Distal Femur FractureFCLNCT01766648
Far Cortical Locking Versus Standard Constructs for Distal Femur Fractures
A study testing Far Cortical locking screw fixation and Standard screw fixation in people with Distal Femur Fracture, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Femur Fracture
- What is being tested?
- Far Cortical locking screw fixation and Standard screw fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Distal Femur Fracture
- Being tested
- Far Cortical locking screw fixation, Standard screw fixation
- Keywords
- Distal, Femur, Locking, Screw, Fracture, Healing
- Medical subject headings
- Femoral Fractures, Distal, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Far Cortical locking screw fixationDevice
Standard screw fixation
Standard screw fixationDevice
| Study group | Role | What they receive |
|---|---|---|
| Far Cortical Locking screw fixation | Experimental | Far Cortical Locking screw fixation Receives: Device: Far Cortical locking screw fixation |
| Standard screw fixation | Active comparator | Standard screw fixation Receives: Device: Standard screw fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
Radiographic healing
Union is defined as the bridging of 1 or more cortices with stable fixation by three months post-fixation.
Measured: 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.
Measured: 3 months
Patient-reported health-related quality of life
Assessment of SF-36 scores (physical component and mental component)
Measured: 3 months
Patient-reported health-related quality of life
Assessment of SF-36 scores (physical component and mental component)
Measured: 12 months
CT quantification of fracture callus volume
Using a quantitative protocol, the volume of callus will be measured.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2022
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Femur FractureStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly A. Lefaivre, University of British Columbia
- Investigators
- Kelly Lefaivre, MD, Principal investigator, University of British Columbia, Vancouver Coastal Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766648
- Sponsor's protocol ID
- H12-03489
- Acronym
- FCL
- Status last verified
- Oct 2022
- First submitted
- 9 Jan 2013
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36197809
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized Trial of Far Cortical Locking Versus Standard Constructs for Acute, Displaced Fractures of the Distal Femur Treated With Locked Plate Fixation
- ClinicalTrials.gov ID
- NCT01766648
- Acronym / sponsor ID
- FCL / H12-03489
- Conditions
- Distal Femur Fracture
- Keywords
- Distal, Femur, Locking, Screw, Fracture, Healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 167 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- May 2022 (actual)
- Study completion
- Apr 2023 (estimated)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Far Cortical Locking screw fixation | Experimental | Device: Far Cortical locking screw fixationFar Cortical Locking screw fixation |
| Standard screw fixation | Active comparator | Device: Standard screw fixationStandard screw fixation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Far Cortical locking screw fixationStandard screw fixation | Device | Far Cortical Locking screw fixation |
| Standard screw fixation | Device | Standard screw fixation |
Primary outcome
Composite fracture healing
Time frame: 3 months
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.
5 secondary outcomes
Radiographic healing
Time frame: 3 months
Clinical healing
Time frame: 3 months
Patient-reported health-related quality of life
Time frame: 3 months
Patient-reported health-related quality of life
Time frame: 12 months
CT quantification of fracture callus volume
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Derived from this study: PubMed 36197809Claireaux 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Lefaivre, MD principal investigator
University of British Columbia, Vancouver Coastal Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Far Cortical locking screw fixation and Standard screw fixation in people with Distal Femur Fracture, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite fracture healing (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01766648, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.