试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Feasibility measurements
研究概览
简要总结
研究富血小板血漿注射治療退化性膝關節炎
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40 至 70（—）
- 性别
- All
入选标准
- •Aged 45 to 75 years old;
- •Self-reported symptoms consistent with KOA per American College of Rheumatology guidelines;
- •Have experienced moderate to severe knee pain for at least 3 months, defined as a score of 3 or more (0-6 ordinal response scale) on the question "What is the average level of your left/right knee pain?"
- •Failed 6 months of usual care;
- •Clinical evidence of KOA according to the American College of Rheumatology guidelines;
- •Radiographic evidence of KOA with Kellgren Lawerance (KL).
排除标准
- •Pregnancy;
- •On anticoagulation, immunosuppressive or daily opioid therapy;
- •History of collagen tissue or other autoimmune disorders;
- •Hematological diseases;
- •Severe cardiovascular diseases;
- •Prior or planned total knee replacement of the affected knee;
- •Allergy or intolerance to acetaminophen or xylocaine;
- •Body mass index (BMI) ≥ 35 kg/m2;
- •Co-morbidity severe enough to prevent reliable or safe study participation;
- •Subjects who cannot read or write in the Chinese Consent form;
- •Interim knee joint infectious arthritis or trauma;
- •Hemoglobin level < 11g/dL;
- •Platelet concentration < 150,000/mm3;
- •Clinical examination suggesting that the patient is not appropriate due to comorbid knee or other conditions.
研究组 & 干预措施
Case series
Intra-articular and extra-articular Platelet Rich Plasma injections 6 ml PRP plus 1 ml of 1% xylocaine (total 7 ml), once, single injection
结局指标
主要结局
Feasibility measurements
时间窗: Baseline, 16 and 26 weeks
Safety of the intervention
次要结局
- Objective functional outcomes(Baseline, 16 and 26 weeks)
- Self-reported knee-specific pain, function and stiffness(Baseline, 16 weeks and 26 weeks)
- Health-related quality of life(Baseline, 16 weeks and 26 weeks)
- Treatment satisfaction(at 26 weeks)
- Analgesics consumption(at 26 weeks)
- Acute and Constant Knee Pain Severity(Basline, 16 and 26 weeks)
研究者
研究点 (1)
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