A Prospective, Double-Blinded, Randomized Controlled Trial of an Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
研究概览
简要总结
The purpose of this study is to determine the dose effect of a single injectable acellular amniotic membrane derived allograft injection for the treatment of knee osteoarthritis and to confirm whether the use of 2 mL of the same amniotic injection offers a statistically significant advantage over the 1 mL injection.
详细描述
It is a prospective, double blinded, Randomized Controlled Trial study. Data will be prospectively collected of all injectable acellular amniotic membrane derived allograft knee performed at our institute (1 vs 2 mL).
60 subjects will be enrolled in this study. Subjects will be randomized 1:1 in treatment arms.
Each of the patient will be treated with one time injection to the knee. Methods for collecting data will be through validated patient-reported outcome tools (KOOS, VAS and WOMAC questionnaire) that the patient will complete pre-injection and at specified time intervals after injection: 90 days, 180 days and 365 days.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 21 to 80 years
- •Diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale
排除标准
- •Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale
- •BMI greater than 40 kg/m2
- •Subject has active infection at the injection site
- •Symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol) and requires other therapy.
- •Subject has rheumatoid arthritis, psoriatic arthritis or has been diagnosed with any other disorder that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor or cancer
- •Subject has documented history of gout or pseudo-gout
- •Subject has an autoimmune disease or known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV
- •Subject has received any of the following to the target knee:
- •Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening
- •Intra-articular cortisone (steroid/corticosteroid) injection into the knee joint within 12 weeks of treatment
- •Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening
- •Has had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment
- •History of partial or total knee arthroplasty
- •Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment
- •Subject has a history of immunosuppressive or chemotherapy in the last 5 years
- •Subject has had prior radiation at the site
- •Subject is currently taking narcotic medication for any reason.
- •Subject is pregnant or plans to become pregnant within 365 days of treatment
- •Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
- •Subject is a worker's compensation patient
- •Subject is a prisoner
研究组 & 干预措施
1 mL NyDYN injection
30 patients (out of 60) will be doubled blinded randomized to this arm and get 1 mL NyDYN injection.
干预措施: Acellular amniotic membrane derived allograft injection (NuDYN) (Drug)
2 mL NyDYN injection
30 patients (out of 60) will be doubled blinded randomized to this arm and get 2 mL NyDYN injection.
干预措施: Acellular amniotic membrane derived allograft injection (NuDYN) (Drug)
结局指标
主要结局
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
时间窗: 180 days
Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.
次要结局
- Exploratory Endpoint using Validated patient-reported outcome tools questionnaires(90, 180 and 365 days)
研究者
Ronak M. Patel
President
Illinois Center for Orthopaedic Research and Education