Efficacy of Bone Marrow Aspirate Concentrate Compared With Platelet Rich Plasma for the Treatment of Symptomatic Knee Osteoarthritis: A Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements
研究概览
简要总结
This study is intended to compare whether bone marrow aspirate concentrate or platelet rich plasma injections is more effective in treating knee osteoarthritis.
详细描述
While PRP shows promise in helping restore function to these patients, there are still concerns with PRP's long term outcomes. Another option that has become more popular for physicians treating this debilitation condition is bone marrow aspirate concentrate (BMA), which use's undifferentiated cells found in the bone marrow to promote healing and tissue regeneration. These cells have the ability to replicate into a multiple different tissue types. With BMA, the marrow is concentrated provide better healing of the damaged tissue and aid in growth and repair. The full benefits of BMA are still unknown, but studies have shown the treatment can reduce swelling, relieve pain, and improve healing in articular cartilage and bone grafts.
Autologous BMA has shown promising clinical potential as a therapeutic agent in regenerative medicine, including the treatment of osteoarthritis and cartilage defects, and the clinical efficacy platelet rich plasma has been documented to alleviate symptoms related to knee osteoarthritis. However, randomized, prospective comparison of the two techniques has not been reported in the literature and long term follow-up for both treatments is limited, and especially limited in the use of BMA for osteoarthritis treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 18-80 years
- •Knee osteoarthritis
- •Subjects must present with pain or swelling to target knee for at least 4 months
- •Kellgren-Lawrence score between 1 and 3 upon x-ray evaluation
- •Must be willing and able to provide informed consent
- •Willing and able to return for scheduled follow-up visits
排除标准
- •Major mechanical axis deviation of more than 50% into either compartment (varus or valgus )
- •Have had a corticosteroid injection within 3 months or a hyaluronic acid injection within 6 months
- •History of the following medical conditions:
- •autoimmune disorders
- •disorders requiring immunosuppression
- •rheumatoid arthritis
- •hemophilic arthropathy
- •infectious arthritis
- •Charcot's knee
- •Paget's disease of the femur or tibia
- •Ongoing infectious disease
- •Significant cardiovascular, renal or hepatic disease
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements
时间窗: Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months
Pain score measurements utilizing patient surveys; scale 0-20 with 20 being most pain and 0 being least pain
次要结局
- Subjective International Knee Documentation Committee Subjective Score (IKDC)(Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months)
