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The FLiP Study, a Pilot Cluster Randomized Trial

NCT03868280 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-07-28

No results posted yet for this study

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

Interventions

PROCEDURE

Antegrade femoral nailing Supine Position

Antegrade femoral nailing in Supine Position using a Fracture Table

PROCEDURE

Antegrade Femoral Nailing Lateral Position

Antegrade femoral nailing in Lateral Position using a Free drape

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Hamilton Academic Health Sciences Organization

    collaborator OTHER

  • Canadian Orthopaedic Trauma Society

    collaborator OTHER

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Herman Johal, MD · McMaster University

  • Sheila Sprague, PhD · McMaster University

  • Daniel Axelrod, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-16
Primary Completion
2022-06-30
Completion
2023-06-30

Countries

  • Canada
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03868280 on ClinicalTrials.gov