NCT05559736

Brief 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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
2mo left

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
May 2023Jun 2026

First Submitted

Initial submission to the registry

September 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

May 24, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

2.6 years

First QC Date

September 26, 2022

Last Update Submit

December 24, 2025

Conditions

Intertrochanteric FracturesFemoral FractureFemoral Neck Fractures

Keywords

Femoral nailCephalomedullary nailArtemis Proximal Femoral NailIntertrochanteric femur fractures

Outcome Measures

Primary Outcomes (2)

  • Rate of fracture nonunion

    Up to 6 months

  • Rate of implant-related failure

    Up to 6 months

Secondary Outcomes (14)

  • Preoperative pain as assessed by a visual analog scale

    30 days preoperatively

  • Preoperative function as assessed by the Functional Independence Measure

    30 days preoperatively

  • Operative duration

    Intraoperative

  • Fluoroscopy usage time

    Intraoperative

  • Estimated blood loss

    Intraoperative

  • +9 more secondary outcomes

Study Arms (1)

Artemis Proximal Femoral Nail (PFN) implant

EXPERIMENTAL

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

Device: Artemis Proximal Femoral Nail (PFN) implant

Interventions

Artemis Proximal Femoral Nail (PFN) implantDEVICE

Artemis Proximal Femoral Nail (PFN) implant

Artemis Proximal Femoral Nail (PFN) implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with traumatic, non-pathologic stable intertrochanteric fractures requiring cephalomedullary nail fixation

You may not qualify if:

  • Pediatric patients (\<18 years)
  • Pregnant females
  • Patients with other concomitant orthopaedic injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21244, United States

Location

MeSH Terms

Conditions

Hip FracturesFemoral FracturesFemoral Neck Fractures

Interventions

Mutagenesis, Insertional

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Protein EngineeringGenetic EngineeringGenetic TechniquesInvestigative TechniquesMutationGenetic VariationGenetic PhenomenaMutagenesis

Study Officials

  • Amiethab Aiyer, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2022

First Posted

September 29, 2022

Study Start

May 24, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

December 31, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)