Femoral Neck FracturesNCT04589598
Femoral Neck System and Multiple Cannulated Screws in Femoral Neck Fracture
A study testing Femoral Neck System and Multiple Cannulated Screw in people with Femoral Neck Fractures, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Investigators will compare the clinical outcomes of femoral neck system with conventional multiple cannulated screw in non-displaced femoral neck fracture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Femoral Neck System and Multiple Cannulated Screw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Oct 2019to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- non-displaced femoral neck fracture
- community ambulator
Who cannot join
- younger than 18 years
- displaced femoral neck fracture
- intertrochanteric fracture
- subtrochanteric fracture
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: 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.
Read the detailed description
Clinical outcomes include reoperation, loss of fixation, and change of mobility.
- Conditions
- Femoral Neck Fractures
- Being tested
- Femoral Neck System, Multiple Cannulated Screw
- Keywords
- Femoral Neck Fractures
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral Neck SystemDevice
femoral neck system using bolt and antirotation screw with one/two hole plate
Multiple Cannulated ScrewDevice
multiple cannulated screw using 3 or 4 cannulated screw
| Study group | Role | What they receive |
|---|---|---|
| FNS | Experimental | those who are treated with femoral neck system (FNS) Receives: Device: Femoral Neck System |
| MCS | Active comparator | those who are treated with multiple cannulated screw (MCS) Receives: Device: Multiple Cannulated Screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation
rate of reoperation
Measured: 3 months
Reoperation
rate of reoperation
Measured: 6 months
Reoperation
rate of reoperation
Measured: 9 months
Reoperation
rate of reoperation
Measured: 12 months
Reoperation
rate of reoperation
Measured: 24 months
Secondary outcomes (5)
loss of fixation
Rate of loss of fixation
Measured: 3 months
loss of fixation
Rate of loss of fixation
Measured: 6 months
loss of fixation
Rate of loss of fixation
Measured: 9 months
loss of fixation
Rate of loss of fixation
Measured: 12 months
loss of fixation
Rate of loss of fixation
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start30 Oct 2019
- Primary completion30 Oct 2024
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Synthes
- Responsible party
- Principal investigator, Young-Kyun Lee, Seoul National University Hospital
- Investigators
- Young-Kyun Lee, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589598
- Sponsor's protocol ID
- FNS-MCS
- Status last verified
- May 2025
- First submitted
- 27 Sep 2020
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Femoral Neck System and Multiple Cannulated Screws in Non-displaced Femoral Neck Fracture
- ClinicalTrials.gov ID
- NCT04589598
- Acronym / sponsor ID
- FNS-MCS
- Conditions
- Femoral Neck Fractures
- Keywords
- Femoral Neck Fractures
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- DePuy Synthes
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FNS | Experimental | Device: Femoral Neck Systemthose who are treated with femoral neck system (FNS) |
| MCS | Active comparator | Device: Multiple Cannulated Screwthose who are treated with multiple cannulated screw (MCS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older
- non-displaced femoral neck fracture
- community ambulator
Key exclusion criteria (4 listed)
- younger than 18 years
- displaced femoral neck fracture
- intertrochanteric fracture
- subtrochanteric fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femoral Neck Systemfemoral neck system using bolt and antirotation screw with one/two hole plate | Device | FNS |
| Multiple Cannulated Screwmultiple cannulated screw using 3 or 4 cannulated screw | Device | MCS |
Primary outcome
Reoperation
Time frame: 3 months
rate of reoperation
Reoperation
Time frame: 6 months
rate of reoperation
Reoperation
Time frame: 9 months
rate of reoperation
Reoperation
Time frame: 12 months
rate of reoperation
Reoperation
Time frame: 24 months
rate of reoperation
5 secondary outcomes
loss of fixation
Time frame: 3 months
loss of fixation
Time frame: 6 months
loss of fixation
Time frame: 9 months
loss of fixation
Time frame: 12 months
loss of fixation
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Kyun Lee principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral Neck System and Multiple Cannulated Screw in people with Femoral Neck Fractures, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reoperation (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.