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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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Open reduction and internal fixation (ORIF) of distal femur fracture

Secondary outcome measures

Distal femur replacement total knee arthroplasty (DFR) of distal femur fracture

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,341 Previous Clinical Trials

715,546 Total Patients Enrolled

Media Library

Distal Femur Replacement Total Knee Arthroplasty (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05792189 — N/A

$Distal Femur Fracture Research Study Groups: Distal femur replacement total knee arthroplasty (DFR) of distal femur fracture, Open reduction and internal fixation (ORIF) of distal femur fracture$

Distal Femur Fracture Clinical Trial 2023: Distal Femur Replacement Total Knee Arthroplasty Highlights & Side Effects. Trial Name: NCT05792189 — N/A

Distal Femur Replacement Total Knee Arthroplasty (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05792189 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment in search of volunteers beyond the age of forty?

"To comply with the regulations of this clinical trial, only volunteers aged between 55 and 100 are able to be enrolled in the program."

Answered by AI

Are recruitment efforts still underway for this experiment?

"As evidenced by the clinicaltrials.gov listing, this trial is presently accepting applications from qualified participants. This medical study was first made available on April 12th 2023 and has been updated as of July 7th 2023."

Answered by AI

How many individual participants are enrolled in the experiment?

"Correct. Evidenced on clinicaltrials.gov, this medical study is actively recruiting patients since its initial posting date of April 12th 2023 and last edit made on July 7th 2023. The trial requires 100 participants from a single site to proceed."

Answered by AI

Who qualifies as an eligible participant in this clinical examination?

"This clinical trial seeks 100 qualified patients aged 55-100 with a distal femur fracture. Specifically, the eligible subjects must be English proficient, present with Su Type II or Su Type II periprosthetic fractures that necessitate surgical intervention, and hold an overall good health status to proceed with surgery."

Answered by AI

Recent research and studies

Journal of Bone and Joint SurgeryJournal

Projected Volume of Primary Total Joint Arthroplasty in the U.S., 2014 to 2030

Sloan, Matthew, Ajay Premkumar, and Neil P. Sheth. 2018. “Projected Volume of Primary Total Joint Arthroplasty in the U.S., 2014 to 2030”. Journal of Bone and Joint Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.17.01617.

clinicaltrials.govStudy

Distal Femur Fx: ORIF(Open Reduction and Internal Fixation) vs DFR (Distal Femur Replacement Total Knee Arthroplasty)

2023. "Distal Femur Fx: ORIF(Open Reduction and Internal Fixation) vs DFR (Distal Femur Replacement Total Knee Arthroplasty)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05792189.