Periprosthetic 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/Actively Recruiting
Led by University of Florida · Updated on 2025-07-31
100
Participants Needed
1
Research Sites
N/A
Total Duration
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
Distal Femur Fx: ORIF(Open Reduction and Internal Fixation) vs DFR (Distal Femur Replacement Total Knee Arthroplasty)
M
Matthew Patrick, MD
D
Dykes Viginia, DAT
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University of Florida
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | ORIF for Distal Femur Fracture | Distal Femur Replacement (DFR) |
|---|---|---|
| What is it? | Surgical procedure using plates, screws, or other hardware to fix the fractured distal femur, aiming to preserve the native knee joint. | Surgical replacement of the distal femur and the knee joint with a prosthetic implant, intended as an alternative to fixation. |
| Role in trial | Primary study arm: patients receive ORIF as their surgical intervention for distal femur fractures. | Comparator arm: patients undergo DFR total knee arthroplasty for the same fractures. |
| Primary use | Restoration of bone alignment and stability following distal femur fracture while keeping the native knee. | Replacement of the broken distal femur and knee joint with a prosthesis to address fractures difficult to repair by fixation. |
| How is it given or performed? | Operation involves surgical exposure of the fracture, reduction of bone fragments, and fixation using plates and screws to stabilize the femur. | Surgery involves removal of damaged bone, preparation for implant, and placement of a prosthetic distal femur and knee joint. |
| Evidence status | Outcomes after ORIF are supported by multiple comparative and systematic reviews, showing successful fracture healing and return of function but higher risk of hardware complications in older patients. | Published reviews and studies indicate DFR may lead to faster recovery and earlier weight-bearing but carries risks such as prosthesis loosening, infection, and mechanical failure. |
| Important limitations | Fixation can be technically challenging in severely comminuted fractures and may be limited by poor bone quality. Nonunion, hardware failure, and prolonged protection from full weight-bearing are more common in older adults. | DFR carries risks related to prosthesis longevity. Implant failure, infection, and revision surgery may occur, particularly in patients with other medical issues. Long-term durability of prosthesis may be less established than traditional fixation. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor