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Procedure
ORIF vs DFR for Distal Femur Fracture
N/A
Recruiting
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial evaluates the effectiveness of two treatments for complicated fractures in patients who have had total knee arthroplasty (TKA). Outcomes will be compared to determine which is best.
Who is the study for?
This trial is for English-speaking patients aged 55 or older with specific types of periprosthetic femur fractures (Su Type II or III) who need surgery and are medically fit for it. It excludes those with open fractures, multiple major injuries, knee prosthetic infections, inability to have surgery, or cancer-related fractures.
What is being tested?
The study compares two surgical treatments for severe knee fractures near a total knee replacement: ORIF (fixing the bone pieces directly) versus DFR (replacing the damaged part of the thigh bone). Outcomes like mobility and knee function scores will be measured.
What are the potential side effects?
Potential side effects may include complications from surgery such as infection, pain at the fracture/surgery site, issues with bone healing, possible damage to nearby nerves or blood vessels, and general risks associated with anesthesia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Open reduction and internal fixation (ORIF) of distal femur fracture
Secondary study objectives
Distal femur replacement total knee arthroplasty (DFR) of distal femur fracture
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Distal femur replacement total knee arthroplasty (DFR) of distal femur fractureActive Control4 Interventions
Su Type 2 or 3 periprosthetic distal femur fractures about a total knee after undergoing DFR for a minimum of 2 years
Group II: Open reduction and internal fixation (ORIF) of distal femur fractureActive Control4 Interventions
Su Type 2 or 3 periprosthetic distal femur fractures about a total knee after undergoing ORIF for a minimum of 2 years
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,409 Previous Clinical Trials
767,359 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a fracture due to cancer.I am 55 or older, speak English, and need surgery for a specific type of thigh bone fracture.I have an infection in my knee replacement.I cannot have surgery for my condition.I have a broken bone that is exposed through my skin.
Research Study Groups:
This trial has the following groups:- Group 1: Distal femur replacement total knee arthroplasty (DFR) of distal femur fracture
- Group 2: Open reduction and internal fixation (ORIF) of distal femur fracture
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.