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临床试验/NCT00537784
NCT00537784已完成不适用

Platelet Concentrate in Achilles Tendon Repair

University Hospital, Linkoeping2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Modulus of elasticity

研究概览

简要总结

People operated for a rupture of the Achilles tendon receive a concentrate of their own platelets injected into the operated area. The study is randomized and single-blinded, with 20 treated patients and 20 controls, who get no injection. The primary endpoint is a mechanical property of the tendon after 12 weeks (modulus of elasticity), as measured by a special type of radiography. This radiography uses 0.8 mm metal markers, which are injected into the tendon. The tendon is mechanically loaded during radiography and its strain can be measured as increased distance between the markers. Other mechanical variables at 6, 12 and 52 weeks are secondary variables, as well as a validated patient-administrated questionaire at 1 year.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Achilles tendon rupture, age 18-65.

排除标准

  • Any counterindication for surgical treatment.

结局指标

主要结局

Modulus of elasticity

时间窗: 12 weeks

次要结局

未报告次要终点

研究者

发起方
University Hospital, Linkoeping
申办方类型
Other
责任方
Principal Investigator
主要研究者

Per Aspenberg

professor

University Hospital, Linkoeping

研究点 (2)

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