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临床试验/NCT01211119
NCT01211119Unknown不适用

Novel One-step Repair of Knee Meniscal Tear Using Platelet-rich Fibrin

Taipei Medical University WanFang Hospital1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
18
试验地点
1
主要终点
MRI T2-map values in healing menisci

研究概览

简要总结

Currently, most knee meniscal tears are treated by partial or complete meniscectomy, or by suture repair when it is possible. Recently, the investigators have successfully developed and implanted a novel biomaterial, platelet-rich fibrin (PRF), to treat articular cartilage defect in pigs. The PRF is autogenesis as a natural fibrin-based biomaterial favorable to the development of microvascularization and enables local and progressive delivery of growth factors providing unique properties for tissue remodeling and wound healing. The advantages of using PRF implantation include no transplant rejection and no need to perform second operation. Knee meniscal repair using PRF has not been reported before. The aim of this study is to investigate whether PRF implantation can facilitate regeneration process of meniscectomized knee and T2-map MRI can monitor the process in those patients with meniscal tears.

A total of 18 adult patients with torn menisci (outer 1/3, posterior horn, medial meniscus) will be recruited and randomly divided into three groups: A (n=6), implantation of PRF after partial menisectomy; B (n=6), implantation of PRF after partial menisectomy and suture; C (n=6), partial menisectomy only. All studied knee will be scanned on a 1.5-T MRI with surface coil at baseline before surgery, 3 months and 6 months and 12 months after surgery.

The investigators believe that PRF enables to facilitate regeneration of meniscectomized knee, and T2-map MRI enables monitoring healing process of meniscal tears.

研究设计

研究类型
Interventional
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 20 to 45 years old;
  • time of injury to surgery within 8 weeks
  • patients who will sign inform consent
  • patients with clinical and MRI diagnosis of meniscal tears who will undergo arthroscopy
  • patients who will make MRI diagnosis at 3, 6, 12 months

排除标准

  • major trauma
  • coexist ligamentous rupture
  • knee dislocations

结局指标

主要结局

MRI T2-map values in healing menisci

时间窗: one-month

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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