Corticosteroid vs Platelet-Rich Plasma Intra-articular Injections in the Treatment of Knee Osteoarthritis in Patients Fifty Years and Older: a Look at Pain and Functional Outcomes at a Single Institution.
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Pain of the Knee
研究概览
简要总结
This study will explore the effectiveness of intra-articular knee injections in patients with osteoarthritis by comparing Corticosteroid (triamcinolone) vs Platelet Rich Plasma (PRP).
This study is a randomized controlled trial with a sample size of one hundred and sixty patients (160). Patients would be recruited via new referrals and follow-up appointments in the Orthopaedic clinic at the UHWI (University Hospital of the West Indies) with knee osteoarthritis.
The aim of the study is to:
- To determine if platelet-rich plasma injections are better at improving functional outcomes in the knee using Western Ontario and McMaster Universities Arthritis Index (WOMAC) when compared to intraarticular steroids.
- To identify adverse reactions related to these injections
详细描述
This study will explore the effectiveness of intra-articular knee injections in patients with osteoarthritis by comparing Corticosteroid (triamcinolone) vs Platelet Rich Plasma (PRP).
This study is a randomized controlled trial with a sample size of one hundred and sixty patients (160). Patients would be recruited via new referrals and follow-up appointments in the Orthopaedic clinic at the UHWI (University Hospital of the West Indies) with knee osteoarthritis.
The recruitment period will run from July 31, 2023 to January 31, 2024 and a subsequent year of follow-up for each patient.
Selected patients will be informed of the study and given informed consent to fill out once they meet the inclusion criteria. Information will be stored on a password-encrypted external storage device that can only be accessed by the investigator or supervisor. Data will be analyzed using Statistical Package for the Social Sciences (SPSS).
The study will be conducted according to the good clinical practice guidelines of the World Medical Association (WMA) declaration of Helsinki which addresses research on human subjects and will conform to local laws and ethical requirements of the Ministry of Health.
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, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Kellgren and Lawrence grades 2-3 Age 50 years and older
排除标准
- •Patients with secondary OA:
- •History of Fractures around the knee joint i. patella ii. tibia plateau iii. intra articular distal femur
- •Bleeding diathesis
- •History of septic arthritis
- •Patients on oral steroid medications
- •Patients who received intraarticular steroid injection < 6 months before enrollment
- •Sickle Cell Disease
- •Rheumatoid arthritis
- •Patients with a diagnosis of knee OA with little or no pain
- •Patient with a diagnosis of knee OA being successfully managed with oral medications and physiotherapy
- •Knee pain not attributed to a diagnosis of OA
- •All patients who refuse to participate
研究组 & 干预措施
Corticosteroid Injection
This arm will receive a corticosteroid (Triamcinalone) injection.
干预措施: Triamcinolone (Drug)
Platelet Rich Plasma Injection (PRP)
This arm will receive a PRP injection.
干预措施: Platelet Rich Plasma (Other)
结局指标
主要结局
Pain of the Knee
时间窗: 1 year of follow up visits, post injection. Follow up will be done at 2 weeks, 3 months, 6 months, and 1 year.
For pain we are primarily using the visual Analogue scale, which is a subjective pain rating numerical scale where the patients rate their pain on a scale of 0-10. The Visual Analogue Scale is a scale from 0-10, where 0 = No Pain and 10 = Worst Pain Possible. The scale also uses faces to indicate the level of pain.
Function of the knee
时间窗: 1 year of follow up visits, post injection. Follow up will be done at 2 weeks, 3 months, 6 months, and 1 year.
For Function we are primarily using the Western Ontario and McMaster Universities Arthritis index (WOMAC), which is a commonly used tool to assess pain and function in patients with arthritis. This is a self administered questionnaire with 24 items in 3 subscales (1) 5 points evaluate pain (2) 2 points stiffness (3) 17 points function a numerical score is calculated and used for comparison. The WOMAC index uses a scale of 0-4 to rate pain, stiffness and difficulty when doing certain activities, where 0 = None and 4 = Extreme.
次要结局
未报告次要终点