Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures

Not Applicable

Recruiting

• Conditions: Femoral Neck Fractures; Femoral Fracture; Intertrochanteric Fractures
• Interventions: Device: Artemis Proximal Femoral Nail (PFN) implant

• Registration Number: NCT05559736
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Intertrochanteric femur fractures are a common injury pattern seen after acute hip trauma, with a very high rate of morbidity and mortality particularly among elderly patients. Cephalomedullary nail fixation has become a mainstay of treatment for both stable and unstable intertrochanteric fractures, offering greater stability than other options without replacing the native hip joint when possible. Despite this, the incidence of fracture nonunion remains high, resulting in poor functional outcomes, higher healthcare costs, and conversion to hemi- or total hip arthroplasty.

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 Artemis PFN implant offers several purported advantages over existing implants. It is manufactured with a titanium core coated with carbon-fiber reinforced polyetheretherketone (PEEK), combining the strength of titanium with the bone-imitating biomechanical properties and radiolucency of PEEK. A number of additional features built into the Artemis System are designed to facilitate lower-complexity assembly/insertion, as well as reduce the likelihood of implant failure.

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 Timeline

• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-29
• Study Start: 2023-05-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-23
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Rate of fracture nonunion	Up to 6 months
Rate of implant-related failure	Up to 6 months

Secondary Outcome Measures

Name	Time	Method
Use of gait-aid device	Up to 6 months	Use of gait-aid device (wheelchair, walker, cane).
Fluoroscopy usage time	Intraoperative	Fluoroscopy usage time in minutes.
Estimated blood loss	Intraoperative	Estimated blood loss in milliliters (mL).
Preoperative pain as assessed by a visual analog scale	30 days preoperatively	Visual Analog Scale: 1(least pain) - 10(most pain).
Preoperative function as assessed by the Functional Independence Measure	30 days preoperatively	Functional Independence Measure: 1(total functional dependence) - 7(total functional independence).
Operative duration	Intraoperative	Operative duration in minutes.
Discharge disposition	Perioperative, up to 6 months post procedure	Discharge to home vs. rehab facility
Postoperative function as assessed by the Functional Independence Measure	Up to 6 months	Functional Independence Measure: 1(total functional dependence) - 7(total functional independence).
Duration of hospital stay	Perioperative, up to 6 months post procedure	Duration of hospital stay in days.
Postoperative complications	Up to 6 months	Any postoperative complications, including: infection, hematoma, thrombosis/embolism, delayed wound healing, etc.
Postoperative pain as assessed by a visual analog scale	Up to 6 months	Visual Analog Scale: 1(least pain) - 10(most pain).
Financial costs	Intraoperative	Implant purchase/manufacturing costs.
Postoperative radiographic healing	Up to 6 months	Fracture healing, position of implant, implant-related failure (subsidence, cutout, loosening, implant fracture).
Environmental costs	Intraoperative	Carbon waste footprint.

Trial Locations

Locations (1)

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States