Study Results
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Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2020-10-16
2023-06-30
Brief Summary
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Detailed Description
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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.
A recent comprehensive review identified only three studies on this specific topic. The best existing evidence of the previous literature comes from a prospective randomized trial led by Stephen et al. The authors described that supine positioning without use of fracture table yielded better post-operative rotation than patients treated with a fracture table. However, this study did not assess the utility of lateral positioning, which is more commonly used in isolated femoral shaft fractures. Moreover, the study was unable to associate malrotation with patient important outcomes or gait abnormalities. This clearly leaves much uncertainty surrounding optimal patient positioning during the definitive treatment of these critical injuries.
Proponents of positioning femoral shaft fracture patients using SFT argue that the fracture table provides a constant traction force to stabilize the fractured limb and allows for better intraoperative imaging. This arguably allows surgeons to reduce operative time and minimize the need for surgical assistants. However, possible downsides of this technique include the need for more invasive surgical adjuncts if there is ongoing difficulty with fracture reduction. Furthermore, constant and prolonged traction poses known risks to neurovascular structures associated with the central post, and may overpower feedback from the natural resting tone of the surrounding thigh musculature, possibly leading to a higher incidence of fixation in a malrotated position. Additionally, fracture tables are expensive and require additional setup in the operating room prior to the procedure.
Orthopedic surgeons who prefer the LRT believe it offers improved access to the start point for IMN as well as to the rest of the femur for manipulation, resulting in a better reduction of the fractured limb. With the entire limb free of traction, the thigh sits in a relatively adducted position at rest and the soft tissues tend to fall away from the operative field. The fracture fragments can be readily accessed and freely manipulated, with muscles returning to their resting tension as alignment is restored. It is believed that this leads to leads to improved limb alignment and less malrotation. Furthermore, there may be benefits to the overall patient, many of whom have other severe injuries that may also be impacted by intraoperative positioning. A recent cohort study, which was adjusted for associated injuries, found that patients treated using the LRT had shorter ICU stays and reduced number of days on a ventilator, indicating that there may be a protective effect from a respiratory standpoint. Additionally, the standard operating room table is readily available, less expense, and does not require additional setup prior to the procedure. However, there are concerns that lateral positioning may lead to longer operative times as additional positioning aids and reduction maneuvers may be required. Specifically, patients receiving delayed fixation may pose a challenge due to increased muscle shortening and tone that may be difficult to overcome with manual traction alone.
Limited previous studies align with biomechanical principles, and suggest that lateral positioning holds potential to reduce the incidence of femoral malrotation and avoid complications associated with the use of a fracture table; leading to improved patient function. Addressing malrotation by using the LRT may represent a simple and reproducible intervention that may improve quality of life for the patient.
NEED FOR A TRIAL Currently, the choice between the two techniques is dependent on surgeon preference, with very limited evidence to guide decision making. A large definitive trial is needed to answer this question and allow orthopaedic surgeons to make an evidence-based decision on how to treat patients with femoral shaft fractures, while reducing the incidence of malrotation and improving patient outcomes. Prior to embarking on a large definitive cluster randomized crossover trial (CRXO), a pilot study is needed to demonstrate feasibility. A pilot study would assess areas of uncertainty that may impact feasibility to perform the definitive trial, including achieving adequate recruitment, adherence to protocol, and minimal contamination.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Supine Positioning, Fracture Table
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.
Antegrade femoral nailing Supine Position
Antegrade femoral nailing in Supine Position using a Fracture Table
Lateral Positioning, Free drape
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
Antegrade Femoral Nailing Lateral Position
Antegrade femoral nailing in Lateral Position using a Free drape
Interventions
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Antegrade femoral nailing Supine Position
Antegrade femoral nailing in Supine Position using a Fracture Table
Antegrade Femoral Nailing Lateral Position
Antegrade femoral nailing in Lateral Position using a Free drape
Eligibility Criteria
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Inclusion Criteria
2. Mid shaft (Diaphyseal) femur fracture appropriate for antegrade fixation
3. Surgery performed by participating surgeon or delegate
4. Provision of informed consent
5. Enrolled within 3 weeks of femoral shaft fixation
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Hamilton Academic Health Sciences Organization
OTHER
Canadian Orthopaedic Trauma Society
OTHER
Hamilton Health Sciences Corporation
OTHER
Responsible Party
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Principal Investigators
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Herman Johal, MD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Sheila Sprague, PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Daniel Axelrod, MD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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McMaster University
Hamilton, Ontario, Canada
Ottawa Civic Hospital
Ottawa, Ontario, Canada
Vall d'Hebron University Hospital
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CTO 2108
Identifier Type: -
Identifier Source: org_study_id
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