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Femoral Neck System and Multiple Cannulated Screws in Femoral Neck Fracture

Primary Purpose

Femoral Neck Fractures

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Femoral Neck System
Multiple Cannulated Screw
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fractures focused on measuring Femoral Neck Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FNS

MCS

Arm Description

those who are treated with femoral neck system (FNS)

those who are treated with multiple cannulated screw (MCS)

Outcomes

Primary Outcome Measures

Reoperation
rate of reoperation
Reoperation
rate of reoperation
Reoperation
rate of reoperation
Reoperation
rate of reoperation
Reoperation
rate of reoperation

Secondary Outcome Measures

loss of fixation
Rate of loss of fixation
loss of fixation
Rate of loss of fixation
loss of fixation
Rate of loss of fixation
loss of fixation
Rate of loss of fixation
loss of fixation
Rate of loss of fixation

Full Information

First Posted
September 27, 2020
Last Updated
April 20, 2023
Sponsor
Seoul National University Hospital
Collaborators
DePuy Synthes
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1. Study Identification

Unique Protocol Identification Number
NCT04589598
Brief Title
Femoral Neck System and Multiple Cannulated Screws in Femoral Neck Fracture
Official Title
Comparison Between Femoral Neck System and Multiple Cannulated Screws in Non-displaced Femoral Neck Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
DePuy Synthes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Investigators will compare the clinical outcomes of femoral neck system with conventional multiple cannulated screw in non-displaced femoral neck fracture.
Detailed Description
Clinical outcomes include reoperation, loss of fixation, and change of mobility.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures
Keywords
Femoral Neck Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
620 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FNS
Arm Type
Experimental
Arm Description
those who are treated with femoral neck system (FNS)
Arm Title
MCS
Arm Type
Active Comparator
Arm Description
those who are treated with multiple cannulated screw (MCS)
Intervention Type
Device
Intervention Name(s)
Femoral Neck System
Intervention Description
femoral neck system using bolt and antirotation screw with one/two hole plate
Intervention Type
Device
Intervention Name(s)
Multiple Cannulated Screw
Intervention Description
multiple cannulated screw using 3 or 4 cannulated screw
Primary Outcome Measure Information:
Title
Reoperation
Description
rate of reoperation
Time Frame
3 months
Title
Reoperation
Description
rate of reoperation
Time Frame
6 months
Title
Reoperation
Description
rate of reoperation
Time Frame
9 months
Title
Reoperation
Description
rate of reoperation
Time Frame
12 months
Title
Reoperation
Description
rate of reoperation
Time Frame
24 months
Secondary Outcome Measure Information:
Title
loss of fixation
Description
Rate of loss of fixation
Time Frame
3 months
Title
loss of fixation
Description
Rate of loss of fixation
Time Frame
6 months
Title
loss of fixation
Description
Rate of loss of fixation
Time Frame
9 months
Title
loss of fixation
Description
Rate of loss of fixation
Time Frame
12 months
Title
loss of fixation
Description
Rate of loss of fixation
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
mobility change
Description
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
Time Frame
3 months
Title
mobility change
Description
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
Time Frame
6 months
Title
mobility change
Description
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
Time Frame
9 months
Title
mobility change
Description
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
Time Frame
12 months
Title
mobility change
Description
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
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young-Kyun Lee
Phone
82-31-787-7204
Email
ykleemd@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Kyun Lee
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-Kyun Lee
Phone
82-31-787-7204
Email
ykleemd@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Femoral Neck System and Multiple Cannulated Screws in Femoral Neck Fracture

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