Clinical trial NCT05559736: 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
Overall status: RECRUITING
Phase: NA
Conditions: Intertrochanteric Fractures
Femoral Fracture
Femoral Neck Fractures
Keywords: Femoral nail
Cephalomedullary nail
Artemis Proximal Femoral Nail
Intertrochanteric femur fractures
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Innov8ortho
First posted: 2022-09-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of fracture nonunion
timeFrame: Up to 6 months
measure: Rate of implant-related failure
timeFrame: Up to 6 months
Secondary outcomes:
measure: Preoperative pain as assessed by a visual analog scale
timeFrame: 30 days preoperatively
measure: Preoperative function as assessed by the Functional Independence Measure
timeFrame: 30 days preoperatively
measure: Operative duration
timeFrame: Intraoperative
measure: Fluoroscopy usage time
timeFrame: Intraoperative
measure: Estimated blood loss
timeFrame: Intraoperative
measure: Duration of hospital stay
timeFrame: Perioperative, up to 6 months post procedure
measure: Discharge disposition
timeFrame: Perioperative, up to 6 months post procedure
measure: Postoperative complications
timeFrame: Up to 6 months
measure: Postoperative pain as assessed by a visual analog scale
timeFrame: Up to 6 months
measure: Postoperative function as assessed by the Functional Independence Measure
timeFrame: Up to 6 months
measure: Use of gait-aid device
timeFrame: Up to 6 months
measure: Postoperative radiographic healing
timeFrame: Up to 6 months
measure: Financial costs
timeFrame: Intraoperative
measure: Environmental costs
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Amiethab Aiyer, MD
role: PRINCIPAL_INVESTIGATOR
References: