RECRUITING

Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-05-24
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05559736

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All patients with traumatic, non-pathologic stable intertrochanteric fractures requiring cephalomedullary nail fixation
  1. * Pediatric patients (\<18 years)
  2. * Pregnant females
  3. * Patients with other concomitant orthopaedic injuries

Contacts and Locations

Study Contact

Amiethab Aiyer, MD
CONTACT
2155101722
aaiyer2@jhmi.edu

Principal Investigator

Amiethab Aiyer, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Amiethab Aiyer, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-24
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-05-24
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Femoral nail
  • Cephalomedullary nail
  • Artemis Proximal Femoral Nail
  • Intertrochanteric femur fractures

Additional Relevant MeSH Terms

  • Intertrochanteric Fractures
  • Femoral Fracture
  • Femoral Neck Fractures