Far Cortical Locking Versus Standard Constructs for Distal Femur Fractures

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2018

Detailed Description

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 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

Interventions

  • Device: Far Cortical locking screw fixation
    • Standard locking screw fixation
  • Device: Standard locking screw fixation

Arms, Groups and Cohorts

  • Experimental: Far Cortical Locking screw fixation
    • Far Cortical Locking screw fixation
  • Active Comparator: Standard locking screw fixation
    • Standard locking screw fixation

Clinical Trial Outcome Measures

Primary Measures

  • 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 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
    • Patient reported QOL using SF36 at the four follow up intervals and CT Scan at 3 months only.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of British Columbia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kelly A. Lefaivre, Principal Investigator – University of British Columbia
  • Overall Official(s)
    • Kelly Lefaivre, MD, Principal Investigator, University of British Columbia, Vancouver Coastal Health Authority
  • Overall Contact(s)
    • Benita Okocha, 604-875-5239, benita.okocha@vch.ca

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