Immediate Weight Bearing Versus Protected Weight Bearing in Supracondylar Distal Femur Fractures (WtBrFemFx)

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

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.

Study Overview

• Status: Completed
• Conditions: Closed Supracondylar Fracture of Femur
• Intervention / Treatment: Procedure: Full Weight Bearing

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Days to Discharge	Investigators record the number of days from surgery to discharge	Up to 30 days
Discharge Disposition	Investigators record the participants' discharge location, e.g. home, rehabilitation facility	Up to 30 days
Change in Pain	Investigators record the pain from 0-10 at each time point	2 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months
Change in Knee Society Score	Participants complete the Knee Society survey at the listed time points	6 weeks, 3 months, 6 months, 12 months
Knee Flexion	Investigators measure knee flexion	12 months
Number of Participants With Non Union	Investigators assess non union at 1 year	12 months
Number of Participants With Malunion	Investigators assess malunion at 1 year	12 months
Number of Participants With Infection	Investigators check for infection	12 months
Deep Vein Thrombosis at Each Time Point	Investigators check for Deep Vein Thrombosis	12 months
Number of Participants With Pulmonary Embolism	Investigators check for Pulmonary Embolism	12 months
Number of Participants With Implant Failure	Investigators check for implant failure at 12 months	12 months
Change in Vit D Level in Age 65 and Older	Investigators assess Vit D level in subject age 65 and older at all time points listed	baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months
Study Mortality	Investigators record any deaths at 12 months	12 months

Collaborators and Investigators

• Sponsor: West Virginia University
• Investigators: Principal Investigator: David F Hubbard, MD, West Virginia University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: April 8, 2015
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 25, 2017

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: 1408401969A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No individual participant data will be shared with other researchers. Shared group data will be presented at Orthopaedic conferences and through manuscript submission.