A Prospective, Single-Center, Randomized, Triple-Blinded, Placebo-Controlled Study of IL-1RA Treatment in Patients With Acute ACL Tear and Painful Effusions
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change of Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptom Score Between Groups
研究概览
简要总结
Injury to the knee during sports participation often involves partial or full detachment of the anterior cruciate ligament (abbreviated as ACL). ACL tears cause pain, swelling and inflammation. While the swelling and inflammation usually goes away in time, individuals with ACL injuries may experience pain and notice knee instability (knee slipping, etc.). Often surgery can repair or replace the ACL within the joint, allowing individuals the ability to walk or run again pain free or participate in sports. Unfortunately, osteoarthritis of the knee, which also causes pain and swelling, can occur in that same knee 10-20 years later for reasons which are not well understood.
In this research study, the investigator hopes to reduce the initial pre-operative pain. The reduction of pain will allow for earlier movement of the knee joint and preparation for surgery. The investigator is interested to see if the use of Kineret does decrease the risk of developing arthritis in individuals with ACL injuries by treating them within 28 days after their injury.
详细描述
Kineret® was chosen because it is safe, well tolerated, and has been used to treat Rheumatoid Arthritis (RA) and post-surgical persistent knee effusions as well as knee stiffness. Although Kineret® is approved by the US Food and Drug Administration (FDA) for the treatment of RA and Neonatal-Onset Multisystem Inflammatory Disease, it is not currently approved by the FDA for use in treating ACL injury. Therefore, the use of Kineret® in this study is investigational.
The research procedures will be conducted at the University of Kentucky (UK) Medical Center. Participants will need to come to the UK Healthcare at Turfland located at 2195 Harrodsburg Road in Lexington, KY. Participants will be asked to come to this location seven times during the study. Each of those visits will take about 30 minutes. All exams and questionnaires will be administered during the otherwise necessary routine visits for any participant who has suffered an ACL tear. No additional visit is necessary. The total amount of time commitment for participation in this study is about 6 1/2 hours, over the next 2 years.
All participants with sports related ACL injuries enrolled in this study will be seen and may elect to undergo surgery, if necessary. Note: Surgery is not part of this protocol. Should participants be enrolled into the study and choose not to undergo ACL reconstruction (surgery), they will receive treatment according to this protocol.
Randomization: Once it has been determined that a participant qualifies for entry into the study, they will be randomized, like the flipping of coin into one of two treatment groups. Groups will receive knee injections with either Kineret® or a saline placebo. The saline placebo will contain no active medication. Both the participant and study doctor will not know what treatment group the participant is assigned to. However, in case of an emergency, the investigator will be able to find out what treatment group the participant has been assigned to.
- Group 1 will receive an injection of Anakinra (Kineret®, IL-1ra; 150mg) 1-28 days after ACL injury.
- Group 2 is the placebo group. Participants enrolled into this group will receive an injection of saline placebo at Visit 1.
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, Investigator)
入排标准
- 年龄范围
- 14 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ACL Tear and Painful Effusions
- •Signed and dated combined informed consent/HIPAA form and if a minor, a signed assent.
- •Willingness to comply with all study procedures and availability for the duration of the study
- •For females of reproductive potential: use of highly effective contraception.
- •Currently participating in a sporting activity
- •Documentation of closed growth plates as noted on the screening x-ray
排除标准
- •underlying inflammatory disease (i.e. Rheumatoid Arthritis, Psoriatic Arthritis etc)
- •have been diagnosed with hepatitis B or tuberculosis
- •currently have an infections, including infection of the skin, or have signs and symptoms of an infection, including fever.
- •any abnormalities in their white blood cell counts
- •have a disease that weakens your immune system such as diabetes, cancer, HIV or AIDs
- •other major medical condition requiring treatment with immunosuppressant or modulating drugs.
- •A history of chronic use of non-steroidal anti-inflammatory drugs
- •Currently taking immunosuppressant medication, including oral and parenteral corticosteroids (topical and stable dose inhaled corticosteriods are acceptable)
- •Females who are pregnant or breastfeeding
- •Received a "live" vaccine (smallpox, MMR (measles, mumps and rubella), flu, polio, typhoid, chicken pox, yellow fever, herpes zoster) 4 weeks prior to screening.
- •A history of bleeding disorders or are taking any blood thinning medications, aspirin or other medications affecting blood clotting.
- •Previous exposure or allergic reaction to anakinra
- •Allergy to latex or tape
- •Allergy to Kineret or have had a reaction to any local or general anesthesia
- •prior knee surgery (contralateral)
- •have received any investigational drug with 4 weeks of study Visit 1
研究组 & 干预措施
Anakinra
Intervention: anakinra (150mg) Participants will receive an intraarticular injection of anakinra (150mg) at 0-28 days post injury
干预措施: anakinra (150mg) (Drug)
Placebo Control
Intervention: Saline (0.9%) Participants will receive a saline placebo injection within 28 days of injury
干预措施: Saline intraarticularly (Other)
结局指标
主要结局
Change of Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptom Score Between Groups
时间窗: 1 year
KOOS symptoms scores range from 0 to 100, with higher scores indicating less severe symptoms.
次要结局
- Change in CTX-II Levels From Injury to Time of Surgery(time of surgery)
研究者
Cale Jacobs, PhD
Assistant Professor Research
University of Kentucky