Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures

Study Overview
=================
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.

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

Conditions
-----------------
Intertrochanteric Fractures, Femoral Fracture, Femoral Neck Fractures

Intervention / Treatment
-----------------
* Device: Artemis Proximal Femoral Nail (PFN) implant


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artemis Proximal Femoral Nail (PFN) implant<br>All participants will receive the Artemis Proximal Femoral Nail (PFN) implant. | Device: Artemis Proximal Femoral Nail (PFN) implant<br>* Artemis Proximal Femoral Nail (PFN) implant<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of fracture nonunion |  | Up to 6 months | 
| Rate of implant-related failure |  | Up to 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Artemis Proximal Femoral Nail, Femoral nail, Cephalomedullary nail, Intertrochanteric femur fractures