Идёт набор NCT05997381

BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears

Без фазы С лечением Rotator Cuff Tears

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: Arthroscopic rotator cuff repair with BioBrace® Implant augmentation., Arthroscopic rotator cuff repair.
Кому может быть актуально: Состояния в реестре: Rotator Cuff Tears. Базовые параметры: 40 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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Официальное название

REinForce: A Prospective, Single Blind, Multi-Center, Randomized, Controlled, Pivotal Study to Evaluate the Safety and Effectiveness of the BioBrace® Implant During Arthroscopic Repair of Full Thickness Rotator Cuff Tears

Обзор

This study aims to evaluate the safety and effectiveness of arthroscopic rotator cuff repair augmented with the BioBrace® Implant vs. arthroscopic rotator cuff repair alone in subjects requiring surgical intervention for a full-thickness rotator cuff tear.

Подробное описание

This is a prospective, single blind, multi-center, randomized, controlled, pivotal clinical study investigating the treatment of full thickness tears of the rotator cuff. Tears must involve the supraspinatus and/or infraspinatus tendons and measure ≥ 2 cm and \< 5 cm. Subjects meeting the inclusion/exclusion criteria will be enrolled and will undergo either arthroscopic rotator cuff repair augmented with the BioBrace® Implant or arthroscopic rotator cuff repair alone. Clinical evaluations will be conducted at baseline (pre-operatively) and at 6 weeks, 3-, 6-, and 12-months post-operatively using various patient-reported outcome measures and MRI to assess repair integrity and re-tear rate.

Вмешательства

Устройство Arthroscopic rotator cuff repair with BioBrace® Implant augmentation.
An arthroscopic rotator cuff repair will be performed and augmented with the BioBrace® Implant. The BioBrace® Implant is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists. It is a bioresorbable, biocomposite scaffold composed of a highly porous collagen sponge and reinforced with poly-L-lactic-acid (PLLA). When used in rotator cuff repairs, it is placed on top of the tendons to augment and reinforce the underlying repair. The BioBrace® is designed to
Процедура Arthroscopic rotator cuff repair
An arthroscopic rotator cuff repair is performed using standard surgical procedure.

Первичные конечные точки

6 Month Retear Rate [Срок оценки: 6 months post-op]

Вторичные конечные точки (4)

12 Month Retear Rate [Срок оценки: 12 months post-op]
Single Assessment Numeric Evaluation (SANE) [Срок оценки: Baseline, 6 weeks, 3-, 6-, and 12-months post-op]
Western Ontario Rotator Cuff Index (WORC) [Срок оценки: Baseline, 6 weeks, 3-, 6-, and 12-months post-op]
EuroQOL Five Dimensions Questionnaire (EQ-5D-5L) [Срок оценки: Baseline, 6 weeks, 3-, 6-, and 12-months post-op]

Критерии участия

Критерии включения

Male or female 40 to 70 years old
Positive diagnostic imaging by MRI within 6 months of enrollment of the index shoulder indicating a full thickness rotator cuff tear (RCT):

Tear of the supraspinatus and/or infraspinatus tendons
Tear size ≥ 2 cm and < 5 cm
Chronic shoulder pain ≥ 3 months
Failed non-operative treatment of the index shoulder to include one or all of the following:

Oral analgesics
Nonsteroidal anti-inflammatory medications (NSAIDs)
Corticosteroid injections
Activity modifications
Physical therapy or home-guided exercises
Able to read and understand the study REB/IRB approved Informed Consent Form (ICF)
Willing to be available to attend each protocol-required follow-up examination

Intraoperative Inclusion Criteria:

Full thickness tear of the supraspinatus and/or infraspinatus tendons
Tear size ≥ 2 cm and < 5 cm
Able to reapproximate the tendons to cover > 50% of the footprint on the greater tuberosity

Критерии исключения

Previous surgery of the index shoulder one year prior to the study surgery excluding diagnostic arthroscopy
Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3 (Goutallier Score)
Major medical condition that could affect quality of life and influence the results of the study as determined by the Investigator
Oral steroid use or steroid injection within 6 weeks prior to surgery
Active smoker
History of insulin-dependent diabetes
Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment
Hypersensitivity to any investigational device materials including collagen of animal origin (bovine type-I), poly-L-lactic acid (PLLA) or polyethylene glycol (PEG)
Presence of an implanted metallic device or other implants that would contraindicate acquisition or inhibit radiologist review of an MRI of the index shoulder
History of claustrophobia that would prevent an MRI of the index shoulder
Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study
Currently participating, or plans to enroll in another clinical trial during this study that would affect the outcomes of this study as determined by the Investigator
History of non-compliance with medical treatment or clinical trial participation
The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant with protocol required follow-up
Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator
The subject is receiving prescription narcotic pain medication
The subject currently has an acute infection in the area surrounding the surgical site
Contralateral shoulder condition where rotator cuff repair is scheduled or to be scheduled over the course of this study
The subject's condition represents a worker's compensation case