Intra-articular Autologous Bone Marrow Aspirate Injection for the Treatment of Knee Osteoarthritis: a Pilot Study With Radiological Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Jr.
研究概览
简要总结
Knee osteoarthritis (OA) is a leading cause of disability. The objectives of treatment are to reduce pain, improve function, and slow down further breakdown of the knee. Recently, research on nonsurgical treatment options for knee OA has increased significantly. One potential treatment of interest is the use of stem cell injections. Stem cells are one's own cells that have the ability to divide into other types of cells, and may cause regrowth of cartilage when injected into the knee. There have been few, but promising, studies that show improvements in pain and function with stem cell injections in those with knee OA. Therefore, more research is needed to identify patients who might benefit from this injection. This pilot study will look at changes in pain and function for 20 patients at 1, 3, 6, and 12 months after a stem cell injection into the knee. Patients will also undergo magnetic resonance imaging at 6 months and 12 months following the injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>=3 months of symptomatic knee OA unresponsive to at least two of the following: activity modification, physical therapy, bracing, assistive devices, acupuncture, non-steroidal anti-inflammatory medications, local steroid injections, and hyaluronic acid injections
- •Radiographically confirmed Kellgren-Lawrence I-II knee OA (mild knee OA; no bone-on-bone)
- •Age 18-79 years
排除标准
- •Presence of loose bodies on baseline magnetic resonance imaging
- •Clinically and radiologically confirmed anterior/posterior cruciate ligament deficiences
- •History of meniscal injury other than degenerative meniscal tears
- •Previous knee surgery
- •Presence of a degenerative meniscal tear causing mechanical symptoms such as locking, buckling, or give-way
- •Intra-articular injection to affected knee within 6 weeks of intra-articular BMA injection
- •Mechanical axis deviation greater than 7 degrees
- •Intolerance to acetaminophen or hydrocodone (i.e., Vicodin)
- •Use of non-steroidal anti-inflammatory drugs <1 weeks prior to BMA
- •Injection of the joint scheduled for treatment within 3 months of BMA injection
- •Body mass index of 30 or more
- •History of drug abuse
- •Current cigarette smokers
- •Current use of systemic steroids
- •History of or current alcohol abuse or dependence
- •History of anemia, bleeding disorders, or inflammatory joint disease
- •Active infection
- •Active malignancy per medical or surgical history, diagnosed by primary case physician or treating specialist, undergoing treatment, has undergone treatment, or has declined treatment
- •Inability to refrain from statin regimen from 1 month pre-injection to 1 month post-injection
- •Pregnancy or breastfeeding at time of treatment
- •Participating or planning to participate in a worker's compensation program at the time of treatment or follow-up period
- •Pending or planned legal action pertaining to knee pain
- •Non-English speaking
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score (KOOS) Jr.
时间窗: 1 month after date of injection
The KOOS Jr. measures patient-reported pain and function. The score ranges from 0-100, with 0 representing total knee disability and 100 representing perfect knee health.
KOOS Jr.
时间窗: 12 months after date of injection
The KOOS Jr. measures patient-reported pain and function. The score ranges from 0-100, with 0 representing total knee disability and 100 representing perfect knee health.
次要结局
- Pain(1 month, 3 months, 6 months, and 12 months after date of injection)
- Presence of side effects(1 month, 3 months, 6 months, and 12 months after date of injection)
- Degree of cartilage change(6 months (first 5 patients only) and 12 months after date of injection)