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Procedure

Single vs Dual Implant for Femur Fractures

N/A

Waitlist Available

Led By Brandon Yuan, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Femur fracture distal to the femoral diaphysis

Patient was previously ambulatory

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of surgery, approximately 2-4 hours

Awards & highlights

Study Summary

This trial looks at a better way to fix broken thigh bones, comparing two fixes to one.

Who is the study for?

This trial is for individuals who need surgery within 72 hours after arriving at the hospital due to a femur fracture near the knee. They must have been able to walk before the injury and be capable of giving consent themselves or through a family member or power of attorney. People with infections, severe cognitive issues, other major leg fractures, bone diseases like Paget's, open fractures, advanced Parkinson's disease, or significant bone loss are not eligible.Check my eligibility

What is being tested?

The study is comparing two methods of surgical repair for thigh bone (femur) fractures close to the knee: one using a single fixation device and another using two devices. The goal is to see which method is more effective in treating these types of injuries.See study design

What are the potential side effects?

Potential side effects from these surgical procedures may include pain at the implant site, infection risks associated with surgery, possible damage to surrounding tissues or nerves during operation, and complications related to healing such as improper bone union.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a broken thigh bone below the midsection.

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I was able to walk on my own before.

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My fracture can be fixed with one or two implants.

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I had surgery within 3 days of arriving at the hospital.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of study-eligible subjects

Secondary outcome measures

Blood loss

Early post-surgical complications

Hospitalization days

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dual Distal Femur Implant GroupExperimental Treatment1 Intervention

Subjects will receive two implants for fixation of the distal femur fracture. The dual implant will be either 2 plates with screws or a plate with screws and a rod. The type of dual implant used will be determined by the surgeon based on the characteristics of the fracture.

Group II: Single Distal Femur Implant GroupActive Control1 Intervention

Subjects will receive one of two types of implants for the distal femur fracture. The single implant will be either a plate and screws or a rod. The type of single implant used will be determined by the surgeon based on the characteristics of the fracture.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,205 Previous Clinical Trials

3,766,724 Total Patients Enrolled

Brandon Yuan, MDPrincipal InvestigatorMayo Clinic

2 Previous Clinical Trials

138 Total Patients Enrolled

Frequently Asked Questions

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

Are there any more openings available for the clinical trial?

"Per information found on clinicaltrials.gov, this medical trial is not currently enlisting participants. The experiment was initially posted in September 1st 2023 and its details were last updated a day later; however, there are 31 additional studies actively recruiting patients at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dual Implant Versus Single Implant Distal End of Femur

Brandon James Yuan 2024. "Dual Implant Versus Single Implant Distal End of Femur". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06032299.