Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures

NCT05559736 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-12-31

No results posted yet for this 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.

Conditions

  • Intertrochanteric Fractures
  • Femoral Fracture
  • Femoral Neck Fractures

Interventions

DEVICE

Artemis Proximal Femoral Nail (PFN) implant

Artemis Proximal Femoral Nail (PFN) implant

Sponsors & Collaborators

Principal Investigators

  • Amiethab Aiyer, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-24
Primary Completion
2025-12-31
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05559736 on ClinicalTrials.gov