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
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