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Implant

Retrograde Femoral Nail for Broken Bones

N/A

Recruiting

Research Sponsored by University of California, San Diego

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 2 years

Awards & highlights

Study Summary

This trial looks at a new femoral nail design to help treat fractures of the femur. Data on healing, complications, pain, etc. will be collected to assess its effectiveness.

Who is the study for?

Adults 18+ with a distal femur or femoral shaft fracture needing surgery can join this trial. They must be treated at UCSD, understand and consent to the study. Excluded are pregnant women, those in other drug studies within the last month, prisoners, and patients with severe diseases not under control.Check my eligibility

What is being tested?

The RFN-Advanced Retrograde Femoral Nailing System is being tested for fixing fractures of the lower thigh bone. The study will track how well it works over three years by looking at healing rates, complications, pain levels, and how well patients can use their legs.See study design

What are the potential side effects?

Potential side effects may include issues like malalignment (bones not lining up correctly) which is common with current nail systems used for these types of fractures. Other general surgical risks may apply.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

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

Healing Rates

Secondary outcome measures

Number of Complications

Pain Score (0-10,0=no pain, 10=most severe)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Retrograde Femoral Nail-AdvancedExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

DePuy SynthesIndustry Sponsor

30 Previous Clinical Trials

4,884 Total Patients Enrolled

1 Trials studying Femur Fractures

53 Patients Enrolled for Femur Fractures

University of California, San DiegoLead Sponsor

1,122 Previous Clinical Trials

1,521,004 Total Patients Enrolled

1 Trials studying Femur Fractures

60 Patients Enrolled for Femur Fractures

Media Library

RFN-Advanced Retrograde Femoral Nailing System (Implant) Clinical Trial Eligibility Overview. Trial Name: NCT05680987 — N/A

Femur Fractures Research Study Groups: Retrograde Femoral Nail-Advanced

Femur Fractures Clinical Trial 2023: RFN-Advanced Retrograde Femoral Nailing System Highlights & Side Effects. Trial Name: NCT05680987 — N/A

RFN-Advanced Retrograde Femoral Nailing System (Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05680987 — N/A

Frequently Asked Questions

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

How many people are enrolled in this research endeavor?

"Affirmative. The online registry of clinical trials presents that this trial is currently searching for participants. It was initially posted on June 23rd 2021 and last edited on January 9th 2023, with 40 people desired at one site."

Answered by AI

Is this trial still open to new participants?

"Yes, the evidence on clinicaltrials.gov documents that this investigation is actively enrolling patients. It was initially posted on June 23rd 2021 and updated most recently on January 9th 2023. The trial necessitates 40 participants from a single site to be accepted in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Retrograde Femoral Nail-Advanced Outcomes for Fixation of Distal Femur and Femoral Shaft Fractures

William Kent 2021. "Retrograde Femoral Nail-Advanced Outcomes for Fixation of Distal Femur and Femoral Shaft Fractures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05680987.