Treatment of Knee Arthrosis: Platelet-derived Growth Factors vs. Hyaluronic Acid. A Phase II-III Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 主要终点
- Efficacy (as determined by improvement at MRI 6 months after the first injection) of intraarticular injections of platelet lysate
研究概览
简要总结
Primary aim of this trial was to assess efficacy three intraarticular injections of platelet lysate when compared to hyaluronic acid. Additional objectives were to compare the treatment groups in terms of a number of functional scales and of number of adverse events.
详细描述
Intra-articular injections of hyaluronic acid are effective in improving symptoms and slow disease progression, but are not able to revert the damage mechanism and trigger cartilage healing.
Growth factors included in PRP could stimulate cartilage repair, normalize synovial fluid viscoelasticity, induce a correction in tissue damage, improve articular function, control pain and ameliorate quality of life.
Primary aim of this trial was to assess, among patients with grade II/III osteoarthrosis of the knee, efficacy (as determined by improvement at MRI 6 months after the first injection) of three intraarticular injections of platelet lysate when compared to hyaluronic acid. Additional objectives were to compare the treatment groups in terms of a number of functional scales (WOMAC, Lysholm, Tegner Knee, Scale, AKS, Lequesne, VAS) and of number of adverse events.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •grade II/III OA of the knee demonstrated at MRI17,18, according to Shahriaree Classification System - modified
- •no previous OA treatment with local hyaluronic acid or steroid injections
- •ife expectancy >1 year
- •no ongoing pregnancy
- •ability to understand and complete clinical and functional scales Lysholm, WOMAC, AKS, VAS
- •written consent.
排除标准
- 未提供
研究组 & 干预措施
Platelet-rich plasma
Patients in the intervention group will receive three autologous PRP plus calcium gluconate (as activator) intraarticular injections at 4-week intervals. Briefly, at the Immunohaematology and Transfusion Service, on each scheduled visit 20 ml of autologous whole blood will be sampled from each patient, 2 ml ACD-A will be added directly the syringe as anticoagulant; finally the vial will be gently centrifuged at 900rpm for 7 minutes. Platelet-rich plasma was collected. The PRP vials plus activator will be immediately shipped to the rehabilitation unit, where intraarticular injection will be performed by an experienced physiatrist.
干预措施: intraarticular injections of platelet lysate (Biological)
hyaluronic acid
Patients in the control group will receive three intraarticular hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) injections at the same intervals, by the same study staff.
干预措施: hyaluronic acid (Drug)
结局指标
主要结局
Efficacy (as determined by improvement at MRI 6 months after the first injection) of intraarticular injections of platelet lysate
时间窗: Six months after the last infiltration
Each knee was improvement, from baseline, by at least one degree the maximum MRI score (Shahriaree Classification System - modified) at 6 month
次要结局
- Adverse event(1 year)
- Lysholm functional scale(At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year)
- Lequesne functional scale(At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year)
- VAS for pain(At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year)
- AKS functional scale(At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year)
- WOMAC functional scale(At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year)
- Tegner Knee functional scale(At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year)
研究者
Claudio Lisi
MD
Fondazione IRCCS Policlinico San Matteo di Pavia