Recruiting

Observational Study

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT03868280

Conditions

Femur Fracture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Antegrade femoral nailing Supine Position

Antegrade Femoral Nailing Lateral Position

Study Details

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

Study ID

NCT03868280

Start date

Oct 16, 2020

Status verified date

Jul, 2021

Completion date

Jun, 2023

Anticipated

Primary completion date

Jun, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adult aged 18 years or older
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:

• 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

active comparator: 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

Interventions

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

Primary outcome measure

  • Feasibility to conduct definitive Clinical Trial [ Time Frame: Six Months ]

Central Contacts and Locations

Central contacts

Gina Del Fabbro, BPH

2898080709delfabbg@mcmaster.ca

Daniel Axelrod, MD

daniel.axelrod@medportal.ca

Locations

McMaster University

Recruiting

Hamilton, Ontario, Canada

Contacts

Gina Del Fabbro, BPH

2898080709delfabbg@mcmaster.ca

Daniel Axelrod, MD

647 528 9234daniel.axelrod@medportal.ca

Principal Investigator:

Herman Johal, MD

Ottawa Civic Hospital

Recruiting

Ottawa, Ontario, Canada

Contacts

Melanie Dodd-Moher

613-737-8899medodd@ohri.ca

Bradley Meulenkamp, MD

bmeulenkamp@toh.ca

Principal Investigator:

Bradley Meulenkamp, MD

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Jul 28, 2021

Last verified

Jul, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2021-07-28.