The FLiP Study, a Pilot Cluster Randomized Trial

NCT03868280 | Unknown DMC

• 1 other identifier: CTO 2108
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Femur Fracture

Outcome Measures

Primary Outcomes (1)

• Feasibility to conduct definitive Clinical Trial

  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

  Six Months

Secondary Outcomes (9)

• Postoperative femur alignment

  Within 6 weeks of injury

• Health Related Quality of Life

  up to 6 months

• Modified Harris Hip Score

  up to 6 months

• Operative Time, Fluoroscopy Time

  At time of Surgery

• Need for Open Reduction

  At time of Surgery

Study Arms (2)

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.

Procedure: Antegrade femoral nailing Supine Position

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

Procedure: Antegrade Femoral Nailing Lateral Position

Interventions

Antegrade femoral nailing Supine Position PROCEDURE

Antegrade femoral nailing in Supine Position using a Fracture Table

Supine Positioning, Fracture Table

Antegrade Femoral Nailing Lateral Position PROCEDURE

Antegrade femoral nailing in Lateral Position using a Free drape

Lateral Positioning, Free drape

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 1. Ipsilateral tibial fracture 2. Bilateral femur fracture 3. Ipsilateral femoral neck fracture 4. Ipsilateral acetabular fracture 5. Periprosthetic fracture 6. Pathologic fracture 7. Previous external fixation of femoral shaft fracture 8. Inability to be positioned in lateral decubitus because of a concomitant injury 9. Pregnancy (due to decubitus positioning) 10. Incarceration 11. Expected injury survival of less than 6 months 12. Terminal illness with expected survival of less than 6 months (expected follow up of study) 13. Inability to provide informed consent (e.g. cognitive disability, language barrier, significant delirium or dementia) 14. Currently involved in study that does not permit co-enrolment 15. Likely problems, in the judgment of study personnel, with maintaining follow-up with the patient

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Hamilton Academic Health Sciences Organization: collaborator
• Canadian Orthopaedic Trauma Society: collaborator

Study Sites (3)

McMaster University

Hamilton, Ontario, Canada

RECRUITING

Ottawa Civic Hospital

Ottawa, Ontario, Canada

RECRUITING

Vall d'Hebron University Hospital

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Herman Johal, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Sheila Sprague, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Daniel Axelrod, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gina Del Fabbro, BPH

CONTACT

2898080709; delfabbg@mcmaster.ca

Daniel Axelrod, MD

CONTACT

daniel.axelrod@medportal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot cluster randomized crossover trial design

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: March 11, 2019
• Study Start: October 16, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2023
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available for request at the end of the study, after primary publication has been completed.
• Access Criteria: Requests will be reviewed by the Principal Investigators.

Locations

ES (1); CA (2)