Far Cortical Locking Versus Standard Constructs for Distal Femur Fractures

Not Applicable

Active, not recruiting

• Conditions: Distal Femur Fracture
• Interventions: Device: Standard screw fixation; Device: Far Cortical locking screw fixation

• Registration Number: NCT01766648
• Lead Sponsor: University of British Columbia

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.

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-09
• Study First Posted: 2013-01-11
• Primary Completion: 2022-05
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-17
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 167

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard screw fixation	Standard screw fixation	Standard screw fixation
Far Cortical Locking screw fixation	Far Cortical locking screw fixation	Far Cortical Locking screw fixation

Primary Outcome Measures

Name	Time	Method
Composite fracture healing	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada