Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears

Официальное название

Evaluation of Safety and Efficacy of a Resorbable Collagen Implant in Treatment of High Grade PArtial ThiCkness Tears; A Prospective, Multicenter, Randomized, Control Trial (IMPACT Study)

Обзор

The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.

Подробное описание

The primary objective of this study is to evaluate the functional recovery of patients with high grade (\>50%) partial thickness tears at 3 months when treated with either Isolated Bioinductive Repair (IBR) or Completion and Repair (CAR).

Вмешательства

• Устройство Isolated Bioinductive Repair
  Isolated Bioinductive repair with REGENETEN™ Bioinductive Implant
• Процедура Completion and Repair
  Standard surgical repair using the 'Completion and Repair' technique.

Первичные конечные точки

• Change in Western Ontario Rotator Cuff (WORC) [Срок оценки: Change from baseline to 3 months post-intervention]

Вторичные конечные точки (12)

• Western Ontario Rotator Cuff (WORC) [Срок оценки: Pre-op, 6 weeks, 3, 6, 12 and 24 months]
• Constant-Murley Score [Срок оценки: Pre-Op, 3, 6, 12 and 24 months]
• Subjective Shoulder Value (SSV) score [Срок оценки: Pre-Op, 6 weeks, 3, 12 and 24 months]
• EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS & index scores [Срок оценки: Pre-Op, 3 and 6 weeks, 3, 6, 12 and 24 months]
• Change in Western Ontario Rotator Cuff (WORC) [Срок оценки: Change from Pre-op to 6 weeks, 3, 6, 12 and 24 months]
• Change in Constant-Murley Score [Срок оценки: Change from Pre-Op to 6 weeks, 3, 12 and 24 months]
• Change in Subjective Shoulder Value (SSV) score [Срок оценки: Change from Pre-Op to 6 weeks, 3, 12 and 24 months]
• Percent Achieving Minimal Clinically Important Difference (MCID) for Constant-Murley Score [Срок оценки: Pre-Op, 3, 6, 12 and 24 months]
• Percent Achieving MCID for Western Ontario Rotator Cuff (WORC) [Срок оценки: Pre-op, 6 weeks, 3, 6, 12 and 24 months]
• Percent Achieving MCID for Subjective Shoulder Value (SSV) score [Срок оценки: Pre-Op, 6 weeks, 3, 12 and 24 months]
• Patient Satisfaction [Срок оценки: 6 weeks, 3, 6, 12 and 24 months]
• Pain, Visual analog scale (VAS) Score [Срок оценки: Pre-Op, 3 and 6 weeks, 3, 12 and 24 months]

Критерии участия

Критерии включения

• The subject must provide written informed consent.
• Subject is > eighteen (18) years of age (no upper limit).
• Subject has an isolated high-grade (>50% or >6mm) (Ellman grade III) partial thickness tear of supraspinatus or supraspinatus with infraspinatus.
• Subject has failed a minimum of 3 months of conservative management for treatment of partial thickness rotator cuff tear.
• Subject willing and able to make all required study visits.
• Subject able to follow instructions and deemed capable of completing all study questionnaires.

Критерии исключения

• Subjects with insufficient tendon tissue quality for management and protection of the tendon injury using the isolated REGENETEN Bioinductive Implant system.
• Subjects where the prescribed Physical Therapy guidelines stated in the protocol are not suitable for their rehabilitation.
• Subjects with Samilson-Prieto osteoarthritis grade 2 and greater.
• Subjects with current or prior infection of the ipsilateral shoulder.
• Subjects with known hypersensitivity to bovine-derived materials.
• Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, chronic joint disease or chronic pain of upper extremities (shoulder(s), arm(s)).
• Subjects with prior shoulder surgery on index shoulder, including subacromial decompression, biceps tenodesis/tenotomy, and acromioclavicular joint (ACJ) excision/distal clavicle excision (DCE).
• Subjects with a planned surgery on the contra-lateral shoulder within the study period.
• Systemic steroid use (oral, IV) or local steroid injection within 3 months of the date of surgery.
• Subjects with a full thickness rotator cuff tear.
• Subjects with a subscapularis tear requiring repair.
• Subjects requiring a concomitant labral fixation procedure, concomitant surgery for bone defects requiring bone implantation or for superior labral tear from anterior to posterior (SLAP).
• Subjects requiring a concomitant os acromiale fixation procedure.
• Subjects with glenohumeral joint instability (multiple dislocations/subluxations).
• Subjects with condition(s) that contraindicate or complicate outcomes of Isolated Bioinductive Repair or completion and repair e.g., > Hamada 3 rotator cuff arthropathy on X-ray, Goutallier atrophy > Grade 3, proximal humeral fracture or scapular fracture, avascular necrosis of the humeral head.
• Subjects with neurologic conditions effecting either upper extremity.
• Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications.
• Subjects who are pregnant or breast feeding.
• Subjects who are currently involved in any injury litigation relating to the index shoulder.
• Subjects with current workers compensation claim.
• Subjects who are enrolled, or plan to enroll, in another clinical trial during this study that would affect the outcomes of this study.
• Subjects with a history of poor compliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation.
• Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, and drug or alcohol abuse.
• Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs).
• Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.
• Subjects who have participated previously in this clinical trial and who have healed or been withdrawn
• Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

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

США · 8 центров

• Harbin Clinic — Rome
• OrthoIllinois LTD — Rockford
• Sinai Hospital Baltimore — Baltimore
• Cleveland Clinic - Sports Health — Garfield Heights
• University of Pittsburgh — Pittsburgh
• Texas Orthopedic Specialists — Bedford
• Houston Methodist The Woodlands — The Woodlands
• Memorial Medical Center — Ashland

Великобритания · 4 центра

• Ashford & St Peter's Hospitals NHS Foundation Trust — Chertsey
• Sulis Hospital — Bath
• North Bristol NHS Trust — Bristol
• Northern Care Alliance NHS Foundation Trust — Salford

Канада · 3 центра

• Access Orthopaedics — Calgary
• Pan Am Clinic — Winnipeg
• Research St. Joseph's — Hamilton

Италия · 2 центра

• IRCCS Istituto Ortopedico Galeazzi, — Milan
• Fondazione Policlinico Universitario Campus Bio-Medico — Roma

Испания · 2 центра

• Hospital Ramón y Cajal — Madrid
• Hospital Fundación Jiménez Díaz — Madrid

Австралия · 1 центр

• OrthoSport Victoria — Richmond

Идентификаторы

NCT: NCT05444465 · REGENETEN.2021.04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗