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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | August 30, 2024 |
Est. primary completion date | July 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Bayview Medical Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of fracture nonunion | Up to 6 months | ||
Primary | Rate of implant-related failure | Up to 6 months | ||
Secondary | Preoperative pain as assessed by a visual analog scale | Visual Analog Scale: 1(least pain) - 10(most pain). | 30 days preoperatively | |
Secondary | Preoperative function as assessed by the Functional Independence Measure | Functional Independence Measure: 1(total functional dependence) - 7(total functional independence). | 30 days preoperatively | |
Secondary | Operative duration | Operative duration in minutes. | Intraoperative | |
Secondary | Fluoroscopy usage time | Fluoroscopy usage time in minutes. | Intraoperative | |
Secondary | Estimated blood loss | Estimated blood loss in milliliters (mL). | Intraoperative | |
Secondary | Duration of hospital stay | Duration of hospital stay in days. | Perioperative, up to 6 months post procedure | |
Secondary | Discharge disposition | Discharge to home vs. rehab facility | Perioperative, up to 6 months post procedure | |
Secondary | Postoperative complications | Any postoperative complications, including: infection, hematoma, thrombosis/embolism, delayed wound healing, etc. | Up to 6 months | |
Secondary | Postoperative pain as assessed by a visual analog scale | Visual Analog Scale: 1(least pain) - 10(most pain). | Up to 6 months | |
Secondary | Postoperative function as assessed by the Functional Independence Measure | Functional Independence Measure: 1(total functional dependence) - 7(total functional independence). | Up to 6 months | |
Secondary | Use of gait-aid device | Use of gait-aid device (wheelchair, walker, cane). | Up to 6 months | |
Secondary | Postoperative radiographic healing | Fracture healing, position of implant, implant-related failure (subsidence, cutout, loosening, implant fracture). | Up to 6 months | |
Secondary | Financial costs | Implant purchase/manufacturing costs. | Intraoperative | |
Secondary | Environmental costs | Carbon waste footprint. | Intraoperative |
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 |