Early Anti-inflammatory Treatment in Patients With Acute ACL Tear and Painful Effusions
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in KOOS score over time
研究概览
简要总结
This research study is designed to allow the investigator to answer many questions about the reasons why anterior cruciate ligament (ACL) injury leads to knee pain and disability and osteoarthritis.
The purpose of this research is to gather information on how safe and effective Gel-One is in alleviating knee pain following ACL surgery.
详细描述
This is a single-center, placebo-controlled, double-blinded, randomized controlled trial.
This trial will be conducted at the University of Kentucky's Orthopaedic and Sports Medicine Center (Turfland Facility), with subjects being recruited from the patient populations of UK's Sports Medicine surgeons (Drs. Christian Lattermann, Darren Johnson, Mary Lloyd Ireland, and Scott Mair) during regularly schedule office visits.
After providing informed consent, subjects will be randomized into one of two groups, and there will be 19 subjects per group. All groups will receive standard of care aspiration and triamcinolone injection (40mg, Kenalog) within 1-10 days after ACL injury. The subjects will undergo initial standard of care pre-habilitation as deemed necessary by the surgeon and will undergo ACL reconstruction surgery. Knee aspiration will be performed 7-10 days after ACL reconstruction surgery and the patients will be randomized into 1 of 2 groups:
- Group 1: will receive injection of Gel-One (3ml 30mg Hyaluronan)
- Group 2: will receive an injection of 3ml of a saline placebo
Knee Aspiration: All subjects will undergo a total of four aspirations.
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)
盲法说明
Once it has been determined that a subject meets the entry requirements of the study they will be randomized, like the flipping of coin into one of two treatment groups. Neither the subject nor the investigator will be told which of the two treatments that the subject is assigned to. However, the investigator can find out in the case of emergency. Treatment assignment will be released to the subject after they have completed all study visits.
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
- •14-33 years of age
- •Currently participating in a sporting activity
- •ACL injury occurred while playing in a sporting activity
- •Normal contralateral knee status
- •Documentation of closed growth plates as noted on the screening x-rays
排除标准
- •Underlying inflammatory disease (i.e. Rheumatoid Arthritis, Psoriatic Arthritis etc)
- •Currently have any infections, including infection of the skin, or have signs and symptoms of an infection, including fever
- •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
- •Received corticosteroid injections into the injured knee within three months of enrollment
- •History of allergic reaction to hyaluronan injections
- •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
Group 1 - Gel-One
Gel-One (3ml/30 mg Hyaluronan) one time injection at visit 3
干预措施: Gel-One (Drug)
Group 1 - Saline Placebo
3 ml saline placebo one time injection at visit 3
干预措施: Saline Placebo (Other)
结局指标
主要结局
Change in KOOS score over time
时间窗: 12 months
Knee Injury and Osteoarthritis Outcome Score (KOOS) symptoms
次要结局
- Change in CTX-II pre and post surgery(up to 4 weeks)
研究者
Cale Jacobs, PhD
Principal Investigator
University of Kentucky