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

Not Applicable

Completed

• Conditions: Closed Supracondylar Fracture of Femur
• Interventions: Procedure: Full Weight Bearing

• Registration Number: NCT03167099
• Lead Sponsor: West Virginia University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2017-05-23
• Study First Posted: 2017-05-25
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Results First Submitted: 2022-02-22
• Status Verified: 2022-06
• Results First Submitted QC: 2022-06-02
• Last Update Submitted: 2022-06-02
• Results First Posted: 2022-08-05
• Last Update Posted: 2022-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full Weight Bearing	Full Weight Bearing	Participants assigned to full weight bearing after fixation of distal femur fracture.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time of Participation in Physical Therapy	up to 1 year	Investigators measure the length of time of physical therapy participation
Time to Ambulation	up to 24 weeks	Investigators measure time to ambulation

Trial Locations

Locations (1)

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States