Immediate Versus Delayed Weight Bearing After Fixation of Pelvis and Acetabulum Fractures: A Multicenter Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 14
- 主要终点
- Study enrollment rates of eligible patients
研究概览
简要总结
The goal of this study to determine if a randomized clinical trial of immediate versus delayed weight bearing after undergoing surgical fixation of a pelvis or acetabulum fracture is feasible. The main questions it aims to answer are:
Are surgeons willing to allow inclusion of their patients into such a trial? Are patients willing to participate in such a trial? Will patients be compliant with assigned weight bearing status in such a trial? Can good patient follow-up be obtained in such a trial? Is participation in such a trial safe?
Patients from 7 medical centers will be enrolled, and randomized to immediate weight bearing as tolerated (WBAT) versus delayed WBAT (for 6-12 weeks). Feasibility metrics revolving around enrollment, follow-up, and documentation will be monitored, as well as medical and surgical complications. This pilot study will help inform feasibility and design of a larger definitive multicenter randomized controlled trial (RCT) on this topic.
详细描述
Early weight bearing is frequently allowed and encouraged following fixation of hip and femoral and tibial shaft fractures, while periarticular and pelvis and acetabulum fractures are often prescribed 6-12 weeks of restricted weight bearing. Early weight bearing has been shown to be associated with a number of benefits following fixation of various lower extremity fractures, and delayed weight bearing is associated with an increased risk of medical complications and delayed improvement in functional outcomes. The risks associated with delayed weight bearing have encouraged clinicians to consider the safety of early weight bearing after fixation of various lower extremity fractures.
Retrospective studies have shown low rates of hardware failure with early weight bearing following fixation of fractures for which early WBAT has not traditionally been allowed, including fractures of the pelvis, acetabulum, distal femur, proximal tibia, and distal tibia. Randomized controlled trials with ankle and distal femur fractures have shown no difference in rates of early hardware failure between early and delayed weight bearing. However, high-quality studies in pelvis and acetabulum are lacking.
A definitive RCT on early versus delayed WBAT after fixation of pelvis and acetabulum fractures is necessary, and this would focus on important outcomes such as surgical and medical complications, patient-reported functional status, and timing of return to work or activities of daily living. However, a pilot trial of adequate size is needed to highlight 1) if participant enrollment is feasible (from a surgeon and patient perspective), and 2) if appropriate follow-up and compliance with documentation can be achieved. A pilot trial would also help establish the safety of such a trial, as perioperative complications would be monitored.
The completion of this pilot trial will assist with the design and implementation of a definitive RCT that will compare patient-relevant outcomes of immediate versus delayed WBAT following fixation of pelvis and acetabulum fractures.
RESEARCH QUESTION Is a randomized controlled trial (RCT) of immediate versus delayed weight bearing following fixation of fractures of the pelvis and acetabulum feasible?
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
- None
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
- •Adults 18 years old and above
- •Patients with surgically treated pelvis or acetabulum fractures
排除标准
- •Presence of fractures to the ipsilateral or contralateral lower extremity that would preclude WBAT on the surgically repaired pelvis/acetabulum fracture
- •Presence of upper extremity injury that would limit weight bearing using an assistive device such as a walker or crutches
- •Severe injuries to other body systems that would prevent patient from being able to comply with weight bearing protocol
- •Presence of significant psychiatric or cognitive disorder or disability that would prevent patient from being able to comply with weight bearing protocol
- •Pre-injury non-ambulatory status
- •Suspected issues with follow-up
- •Language barriers precluding obtaining adequate informed consent
结局指标
主要结局
Study enrollment rates of eligible patients
时间窗: Within 72 hours after surgery
Target enrollment of 50% of patients (surgeon agreement to enroll patient) and 50% of patients eligible for inclusion to agree to participate in study
Clinic follow-up rates for patients enrolled in study
时间窗: 3 months
\>90% target follow-up of patients at 3-month postoperative visit
Correct documentation of randomized weight bearing status in medical charts of patients
时间窗: 12 months
Target 100% correct documentation of assigned weight bearing status in postoperative medical documentation (both in-hospital documentation and during follow-up visits)
Correct documentation of secondary outcome of reoperation in medical documentation
时间窗: 12 months
Target 100% correct documentation of secondary outcome of reoperation in medical documentation during follow-up visits
次要结局
- Patient reoperation for any reason in the postoperative period(12 months)
研究者
Peter Mittwede
Assistant Professor
University of Mississippi Medical Center