Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures
NCT05559736 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2025-12-31
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
-
Innov8ortho
collaborator UNKNOWN - lead OTHER
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
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