Femoral Neck System and Multiple Cannulated Screws in Femoral Neck Fracture

June 5, 2025 updated by: Young-Kyun Lee, Seoul National University Hospital

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

620

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FNS
those who are treated with femoral neck system (FNS)
Device: Femoral Neck System
femoral neck system using bolt and antirotation screw with one/two hole plate
Active Comparator: MCS
those who are treated with multiple cannulated screw (MCS)
Device: Multiple Cannulated Screw
multiple cannulated screw using 3 or 4 cannulated screw

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperation
Time Frame: 3 months
rate of reoperation
3 months
Reoperation
Time Frame: 6 months
rate of reoperation
6 months
Reoperation
Time Frame: 9 months
rate of reoperation
9 months
Reoperation
Time Frame: 12 months
rate of reoperation
12 months
Reoperation
Time Frame: 24 months
rate of reoperation
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
loss of fixation
Time Frame: 3 months
Rate of loss of fixation
3 months
loss of fixation
Time Frame: 6 months
Rate of loss of fixation
6 months
loss of fixation
Time Frame: 9 months
Rate of loss of fixation
9 months
loss of fixation
Time Frame: 12 months
Rate of loss of fixation
12 months
loss of fixation
Time Frame: 24 months
Rate of loss of fixation
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
mobility change
Time Frame: 3 months

Change of mobility

  1. independent community ambulatory
  2. community ambulatory with cane
  3. community ambulatory with crutch, walker
  4. independent household ambulatory
  5. household ambulatory with cane
  6. household ambulatory with crutch, walker
  7. nonfunctional ambulatory
3 months
mobility change
Time Frame: 6 months

Change of mobility

  1. independent community ambulatory
  2. community ambulatory with cane
  3. community ambulatory with crutch, walker
  4. independent household ambulatory
  5. household ambulatory with cane
  6. household ambulatory with crutch, walker
  7. nonfunctional ambulatory
6 months
mobility change
Time Frame: 9 months

Change of mobility

  1. independent community ambulatory
  2. community ambulatory with cane
  3. community ambulatory with crutch, walker
  4. independent household ambulatory
  5. household ambulatory with cane
  6. household ambulatory with crutch, walker
  7. nonfunctional ambulatory
9 months
mobility change
Time Frame: 12 months

Change of mobility

  1. independent community ambulatory
  2. community ambulatory with cane
  3. community ambulatory with crutch, walker
  4. independent household ambulatory
  5. household ambulatory with cane
  6. household ambulatory with crutch, walker
  7. nonfunctional ambulatory
12 months
mobility change
Time Frame: 24 months

Change of mobility

  1. independent community ambulatory
  2. community ambulatory with cane
  3. community ambulatory with crutch, walker
  4. independent household ambulatory
  5. household ambulatory with cane
  6. household ambulatory with crutch, walker
  7. nonfunctional ambulatory
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

DePuy Synthes

Investigators

  • Principal Investigator: Young-Kyun Lee, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2019

Primary Completion (Actual)

October 30, 2024

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

September 27, 2020

First Submitted That Met QC Criteria

October 14, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNS-MCS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Femoral Neck Fractures

Clinical Trials on Femoral Neck System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe