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临床试验/NCT01812564
NCT01812564已完成2 期

Clinical Utilization of Growth Factors Preparations in the Management of Acute Hamstring Muscle Strain Injury

Aspetar2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2009年11月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
Aspetar
入组人数
90
试验地点
2
主要终点
Time to Return to Play

研究概览

简要总结

The purpose of this study is to evaluate the therapeutic benefit of utilizing complex growth factor preparations (Platelet Rich Plasma (PRP) in the management of acute hamstring injuries.

The hypothesis is that the time to return to sport is shorter in the patient group treated with Complex Growth Factor Preparations (PRP) in combination with exercise therapy in comparison with 2 control groups:

  • the patient group treated with Platelet Poor Plasma (PPP) injections in combination with exercise therapy (control injection AND usual care).
  • the patient group treated with exercise therapy (usual care)

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Acute onset posterior thigh pain
  • MRI confirmed Grade I, II hamstring lesions
  • < 5 days from injury
  • Able to perform Physiotherapy at ASPETAR (5 sessions/week)
  • Available for follow-up
  • Age > 18 years

排除标准

  • Diabetes, immuno-compromised state
  • Overlying skin infection
  • Re-injury or Chronic ongoing hamstring injury
  • Unwilling to comply with follow up
  • Contraindication to MRI
  • Needle Phobia
  • Bleeding disorder or other medical contraindication to injection
  • Medication increasing bleeding risk (e.g. Plavix)
  • Concurrent other injury inhibiting rehabilitation

结局指标

主要结局

Time to Return to Play

时间窗: Patients will be followed for the duration of time to return to play with an expected average of 27 days and up to 1 year.

Time to return to full sports activity; either training or match play.

次要结局

  • Recurrent hamstring lesions.(2 months after return to play, 1 year after return to play.)

研究者

发起方
Aspetar
申办方类型
Other
责任方
Sponsor

研究点 (2)

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