Early Anti-inflammatory Treatment in Patients With Acute ACL Tear
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Participant Pain Assessment
研究概览
简要总结
This research study is the first of its kind and will allow health care professionals and researchers to answer many questions about the reasons why anterior cruciate ligament (ACL) injury leads to knee pain and disability and osteoarthritis. We also hope that this study will be the beginning of new, more powerful and safer drugs to help patients with ACL injuries heal sooner and return to sports or daily activities pain free. Study participants will be recruited from the University of Kentucky and Vanderbilt University.
The purpose of this research is to gather information on how safe and effective Kenalog® is in alleviating knee pain following ACL rupture.
详细描述
Injury to the knee during sports participation often involves partial of full detachment of the 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, we hope to prevent and reduce the initial post-operative pain. The reduction of pain will allow for earlier movement of the knee joint and preparation for surgery. It may also reduce the risk to develop osteoarthritis in individuals with ACL injuries by treating them within 1-2 days after their injury.
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 33 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •currently participating in sporting activities
- •Normal contralateral knee status
- •Anterior Cruciate Ligament (ACL) injury occurred while playing a sporting activity
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 infection, including infection of the skin
- •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
- •previous exposure or allergic reaction to Kenalog
- •prior knee surgery (Ipsilateral or contralateral)
- •have received any investigational drug with 4 weeks of study Visit 1
研究组 & 干预措施
Kenalog or Placebo
Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.
干预措施: Kenalog or placebo (Drug)
Kenalog then placebo
Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.
干预措施: Kenalog then Placebo (Drug)
Kenalog only
Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®
干预措施: Kenalog (Drug)
Placebo
subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.
干预措施: Placebo (Drug)
结局指标
主要结局
Participant Pain Assessment
时间窗: Up to seven days
Participants with be given a Visual Analog Scale (VAS) pain assessment questionnaire which scores the participant's perceived pain on a scale of 0-10 were zero is no pain and 10 is the worst pain imaginable. The scale will be administered during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
次要结局
- Efficacy of Kenalog to Alleviate Knee Pain(Up to seven days)
- Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration(Up to seven days)
- Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration(Up to seven days)
- Synovial Interleukin-1α (IL-1α) Concentration(Up to seven days)
- Synovial C-terminal Peptide II (CTXII) Concentration(Up to seven days)
- Synovial Glycosaminoglycans (GAG) Concentration(Up to seven days)
- Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration(Up to seven days)
- Synovial Interleukin-1β (IL-1β) Concentration(Up to seven days)
- Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration(Up to seven days)
- Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration(Up to seven days)
- Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration(Up to seven days)
- Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration(Up to seven days)
研究者
Cale Jacobs
Sponsor/Investigator
University of Kentucky