Lithium for Fracture Treatment: a Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 5
- 主要终点
- radiographic healing of fracture
研究概览
简要总结
This is a study designed to see if a low dose of Lithium treatment, taken for 2 weeks, can improve fracture healing and improve patients' function and productivity.
详细描述
Despite the success of traditional treatments for broken bones (surgery, immobilization, or both) 10% of fractures do not heal or take longer than normal to heal. This can have a significant effect on a patient's function and productivity, as well as on healthcare expenditures. Very few advances in fracture healing have been made, despite the need for new approaches to fracture treatment. This study proposes a simple, economical, and non-invasive approach to complement traditional fracture treatment that could decrease healing time and reduce the incidence of delayed healing. The investigators think that this can improve health outcomes for patients and reduce health care costs for the healthcare system in general. The goal is to see if a low-dose of Lithium treatment can have a positive effect on fracture healing and can reduce pain and improve function in patients who have broken a bone.
The LiFT study is a participant, surgeon and observer blinded single-centre randomized (1:1), controlled, superiority trial with 2 parallel groups. A minimization procedure will stratify participants based on the fractured long bone (clavicle, humerus, femur or tibia/fibula) and smoking.
Participants will be randomized to 1 of 2 groups: lithium capsules or placebo. The Lithium/placebo will be taken daily for 2 weeks, starting 2 weeks after the fracture occurs (or 2 weeks after surgery if the participant is treated with surgery).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-55 years.
- •ASA (American Society of Anesthesiologists) ≤ 2 class (healthy) prior to injury.
- •Diaphyseal fracture of the humerus, femur or combined tibia/fibula (OTA diaphyseal subclass 2A or B), and clavicle (OTA diaphyseal subclass B1 or B2), with or without nerve injury.
- •Fracture that is primarily closed or open fracture that has complete wound coverage.
- •Randomization ≤14 days from injury or surgery (for surgical patients).
- •Fractures treated surgically or nonsurgically by endochondral/secondary bone healing.
- •For surgical patients, surgery must be within 14 days of injury.
排除标准
- •Currently pregnant or breastfeeding.
- •Any past or current malignancy that, in the opinion of an investigator, is not medically controlled.
- •Metabolic bone disease based on clinical history that, in the opinion of an investigator, is not medically controlled.
- •Autoimmune disease that, in the opinion of an investigator, is not medically controlled.
- •Hypothyroidism based on clinical history that, in the opinion of an investigator, is not medically controlled.
- •Renal impairment based on clinical history.
- •Past allergy or adverse reaction to Lithium.
- •Lactose intolerance.
- •Fractures surgically treated with absolute stability/primary bone healing.
- •Isolated tibia or isolated fibula fracture.
- •Currently taking Lithium or anti-psychotic or anti-seizure medication for the treatment of these conditions or at the discretion of an investigator.
- •Inability to comply with study protocol, in the opinion of the investigator(s).
- •Participation in another interventional clinical trial, at the discretion of the principal investigator.
- •Use of concomitant ultrasound or other bone stimulation device.
研究组 & 干预措施
Lithium carbonate
Lithium carbonate 300mg capsule; once per day for 2 weeks.
干预措施: Lithium Carbonate (Drug)
Lactose placebo
Lactose placebo capsule; once per day for 2 weeks.
干预措施: Lactose Placebo (Drug)
结局指标
主要结局
radiographic healing of fracture
时间窗: 8 weeks after injury (non-surgical participants) or 8 weeks after surgery (surgical participants)
radiographic healing using the RUST score at 8 weeks
次要结局
- radiographic union of fracture(4, 6, 12, and 24 weeks after injury (non-surgical participants) or 4, 6, 12, and 24 weeks after surgery (surgical participants))
- visual analogue pain score(baseline then 4, 6, 8, 12, and 24 weeks after injury (non-surgical participants) or baseline then 4, 6, 8, 12, and 24 weeks after surgery (surgical participants))
- NSAID use(baseline then 3, 4, 6, 8, 12, and 24 weeks after injury (non-surgical participants) or baseline then 3, 4, 6, 8, 12, and 24 weeks after surgery (surgical participants))
- adverse events(2-6 weeks after injury (non-surgical participants) or 2-6 weeks after surgery (surgical participants))
- physical function(baseline then 4, 6, 8, 12, and 24 weeks after injury (non-surgical participants) or baseline then 4, 6, 8, 12, and 24 weeks after surgery (surgical participants))
- re-operation (after initial fracture management)(4, 6, 8, 12, and 24 weeks after injury (non-surgical participants) or 4, 6, 8, 12, and 24 weeks after surgery (surgical participants))