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临床试验/NCT07609849
NCT07609849进行中(未招募)不适用

Comparison of Isolated Meniscus Repair Versus Combined Meniscus Repair and Notch Microfracture: A Randomized Controlled Trial Evaluating Functional and Imaging Outcomes

Ain Shams University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
1

研究概览

简要总结

This study aims to evaluate the efficacy of microfracture as an adjunctive augmentation technique in the repair of isolated meniscal tears. This will be achieved through comparing the functional and imaging outcomes of meniscus repair with notch microfracture in comparison with meniscal repair alone through a randomized control trial.

详细描述

Meniscal tears are the most common injury among musculoskeletal injuries. The incidence rate has varied across different studies in Europe, with a mean incidence of 60 to 70 per 100,000 annually. Despite advanced meniscal repair techniques, the failure rates are still 20-24% within two years, rising to 26% in medial tears.

Outcomes improve significantly when repair is combined with ACL reconstruction, where healing rates increase up to 93%, likely due to the biologically enriched environment created by bone tunnels and associated release of growth factors. The microfracture technique reproduces this environment by making small channels in the intercondylar notch of the femur that release marrow-derived factors to enhance healing.

Retrospective studies have been undertaken comparing the two repair methodologies. However, prospective comparative studies have not yet been explored in human populations.

This study aims to compare the functional and imaging outcomes of meniscus repair with notch microfracture in comparison with meniscal repair alone through a randomized controlled trial.

Although meniscal preservation is considered essential for long-term knee function, isolated repairs continue to show high failure rates. Evidence of superior outcomes when repair is combined with ACL reconstruction highlights the importance of a biologically enriched intra-articular environment. Microfracture replicates this environment by releasing stem cells and growth factors into the joint.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Isolated Lateral or Medial repairable meniscus tears
  • Vertical Longitudinal meniscal tears.
  • Adults aged 18-50 years-old
  • Both Genders

排除标准

  • Associated ligament injury.
  • Associated bone angular deformity.
  • Associated chondral injuries that require cartilage reconstruction procedures (microfracture, osteochondral graft or autologous chondrocyte implantation).
  • Meniscal tears that occurred more than 6 months before the procedure.

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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