跳至主要内容
临床试验/NCT01111747
NCT01111747已完成4 期

Regeneration of the Patellar Tendon After Harvesting Its Central Third With Platelet-rich Plasma. Prospective and Randomized Study.

University of Sao Paulo General Hospital0 个研究点目标入组 27 人开始时间: 2008年11月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
27
主要终点
Evaluation of the patellar tendon regeneration with magnetic resonance imaging.

研究概览

简要总结

The central third of the patellar tendon is used as a donor site for anterior cruciate ligament (ACL) reconstruction. After months or years the harvest site partially regenerates. The regeneration process is accomplished by biological mechanisms,including cells and proteins known as growth factors. The platelets are natural reservoirs of growth factors, and a platelet concentrate known as Platelet-Rich Plasma (PRP) has a three to five fold increase in growth factors. The hypothesis of the study is that the PRP can improve the regeneration of the patellar tendon.

The platelets are obtained from the patient's blood through a filtration system called apheresis, with the use of 250 milliliters of blood, with a sterile system. All the others components of blood (red cells, plasma, white cells) returns to the patient. The PRP is then applied in the harvest site on the patellar tendon, at the end of ACL reconstruction.

The patients are randomized in two groups, one with the use of PRP and the other group without PRP. This information for the patients will be granted just at the end of the research. After the surgery the rehabilitation protocol is the same for both groups. An isokinetic testing is done before the surgery and after six months. Questionnaires about the knee function are asked before the surgery and after six months. A magnetic resonance imaging is performed after six months to evaluate the tendon regeneration.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • indication of anterior cruciate ligament surgery with patellar ligament
  • skeletal maturity

排除标准

  • other knee ligament injuries
  • severe chondral lesions
  • osteoarthritis
  • non-compliance to the rehabilitation
  • previous surgery in the affected knee
  • reoperation during the time of the study for an unrelated condition
  • infection

结局指标

主要结局

Evaluation of the patellar tendon regeneration with magnetic resonance imaging.

时间窗: Six months

Six months after the surgery a magnetic resonance imaging will be done to evaluate the regeneration of the patellar tendon donor site. The area of the gap, related to the tendon harvest, will be measured and compared between the groups.

次要结局

  • Isokinetic testing and questionaires.(Six months)

研究者

申办方类型
Other
责任方
Sponsor

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