跳至主要内容
临床试验/NL-OMON55402
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.

研究者

发起方
niversitair Medisch Centrum Utrecht

相似试验