Идёт набор NCT06918041

FiberLocker® System Augmentation of Rotator Cuff Repairs

Без фазы С лечением Rotator Cuff Tear Rotator Cuff Tears Rotator Cuff Tears of the Shoulder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: FiberLocker® System (encompassing FiberLocker® Instrument & SpeedPatch® PET).
Кому может быть актуально: Состояния в реестре: Rotator Cuff Tear, Rotator Cuff Tears, Rotator Cuff Tears of the Shoulder. Базовые параметры: 30 лет — 70 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The purpose of this study is to prospectively evaluate healing, functional clinical outcomes, and safety of arthroscopic rotator cuff repairs augmented with the FiberLocker® System (encompassing the SpeedPatch® PET and the FiberLocker® Instrument). The primary outcome measure is healing evaluation based on Magnetic Resonance Imaging (MRI) at a minimum of 6 months post-operatively. The secondary outcome measures are the Sugaya classification, Goutallier Stage and tendon quality based on MRI as well as objective scores and patient-reported outcome measures (PROMs) from validated outcome scoring systems.

Вмешательства

Устройство FiberLocker® System (encompassing FiberLocker® Instrument & SpeedPatch® PET)
The FiberLocker® System is a mechanical augmentation system that includes an implant (SpeedPatch® PET) and an instrument (FiberLocker® Instrument) for its attachment. The implant is composed of non-woven PET fibers, and the instrument features a reciprocating needle at its tip, which pushes the individual patch fibers into the underlying tendon tissue.

Первичные конечные точки

Healing Evaluation [Срок оценки: Pre-operatively & minimum 6 months post-operatively]

Вторичные конечные точки (11)

Sugaya Classification [Срок оценки: Minimum 6 months post-operatively]
Goutallier Stage [Срок оценки: Pre-operatively & minimum 6 months post-operatively]
Tendon Quality [Срок оценки: Pre-operatively & minimum 6 months post-operatively]
American Shoulder and Elbow Surgeons (ASES) Score [Срок оценки: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months]
Single Assessment Numeric Evaluation (SANE) Score [Срок оценки: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months]
Visual Analog Scale for pain (VAS Score) [Срок оценки: Pre-operatively, Post-operatively: 2 weeks, 6 months, 12 months, 24 months]
Veterans RAND 12-Item Health Survey (VR-12) [Срок оценки: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months]
Range of Motion (ROM) Assessment [Срок оценки: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months]
Strength Assessment [Срок оценки: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months]
Constant-Murley Score [Срок оценки: Pre-operatively, Post-operatively: 6 months, 12 months, 24 months (all optional)]
(Serious) Adverse Events, (Serious) Adverse Device Effects and Device Deficiencies [Срок оценки: From the surgical intervention to 24 months postoperatively]

Критерии участия

Критерии включения

The Subject is between the ages of 30 and 70 years.
Subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (RCT)
Tear size ≥ 2 cm
Primary rotator cuff repair
Subject preoperative MRI obtained within 1 year prior to surgery

Критерии исключения

The Subject is unable or unwilling to sign the Patient Informed Consent, approved by the Institutional Review Board.
The Subject objects to the use of the FiberLocker® System
History or known allergy or intolerance to polyester
Complete full-thickness subscapularis tears of > than the superior 1/3 of the tendon (Lafosse grade 3 and above)
Hamada grade III and above
Less than 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
Recurrent shoulder instability
Corticosteroid injection in the operative shoulder within three months before surgery
Subjects with inflammatory or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus)
Subjects with current acute infection in the area surrounding the surgical site
Revision rotator cuff repair
Pregnant or planning to become pregnant during the study period
Subject is breastfeeding during the study period
Subject has conditions or circumstances that would interfere with study requirements
The subject's condition represents a worker's compensation case

Intraoperative Exclusion Criteria: