NCT02189408已完成4 期
Effect of Platelet Rich Plasma ( PRP ) Applied During Knee Arthroscopy on Pain, Function and Quality of Life - A RCT With a Follow up of 12 Months
Ruhr University of Bochum2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2010年7月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- pain ( VAS )
研究概览
简要总结
The purpose of this study is to investigate reduction of pain, gain of function and improvement of life quality by intraoperative applied platelet- rich- plasma ( PRP ) during knee arthroscopy for degeneration and osteoarthritis OA by conducting a randomized- controlled, double-blinded trial ( RCT ) including 58 patients with a follow up of 12 months and pain, assessed by Visual- Analogue Scale (VAS) after 6 months as primary endpoint.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •degenerative knee pain
- •age: > 18 years
- •informed consent
- •none to moderate comorbidity
- •arthroscopy under general anaesthesia indicated
排除标准
- •trauma of the knee within the last 6 weeks before surgery
- •circumscribed cartilage lesion with possibility of repair microfracture or autologous chondrocyte transplantation - procedures
- •contraindications against PRP. application
- •malignancies
- •severe comorbidities
- •age <18 years
- •physically or mentally not able to provide informed consent
- •severe knee instability
- •corticosteroid injections within the last 6 weeks before surgery
结局指标
主要结局
pain ( VAS )
时间窗: 6 months
measurement of pain using a 100 mm VAS as platelet- rich-plasma demonstrated temporarily analgetic effects up to 6-9 months after application.
次要结局
- quality of life ( physical und mental summaries of SF-36 German version )(6 weeks, 6 months and 12 months)
- knee function (Lysholm-score )(6 weeks, 6 months, 12 months)
- pain ( VAS )(6 weeks, 12 months)
研究者
Christian Duif MD
PostDoc Department of Orthopaedics
Ruhr University of Bochum
研究点 (2)
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