Femoral Fracture, Femoral Neck Fractures, Intertrochanteric Fractures
Conditions
Keywords
Femoral nail, Cephalomedullary nail, Artemis Proximal Femoral Nail, Intertrochanteric femur fractures
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.
Interventions
DEVICEArtemis Proximal Femoral Nail (PFN) implant
Artemis Proximal Femoral Nail (PFN) implant
Sponsors
Innov8ortho
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of fracture nonunion | Up to 6 months |
| Rate of implant-related failure | Up to 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative duration | Intraoperative | Operative duration in minutes. |
| Fluoroscopy usage time | Intraoperative | Fluoroscopy usage time in minutes. |
| Estimated blood loss | Intraoperative | Estimated blood loss in milliliters (mL). |
| Duration of hospital stay | Perioperative, up to 6 months post procedure | Duration of hospital stay in days. |
| Discharge disposition | Perioperative, up to 6 months post procedure | Discharge to home vs. rehab facility |
| Postoperative complications | Up to 6 months | Any postoperative complications, including: infection, hematoma, thrombosis/embolism, delayed wound healing, etc. |
| Preoperative pain as assessed by a visual analog scale | 30 days preoperatively | Visual Analog Scale: 1(least pain) - 10(most pain). |
| Postoperative function as assessed by the Functional Independence Measure | Up to 6 months | Functional Independence Measure: 1(total functional dependence) - 7(total functional independence). |
| Use of gait-aid device | Up to 6 months | Use of gait-aid device (wheelchair, walker, cane). |
| Postoperative radiographic healing | Up to 6 months | Fracture healing, position of implant, implant-related failure (subsidence, cutout, loosening, implant fracture). |
| Financial costs | Intraoperative | Implant purchase/manufacturing costs. |
| Environmental costs | Intraoperative | Carbon waste footprint. |
| Postoperative pain as assessed by a visual analog scale | Up to 6 months | Visual Analog Scale: 1(least pain) - 10(most pain). |
| Preoperative function as assessed by the Functional Independence Measure | 30 days preoperatively | Functional Independence Measure: 1(total functional dependence) - 7(total functional independence). |
Countries
United States
Outcome results
None listed