NCT05792189 Distal Femur Fx: ORIF(Open Reduction and Internal Fixation) vs DFR (Distal Femur Replacement Total Knee Arthroplasty)
| NCT ID | NCT05792189 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Distal Femur Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-04-12 |
| Primary Completion | 2029-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-04-12 with a primary completion date of 2029-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Supracondylar femur periprosthetic fractures about a total knee arthroplasty (TKA) are a catastrophic and challenging complication of TKA and unfortunately are increasing in incidence. Fixation of these fractures can be challenging due to altered anatomy for the TKA and the presence of the metallic femoral component and have a relatively high complication rate. As a result, some surgeons elect to treat these fractures with a distal femur replacement total knee arthroplasty (DFR). The purpose of this study is to prospectively evaluate periprosthetic femur fractures treated with ORIF or DFR and compare various outcomes measures (Get up and go times, KOOS Jr score)
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05792189 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 100 Years, studying Distal Femur Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05792189 currently recruiting?
Yes, NCT05792189 is actively recruiting participants. Contact the research team at patrimr@ortho.ufl.edu for enrollment information.
Where is the NCT05792189 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT05792189 clinical trial?
NCT05792189 is sponsored by University of Florida. The trial plans to enroll 100 participants.