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

University of British Columbia logo

University of British Columbia

Status

Active, not recruiting

Conditions

Distal Femur Fracture

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01766648
H12-03489

Details and patient eligibility

About

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.

Full 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

Enrollment

167 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

167 participants in 2 patient groups

Far Cortical Locking screw fixation
Experimental group
Description:
Far Cortical Locking screw fixation
Treatment:
Device: Far Cortical locking screw fixation
Standard screw fixation
Active Comparator group
Description:
Standard screw fixation
Treatment:
Device: Standard screw fixation

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems