Injection of Autologous Adipose Tissue for Treatment of Osteoarthritis in the Knee: A Controlled, Double-Blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- Safety - Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
Evaluating the safety and efficacy of a single injection of autologous adipose tissue for treatment of osteoarthritis of the knee.
详细描述
This clinical trial is a single site, double blinded, paired within groups, controlled clinical study to investigate the safety and efficacy in the use of adult autologous adipose tissue for the treatment of pain associated with joint OA. The hypothesis of this trial is that the treatment will be safe and the proposed clinical outcome measures of reduced pain resulting from the treatment of OA of the knee joint with autologous adipose tissue will be superior to a placebo control 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
- Double (Participant, Care Provider)
盲法说明
Patient and treating physician are both blinded, being that neither are aware of which knee received the autologous adipose tissue injection and which knee received the placebo lactated ringers injection
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral K-L Grade II through Grade IV osteoarthritis as diagnosed by physician review of weight bearing X-ray or MRI excluding subjects whose knee pain is caused by, (i) diffuse edema, (ii) displaced meniscus tear, (iii) lesion greater than 1 cm in any direction, or (iv) osteochondritis dissecans.
- •Study Participants must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed.
- •Males and females 40-75 years old.
- •Participants will be in good health (ASA Class I-II) with a BMI <
- •Continued pain in the knee despite conservative therapies for at least 6 months.
- •Participants must present with a bilateral knee pain scores ≥6 and ≤16 using the short-form WOMAC pain (A1 subscale, 20 total points).
- •Must speak, read and understand English.
- •Subjects must be reasonably able to return for multiple follow-up visits.
排除标准
- •Participants who have had surgery of either knee within 6 months prior to the screening visit.
- •Participants who have had a major injury to either knee within 12 months prior to enrolling in the study.
- •Participants who have had an injection in either knee in the prior 6 months, including corticosteroids, viscosupplementation or platelet rich plasma (PRP).
- •Participants who have gout, rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, severe bone deformity, infection of the knee joint, fibromyalgia, pes anserine bursitis, or neurogenic or vascular claudication.
- •Participants who have symptomatic OA of the hips, spine, or ankle that would interfere with the evaluation of the treated knee.
- •Participants that are unwilling to stop taking prescription pain medication 7 days prior to any visit.
- •Participants that are allergic to lidocaine, epinephrine or valium
- •History of bleeding disorders, anticoagulation therapy that cannot be stopped 3 days prior to injection
- •Subjects that use any form of tobacco to include e-cigarettes more than once a week within the last 6 months
研究组 & 干预措施
Injection of Autologous Adipose Tissue
Treatment knee receives injection of 1.5 cc's of adipose tissue mixed with 1.5 cc's of Lactated Ringers
干预措施: Injection of Autologous Adipose Tissue (Other)
Injection of Lactated Ringers
Placebo control group receives injection of 3 cc's of Lactated Ringers with no adipose tissue
干预措施: Injection of lactated ringers (Other)
结局指标
主要结局
Safety - Incidence of Treatment-Emergent Adverse Events
时间窗: 6 months
Subjects will be monitored for adverse events
次要结局
- Efficacy - Change in Pain Scores on the WOMAC Scale at All Follow-Up Visits(1 week, 6 weeks, 3 months, and 6 months)
- Efficacy - Change in Function Scores on the WOMAC Scale at All Follow-Up Visits(1 week, 6 weeks, 3 months, and 6 months)
- Efficacy - Change in Stiffness Scores on the WOMAC Scale at All Follow-Up Visits(1 week, 6 weeks, 3 months, and 6 months)