Comparison of Intraarticular Platelet-rich Plasma Injections With Intraarticular Corticosteroid Injections in the Treatment of Primary Knee Osteoarthritis : A Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Improvement in WOMAC Knee Score
研究概览
简要总结
Aim: To study and compare the clinical effects of platelet-rich plasma (PRP) injections and intra-articular (IA) corticosteroid injections in patients with primary osteoarthritis (OA) of the knee. This study aims to demonstrate this by using the Oxford Knee Score and Western Ontario and McMaster Universities Arthritis Index (WOMAC) to illustrate quantifiable difference between the two treatment modalities. Patient satisfaction will be compared by utilizing the Short-Form Survey-12 (SF-12) Score. Our null hypothesis states that intra-articular PRP injections is more beneficial in the long-term treatment of primary OA of the knee.
详细描述
This is a single blinded, randomized clinical trial. Subjects will be male or female patients with Grade 1,2 or 3 OA of the knee classified based on the radiological Kellgren -Lawrence grading system.
100 patients will be recruited for this study and 50 patients each will be randomized to one of the treatment groups using block randomization i.e. receiving either treatment IA corticosteroids or IA PRP injections. The patients will be informed of and will be consented to the treatment they will be receiving. An investigator from the research team, blinded to group assignment, will assist patients in completing the Oxford Knee score, WOMAC and SF-12 scores prior to receiving the treatment and at 6 weeks, 3 months and 6 months after receiving the treatment. In addition, they will be followed by regularly (at 3 weeks, 9 weeks, 4 months and 5 months) via telephone to inquire about any side effects of the treatment and to document patient satisfaction. Subjects in both groups will continue to receive concomitant treatments both pharmacological and nonpharmacological. All subjects will receive physiotherapy sessions with their respective intervention. Subjects will continue to receive treatment even if they wish to withdraw from the study at any point.
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
- Single (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
- •Clinical and radiological diagnosis of Primary Osteoarthritis of Knee joint
- •Grade 1, 2, or 3 as per Kellgren and Lawrence radiological grading system.
- •Symptomatic at presentation as per Visual Analogue pain scale
- •Above 18 years of age
- •Consenting to participate
排除标准
- •Deformities
- •Malalignments
- •Rheumatoid lesions
- •Gouty lesions
- •BMI more than 35
- •Use of steroids in the recent 6 weeks
- •Breast feeding
- •Active malignancy
- •Active infections
- •Hemoglobin less than 11
- •Platelet less than 150,000/mm3 and
- •Bleeding disorders/blood dyscrasias or hemoglobinopathies
- •Any contraindications to treatments
- •Uncontrolled diabetes.
研究组 & 干预措施
Intra-articular corticosteroid
Intra-articular corticosteroid injections Patients receiving the IA corticosteroid will be injected 3mL of 0.5% Bupivacaine and 2mL of 80mg Depo Medrol in a 10cc syringe, using an aseptic technique into the suprapatellar pouch. After an IA corticosteroid injection, patients are always advised to rest for 24 hours, and weigh bear as little as possible for the following 3 days. The procedure will be performed by a senior resident with several years of experience or a consultant Orthopedic surgeon.
干预措施: Intra-articular corticosteroid injections (Drug)
Intra-articular platelet-rich plasma
IA PRP procedure This involves withdrawal of 10-15cc of patient's blood, which is collected and centrifuged in Rotofix 32 A Centrifuge machine at 1500 cycles/minute for 5 minutes. 3-4cc of the PRP is obtained and injected into the suprapatellar pouch using an aseptic technique. The procedure will be performed by the principal investigator, a qualified consultant Orthopedic surgeon. Analgesia will be administered as needed.
干预措施: Intra-articular platelet-rich plasma (Drug)
结局指标
主要结局
Improvement in WOMAC Knee Score
时间窗: 6 weeks to 6 months
WOMAC - Western Ontario and Mcmaster index of Osteoarthritis
次要结局
- Improvement in SF12 score(6 weeks to 6 months)
- Improvement in Oxford Knee Score(6 weeks to 6 months)