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Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures

Primary Purpose

Intertrochanteric Fractures, Femoral Fracture, Femoral Neck Fractures

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Artemis Proximal Femoral Nail (PFN) implant
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intertrochanteric Fractures focused on measuring Femoral nail, Cephalomedullary nail, Artemis Proximal Femoral Nail, Intertrochanteric femur fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Bayview Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Artemis Proximal Femoral Nail (PFN) implant

Arm Description

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

Outcomes

Primary Outcome Measures

Rate of fracture nonunion
Rate of implant-related failure

Secondary Outcome Measures

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

Full Information

First Posted
September 26, 2022
Last Updated
June 20, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT05559736
Brief Title
Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures
Official Title
Pilot Evaluation: Artemis Proximal Femoral Nail (PFN) for Internal Fixation of Intertrochanteric Femur Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intertrochanteric Fractures, Femoral Fracture, Femoral Neck Fractures
Keywords
Femoral nail, Cephalomedullary nail, Artemis Proximal Femoral Nail, Intertrochanteric femur fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amiethab Aiyer, MD
Phone
2155101722
Email
aaiyer2@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amiethab Aiyer, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21244
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amiethab Aiyer
Phone
215-510-1722
Email
aaiyer2@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Vishal Hegde
Phone
410-550-0452
Email
vhedge2@jhmi.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures

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