NL-OMON55402已完成3 期
Randomized controlled trial on clinical outcomes and safety of Instant MSC Product accompanying Autologous Chondron Transplantation (IMPACT) for focal articular cartilage lesions of the knee - IMPACT2
niversitair Medisch Centrum Utrecht0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •- Provides written informed consent, is able to understand the content of the
- •study, understands the requirements for follow-up visits and is willing to
- •provide the required information at follow-up visits and in the questionnaires.
- •- Symptomatic articular cartilage lesion of the knee (femoral condyles or
- •- Age 18 to 45 years old
- •- Modified Outerbridge Grade III or IV isolated cartilage lesion of the knee.
- •- A post-debridement size of the cartilage lesion > 2cm2 and <= 8 cm2
- •- At least 50% of functional meniscus remaining. Meniscal repair or resection
- •is allowed during the IMPACT surgery provided that the surgeon is able to
- •confirm that at least 50% of functional meniscus remains.
- •- Stable knee ligaments (i.e. anterior and posterior cruciate ligaments).
排除标准
- •- Malalignment of >5 degrees
- •- (History of) osteoarthritis, defined as Kellgren-Lawrence grade >3 as
- •determined from appropriate X-ray.
- •- Concomitant inflammatory disease that affects the joint (rheumatoid
- •arthritis, metabolic bone disease, psoriasis, gout, symptomatic
- •chondrocalcinosis)
- •- (History of) Septic arthritis.
- •- (History of) Total menisectomy in the target knee joint.
- •- Any surgery in the knee joint for cartilage treatment, 6 months prior to
- •study inclusion.
- •- Risk groups for MRI scanning due to the magnetic field like patients with
- •pacemakers, nerve stimulators, metal particles, stents, clips or implants,
- •(possible) pregnancy or breast feeding.
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