Prospective, Randomized, Double-blind Clinical Trial to Investigate the Efficacy of Autologous Bone Marrow Aspirate Concentrate Post-Meniscectomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- International Knee Documentation Committee (IKDC) Score
研究概览
简要总结
The proposed research study aims to evaluate the effects of autologous bone marrow aspirate concentrate (BMAC) on the development and progression of osteoarthritis (OA) in patients undergoing meniscectomy. This prospective, randomized, double-blind clinical trial will compare patient-reported outcomes, specifically IKDC scores between patients who receive BMAC post-meniscectomy and those who receive a saline control injection. The study will also compare physical examination, MRI, radiographs, and synovial fluid analysis. Our hypothesis is that those who receive the autologous BMAC injection after the procedure will have better outcomes than those who do not.
详细描述
Recent studies have demonstrated both the safety of BMAC intra-articular injection and improvements in subjective, patient reported outcomes in patients with existing knee OA. Unfortunately these studies were largely uncontrolled, underpowered, and/or retrospective in nature. Additionally, a recent prospective, randomized clinical study of allograft mesenchymal stem cells (MSCs) injected at a separate time point post surgical intervention has highlighted the ability of MSCs to increase meniscal volume and improve knee pain following injection.
This will be the first study to examine the effects of autograft BMAC intra-articular injection in a single-stage procedure and in a prospective, randomized, double-blind fashion. The results of this study, if the null hypothesis is rejected, will have far-reaching implications for the standard of care in meniscal treatment and on OA progression in the knee. Additionally, if the results of this study are favorable in reduction of OA progression this study will change the surgical approach to all axial, synovial joints including the shoulder, elbow, wrist, hip, and ankle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Subject is greater than 18 years old
- •Written informed consent is obtained
- •Subject is determined to have a symptomatic meniscal tear requiring a meniscectomy
- •Meniscal pathology is confirmed through MRI and arthroscopically
- •Subject agrees to all follow-up evaluations
- •Osteoarthritis Kellen-Lawrence grade 1-3 on flexion PA and extension AP views
排除标准
- •Any subject lacking decisional capability
- •Unwillingness to participate in the necessary follow-up
- •Subject is pregnant or may become pregnant
- •History of diabetes mellitus
- •History of rheumatoid arthritis or other autoimmune disorder
- •History of solid organ or hematologic transplantation
- •Diagnosis of a non-basal cell malignancy within the preceding 5 years
- •Infection requiring antibiotic treatment within the preceding 3 months
- •Osteoarthritis Kellen-Lawrence grade 4 on flexion posterior-anterior (PA) or extension anteroposterior (AP) views
- •Prior surgery on the index meniscus
- •Concomitant surgery such as ligament surgery or cartilage repair or restoration
- •Infection
- •Prior cortisone/viscosupplementation/ (platelet rich plasma) PRP injection within 6 weeks
研究组 & 干预措施
Meniscectomy with Bone Marrow Aspirate Concentrate (BMAC)
Subjects will undergo the scheduled meniscectomy procedure. Following the procedure the investigator will make a small incision and create the marrow access channel in the proximal tibia. The experimental group will then have bone marrow harvested and BMAC will be prepared using a BMAC harvesting system. The automated centrifuge system rapidly concentrates cellular contents and growth factors in bone marrow aspirate using flow cytometry. The BMAC will be injected intra-articularly.
干预措施: Standard Meniscectomy (Procedure)
Meniscectomy with Placebo
Subjects will undergo the same meniscectomy procedure and will also have an incision and marrow access channel made in the proximal tibia, however no bone marrow will be harvested. The control group will have a placebo injection of saline into the affected knee.
干预措施: Standard Meniscectomy (Procedure)
Meniscectomy with Bone Marrow Aspirate Concentrate (BMAC)
Subjects will undergo the scheduled meniscectomy procedure. Following the procedure the investigator will make a small incision and create the marrow access channel in the proximal tibia. The experimental group will then have bone marrow harvested and BMAC will be prepared using a BMAC harvesting system. The automated centrifuge system rapidly concentrates cellular contents and growth factors in bone marrow aspirate using flow cytometry. The BMAC will be injected intra-articularly.
干预措施: Bone Marrow Aspirate Concentrate (Biological)
结局指标
主要结局
International Knee Documentation Committee (IKDC) Score
时间窗: One Year
The primary outcome measure will be the IKDC score at one year follow-up
次要结局
- Patient reported outcomes throughout follow-up period (IKDC)(7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years)
- Patient reported outcomes throughout follow-up period(7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years)
- Radiographic analysis(1 year, 2 years)
- Patient reported outcomes throughout follow-up period (VAS)(7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years)
- Patient reported outcomes throughout follow-up period (KOOS)(7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years)
- Synovial fluid analysis(2 weeks, 6 weeks)
- Patient reported outcomes throughout follow-up period (SF-12)(7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years)