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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 19, 2014
Last verified: June 2014

January 9, 2013
June 19, 2014
December 2013
December 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01766648 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Far Cortical Locking Versus Standard Constructs for Distal Femur Fractures
A Multicentre, Randomized Trial of Far Cortical Locking Versus Standard Constructs for Acute, Displaced Fractures of the Distal Femur Treated With Locked Plate Fixation

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.

A multicentre randomized controlled trial with a Sample size of 130 subjects.

Primary Outcome is fracture healing at 3 months via x-ray and and clinical assessment.

Radiographic healing will be defined as bridging of two or more cortices as seen on x-ray. Radiographic assessment will be centrally adjudicated by a committee of three study investigators.

Clinical healing will be assessed using the Function Index for Trauma (FIX-IT). (Bhandari et al, data in press)

Secondary outcome measurements will include patient-reported quality of life and CT quantification of fracture callus volume.

Quality of life will be measured with the Short-Form 36 Version 2 (SF-36) instrument at all follow-up intervals.

A CT scan of the fracture site will be performed at the 3 month follow-up. Using a quantitative protocol the volume of callus will be measured and the extent of cortical bridging will be assessed.

Additional secondary outcomes include radiographic and patient-important complications. These will include adverse events, delayed union (>6 months), non union (failure for fracture healing to progress on serial x-rays between 6 and 9 months), malalignment (>5 degrees), hardware failure, infection, and reoperation. Information surrounding the type of complication, duration, management and/or treatment of all complications will be recorded

A Data Safety Monitoring Board will be established to independently monitor trial data.

Specific inclusion criteria:

  • Men or women aged 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

Specific 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.)

  • Metabolic bone disease that would affect fracture healing
  • Non-ambulatory patients
  • Severe osteoporosis as documented by pre-injury Bone Mineral Density (BMD) Scan
  • 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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Distal Femur Fracture
  • Device: Far Cortical locking screw fixation
    Standard locking screw fixation
  • Device: Standard locking screw fixation
  • Experimental: Far Cortical Locking screw fixation
    Far Cortical Locking screw fixation
    Intervention: Device: Far Cortical locking screw fixation
  • Active Comparator: Standard locking screw fixation
    Standard locking screw fixation
    Intervention: Device: Standard locking screw fixation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
December 2017
December 2016   (final data collection date for primary outcome measure)

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.)
Both
18 Years and older
No
Contact: Raman Johal 604-875-5239 raman.johal@vch.ca
Canada
 
NCT01766648
H12-03489
Yes
University of British Columbia
University of British Columbia
Not Provided
Not Provided
University of British Columbia
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP