current guidelines
• Patient aged 18 years or older
• Up to 2 cm tear size (medio-lateral) of supraspinatus, infraspinatus
• Up to 2 cm tear size (anterior-posterior) of supraspinatus, infraspinatus

Критерии исключения

• Subject has had previous rotator cuff, arthroplasty or fracture procedures on the operative shoulder
• History of alcoholism, drug abuse, psychological or other emotional problems likely to interfere with participation in the study follow-up schedule and assessments
• Inflammatory arthropathies
• Subject with a contraindication/non-compliance for MRI examination
• Subject 's unwillingness to undergo surgical rotator cuff repair, participate in post-operative rehabilitation program, and / or adhere to follow up schedule
• Pregnant and breastfeeding woman

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Германия · 2 центра

• Kreiskrankenhaus Mechernich GmbH (KKHM) — Mechernich
• Orthopädisch Chirurgisches Centrum (OCC) — Tübingen

Идентификаторы

NCT: NCT06818448 · SINEFIX-2022 Comparative Phase

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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