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临床试验/ACTRN12614000812695
ACTRN12614000812695终止2 期

The effect of mesenchymal stem cell injections following arthroscopic microfracture versus microfracture alone on cartilage healing in patients with an isolated knee cartilage defect.

Magellan Stem Cells0 个研究点目标入组 40 人开始时间: 2014年7月31日最近更新:

试验速览

阶段
2 期
状态
终止
发起方
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 50 Years(—)
性别
All

入选标准

  • 1.Aged between 18 – 50 (inclusive). As isolated full thickness chondral defects are often traumatic in nature it is likely that this age restriction represents the majority of patients who undergo microfracture.
  • 2.Pre-operative radiological diagnosis of an isolated full thickness knee cartilage defect of the medial or lateral femoral condyle
  • 3.Planned arthroscopic microfracture/osteoplasty
  • 4.Sufficient English skills to complete the questionnaires required for the study, as well as to understand the instructions given by the study doctors.
  • 5.No plans at the time of enrolment to undergo surgery in the following three months. This criterion is aimed at avoiding co-interventions that may confound the results of the study. While involvement in the project will not strictly prevent participants from undertaking such interventions if required, we will exclude volunteers who already have such procedures scheduled

排除标准

  • 1.Pregnancy (accepted contra-indication as no safety data on this population).
  • 2.Have other causes of their knee symptoms suspected to be due to serious pathology such as tumour or referral from the hip or lumbar spine. These conditions are not under investigation within the current project;
  • 3.Blood disorder (accepted contra-indication as no safety data on this population)
  • 4.MRI confirmed displaced meniscial tear.
  • 5.MRI confirmed Grade II-IV degenerative osteoarthritis
  • 6.History of cancer
  • 7.History of atypical chronic pain syndrome

研究者

发起方
Magellan Stem Cells

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