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NCT05559736 | Recruiting | Intertrochanteric Fractures


Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures
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.

Condition or disease

Intertrochanteric Fractures

Femoral Fracture

Femoral Neck Fractures

Intervention/treatment

Artemis Proximal Femoral Nail (PFN) implant

Phase

Not Applicable

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 Type : Interventional
Estimated Enrollment : 20 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Pilot Evaluation: Artemis Proximal Femoral Nail (PFN) for Internal Fixation of Intertrochanteric Femur Fractures
Actual Study Start Date : May 24, 2023
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024
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

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

Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures

Location Details


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Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures

How to Participate

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Locations


Recruiting

United States, Maryland

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States, 21244

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