跳至主要内容
临床试验/NCT00761423
NCT00761423已完成4 期

The Value of Platelet-Rich Plasma in Chronic Midportion Achilles Tendinopathy: a Double-blind Randomized Clinical Trial

Zimmer Biomet1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
Zimmer Biomet
入组人数
81
试验地点
1
主要终点
VISA-A Score

研究概览

简要总结

The study will be a double-blind randomized single-center clinical trial comparing 3 treatment groups with chronic midportion Achilles tendinopathy.

详细描述

Introduction- Overuse injury of the Achilles tendon is a common entity in athletes and older athletes are at an increased risk. When the exact origin of tendon pain is unclear, the term tendinopathy is preferred. Most accepted treatment at this moment is an eccentric exercise programme, according to the Dutch guidelines. However, a recent systematic review on the effectiveness of eccentric exercises to treat lower extremity tendinoses concluded that it is unclear whether eccentric exercises are more effective than other forms of treatment.

Recent studies described new treatment strategies in tendinopathies, such as the use of platelet-rich plasma (PRP). Platelets can participate actively in tissue repair processes and stimulate the release of several growth factors. Recently, it was found that platelet-rich plasma clot releasate stimulates cell proliferation, collagen deposition, and enhances the gene expression of matrix degrading enzymes and endogenous growth factors by human tendon cells in vitro. The only published clinical cohort study in tendon research reported 93% reduction of pain for PRP-treated patients with chronic elbow tendinosis. Also on short term follow-up, the PRP injection was more beneficial than injection with an anaesthetic agent.

Aim- To monitor the potential clinical improvement of chronic midportion Achilles tendinopathy after injection with PRP and to evaluate the recovery process in time using a new Ultrasonographic method (Ultrasonographic Tissue Characterisation).

Hypothesis: The average VISA-A score is higher in the patient group treated with eccentric exercise therapy in combination with a PRP injection in comparison with the group treated with a saline injection in combination with eccentric exercises.

Study population- In total, 54 patients with symptomatic Achilles tendinopathy will be included in the study.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

VISA-A Score

时间窗: 6, 12, 24 and 52 weeks

次要结局

  • Power doppler sound(6, 12, 24 and 52 weeks)
  • Complications(Anytime)
  • Patient satisfaction(6, 12, 24 and 52 weeks)
  • Return to sport(6, 12, 24 and 52 weeks)
  • Ultrasonographic Tissue Characterization(6,12, 24 and 52 weeks)

研究者

发起方
Zimmer Biomet
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

The Value of Platelet-Rich Plasma in Chronic... | 临床试验