Prospective monocenter study on clinical outcomes and safety of Instant MSC Product accompanying Autologous Chondron Transplantation (IMPACT) for focal articular cartilage lesions of the knee - IMPACT

niversitair Medisch Centrum Utrecht0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年4月15日

试验速览

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•- 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 trochlea).
•- Age >18 and <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).

•- 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 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.

发起方

niversitair Medisch Centrum Utrecht