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Internal Fixation Device

PFN Implant for Hip Fracture

N/A
Recruiting
Led By Amiethab Aiyer, MD
Research Sponsored by Johns Hopkins University
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 6 months
Awards & highlights

Study Summary

This trial evaluates the safety, efficacy and feasibility of a new device for treating femur fractures, the Artemis PFN, which has been approved by the FDA.

Who is the study for?
This trial is for adults with stable intertrochanteric femur fractures needing internal fixation. It's not open to children under 18, pregnant women, or patients with other orthopedic injuries.Check my eligibility
What is being tested?
The Artemis Proximal Femoral Nail (PFN) System is being tested for fixing broken hip bones near the top of the thigh bone. The study compares its safety and effectiveness to past methods used on similar patients.See study design
What are the potential side effects?
While specific side effects are not listed, common risks associated with internal fixation devices include pain at the site of implantation, infection, bone healing problems, and possible need for additional surgeries.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of fracture nonunion
Rate of implant-related failure
Secondary outcome measures
Discharge disposition
Duration of hospital stay
Environmental costs
+11 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Artemis Proximal Femoral Nail (PFN) implantExperimental Treatment1 Intervention
All participants will receive the Artemis Proximal Femoral Nail (PFN) implant.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,837,477 Total Patients Enrolled
Amiethab Aiyer, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Artemis Proximal Femoral Nail (PFN) implant (Internal Fixation Device) Clinical Trial Eligibility Overview. Trial Name: NCT05559736 — N/A
Femoral Neck Fracture Research Study Groups: Artemis Proximal Femoral Nail (PFN) implant
Femoral Neck Fracture Clinical Trial 2023: Artemis Proximal Femoral Nail (PFN) implant Highlights & Side Effects. Trial Name: NCT05559736 — N/A
Artemis Proximal Femoral Nail (PFN) implant (Internal Fixation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05559736 — 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 individuals are involved in this experiment?

"Affirmative. According to clinicaltrials.gov, this research continues to seek participants since first being posted on May 24th 2023 and most recently updated June 20th of the same year. The protocol requires a total sample size of twenty patients from one site."

Answered by AI

Are there any available slots in this trial for participants?

"Clinicaltrials.gov verifies that this clinical trial is presently enrolling volunteers. This investigation, which commenced on May 24th 2023, was recently updated on June 20th of the same year."

Answered by AI

What tangible results are researchers expecting to attain from this clinical trial?

"This 6-month study strives to understand the rate of fracture nonunion. Secondary objectives include measuring financial costs, radiographic evidence of healing, and usage of gait-aid devices like wheelchairs or canes."

Answered by AI
~0 spots leftby Apr 2024