Effectiveness and Safety of Knee Cartilage Lesion Treatment Using CartiONE: 1-to-13 Year Follow-up.
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Knee Cartilage Lesion. Базовые параметры: от 18 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
- Бельгия, Польша, Великобритания
- 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
Effectiveness and Safety of Knee Cartilage Lesion Treatment Using CartiONE: 1-to-13 Year Follow-up
Обзор
CartiONE is a technique used in autologous articular-chondrocyte-based treatments for symptomatic focal articular-cartilage lesions of the knee. The CartiONE technique was evaluated in combination with an osteochondrally placed, biodegradable, biocompatible, load-bearing copolymer (PolyActive) scaffold in the INSTRUCT trial (NCT01041885). To evaluate the clinical effectiveness of the CartiONE technique and confirm its safety, in this study retrospective baseline data and follow-up data, documented as per the standard of care at the participating hospitals, will be collected for patients who were treated with CartiONE. The potential number of patients in this study is 122 and involves patients treated with CartiONE from 2010 to 2023 with a minimum follow-up period of six months, spread across five countries: Belgium, England, Greece, Poland, and Austria.
Подробное описание
Inclusion and exclusion criteria Inclusion criteria Patients treated with CartiONE for knee cartilage lesion more than 6 months prior to inclusion in this study.
The study site holds a patient record of all relevant medical history data, including operation reports of any prior knee surgeries, the index knee surgery report, and posttreatment observations and re-intervention reports, if applicable.
Exclusion criterion Patients cannot be included if any condition exists that is judged by the treating surgeon as making the patient not suited for participation.
Statistics This is a retrospective, open label, non-randomized, single arm trial. Since different questionnaires for effectiveness and for quality of life (e.g., KOOS, EQ-5D,…) may have been used, the total score of the questionnaires ranging from the minimum total score (i.e. 0 or 1) to the maximum total score will be transformed into the range from 0 respective 1 to 100. Now they can be combined across patients and effectiveness questionnaires or across patients and quality of life questionnaires. Details will be provided in the Statistical Analysis Plan.
There are two co-primary endpoints:
Primary endpoint safety:
Adverse events with particular focus on Treatment failure rate and on other AESIs
Primary endpoint effectiveness:
MOCART sub-score 1 "Volume fill of cartilage defect"
Efficacy/Effectiveness:
Key secondary endpoints:
Non-inferiority in MOCART/MOCART 2.0 total scores when measured at two different visits, i.e., at the reference visit and later.
Non-inferiority in mean "Radiologist's overall knee status assessment" when measured on a scale from 0 (extremely bad) to 100 (extremely good) at two different visits, i.e., at the reference visit and later.
Other secondary endpoints:
Improvement in other effectiveness questionnaire total scores Improvement in quality-of-life total scores Improvement in other questionnaires when applicable
Exploratory endpoint:
"Radiologist's overall knee status assessment" on a scale from 0 (extremely bad) to 100 (extremely good) of the two readers.
Первичные конечные точки
- Adverse events with particular focus on Treatment failure rate and on other AESIs [Срок оценки: periprocedurally, through to study completion up to 2 years]
- MOCART sub-score 1 "Volume fill of cartilage defect" [Срок оценки: baseline, month 3, month 6, year 1, year 2]
Критерии участия
Критерии включения
- Patients treated with CartiONE for knee cartilage lesion more than 6months prior to inclusion in this study.
- The study site holds a patient record of all relevant medical history data, including operation reports of any prior knee surgeries, the index-knee surgery report, and posttreatment observations and re-intervention reports, if applicable.
Критерии исключения
- Patients cannot be included if any condition exists that is judged by the treating surgeon as making the patient not suited for participation.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Бельгия · 2 центра
- UZ Ghent — Ghent
- AZ Monica — Antwerp
Великобритания · 2 центра
- University Hospitals Coventry & Warwickshire NHS Trust — Coventry
- Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust — Oswestry
Польша · 1 центр
- MIRAI — Warsaw
Идентификаторы
NCT: NCT06809231 · CRS001-2023 · IRAS ID 345492