Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030.
Steven Kurtz, Kevin Ong, Edmund Lau...
https://pubmed.ncbi.nlm.nih.gov/17403800Actively Recruiting
Phase Not Applicable
Age: 55Years - 100Years
All Genders
ID05792189
Evaluation of Periprosthetic Distal Femur Fractures Treated with ORIF or Distal Femur Replacement: A Prospective Cohort Study
Led by University of Florida · Updated on 2025-07-31
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate treatment outcomes for supracondylar femur periprosthetic fractures occurring around a total knee arthroplasty (TKA), a serious complication that is becoming more common. These fractures are difficult to fix due to changes in anatomy from the TKA and the presence of a metal femoral component, often leading to high complication rates. The study compares two surgical treatments: open reduction and internal fixation (ORIF) and distal femur replacement total knee arthroplasty (DFR), focusing on mobility and knee function outcomes. Participants receive either ORIF or DFR surgery for their distal femur fracture, with each group followed for at least two years. The study measures include the Timed Up and Go Test, which assesses mobility by timing participants as they stand, walk 10 feet, return, and sit, and the KOOS Jr assessment, a questionnaire evaluating knee symptoms, pain, daily activities, sports, and quality of life. These tests are performed at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. During the study, participants will attend scheduled assessments to complete the mobility test and knee function questionnaire at the specified intervals. Researchers will collect data on recovery progress, knee health, and functional abilities over the two-year period. The main outcomes focus on how well patients regain mobility and knee function after either ORIF or DFR treatment. The study is designed to monitor safety and effectiveness of these surgical methods in treating distal femur fractures.
CONDITIONS
Brief Title
Distal Femur Fx: ORIF(Open Reduction and Internal Fixation) vs DFR (Distal Femur Replacement Total Knee Arthroplasty)
Who Can Participate
Age: 55Years - 100Years
All Genders
Eligibility Criteria
You may qualify if you...
- English speaking patients
- Age 55 years or older
- Diagnosed with Su Type II or III periprosthetic femur fractures or OTA/OA 33C or 338/3 native knee distal femur fractures
- Fractures requiring surgical intervention
- Medically fit to undergo surgery
You will not qualify if you...
- Active total knee prosthetic infection
- Unable to undergo surgical intervention
- Open fracture
- Non-English-speaking patients
- Oncologic or pathologic fracture
- Poly-trauma or major associated orthopedic injuries
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Surgical treatment and immediate recovery period
Participants undergo surgery to treat their distal femur fracture either by open reduction and internal fixation (ORIF) or distal femur replacement total knee arthroplasty (DFR).
1 surgical visit
Post-operative Follow-up
Duration - Up to 24 months post surgical treatment
Participants complete mobility and knee function assessments including the Timed Up and Go Test and KOOS Jr questionnaire at multiple points after surgery to evaluate recovery and outcomes.
5 visits at 6 weeks, 3 months, 6 months, 12 months, and 24 months post surgery
Trial Site Locations
Total: 1 location
1
UF & Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, United States, 32607
Actively Recruiting
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Research Team
M
Matthew Patrick, MD
D
Dykes Viginia, DAT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Projected Volume of Primary Total Joint Arthroplasty in the U.S., 2014 to 2030.
Matthew Sloan, Ajay Premkumar, Neil P Sheth
https://pubmed.ncbi.nlm.nih.gov/30180053Open Reduction vs Distal Femoral Replacement Arthroplasty for Comminuted Distal Femur Fractures in the Patients 70 Years and Older.
Gavin P Hart, Jeffrey S Kneisl, Bryan D Springer...
https://pubmed.ncbi.nlm.nih.gov/27449717Distal Femur Replacement Versus Open Reduction and Internal Fixation for Treatment of Periprosthetic Distal Femur Fractures: A Systematic Review and Meta-Analysis.
Harsh Wadhwa, Brett P Salazar, L Henry Goodnough...
https://pubmed.ncbi.nlm.nih.gov/34001801Periprosthetic Fractures of the Distal Femur: Is Open Reduction and Internal Fixation or Distal Femoral Replacement Superior?
Brian Darrith, Daniel D Bohl, Mark S Karadsheh...
https://pubmed.ncbi.nlm.nih.gov/31924488