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NCT04589598 Clinical Trial

Femoral Neck System and Multiple Cannulated Screws in Femoral Neck Fracture

Femoral Neck Fractures Clinical Trial

Official title:
Comparison Between Femoral Neck System and Multiple Cannulated Screws in Non-displaced Femoral Neck Fracture

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04589598
Other study ID # FNS-MCS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 30, 2019
Est. completion date October 30, 2025

Study information
Verified date April 2023
Source Seoul National University Hospital
Contact Young-Kyun Lee
Phone 82-31-787-7204
Email ykleemd@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigators will compare the clinical outcomes of femoral neck system with conventional multiple cannulated screw in non-displaced femoral neck fracture.

Description:

Clinical outcomes include reoperation, loss of fixation, and change of mobility.

Recruitment information / eligibility
Status Recruiting
Enrollment 620
Est. completion date October 30, 2025
Est. primary completion date October 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years and older - non-displaced femoral neck fracture - community ambulator Exclusion Criteria: - younger than 18 years - displaced femoral neck fracture - intertrochanteric fracture - subtrochanteric fracture

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Femoral Neck System
femoral neck system using bolt and antirotation screw with one/two hole plate
• Multiple Cannulated Screw
multiple cannulated screw using 3 or 4 cannulated screw

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam Gyeonggi-do

Sponsors (2)
Lead Sponsor Collaborator
Seoul National University Hospital DePuy Synthes

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Other mobility change Change of mobility
independent community ambulatory
community ambulatory with cane
community ambulatory with crutch, walker
independent household ambulatory
household ambulatory with cane
household ambulatory with crutch, walker
nonfunctional ambulatory		 3 months
Other mobility change Change of mobility
independent community ambulatory
community ambulatory with cane
community ambulatory with crutch, walker
independent household ambulatory
household ambulatory with cane
household ambulatory with crutch, walker
nonfunctional ambulatory		 6 months
Other mobility change Change of mobility
independent community ambulatory
community ambulatory with cane
community ambulatory with crutch, walker
independent household ambulatory
household ambulatory with cane
household ambulatory with crutch, walker
nonfunctional ambulatory		 9 months
Other mobility change Change of mobility
independent community ambulatory
community ambulatory with cane
community ambulatory with crutch, walker
independent household ambulatory
household ambulatory with cane
household ambulatory with crutch, walker
nonfunctional ambulatory		 12 months
Other mobility change Change of mobility
independent community ambulatory
community ambulatory with cane
community ambulatory with crutch, walker
independent household ambulatory
household ambulatory with cane
household ambulatory with crutch, walker
nonfunctional ambulatory		 24 months
Primary Reoperation rate of reoperation 3 months
Primary Reoperation rate of reoperation 6 months
Primary Reoperation rate of reoperation 9 months
Primary Reoperation rate of reoperation 12 months
Primary Reoperation rate of reoperation 24 months
Secondary loss of fixation Rate of loss of fixation 3 months
Secondary loss of fixation Rate of loss of fixation 6 months
Secondary loss of fixation Rate of loss of fixation 9 months
Secondary loss of fixation Rate of loss of fixation 12 months
Secondary loss of fixation Rate of loss of fixation 24 months
See also
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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
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
Withdrawn NCT00317837 - Bipolar Versus Unipolar Hemiarthroplasty for Patients With a Hip Fracture N/A