Comparing two surgical methods for treating distal femur fractures
Evaluation of the Management of Periprosthetic Distal Femur Fractures and Native Knee Distal Femur Fractures, Comparing Open Reduction Internal Fixation With Distal Femur Replacement, a Prospective Cohort Study
This study is testing which of two surgical methods works better for helping older patients recover from specific knee fractures after they've had knee replacement surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 55 Years to 100 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT05792189 on ClinicalTrials.gov |
What this trial studies
This study evaluates the outcomes of two surgical approaches for treating supracondylar femur periprosthetic fractures in patients who have undergone total knee arthroplasty. It compares Open Reduction and Internal Fixation (ORIF) with Distal Femur Replacement (DFR) to determine which method yields better recovery metrics, such as mobility and knee function. The study will prospectively assess patients aged 55 and older who meet specific criteria and will measure outcomes using the Timed Up and Go Test and KOOS Jr score. The goal is to provide clearer guidance on the best surgical intervention for these complex fractures.
Who should consider this trial
Good fit: Ideal candidates are English-speaking patients aged 55 and older with specific types of periprosthetic femur fractures requiring surgical intervention.
Not a fit: Patients with active infections, open fractures, or those unable to undergo surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients with distal femur fractures following knee arthroplasty.
How similar studies have performed: While several small retrospective studies have explored this topic, this is the first prospective study aimed at directly comparing these two surgical methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * English speaking patients * 55 years or older with Su Type II or Su Type III periprosthetic femur fractures or OTA/OA 33C or 338/3 native knee distal femur fracturing requiring surgical intervention and are medically fit to undergo surgical intervention Exclusion Criteria: * Patients with an active total knee prosthetic infection * Patients unable to undergo surgical intervention * Patient with an open fracture * Non-English-speaking patients * Oncologic/pathologic fracture * Poly-trauma patient (or other associated major orthopaedic injuries)
Where this trial is running
Gainesville, Florida
- UF & Shands Orthopaedics and Sports Medicine Institute — Gainesville, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Matthew Patrick, MD
- Email: patrimr@ortho.ufl.edu
- Phone: 352-273-7188
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.