跳至主要内容
临床试验/NCT03868280
NCT03868280Unknown不适用

Fracture Table vs. Lateral Positioning for Intramedullary Fixation of Femur Fractures (The FLiP Study): A Pilot Cluster Randomized Crossover Trial

Hamilton Health Sciences Corporation3 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2020年10月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
3
主要终点
Feasibility to conduct definitive Clinical Trial

研究概览

简要总结

The primary objective of this pilot trial is to assess the feasibility of a definitive trial to determine the effect of lateral patient positioning versus supine positioning with fracture table use for reamed antegrade intramedullary fixation of femur fractures.

详细描述

Femoral shaft fractures typically occur alongside other complex, high-energy injuries in the poly-traumatized patient. Femur fractures can cause extensive bleeding and surrounding muscle injury, and have a high global burden; occurring at a rate between 14 and 42.5 /100,000 person years, with approximately 1 in 10 road traffic accidents worldwide resulting in a femoral shaft fracture requiring surgery. Additionally, there is significant disparity in the burden of diaphyseal femur fractures, with 91% occurring in lower middle-class income countries, and the majority affecting younger males.

To help mitigate the effects of ongoing pain, blood-loss, worsening inflammation from unstable fracture ends, femoral shaft fractures require urgent management using either an early total-care or damage-control orthopaedics approach. Associated injuries, markers of resuscitation, and overall patient stability guide operative decision making and the timing of surgical intervention. Definitive internal fixation using reamed, locked intramedullary nailing (IMN) has become the standard of care in an adequately resuscitated patient, as it provides fracture stability while facilitating nursing care and patient mobilization. Multiple femoral IMN techniques exist; however, most femoral shaft fractures can be treated with an antegrade nail using either supine (fracture table) or lateral (free-leg drape) positioning.

Femoral Malrotation is a Common and Significant Complication

Despite the adoption of femoral IMN, patient-reported function following femur fracture fixation varies widely. Incorrect positioning of the fracture fragments by more than 15° relative to the native limb rotation (femoral malrotation) is associated with poor functional recovery, low health-related quality of life, gait abnormalities, difficulty with stairs, and delayed return to pre-injury activity. Significant femoral malrotation (>15°) occurs in up to 55% of patients following femoral shaft fracture IMN, as measured by post-operative computer tomography (CT) scans. Numerous intraoperative assessments have been used to judge rotation, including cortical diameter, lesser trochanter profile and others; though none are easily reproducible or reliable. The preferred technique by surgeons is the lesser trochanter profile, but this method requires a true anteroposterior view of the pelvis, which can be challenging to obtain with the fracture table in place.

A Lack of Consensus On Operative Table and Patient Positioning While the orthopaedic surgery community agrees that femoral shaft fractures should be treated with IMN, there is a lack of agreement on whether the patient should be placed in the supine position on fracture table (SFT) or in the lateral position on a standard radiolucent operating table (LRT). Our research team recently conducted a survey of the Canadian Orthopaedic Association membership and found a clear divide on patient positioning, with 56% of respondents using supine position on fracture table and 44% using a form of lateral positioning.

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
Triple (Participant, 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

  • •Adult aged 18 years or older
  • •Mid shaft (Diaphyseal) femur fracture appropriate for antegrade fixation
  • •Surgery performed by participating surgeon or delegate
  • •Provision of informed consent
  • •Enrolled within 3 weeks of femoral shaft fixation

排除标准

  • •Ipsilateral tibial fracture
  • •Bilateral femur fracture
  • •Ipsilateral femoral neck fracture
  • •Ipsilateral acetabular fracture
  • •Periprosthetic fracture
  • •Pathologic fracture
  • •Previous external fixation of femoral shaft fracture
  • •Inability to be positioned in lateral decubitus because of a concomitant injury
  • •Pregnancy (due to decubitus positioning)
  • •Incarceration
  • •Expected injury survival of less than 6 months
  • •Terminal illness with expected survival of less than 6 months (expected follow up of study)
  • •Inability to provide informed consent (e.g. cognitive disability, language barrier, significant delirium or dementia)
  • •Currently involved in study that does not permit co-enrolment
  • •Likely problems, in the judgment of study personnel, with maintaining follow-up with the patient

研究组 & 干预措施

Supine Positioning, Fracture Table

Active Comparator

During the supine fracture table phase, patients will be positioned supine on a fracture table. The operative leg will be placed in a boot, attached to the traction limb. The non-operative leg will either be scissored away from the operating area in a traction boot (without traction placed) or placed in a stirrup at 90 degrees of hip flexion in hemi-lithotomy. A central post will be used to prevent patient movement during application of traction, and all bony prominences will be padded. Fluoroscopy will be obtained through standard practices intraoperative to document assessment of rotation.

干预措施: Antegrade femoral nailing Supine Position (Procedure)

Lateral Positioning, Free drape

Active Comparator

During the lateral positioning phase, patients will be placed in lateral position after anaesthetic has been provided. A beanbag will be placed below the patient, and the patient will be safely turned to a lateral position. The beanbag will be inflated, the leg will be prepped, and a free drape will be applied. No traction will be used. Alternatively, some participating sites may use stulberg positioners rather than an inflatable beanbag, based on hospital preference. This positioning mirrors the positioning utilized for the direct lateral, posterior or posterolateral approach to a total hip arthroplasty or hemiarthroplasty

干预措施: Antegrade Femoral Nailing Lateral Position (Procedure)

结局指标

主要结局

Feasibility to conduct definitive Clinical Trial

时间窗: Six Months

Our primary outcome for the pilot trial is feasibility, which includes the following: * Recruitment (number of participants recruited across all sites over study period, goal of approximately 100 participants) * Cluster crossover randomization protocol adherence * Complete primary outcome collection (CT scans) on all enrolled patients. * Participant retention and follow-up data * Accuracy of 15 degrees as a cut off for malrotation

次要结局

  • Health Related Quality of Life(up to 6 months)
  • Modified Harris Hip Score(up to 6 months)
  • Operative Table Complications(At time of Surgery, Up to 6 months)
  • Use of Reduction Adjuncts(At time of Surgery)
  • Postoperative femur alignment(Within 6 weeks of injury)
  • Operative Time, Fluoroscopy Time(At time of Surgery)
  • Need for Open Reduction(At time of Surgery)
  • Days of Ventilator Support(At initial admission)
  • Length of Hospital, ICU Stay(At initial admission)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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