Femoral Neck Fractures Clinical Trial
Official title:
Pilot Evaluation: Artemis Proximal Femoral Nail (PFN) for Internal Fixation of Intertrochanteric Femur Fractures
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05505604 -
PENG vs FICB for Hip Fracture in ED Patients
|
N/A | |
Recruiting |
NCT04462172 -
A Prospective Multicenter Cohort Study About Internal Fixation Using FNS Versus MCS for Femoral Neck Fracture
|
N/A | |
Enrolling by invitation |
NCT04110639 -
Intraoperative Monitoring of Femoral Head Perfusion
|
N/A | |
Terminated |
NCT01908751 -
Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2)
|
Phase 3 | |
Recruiting |
NCT01934049 -
Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty
|
Phase 4 | |
Recruiting |
NCT01219088 -
Intrathecal Morphine,Femoral Nerve Block,Periarticular Bupivacaine Infiltration for Pain After Intramedullary Hip Screw
|
Phase 4 | |
Not yet recruiting |
NCT00749710 -
Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel
|
N/A | |
Active, not recruiting |
NCT00491673 -
A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures
|
N/A | |
Completed |
NCT00464230 -
Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures
|
Phase 4 | |
Recruiting |
NCT03966716 -
Hips Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients (HipSTHeR)
|
N/A | |
Recruiting |
NCT05227924 -
Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
|
||
Completed |
NCT03666637 -
Femoral Neck Fracture in Adult and Avascular Necrosis and Nonunion
|
||
Terminated |
NCT03721835 -
Safety Study of Femoral Neck Fracture System
|
N/A | |
Not yet recruiting |
NCT04408053 -
Mini-invasive Preventive Fixation of the Contralateral Femoral Neck in Patients Operated on for a Femoral Neck Fracture
|
Phase 3 | |
Recruiting |
NCT04577261 -
FNS (FEMORAL NECK SYSTEM) Study
|
||
Recruiting |
NCT04589598 -
Femoral Neck System and Multiple Cannulated Screws in Femoral Neck Fracture
|
N/A | |
Not yet recruiting |
NCT06078371 -
Opioid-Free Pain Treatment in Trauma Patients
|
N/A | |
Withdrawn |
NCT02198820 -
Practice Survey on Femoral Neck Fractures and the Incidence of Type of Anesthesia on Patient Outcome
|
N/A | |
Active, not recruiting |
NCT02246335 -
Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly
|
N/A | |
Not yet recruiting |
NCT00926666 -
A Dose Finding Study for Pain Relief of a Broken Hip
|
Phase 4 |