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NCT Number: NCT04589598

Femoral Neck System and Multiple Cannulated Screws in Femoral Neck Fracture

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

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

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

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Femoral Neck System

Device

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

Multiple Cannulated Screw

Device

multiple cannulated screw using 3 or 4 cannulated screw

Primary outcomes

  1. Reoperation

    Time frame: 3 months

    rate of reoperation

  2. Reoperation

    Time frame: 6 months

    rate of reoperation

  3. Reoperation

    Time frame: 9 months

    rate of reoperation

  4. Reoperation

    Time frame: 12 months

    rate of reoperation

  5. Reoperation

    Time frame: 24 months

    rate of reoperation

Secondary outcomes

  1. loss of fixation

    Time frame: 3 months

    Rate of loss of fixation

  2. loss of fixation

    Time frame: 6 months

    Rate of loss of fixation

  3. loss of fixation

    Time frame: 9 months

    Rate of loss of fixation

  4. loss of fixation

    Time frame: 12 months

    Rate of loss of fixation

  5. loss of fixation

    Time frame: 24 months

    Rate of loss of fixation

Other outcomes

  1. mobility change

    Time frame: 3 months

    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
  2. mobility change

    Time frame: 6 months

    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. mobility change

    Time frame: 9 months

    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
  4. mobility change

    Time frame: 12 months

    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
  5. mobility change

    Time frame: 24 months

    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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • DePuy Synthes

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Oct 19, 2020
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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