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

Primary Purpose

Closed Supracondylar Fracture of Femur

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Full Weight Bearing
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Closed Supracondylar Fracture of Femur

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • West Virginia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Full Weight Bearing

Partial Weight Bearing

Arm Description

Participants assigned to full weight bearing after fixation of distal femur fracture.

Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to Ambulation
Investigators measure time to ambulation
Time of Participation in Physical Therapy
Investigators measure the length of time of physical therapy participation

Full Information

First Posted
April 8, 2015
Last Updated
June 2, 2022
Sponsor
West Virginia University
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1. Study Identification

Unique Protocol Identification Number
NCT03167099
Brief Title
Immediate Weight Bearing Versus Protected Weight Bearing in Supracondylar Distal Femur Fractures
Acronym
WtBrFemFx
Official Title
Immediate Weight Bearing as Tolerated Versus Protected Weight Bearing in Supracondylar Distal Femur Fractures; a Prospective, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Closed Supracondylar Fracture of Femur

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Both investigators and participants are aware of the assignment. There is no masking; only randomization.
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full Weight Bearing
Arm Type
Experimental
Arm Description
Participants assigned to full weight bearing after fixation of distal femur fracture.
Arm Title
Partial Weight Bearing
Arm Type
No Intervention
Arm Description
Participants assigned to partial weight bearing, standard of care, after fixation of distal femur fracture.
Intervention Type
Procedure
Intervention Name(s)
Full Weight Bearing
Intervention Description
full weight bearing after fixation of a distal femur fracture
Primary Outcome Measure Information:
Title
Time to Distal Femur Fracture Healing by Radiographic Evidence
Description
Radiographs were analyzed postoperatively to determine bridging of 3 or 4 cortices per standard of care during follow-up office visits.
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Time to Ambulation
Description
Investigators measure time to ambulation
Time Frame
up to 24 weeks
Title
Time of Participation in Physical Therapy
Description
Investigators measure the length of time of physical therapy participation
Time Frame
up to 1 year
Other Pre-specified Outcome Measures:
Title
Number of Days to Discharge
Description
Investigators record the number of days from surgery to discharge
Time Frame
Up to 30 days
Title
Discharge Disposition
Description
Investigators record the participants' discharge location, e.g. home, rehabilitation facility
Time Frame
Up to 30 days
Title
Change in Pain
Description
Investigators record the pain from 0-10 at each time point
Time Frame
2 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months
Title
Change in Knee Society Score
Description
Participants complete the Knee Society survey at the listed time points
Time Frame
6 weeks, 3 months, 6 months, 12 months
Title
Knee Flexion
Description
Investigators measure knee flexion
Time Frame
12 months
Title
Number of Participants With Non Union
Description
Investigators assess non union at 1 year
Time Frame
12 months
Title
Number of Participants With Malunion
Description
Investigators assess malunion at 1 year
Time Frame
12 months
Title
Number of Participants With Infection
Description
Investigators check for infection
Time Frame
12 months
Title
Deep Vein Thrombosis at Each Time Point
Description
Investigators check for Deep Vein Thrombosis
Time Frame
12 months
Title
Number of Participants With Pulmonary Embolism
Description
Investigators check for Pulmonary Embolism
Time Frame
12 months
Title
Number of Participants With Implant Failure
Description
Investigators check for implant failure at 12 months
Time Frame
12 months
Title
Change in Vit D Level in Age 65 and Older
Description
Investigators assess Vit D level in subject age 65 and older at all time points listed
Time Frame
baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months
Title
Study Mortality
Description
Investigators record any deaths at 12 months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David F Hubbard, MD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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