Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures

Last updated: January 22, 2025
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoporosis

Treatment

Artemis Proximal Femoral Nail (PFN) implant

Clinical Study ID

NCT05559736
IRB00344949
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients with traumatic, non-pathologic stable intertrochanteric fracturesrequiring cephalomedullary nail fixation

Exclusion

Exclusion Criteria:

  • Pediatric patients (<18 years)

  • Pregnant females

  • Patients with other concomitant orthopaedic injuries

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Artemis Proximal Femoral Nail (PFN) implant
Phase:
Study Start date:
May 24, 2023
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland 21244
    United States

    Active - Recruiting

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