Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation

Официальное название

Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation: A Prospective, Single-Arm, Non-Randomized, Pilot Study

Обзор

The overall objective of this clinical investigation is to assess the safety and efficacy of full-thickness arthroscopic rotator cuff repairs augmented with the FiberLocker System for the subjects. The primary outcome of the investigation is to assess the safety after full-thickness arthroscopic rotator cuff repairs augmented with the FiberLocker System in terms of postoperative adverse events through the 12-month follow-up. Main secondary outcomes include measures of efficacy and clinical performance evaluated at 6-week, 4.5-month, and 12-month follow-ups including retear rate assessed using MRI and different functional performance scores.

Вмешательства

• Устройство FiberLocker® System (encompassing SpeedPatch® PET and FiberLocker Instrument® SN)
  The FiberLocker® System is a mechanical augmentation system that includes an implant (SpeedPatch® PET) and an instrument (FiberLocker® Instrument SN) 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

• Total Number of Adverse Events (AEs) [Срок оценки: Surgery to 12-month follow-up]
• Total Number of Serious Adverse Events (SAEs) [Срок оценки: Surgery to 12-month follow-up]
• Number of AE related to Device [Срок оценки: Surgery to 12-month follow-up]
• Number of SAE related to Device [Срок оценки: Surgery to 12-month follow-up]
• Number of AE related to Procedure [Срок оценки: Surgery to 12-month follow-up]
• Number of SAE related to Procedure [Срок оценки: Surgery to 12-month follow-up]

Вторичные конечные точки (10)

• Retear Rate [Срок оценки: 6-week, 4.5-month and 12-month follow-up]
• Constant-Murley Score [Срок оценки: Baseline and 12-month follow-up]
• Visual Analog Scale for Pain (VAS) [Срок оценки: Baseline, 2-week, 4.5-month and 12-month follow-up]
• Subjective Shoulder Value (SSV) Score [Срок оценки: Baseline, 4.5-month and 12-month follow-up]
• EQ-5D-5L survey [Срок оценки: Baseline, 4.5-month and 12-month follow-up]
• American Shoulder and Elbow Society (ASES) score [Срок оценки: Baseline, 4.5-month and 12-month follow-up]
• Sugaya Classification [Срок оценки: 6-week, 4.5-month and 12-month follow-up]
• Goutallier Classification [Срок оценки: Baseline, 6-week, 4.5-month and 12-month follow-up]
• Tendon Thickness [Срок оценки: Baseline, 6-week, 4.5-month and 12-month follow-up]
• Fat Fraction of Muscle [Срок оценки: Baseline, 6-week, 4.5-month and 12-month follow-up]

Критерии участия

Критерии включения

• Subject requires surgical treatment of a full-thickness rotator cuff tear, according to Balgrist standard procedure
• Full-thickness tear of the supraspinatus or combined infraspinatus and supraspinatus
• The rotator cuff tear is of traumatic origin.
• Subject is ≥ 40 years of age \& ≤ 65 years of age.
• Primary rotator cuff repair
• Informed Consent signed by the subject
• Pre-operative MRI performed

Критерии исключения

• Vulnerable subjects (as defined in ISO 14155)
• Subjects who do not have the power of judgement or are unable to fully understand all aspects of the investigation that are relevant to the decision to participate
• Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation,
• Previous enrolment into the current investigation,
• Enrolment of the PI, his/her family members, employees and other dependent persons,
• Inability to follow the procedures of the investigation, or known or suspected non-compliance, e.g. due to language problems, psychological disorders, dementia, drug or alcohol abuse, etc. of the subject
• Active smoker
• History of claustrophobia that would prevent an MRI of the index shoulder
• Presence of an implanted metallic device or other implants that would contraindicate acquisition or inhibit radiologist review of an MRI of the index shoulder
• Pregnant or planning to become pregnant during the study period
• Breast feeding women
• Subject has conditions or circumstances that would interfere with study requirements.
• Contraindications and limitations of the MD as described in the IFUs.
• Partial rotator cuff tears
• History or known allergy or intolerance to polyester
• Complete full-thickness subscapularis tears greater than the superior 1/3 of the tendon, with Lafosse grade 3 or greater
• Massive rotator cuff tears, tear size equal to or greater than 4 cm in the anterior-posterior dimension or irreparable rotator cuff tear
• Limited space or exposure for implant delivery
• Structural or pathological condition of the bone or soft tissue that could impair healing.
• Intraoperative rotator cuff tear characteristics differ from preoperatively expected characteristics and fulfil one of the abovementioned criteria
• Fatty infiltration of the index shoulder rotator cuff muscle > Goutallier Score 2
• Corticosteroid injection in the operative shoulder within 6 weeks of operation
• Subject shows frozen shoulder/adhesive capsulitis at day of surgery
• Cases of moderate to severe osteoarthritis
• Patients with inflammatory disease or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, arthropathy)
• Subjects with diabetes type I or II
• The subject currently has an acute infection in the area surrounding the surgical site
• Evidence of active infection, osteomyelitis, sepsis or distant infection which could spread to the index joint.
• Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• Balgrist University Hospital — Zurich

Идентификаторы

NCT: NCT07005063 · ZM072024 · SNCTP000006378

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗