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

Overview

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.

Full Title of Study: “Immediate Weight Bearing as Tolerated Versus Protected Weight Bearing in Supracondylar Distal Femur Fractures; a Prospective, Randomized Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2019

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.

Interventions

  • Procedure: Full Weight Bearing
    • Participants will be randomized to one of two groups; full weight bearing, which is the intervention, or partial weight bearing, which is standard of care, after fixation of a distal femur fracture.

Arms, Groups and Cohorts

  • Experimental: Full Weight Bearing
    • Participants assigned to full weight bearing after fixation of distal femur fracture.
  • No Intervention: Partial Weight Bearing
    • Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture.

Clinical Trial Outcome Measures

Primary Measures

  • Time to distal femur fracture healing by radiographic evidence
    • Time Frame: up to 12 weeks
    • Participants are randomly assigned to partial weight bearing or full weight bearing after fixation of distal femur fracture. Radiographs taken at 12 weeks to determine bridging of 3 or 4 cortices.

Secondary Measures

  • Time to ambulation
    • Time Frame: up to 12 weeks
    • Investigators measure time to ambulation at 12 weeks.
  • Time of participation in physical therapy
    • Time Frame: up to 1 year
    • Investigators measure the length of time of physical therapy participation

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • West Virginia University
  • Provider of Information About this Clinical Study
    • Principal Investigator: David Hubbard, MD, MD, Chief, Orthopaedic Trauma Service, Professor – West Virginia University
  • Overall Official(s)
    • David F Hubbard, MD, Principal Investigator, West Virginia University

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