Effect of Intra-Articular Platelet-Rich Plasma (PRP) Injections on Cartilage Oligomeric Matrix Protein (COMP) Levels in Knee Osteoarthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- The study will show improvement, if any, in serum COMP levels in OA knee patients receiving PRP injection at 6 weeks follow-up.
研究概览
简要总结
This study is a randomized controlled trial to be conducted in the Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences (AIIMS) Guwahati in patients diagnosed with primary knee osteoarthritis according to ACR criteria. After securing ethical clearance, consent will be obtained from each patient before enrolment into the study. Biochemical evaluation involves serum COMP level, and clinical evaluation involves parameters such as VAS for pain intensity and KOOS for OA functional assessment. A total of 110 participants meeting the inclusion and exclusion criteria will be enrolled and randomly allocated into two groups: 55 patients in the intervention group and 55 patients in the control group. The intervention group will receive 3 doses of PRP injections, which will be administered one week apart along with standard conservative treatment. The control group will receive standard conservative treatment. Follow-up assessment will be done 6 weeks after the last dose of PRP. Documentation will be done, and data will be collected and analysed using SPSS version 29.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with primary OA knee fulfilling ACR criteria (1986) Patients with OA knee symptoms of more than 3 months’ duration.
排除标准
- •Patients with secondary knee osteoarthritis Uncontrolled Hypertension and Diabetes Mellitus Type 2 Inflammatory arthritis, spondyloarthropathies.
- •History of trauma with diagnosed ligament tear History of surgery, manipulation, mobilization, or arthroscopy History of steroid, local anaesthetic, or hyaluronic acid injection over the last 3 months Bleeding disorders, patients using anticoagulant or antiaggregant medications.
结局指标
主要结局
The study will show improvement, if any, in serum COMP levels in OA knee patients receiving PRP injection at 6 weeks follow-up.
时间窗: baseline 0 weeks, 8 weeks
次要结局
- The study may also establish a correlation between change in COMP levels & the functional & pain status of the patients after PRP injections.(baseline 0 weeks & 8 weeks)