RECRUITING

Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures

Description

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

Study Details

Study overview

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.

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

Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures

Condition
Intertrochanteric Fractures
Intervention / Treatment

-

Contacts and Locations

Baltimore

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * All patients with traumatic, non-pathologic stable intertrochanteric fractures requiring cephalomedullary nail fixation
  • * Pediatric patients (\<18 years)
  • * Pregnant females
  • * Patients with other concomitant orthopaedic injuries

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Amiethab Aiyer, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2024-12-31