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临床试验/ACTRN12617000853347
ACTRN12617000853347已完成未知

platelet-Rich plasma as a symptom- and disEaSe-modifying Treatment fOR knee ostEoarthritis - the RESTORE trial

niversity of Melbourne0 个研究点目标入组 288 人开始时间: 2017年6月9日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
288

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
50 Years 至 o limit(—)
性别
All

入选标准

  • 1)aged greater than or equal to 50 years;
  • 2)knee pain on most days in the last month;
  • 3)tibiofemoral osteophytes on x-ray; and
  • 4)A minimum pain score of 4 on an 11-point numeric rating scale for the last week.

排除标准

  • 1)Kellgren and Lawrence (KL) grade 1 indicating questionable disease or grade 4 indicating severe disease;
  • 2)predominant lateral tibiofemoral disease;
  • 3)Hyaluronic acid injection in past 6 months, corticosteroid injection in past 3 months or autologous blood product in the past;
  • 4)knee surgery on their most painful knee within past 12 months;
  • 5)systemic or inflammatory joint disease;
  • 6)history of crystalline or neuropathic arthropathy;
  • 7)knee joint replacement or high tibial osteotomy on their most painful knee;
  • 8)plan for joint surgery in next 12 months;
  • 9)other muscular, joint or neurological condition affecting lower limb function;
  • 10)needle phobia;
  • 11)immunosuppression or acute infective processes;
  • 12)cancer or other tumour-like lesions;
  • 13)bleeding disorder or receiving anti-coagulation therapy;
  • 14)presence of a warm tense joint effusion;
  • 15)platelet count greater than or equal to 150,000/microlitre;
  • 16)any other medical condition precluding participation in the study including contraindication to MRI such as pregnancy;
  • 17)be unwilling to discontinue NSAID and other analgesic usage for knee pain, with the exception of paracetamol for rescue pain relief, from 2 weeks prior to baseline assessment until the 12 month follow up assessment;
  • 18)Body mass index (BMI) >40kg/m2 because of problems fitting in to the MRI machine knee coil; and
  • 19)Inability to understand written/spoken English.

研究者

发起方
niversity of Melbourne

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