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

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 screw constructs.

Fracture healing at 3 months will be assessed via radiographic 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 screw fixation.

Study Overview

• Status: Active, not recruiting
• Conditions: Distal Femur Fracture
• Intervention / Treatment: Device: Far Cortical locking screw fixation; Device: Standard screw fixation

Detailed Description

A multicentre randomized controlled trial with a sample size of 138 subjects.

Primary Outcome is fracture healing at 3 months via radiographic and and clinical assessment.

Radiographic healing will be defined as bridging of one 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).

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 clinical healing, as well as 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

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Far Cortical Locking screw fixation	Device: Far Cortical locking screw fixation; Standard screw fixation
ACTIVE_COMPARATOR: Standard screw fixation	Device: Standard screw fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite fracture healing	Radiographic fracture healing defined as bridging of 1 or more cortices. Clinical fracture healing assessed with FIX-IT. Using the win ratio method, we hierarchically assessed radiographic healing, followed by clinical fracture healing. The pairwise comparison proceeds in a hierarchical fashion, using radiographic healing, followed by the FIX-IT score when patients cannot be differentiated based on radiographic healing. For each pairwise comparison, the treatment groups are assigned a win, loss, or tie. We calculate the win ratio as the number of wins in the FCL screw treatment group divided by the number of wins in the Standard screw group.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic healing	Union is defined as the bridging of 1 or more cortices with stable fixation by three months post-fixation.	3 months
Clinical healing	We assessed clinical fracture healing using the Function Index for Trauma (FIX-IT) score. The FIX-IT instrument quantifies clinical healing by aggregating a 0- to 6-point assessment of weight-bearing and fracture site pain for a maximum score of 12 points, indicating the highest level of functional healing.	3 months
Patient-reported health-related quality of life	Assessment of SF-36 scores (physical component and mental component)	3 months
Patient-reported health-related quality of life	Assessment of SF-36 scores (physical component and mental component)	12 months
CT quantification of fracture callus volume	Using a quantitative protocol, the volume of callus will be measured.	3 months

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Kelly Lefaivre, MD, University of British Columbia, Vancouver Coastal Health Authority

Publications and helpful links

General Publications

• Claireaux HA, Searle HK, Parsons NR, Griffin XL. Interventions for treating fractures of the distal femur in adults. Cochrane Database Syst Rev. 2022 Oct 5;10(10):CD010606. doi: 10.1002/14651858.CD010606.pub3.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2013
• Primary Completion (ACTUAL): May 1, 2022
• Study Completion (ANTICIPATED): April 1, 2023

Study Registration Dates

• First Submitted: January 9, 2013
• First Submitted That Met QC Criteria: January 9, 2013
• First Posted (ESTIMATE): January 11, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Fracture; Healing; Femur; Distal; Screw; Locking
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: H12-03489

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes