A Prospective, Double-Blinded, Randomized Controlled Trial of an Amniotic Membrane Allograft Injection Comparing Two Doses (1 mL and 2mL Injection) and a Placebo (Sterile Saline) in the Treatment of Osteoarthritis of the Knee
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 90
- 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 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 when compared to a placebo.
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).
90 subjects will be enrolled in the study. Subjects will be randomized 1:1:1 in treatment arms.
It compares the dose affect of an amniotic membrane allograft between a 1 mL dose and a 2 mL dose when compared to a placebo of sterile saline in the treatment of osteoarthritis of the knee. This will be offered as a free pain management alternative to patients who meet the inclusion criteria. The results will be determined by validated patient-reported outcome tools (KOOS, VAS, and WOMAC questionnaires) and physical examinations taken before the injection, one month after the injection, three months after the injection, six months after the injection, and one year after the injection. There will be a phone call 24 hours after the injection for every patient participating in the study regarding any potential adverse events.
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)
盲法说明
Assistants not part of the study used a randomizer generating software to randomly assign a patient a dose. The randomly assigned dose was put in a sealed envelope labeled with the corresponding number and was recorded. Prior to the injection, a medical assistant not involved in the study retrieves the envelope to determine the dose, prepares the injection, then seals the syringe in black tape before giving it to the research staff who then performs the injection.
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
- •Patient is a candidate for non-surgical intervention of the knee
- •Patient must be between the ages of 21 and 80 years old
- •Patient must have a diagnosis of osteoarthritis (OA) of the knee defined as grade 1 to 3 on the Kellgren-Lawrence grading scale
排除标准
- •Patient has a diagnosis of osteoarthritis with a Kellgren-Lawrence grade of 4
- •Patient has a BMI greater than 40 kg/m2, 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
- •Patient has rheumatoid arthritis, psoriatic arthritis or diagnosis with any other disorder that is the primary source of their knee pain
- •Patient has an autoimmune disease or known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
- •Patient has any of the following treatments to the target knee within 12 weeks prior to screening
- •Intra-articular hyaluronic acid (HA) injection
- •Steroid or platelet rich plasma (PRP) injection
- •Use of any investigational drug, device, or biologic
- •Patient had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment
- •Patient has a history of partial or total knee arthroplasty
- •Patient has undergone immunotherapy or chemotherapy in the last 5 years, prior radiation at the site, or is currently taking a narcotic medication for any reason
- •Patient is pregnant or plans to become pregnant within 365 days of treatment
- •Patient has any significant medical condition that would interfere with protocol evaluation and participation
- •Patient is a recipient of worker's compensation
- •Patient is a current prisoner
研究组 & 干预措施
1 mL NyDYN Injection
30 patients (out of 90) will be blind to and randomly assigned to a 1 mL NyDYN injection.
干预措施: Acellular Amniotic Membrane Derived Allograft Injection (NuDYN) (Other)
2 mL NuDYN Injection
30 patients (out of 90) will be blind to and randomly assigned to a 2 mL NyDYN injection.
干预措施: Acellular Amniotic Membrane Derived Allograft Injection (NuDYN) (Other)
Placebo of Sterile Saline
30 patients (out of 90) will be blind to and randomly assigned to a 2 mL dose of sterile saline.
干预措施: Acellular Amniotic Membrane Derived Allograft Injection (NuDYN) (Other)
结局指标
主要结局
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
时间窗: 1 year
Knee injury and Osteoarthritis Outcome Score (KOOS)- assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. It is a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
次要结局
- Exploratory Endpoint using Validated patient-reported outcome tools questionnaires(30, 90, 180, 365 days)
研究者
Eyal Ginesin
Orthopedic Surgeon / Fellow Researcher
Illinois Center for Orthopaedic Research and Education