Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures

Johns Hopkins University

Status: Enrolling

Conditions: Femoral Neck Fractures; Femoral Fracture; Intertrochanteric Fractures

Treatments: Device: Artemis Proximal Femoral Nail (PFN) implant

Study type: Interventional

Funder types: Other

Identifiers

NCT05559736

IRB00344949

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Artemis Proximal Femoral Nail (PFN) implant

Experimental group

Description:

All participants will receive the Artemis Proximal Femoral Nail (PFN) implant.

Treatment:

Device: Artemis Proximal Femoral Nail (PFN) implant