2026-526179-49-00招募中4 期
Non-inferiority of surgical treatment of cartilage defects of the knee with autologous minced cartilage implantation (AMCI) and matrix-asscociated autologous chondrocyte implantation with respect to KOOS at 24 months (M ACI) - MinCaRCT
Medical Center - University Of Freiburg8 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2026年6月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 166
- 试验地点
- 8
- 主要终点
- The primary efficacy endpoint is the KOOS5 (composite Knee injury and Osteoarthritis Outcome Score) at 24 months after randomisation
研究概览
简要总结
Assessment of the mid-term efficacy of the “Minced Cartilage” procedure (AMCI) in comparison to matrix-associated autologous chondrocyte implantation (M ACI) in the treatment of large full-thickness cartilage defects of knee joints as measured in KOOS.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patient with isolated ICRS grade III or IV cartilage defect of the knee with intact grade I to II corresponding cartilage joint surface
- •Defect size: 3-6 cm2 with surrounding healthy cartilage and healthy under laying bone diagnosed before enrolment by MRI or arthroscopy
- •Male or female patients aged > 18 years (and completely closed growth plate in the affected joint) to ≤ 55 years
- •established diagnosis for each of the treatment methods applied/used in the clinical trial before randomisation
排除标准
- •Any signs of subjective and objective knee instability
- •Valgus or varus malalignment (more than 3 angular degree over the mechanical axis), which is not corrected as a parallel treatment at time of intervention
- •Partial resection of the meniscus with more than 1/3 resected or total resection in the affected knee (ipsilateral)
- •Rheumatoid arthritis, parainfectious or infectious arthritis; condition after these diseases
- •Defects on both knees at the same time or second cartilage lesion on the same knee
- •Radiological signs (X-ray, two levels) of osteoarthritis exceeding grade I on Kellgren-Lawrence Scale
- •history of and/or signs for clinically relevant organ dysfunctions
- •history of and/or signs for clinical contraindications against surgical, anesthesiologic and imaging methods applied in the clinical trial
结局指标
主要结局
The primary efficacy endpoint is the KOOS5 (composite Knee injury and Osteoarthritis Outcome Score) at 24 months after randomisation
The primary efficacy endpoint is the KOOS5 (composite Knee injury and Osteoarthritis Outcome Score) at 24 months after randomisation
次要结局
- Following scores and questionnaires at 3, 6, 12, 24 months after randomisation: IKDC, KOOS5, KOOS subscales (Pain, Symptoms, ADL, Sport and Recreation, QOL), Lysholm, QOL SF-12, absence from work and incidence and number of revision surgeries.
研究者
Coordinating Investigator
Scientific
Medical Center - University Of Freiburg
研究点 (8)
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