Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05559736
• Collaborator: (none)
• Enrollment: 20
• Arm: 1
• Anticipated Duration (Months): 10

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intertrochanteric Fractures; Femoral Fracture; Femoral Neck Fractures	Device: Artemis Proximal Femoral Nail (PFN) implant	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Evaluation: Artemis Proximal Femoral Nail (PFN) for Internal Fixation of Intertrochanteric Femur Fractures
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Artemis Proximal Femoral Nail (PFN) implant All participants will receive the Artemis Proximal Femoral Nail (PFN) implant.	Device: Artemis Proximal Femoral Nail (PFN) implant; Artemis Proximal Femoral Nail (PFN) implant

Outcome Measures

Primary Outcome Measures

1. Rate of fracture nonunion [Up to 6 months]

2. Rate of implant-related failure [Up to 6 months]

Secondary Outcome Measures

1. Preoperative pain as assessed by a visual analog scale [30 days preoperatively]

   Visual Analog Scale: 1(least pain) - 10(most pain).

2. Preoperative function as assessed by the Functional Independence Measure [30 days preoperatively]

   Functional Independence Measure: 1(total functional dependence) - 7(total functional independence).

3. Operative duration [Intraoperative]

   Operative duration in minutes.

4. Fluoroscopy usage time [Intraoperative]

   Fluoroscopy usage time in minutes.

5. Estimated blood loss [Intraoperative]

   Estimated blood loss in milliliters (mL).

6. Duration of hospital stay [Perioperative, up to 6 months post procedure]

   Duration of hospital stay in days.

7. Discharge disposition [Perioperative, up to 6 months post procedure]

   Discharge to home vs. rehab facility

8. Postoperative complications [Up to 6 months]

   Any postoperative complications, including: infection, hematoma, thrombosis/embolism, delayed wound healing, etc.

9. Postoperative pain as assessed by a visual analog scale [Up to 6 months]

   Visual Analog Scale: 1(least pain) - 10(most pain).

10. Postoperative function as assessed by the Functional Independence Measure [Up to 6 months]

    Functional Independence Measure: 1(total functional dependence) - 7(total functional independence).

11. Use of gait-aid device [Up to 6 months]

    Use of gait-aid device (wheelchair, walker, cane).

12. Postoperative radiographic healing [Up to 6 months]

    Fracture healing, position of implant, implant-related failure (subsidence, cutout, loosening, implant fracture).

13. Financial costs [Intraoperative]

    Implant purchase/manufacturing costs.

14. Environmental costs [Intraoperative]

    Carbon waste footprint.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Johns Hopkins University

Investigators

• Principal Investigator: Amiethab Aiyer, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT05559736
• Other Study ID Numbers: IRB00344949
• First Posted: Sep 29, 2022
• Last Update Posted: Jan 10, 2023
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Johns Hopkins University: Femoral nail; Cephalomedullary nail; Artemis Proximal Femoral Nail; Intertrochanteric femur fractures
• Additional relevant MeSH terms: Fractures, Bone; Femoral Neck Fractures; Femoral Fractures; Hip Fractures

Study Results

No Results Posted as of Jan 10, 2023