Far Cortical Locking Versus Standard Constructs for Distal Femur Fractures

Distal Femur Fracture Clinical Trial

— FCL  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01766648
• Other study ID #: H12-03489
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2013
• Est. completion date: April 2023

Study information

• Verified date: October 2022
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 167
• Est. completion date: April 2023
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Femur Fracture
• Femoral Fractures
• Fractures, Bone

Intervention

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

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Radiographic healing	Union is defined as the bridging of 1 or more cortices with stable fixation by three months post-fixation.	3 months
Secondary	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
Secondary	Patient-reported health-related quality of life	Assessment of SF-36 scores (physical component and mental component)	3 months
Secondary	Patient-reported health-related quality of life	Assessment of SF-36 scores (physical component and mental component)	12 months
Secondary	CT quantification of fracture callus volume	Using a quantitative protocol, the volume of callus will be measured.	3 months