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

• 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.
  
  

• 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.
  
  

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

Primary Outcome is fracture healing at 3 months via x-ray 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), 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.)