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

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ClinicalTrials.gov Identifier: NCT01766648
Recruitment Status : Unknown
Verified September 2015 by University of British Columbia.
Recruitment status was:  Recruiting
First Posted : January 11, 2013
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Distal Femur Fracture Device: Far Cortical locking screw fixation Device: Standard locking screw fixation

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Fracture healing [ Time Frame: 3 months ]
    Radiographic and clinical assessment of fracture healing defined as bridging of 2 or more cortices. Clinical healing assessed with FIX-IT.


Secondary Outcome Measures :
  1. Patient reported Quality of Life (QOL)and CT quantification of fracture callus volume [ Time Frame: 6 weeks, 3 months, 6 months and 12 months ]
    Patient reported QOL using SF36 at the four follow up intervals and CT Scan at 3 months only.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Specific 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 Ability to read and speak English or availability of translator willing to assist with completion of study forms Fractures < 14 days post injury Provision of informed consent

Specific exclusion criteria:

Open distal femur fracture requiring flap or vascular repair (grade 3b or 3c) Planned fixation strategy includes interfragmentary lag fixation of non-articular fractures Active local 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.) Non-ambulatory patients Lack of bone substance or poor bone quality which, in the surgeon's judgment, makes locked plate fixation impossible Periprosthetic fractures Any concomitant lower-extremity injury that requires non-weight-bearing beyond 6 weeks post-operative Addition of bone graft, bone graft substitute or BMP Pregnant women

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766648


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

Locations
Canada, British Columbia
Vancouver General Hospital Division of Orthopaedic Trauma Recruiting
Vancouver, British Columbia, Canada, V5Z 1L8
Contact: Raman Johal    604-875-5239    raman.johal@vch.ca   
Principal Investigator: Kelly A Lefaivre, MD MSc FRCSC         
Principal Investigator: Peter J O'Brien, MD FRCSC         
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1L8
Principal Investigator: K A Lefaivre, MD MSc 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
Investigators
Principal Investigator: Peter J O'Brien, MD University of British Columbia, Vancouver Coastal Health Authority
More Information

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01766648     History of Changes
Other Study ID Numbers: H12-03489
First Posted: January 11, 2013    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 2015

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

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