Immediate Weight Bearing Versus Protected Weight Bearing in Supracondylar Distal Femur Fractures

Study Overview
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Brief Summary
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This study is designed to examine if immediate weight bearing on a distal femur fracture fixed with a primary locking plate, either a distal condylar locking plate or a LISS (less invasive stabilization system), is safe and promotes more rapid fracture healing than partial weight bearing, which is standard of care.

Detailed Description
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This study is designed to examine if immediate weight bearing on a distal femur fracture fixed with a primary locking plate, either a distal condylar locking plate or a LISS (less invasive stabilization system), is safe and promotes more rapid fracture healing than partial weight bearing, which is standard of care. Historically and currently patients are kept partial weight bearing after fixation of these fractures for 6-12 weeks until callous formation is observed on radiographs. The hypothesis is that participants allowed to bear weight immediately will heal at least as quickly as those who have weight bearing status protected with the added benefits from early mobilization. Fracture healing will be monitored closely by follow up appointments and complications will be documented.

Official Title
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Immediate Weight Bearing as Tolerated Versus Protected Weight Bearing in Supracondylar Distal Femur Fractures; a Prospective, Randomized Study

Conditions
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Closed Supracondylar Fracture of Femur

Intervention / Treatment
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* Procedure: Full Weight Bearing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged > 18 yo distal supracondylar femur fracture (Supracondylar distal femur fractures treated with a locked plate, either a distal condylar locking plate or a LISS (less invasive stabilization system), including peri-prosthetic fractures) both male and female Exclusion Criteria: Patients with an intracondylar split, polytrauma patients with associated trauma that will inhibit their ability to weight bear, metastatic disease, incomplete follow up, subjects with questionable ability to bear weight (ie advanced dementia), open fractures with bone loss.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full Weight Bearing<br>Participants assigned to full weight bearing after fixation of distal femur fracture. | Procedure: Full Weight Bearing<br>* full weight bearing after fixation of a distal femur fracture<br>|
| No Intervention: Partial Weight Bearing<br>Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Distal Femur Fracture Healing by Radiographic Evidence | Radiographs were analyzed postoperatively to determine bridging of 3 or 4 cortices per standard of care during follow-up office visits. | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Ambulation | Investigators measure time to ambulation | up to 24 weeks | 
| Time of Participation in Physical Therapy | Investigators measure the length of time of physical therapy participation | up to 1 year |