NCT01766648

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2013

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

October 17, 2022

Status Verified

October 1, 2022

Enrollment Period

9.3 years

First QC Date

January 9, 2013

Last Update Submit

October 13, 2022

Conditions

Distal Femur Fracture

Keywords

DistalFemurLockingScrewFractureHealing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Radiographic healing

    3 months

  • Clinical healing

    3 months

  • Patient-reported health-related quality of life

    3 months

  • Patient-reported health-related quality of life

    12 months

  • CT quantification of fracture callus volume

    3 months

Study Arms (2)

Far Cortical Locking screw fixation

EXPERIMENTAL

Far Cortical Locking screw fixation

Device: Far Cortical locking screw fixation

Standard screw fixation

ACTIVE COMPARATOR

Standard screw fixation

Device: Standard screw fixation

Interventions

Far Cortical locking screw fixationDEVICE

Standard screw fixation

Far Cortical Locking screw fixation
Standard screw fixationDEVICE
Standard screw fixation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (1)

  • Claireaux HA, Searle HKC, 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.

    PMID: 36197809DERIVED

MeSH Terms

Conditions

Femoral Fractures, DistalFractures, Bone

Condition Hierarchy (Ancestors)

Femoral FracturesWounds and InjuriesLeg Injuries

Study Officials

  • Kelly Lefaivre, MD

    University of British Columbia, Vancouver Coastal Health Authority

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 9, 2013

First Posted

January 11, 2013

Study Start

January 1, 2013

Primary Completion

May 1, 2022

Study Completion

April 1, 2023

Last Updated

October 17, 2022

Record last verified: 2022-10

Locations

CA(1)