Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures

Femoral Neck Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05559736
• Other study ID #: IRB00344949
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: April 2024
• Source: Johns Hopkins University
• Contact: Amiethab Aiyer, MD
• Phone: 2155101722
• Email: aaiyer2[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fracture
• Femoral Fractures
• Femoral Neck Fractures
• Fractures, Bone
• Hip Fractures
• Intertrochanteric Fractures

Intervention

Device:
• Artemis Proximal Femoral Nail (PFN) implant
Artemis Proximal Femoral Nail (PFN) implant

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

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