Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures

Pilot Evaluation: Artemis Proximal Femoral Nail (PFN) for Internal Fixation of Intertrochanteric Femur Fractures

In February 2021, Altior Trauma Innovations™ announced that it had received 501(k) FDA approval for the Artemis Proximal Femoral Nail (PFN) System for internal fixation of intertrochanteric femur fractures. The objective of this pilot study is to evaluate safety, efficacy and feasibility of the Artemis PFN implant for operative fixation of intertrochanteric femoral fractures, compared to matched historical control patients who received other implants.

Study Overview

• Status: Withdrawn
• Conditions: Femoral Fracture; Femoral Neck Fractures; Intertrochanteric Fractures
• Intervention / Treatment: Device: Artemis Proximal Femoral Nail (PFN) implant

Detailed Description

Intertrochanteric femur fractures are a common injury pattern seen after acute hip trauma, with a very high rate of morbidity and mortality particularly among elderly patients. Cephalomedullary nail fixation has become a mainstay of treatment for both stable and unstable intertrochanteric fractures, offering greater stability than other options without replacing the native hip joint when possible. Despite this, the incidence of fracture nonunion remains high, resulting in poor functional outcomes, higher healthcare costs, and conversion to hemi- or total hip arthroplasty.

In February 2021, Altior Trauma Innovations™ announced that it had received 501(k) FDA approval for the Artemis Proximal Femoral Nail (PFN) System for internal fixation of intertrochanteric femur fractures. The Artemis PFN implant offers several purported advantages over existing implants. It is manufactured with a titanium core coated with carbon-fiber reinforced polyetheretherketone (PEEK), combining the strength of titanium with the bone-imitating biomechanical properties and radiolucency of PEEK. A number of additional features built into the Artemis System are designed to facilitate lower-complexity assembly/insertion, as well as reduce the likelihood of implant failure.

The objective of this pilot study is to evaluate safety, efficacy and feasibility of the Artemis PFN implant for operative fixation of intertrochanteric femoral fractures, compared to matched historical control patients who received other implants.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21244
      • Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Artemis Proximal Femoral Nail (PFN) implant; All participants will receive the Artemis Proximal Femoral Nail (PFN) implant.	Device: Artemis Proximal Femoral Nail (PFN) implant; Artemis Proximal Femoral Nail (PFN) implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of fracture nonunion	Up to 6 months
Rate of implant-related failure	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative pain as assessed by a visual analog scale	Visual Analog Scale: 1(least pain) - 10(most pain).	30 days preoperatively
Preoperative function as assessed by the Functional Independence Measure	Functional Independence Measure: 1(total functional dependence) - 7(total functional independence).	30 days preoperatively
Operative duration	Operative duration in minutes.	Intraoperative
Fluoroscopy usage time	Fluoroscopy usage time in minutes.	Intraoperative
Estimated blood loss	Estimated blood loss in milliliters (mL).	Intraoperative
Duration of hospital stay	Duration of hospital stay in days.	Perioperative, up to 6 months post procedure
Discharge disposition	Discharge to home vs. rehab facility	Perioperative, up to 6 months post procedure
Postoperative complications	Any postoperative complications, including: infection, hematoma, thrombosis/embolism, delayed wound healing, etc.	Up to 6 months
Postoperative pain as assessed by a visual analog scale	Visual Analog Scale: 1(least pain) - 10(most pain).	Up to 6 months
Postoperative function as assessed by the Functional Independence Measure	Functional Independence Measure: 1(total functional dependence) - 7(total functional independence).	Up to 6 months
Use of gait-aid device	Use of gait-aid device (wheelchair, walker, cane).	Up to 6 months
Postoperative radiographic healing	Fracture healing, position of implant, implant-related failure (subsidence, cutout, loosening, implant fracture).	Up to 6 months
Financial costs	Implant purchase/manufacturing costs.	Intraoperative
Environmental costs	Carbon waste footprint.	Intraoperative

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Innov8ortho
• Investigators: Principal Investigator: Amiethab Aiyer, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cephalomedullary nail; Femoral nail; Artemis Proximal Femoral Nail; Intertrochanteric femur fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Hip Injuries; Femoral Fractures; Hip Fractures; Femoral Neck Fractures; Investigative Techniques; Genetic Phenomena; Genetic Techniques; Genetic Variation; Protein Engineering; Genetic Engineering; Mutation; Mutagenesis; Mutagenesis, Insertional
• Other Study ID Numbers: IRB00344949

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No