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Early Weight Bearing on Supracondylar Distal Femur Fractures in Elderly Patients

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ClinicalTrials.gov Identifier: NCT02475941
Recruitment Status : Recruiting
First Posted : June 19, 2015
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
St. Louis University

Brief Summary:
The investigators will be looking at geriatric distal femur fractures. The investigators will prospectively enroll these patients and allow patients to either weight bear as tolerated or limit their weight bearing post operatively. The investigators will evaluate functional outcomes.

Condition or disease Intervention/treatment Phase
Distal Femur Fractures Other: Non Weight bearing Other: Early Weight Bearing Not Applicable

Detailed Description:

Supracondylar femur fractures represent 4-7% of femur fractures. These are a common orthopaedic injury with an overall incidence of 37 per 100,000 person-years. These fractures are complex and challenging for orthopaedic surgeons. The fracture needs to be correctly reduced and, like nearly all fractures, fixed with enough stability to permit early joint motion. This allows for earlier patient rehabilitation, which can improve outcomes. There are a number of different fixation devices. Fixed angle implants such as retrograde intramedullary nails, angled blade plates, and 95-degree side plates have had good clinical outcomes with resistance to varus collapse. Recently, locking plates have become the standard method for distal femoral fracture fixation. Hendersen et al. provided a systematic review of locking plate fixation and demonstrated the range of complications as 0% to 32% and implant failure occurring late with 75% of failures occurring after 3 months and 50% occurring after 6 months. Ricci et al. sought to determine risk factors associated with failure of locked plate fixation of distal femur fractures and found that 19% required reoperation. The risk factors for reoperation found in this study were diabetes, smoking, increased body mass index, shorter plate length and open fracture. Most factors are out of surgeon control but are important to evaluate when considering prognosis.

After the fracture has been open reduced and internally fixed, there is debate on postoperative management of weight bearing. Weight bearing following fixation is generally restricted for 6 to 12 weeks until radiologic evidence of evidence demonstrates sufficient callous. This restricted weight bearing is primarily due to concerns of implant failure and loss of reduction. A study by Brumback et al. examined intramedullary nail fixation of distal femur fractures and concluded to allow full weight bearing of comminuted femoral shaft fractures with antegrade intramedullary nail. This study led surgeons to accelerate their rehabilitation protocols.

The post-operative weight bearing recommendations for distal femur fractures treated with locking plate vary widely which motivated Granata et al. to evaluate the biomechanics of immediate weight bearing of distal femur fractures treated with locked plate fixation. They found that the fatigue limit of the locked plate constructs was 1.9 times body weight for an average 70-kilogram patient over a simulated 10-week postoperative course. Although this study could not fully support immediate weight bearing due to the fact that femoral loads during gait have been estimated to be around 2 times body weight, it demonstrated adequate hardware fixation with weight bearing.

The benefits of early weight bearing are accelerated functional recovery, increased independence, decreased impact on the family, increased psychological benefits, reduced use of healthcare resources, decreased need for family intervention, and family to take care of the patient. The downside is the strength of fixation, the risk of implant failure, and the risk of loss of reduction. The goals are to evaluate the fracture, the complication rate, the mortality rate, and the risks of healthcare resources that have been used.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Weight Bearing on Supracondylar Distal Femur Fractures in Elderly Patients
Actual Study Start Date : May 11, 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early Weight Bearing
Surgeon based prospective cohort supported in the literature to answer research questions in which surgeons have a preferred treatment type. Early weight bearing are those who are permitted in the post operative instructions to be Weight Bear as tolerated after fracture fixation.
Other: Early Weight Bearing

The design will be a surgeon based prospective cohort supported in the literature to answer research questions in which surgeons may have a preferred treatment type. Each surgeon will treat study subjects by his or her single chosen method (weight bearing as tolerated post operatively versus non weight bearing).

The benefits of early weight bearing are accelerated functional recovery, increased independence, decreased impact on the family, increased psychological benefits, reduced use of healthcare resources, decreased need for family intervention, and family to take care of the patient.


Active Comparator: Non Weight Bearing
Surgeon based prospective cohort supported in the literature to answer research questions in which surgeons have a preferred treatment type. Non weight bearing are those who are NOT permitted in the post operative instructions to be Weight Bear after fracture fixation.
Other: Non Weight bearing

The design will be a surgeon based prospective cohort supported in the literature to answer research questions in which surgeons may have a preferred treatment type. Each surgeon will treat study subjects by his or her single chosen method (weight bearing as tolerated post operatively versus non weight bearing).

The benefits of early weight bearing are accelerated functional recovery, increased independence, decreased impact on the family, increased psychological benefits, reduced use of healthcare resources, decreased need for family intervention, and family to take care of the patient.





Primary Outcome Measures :
  1. Fracture Healing in Early Weight Bearing assessed by radiographs [ Time Frame: Post op-3 months ]
    Will assess radiographs to assess for a healed fracture with no loss of fixation or need for secondary surgery


Secondary Outcome Measures :
  1. Visual Analog Scale to assess pain [ Time Frame: Pre-injury function and at 6 weeks, 3, 6 and 12 months post-injury ]
    Assess pain to compare between two groups

  2. Oxford Knee Score to measure knee function [ Time Frame: Pre-injury function and at 6 weeks, 3, 6 and 12 months post-injury ]
    Validated outcome measure to document knee function to compare between two groups

  3. SF12 to measure return to function [ Time Frame: Pre-injury function and at 6 weeks, 3, 6 and 12 months post-injury ]
    Measures patients outcome based on their return to function.



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Ages Eligible for Study:   64 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Distal femur fractures, including periprosthetic fractures
  • AO/OTA classification 33
  • Above 64 years of age and below 90 years of age
  • Household ambulators: defined as an individual who can walk continuously for distances that are considered reasonable for walking inside the home but limited for walking in the community due of endurance, strength, or safety concerns

Exclusion Criteria:

  • Those who do not fit the inclusion criteria
  • Concomitant ipsilateral lower extremity injury
  • Contralateral lower extremity injury.
  • Vascular injury of concomitant lower extremity requiring repair
  • Pathologic fracture
  • Definitive treatment delay of more than 2 weeks from initial injury
  • Unable to comply with post-operative rehabilitation protocols or instructions
  • Current or impending incarceration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475941


Contacts
Contact: Sarah Dawson, RN 314-577-8527 sdawson@slu.edu

Locations
United States, Georgia
Wellstar Recruiting
Atlanta, Georgia, United States, 30312
Contact: JenNifer Bruggers, MD         
Principal Investigator: Jennifer Bruggers, MD         
United States, Missouri
St. Louis Medical Center Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Sarah Dawson       sarah.dawson@health.slu.edu   
Principal Investigator: Lisa Cannada, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27703
Contact: Steve Olson, MD         
Contact: Cameron Howes    919-613-5747      
Wake Forest University Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Eben Carroll, MD         
Principal Investigator: Eben Carroll, MD         
Sub-Investigator: Jason Halvorson, MD         
United States, South Carolina
Grennville Health Sysytems Recruiting
Greenville, South Carolina, United States, 29604
Contact: Kyle Jeray, MD         
Principal Investigator: Kyle Jeray, MD         
United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: William T Obremskey, MD         
Principal Investigator: William T. Obremskey, MD, MPH         
Sponsors and Collaborators
St. Louis University
Investigators
Principal Investigator: Lisa K Cannada, MD St. Louis University

Publications of Results:

Responsible Party: St. Louis University
ClinicalTrials.gov Identifier: NCT02475941     History of Changes
Other Study ID Numbers: 24664
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018

Keywords provided by St. Louis University:
geriatric fractures

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries