NCT04589598

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
620

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

June 10, 2025

Status Verified

May 1, 2025

Enrollment Period

5 years

First QC Date

September 27, 2020

Last Update Submit

June 5, 2025

Conditions

Femoral Neck Fractures

Keywords

Femoral Neck Fractures

Outcome Measures

Primary Outcomes (5)

  • Reoperation

    rate of reoperation

    3 months

  • Reoperation

    rate of reoperation

    6 months

  • Reoperation

    rate of reoperation

    9 months

  • Reoperation

    rate of reoperation

    12 months

  • Reoperation

    rate of reoperation

    24 months

Secondary Outcomes (5)

  • loss of fixation

    3 months

  • loss of fixation

    6 months

  • loss of fixation

    9 months

  • loss of fixation

    12 months

  • loss of fixation

    24 months

Other Outcomes (5)

  • mobility change

    3 months

  • mobility change

    6 months

  • mobility change

    9 months

  • +2 more other outcomes

Study Arms (2)

FNS

EXPERIMENTAL

those who are treated with femoral neck system (FNS)

Device: Femoral Neck System

MCS

ACTIVE COMPARATOR

those who are treated with multiple cannulated screw (MCS)

Device: Multiple Cannulated Screw

Interventions

Femoral Neck SystemDEVICE

femoral neck system using bolt and antirotation screw with one/two hole plate

FNS
Multiple Cannulated ScrewDEVICE

multiple cannulated screw using 3 or 4 cannulated screw

MCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • non-displaced femoral neck fracture
  • community ambulator

You may not qualify if:

  • younger than 18 years
  • displaced femoral neck fracture
  • intertrochanteric fracture
  • subtrochanteric fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Young-Kyun Lee

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 27, 2020

First Posted

October 19, 2020

Study Start

October 30, 2019

Primary Completion

October 30, 2024

Study Completion

October 30, 2025

Last Updated

June 10, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)