Using Artemis Proximal Femoral Nail for fixing hip fractures
Pilot Evaluation: Artemis Proximal Femoral Nail (PFN) for Internal Fixation of Intertrochanteric Femur Fractures
This study is testing a new type of hip implant called the Artemis Proximal Femoral Nail to see if it helps people with certain hip fractures heal better than older implants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05559736 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the safety, efficacy, and feasibility of the Artemis Proximal Femoral Nail (PFN) for the internal fixation of intertrochanteric femoral fractures. The study compares outcomes of patients receiving the Artemis PFN implant to matched historical controls who received other fixation implants. The Artemis PFN is designed with a titanium core and a carbon-fiber reinforced polyetheretherketone (PEEK) coating, aiming to improve stability and reduce the risk of implant failure. The study focuses on patients with traumatic, non-pathologic stable intertrochanteric fractures requiring surgical intervention.
Who should consider this trial
Good fit: Ideal candidates include adults with traumatic, non-pathologic stable intertrochanteric fractures requiring surgical fixation.
Not a fit: Patients who are pediatric, pregnant, or have other concomitant orthopedic injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved healing outcomes and reduced complications for patients with hip fractures.
How similar studies have performed: Other studies have shown success with similar cephalomedullary nail fixation approaches, but the Artemis PFN is a novel device.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients with traumatic, non-pathologic stable intertrochanteric fractures requiring cephalomedullary nail fixation Exclusion Criteria: * Pediatric patients (\<18 years) * Pregnant females * Patients with other concomitant orthopaedic injuries
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Amiethab Aiyer, MD — Johns Hopkins University
- Study coordinator: Amiethab Aiyer, MD
- Email: aaiyer2@jhmi.edu
- Phone: 2155101722
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.