Randomized, Double Blind, Placebo Controlled Trial of Ketotifen in Patients With Elbow Fractures or Dislocations
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 3
- 主要终点
- Joint range of motion
研究概览
简要总结
Injured joints, especially at the elbow, are at risk for permanent motion loss, also known as joint contractures. Joint contractures limit the function of an elbow and are a recognized complication that occurs often after a traumatic injury. The benefits of early motion after injury has helped in preventing joint contractures but there are still several patients that develop debilitating joint contractures. Current research suggests that mast cells, which are found in the joint, are key in causing joint contractures. Research has been done using a medication called Ketotifen. Ketotifen has been linked to stabilizing mast cells and preventing the joint contracture. It is hoped that short-term use of this medication after an injury will prevent the contracture from occurring.
详细描述
Individuals ≥ 18 years old with isolated distal 1/3 humerus and/or proximal 1/3 ulna and/or proximal 1/3 radius fractures and/or elbow dislocations (open fractures with or without nerve injury may be included) and presented to Peter Lougheed Centre (PLC), Foothills Medical Center (FMC), or South Health Campus (SHC).
Participants were required to take Ketotifen 5mg by mouth twice a day for 6 weeks or placebo twice a day by mouth for 6 weeks. Neither the participant nor the physician knew if the participant was taking Ketotifen or placebo. Sometimes this type of injury requires surgery. This study invited both patients that do and do not require surgery to participate.
We took a sample of blood to measure tryptase (normally found in the body). We predicted people with high levels of tryptase were more likely to develop stiffening in the joint.
Participants were asked to return for follow up visits 2, 6, 12, 24, and 52 weeks after surgery or date of initial injury if surgery was not required. These visits were part of normal care for this type of injury.
At the visit participants were asked to do the following, some of which was not part of normal care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Isolated distal 1/3 humerus fractures
- •Proximal 1/3 ulna fractures
- •Proximal 1/3 radial fractures
- •Elbow dislocations
- •Open fractures with or without nerve injury
- •Presentation to Peter Lougheed Centre (PLC), Foothills Medical Centre (FMC) or South Health Campus (SHC).
排除标准
- •Pre-existing elbow contracture
- •Osteoarthritis of affected elbow
- •Inflammatory arthritis of affected elbow
- •Gout of affected elbow
- •Nonspecific monoarticular arthritis of the affected elbow
- •Inability to give informed consent due to irreversible cognitive disorder
- •Inability to comply with post-operative physiotherapy
- •Injury > 7 days at the time of presentation
- •Inability to mobilize elbow injury within 2 weeks of injury or surgery
- •Pregnancy
- •Breast feeding
- •Oral hypoglycemic medications
- •History of epilepsy
- •Lactose intolerance
研究组 & 干预措施
Operative, Ketotifen
Ketotifen 5mg orally twice per day for 6 weeks.
干预措施: Ketotifen (Drug)
Non-operative, Ketotifen
Ketotifen 5mg orally twice per day for 6 weeks.
干预措施: Ketotifen (Drug)
Operative, Placebo
Placebo oral medication twice daily for 6 weeks.
干预措施: Placebo (Drug)
Non-operative, Placebo
Placebo oral medication twice daily for 6 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Joint range of motion
时间窗: 12 months post-injury
Extension-flexion arc of motion
次要结局
- Patients requiring (re)operation for elbow-related causes(12 months)
- Radiographic evaluation for fracture healing/non-union(12-52 weeks)
- Range of motion(2,6,12,24 and 52 weeks post injury)
研究者
Dr. Kevin Hildebrand
Orthopaedic Surgeon
University of Calgary