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

June 2, 2022 updated by: David Hubbard, MD, West Virginia University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to Distal Femur Fracture Healing by Radiographic Evidence
Time Frame: 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.
up to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Ambulation
Time Frame: up to 24 weeks
Investigators measure time to ambulation
up to 24 weeks
Time of Participation in Physical Therapy
Time Frame: up to 1 year
Investigators measure the length of time of physical therapy participation
up to 1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Days to Discharge
Time Frame: Up to 30 days
Investigators record the number of days from surgery to discharge
Up to 30 days
Discharge Disposition
Time Frame: Up to 30 days
Investigators record the participants' discharge location, e.g. home, rehabilitation facility
Up to 30 days
Change in Pain
Time Frame: 2 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months
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
Time Frame: 6 weeks, 3 months, 6 months, 12 months
Participants complete the Knee Society survey at the listed time points
6 weeks, 3 months, 6 months, 12 months
Knee Flexion
Time Frame: 12 months
Investigators measure knee flexion
12 months
Number of Participants With Non Union
Time Frame: 12 months
Investigators assess non union at 1 year
12 months
Number of Participants With Malunion
Time Frame: 12 months
Investigators assess malunion at 1 year
12 months
Number of Participants With Infection
Time Frame: 12 months
Investigators check for infection
12 months
Deep Vein Thrombosis at Each Time Point
Time Frame: 12 months
Investigators check for Deep Vein Thrombosis
12 months
Number of Participants With Pulmonary Embolism
Time Frame: 12 months
Investigators check for Pulmonary Embolism
12 months
Number of Participants With Implant Failure
Time Frame: 12 months
Investigators check for implant failure at 12 months
12 months
Change in Vit D Level in Age 65 and Older
Time Frame: baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months
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
Time Frame: 12 months
Investigators record any deaths at 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
West Virginia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David F Hubbard, MD, West Virginia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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