A Post Approval Multicenter 10 Year Follow-up Observational Trial of Marketed Product - MP01 vs. Surgical Standard of Care (SSOC) Used for the Treatment of Joint Surface Lesions of the Knee
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: Marketed Product - MP01, Surgical Standard of Care.
- Кому может быть актуально
- Состояния в реестре: Knee Injuries, Joint Surface Knee Lesions. Базовые параметры: 21 лет — 75 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, Бельгия, Израиль, Италия, Румыния +1
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
The purpose of the study is to support market adoption and global market access via collection of long-term effectiveness, safety, and radiographic data. The primary hypothesis is that Marketed Product (MP01) retains its superiority over Surgical Standard of Care (SSOC) at 7 years in term of mean improvement in the overall Knee Injury and Osteoarthritis Outcome Score (KOOS).
Подробное описание
This is a post approval, multicenter, prospective, comparative, non blinded 10-year follow-up observational study of Marketed Product - MP01 vs SSOC used for the treatment of joint surface lesions of the knee. Up to 12 sites in the United States (US) and outside of the US (OUS) that participated in the pivotal study "A Prospective Multicenter Open-label Randomized Controlled Trial of Marketed Product - MP01 vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee" (Marketed Product - MP01 vs. SSOC) will enroll up to 170 subjects who participated in the pivotal study and were not withdrawn due to the index knee requiring a unicompartmental or total knee arthroplasty. Enrolled subjects will be followed up to an additional 5 years post pivotal study procedure. As randomization was 2:1 in the pivotal study, the expected number of Marketed Product - MP01 and SSOC subjects enrolled into this study are approximately 114 and 56, respectively.
Вмешательства
- Устройство Marketed Product - MP01
Marketed Product - MP01 was implanted via a mini-arthrotomy or arthrotomy approach, using the designated surgical tools and surgical technique. - Процедура Surgical Standard of Care
As no single, current therapy could be used as a single comparator for the treatment of the knee lesions treated in the pivotal study which included focal cartilage lesions on the one hand and moderate knee osteoarthritis on the other, current general practice (e.g., SSOC: Deb and MFx) was used. Deb (SSOC) is a common orthopedic surgical procedure that removes damaged cartilage and tissue from the knee. MFx (SSOC) is another common orthopedic surgical procedure that treats knee cartilage defect
Первичные конечные точки
- Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 7 Years [Срок оценки: Baseline and 7 years]
Вторичные конечные точки (11)
- Safety of Marketed Product - MP01 vs SSOC: Time to Event of Secondary Invasive Interventions (excluding intra-articular injections) [Срок оценки: up to 10 years]
- Safety of Marketed Product - MP01 vs SSOC: Time to Event of Secondary Invasive Interventions (including intra-articular injections) [Срок оценки: up to 10 years]
- Safety of Marketed Product - MP01 vs SSOC: Cumulative Incidence Rate [Срок оценки: up to 10 years]
- Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 7 Years [Срок оценки: Baseline and 7 years]
- Change from Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 10 Years [Срок оценки: Baseline and 10 years]
- Change from Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscales at 7 Years [Срок оценки: Baseline and 7 years]
- Change from Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscales at 10 Years [Срок оценки: Baseline and 10 years]
- Change from Baseline in Tegner Activity Scale Score at 7 Years [Срок оценки: Baseline and 7 years]
- Change from Baseline in Tegner Activity Scale Score at 10 Years [Срок оценки: Baseline and 10 years]
- Change from Baseline in Total 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 7 Years [Срок оценки: Baseline and 7 years]
- Change from Baseline in Total 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 10 Years [Срок оценки: Baseline and 10 years]
Критерии участия
Критерии включения
- Participated in the pivotal study.
- Must be physically and mentally willing and able to comply with the follow-up schedule.
- Signed and dated the IEC/IRB approved Informed Consent Form and HIPPA (if applicable).
Критерии исключения
- Withdrawn from the pivotal study due to index knee requiring a unicompartmental or total knee arthroplasty.
- Chemotherapy in the past 12 months.
- Participation in other clinical trials involving knee procedures.
- Vulnerable individual including prisoners (i.e., unable to fully understand all aspects of the study that are relevant to the decision to participate or could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 2 центра
- Humanitas Gavazzeni — Bergamo
- Istituto Clinico Humanitas — Milan
Сербия · 2 центра
- Institut za Ortopedsko hiruske Bolesti "Banjica" — Belgrade
- Klinika Orto MD — Novi Sad
США · 1 центр
- Horizon Clinical Research — La Mesa
Бельгия · 1 центр
- AZ Monica — Antwerp
Израиль · 1 центр
- Hadassah Medical Center — Jerusalem
Румыния · 1 центр
- County Hospital Timis Othopedy and Trauma Clinic II — Timișoara
Идентификаторы
NCT: NCT06916728 · CLN-0029-1272