Far Cortical Locking Versus Standard Constructs for Distal Femur Fractures (FCL)

This study is currently recruiting participants.
Verified December 2013 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01766648
First received: January 9, 2013
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

To determine if Far Cortical Locking screws increase fracture healing rates at 3 months in Closed Distal Femur Fractures in adults when compared to standard locking screw constructs.

Fracture healing at 3 months will be assessed via x-ray and clinical assessment of the fracture.

Null Hypothesis: There will be no difference in fracture healing at 3 months post-fixation between subjects treated with far cortical locking screw or standard locking screw fixation.


Condition Intervention
Distal Femur Fracture
Device: Far Cortical locking screw fixation
Device: Standard locking screw fixation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre, Randomized Trial of Far Cortical Locking Versus Standard Constructs for Acute, Displaced Fractures of the Distal Femur Treated With Locked Plate Fixation

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Fracture healing [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Radiographic and clinical assessment of fracture healing defined as bridging of 2 or more cortices. Clinical healing assessed with FIX-IT.


Secondary Outcome Measures:
  • Patient reported Quality of Life (QOL)and CT quantification of fracture callus volume [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
    Patient reported QOL using SF36 at the four follow up intervals and CT Scan at 3 months only.


Estimated Enrollment: 130
Study Start Date: December 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Far Cortical Locking screw fixation
Far Cortical Locking screw fixation
Device: Far Cortical locking screw fixation
Standard locking screw fixation
Active Comparator: Standard locking screw fixation
Standard locking screw fixation
Device: Standard locking screw fixation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women ages 18 years or older
  • Displaced distal femur fracture (OTA 33A or 33C) as seen in radiographs
  • Planned treatment using a distal femur locking plate
  • Fractures < 14 days post injury
  • Provision of informed consent

Exclusion Criteria:

  • Open distal femur fracture
  • Vascular injury present at the site of the fracture
  • Planned fixation strategy includes interfragmentary lag fixation of non- articular fractures
  • History of previous femur infection
  • Limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery
  • Inability to comply with rehabilitation or form completion
  • Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01766648

Contacts
Contact: Raman Johal 604-875-5239 raman.johal@vch.ca

Locations
Canada, British Columbia
Vancouver General Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1L8
Principal Investigator: K A Lefaivre, MD MSc FRCSC         
Vancouver General Hospital Division of Orthopaedic Trauma Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1L8
Contact: Raman Johal    604-875-5239    raman.johal@vch.ca   
Principal Investigator: K A Lefaivre, MD MSc FRCSC         
Sub-Investigator: Gerard P Slobogean, MD MPH FRCSC         
Sub-Investigator: Peter J O'Brien, MD FRCSC         
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Raman Johal    604-875-5239    raman.johal@vch.ca   
Principal Investigator: Kelly Lefaivre, MD FRCSC         
Sponsors and Collaborators
University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01766648     History of Changes
Other Study ID Numbers: H12-03489
Study First Received: January 9, 2013
Last Updated: December 4, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Distal
Femur
Locking
Screw
Fracture
Healing

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on April 17, 2014