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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.
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:
Specific exclusion criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Far Cortical Locking screw fixation | Experimental | Far Cortical Locking screw fixation |
|
| Standard screw fixation | Active Comparator | Standard screw fixation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Far Cortical locking screw fixation | Device | Standard screw fixation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic healing | Union is defined as the bridging of 1 or more cortices with stable fixation by three months post-fixation. | 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. |
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Specific inclusion criteria:
Specific exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly Lefaivre, MD | University of British Columbia, Vancouver Coastal Health Authority | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36197809 | Derived | 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. |
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| ID | Term |
|---|---|
| D000092524 | Femoral Fractures, Distal |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| Standard screw fixation | Device |
|
| 3 months |
| Patient-reported health-related quality of life | Assessment of SF-36 scores (physical component and mental component) | 3 months |
| Patient-reported health-related quality of life | Assessment of SF-36 scores (physical component and mental component) | 12 months |
| CT quantification of fracture callus volume | Using a quantitative protocol, the volume of callus will be measured. | 3 months |