New hip fracture fixation device put to the test against traditional screws

NCT ID NCT04462172

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This study compares two surgical methods for fixing a broken hip bone (femoral neck fracture): a newer plate-and-screw system called the Femoral Neck System (FNS) versus the traditional approach using multiple cancellous screws (MCS). Researchers will track about 290 adults over two years to see which method has fewer failures, such as the implant cutting out or the bone not healing. The goal is to determine if the newer device offers better stability and outcomes for patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a surgical device called the Femoral Neck System (FNS) compared with multiple cancellous screws (MCS)
What this could lead to
If FNS proves more reliable, it could become a standard surgical option for hip fractures, reducing the need for repeat surgeries.
What could go wrong
This is an observational study, not a randomized trial, so results may be influenced by patient or surgeon choice. The follow-up is only two years, and long-term outcomes are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

290 people

The number who actually took part.

Started

Oct 2021

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥18 years 2. Patients with unilateral femoral neck fractures that will be treated with internal fixation 3. According to AO fracture classification, subjects with the fracture type (31-B) 4. Subjects (with the help of relatives) can understand the informed documents and patient questionnaires. 5. Subjects (with the help of relatives) voluntarily provide written informed consent to participate in the clinical study and authorize the transfer of their information to the sponsor. 6. The investigator believes that the subject can understand the clinical study, is willing and able to complete all research procedures and follow-up visits and can cooperate with the research procedures. 7. In-label use of the MCS and FNS. Exclusion Criteria: 1. Subject does not provide voluntary consent to participate in the study. 2. The researcher believes that the subjects have conditions that affect the participation and follow-up of this study. (for example, the patient lives in a remote area or has difficulty in going back to the hospital for follow-up or does not cooperate with the medical guidance and suggestions of the surgeon.) 3. The subjects were pregnant or lactating women. 4. The researchers believe that the subjects have psychological disorders, which may affect the treatment outcome. 5. Garden classification III and IV of femoral neck fracture patients older than 65 years 6. Concurrent hip osteoarthritis. 7. Fractures where the operative treatment will occur more than three weeks after the primary injury 8. Patients combined with other bone fractures. 9. Pathological fracture (e.g., primary or metastatic tumor) 10. Serious soft tissue injury, judged by the investigator, will impact the union of the fracture, combined open fractures, vascular injury, and combined osteofascial compartment syndrome 11. Multiple systemic injuries judged by researchers not suitable for enrollment. 12. Revision surgeries (for example, due to malunion, nonunion or infection) 13. Concurrent medical conditions judged by researchers not suitable for enrollment, such as: metabolic bone disease, post-polio syndrome, poor bone quality, prior history of poor fracture healing, etc 14. Patients with anaesthetic and surgical contraindications 15. Patients known to be allergic to implant components 16. Patients who are currently using chemotherapeutics or accepting radiotherapy, use systematically corticosteroid hormone or growth factor, or long-term use sedative hypnotics (continuous use over 3 months) or non-steroidal anti-inflammatory drugs (continuous use over 3 months) 17. Intemperance judged by researchers not suitable for enrollment (e.g., excessive daily drinking or smoking, drug abuse); 18. Subjects participated in other clinical studies in the past 3 months, which may affect the outcome and follow-up according to the judgment of researchers. 19. Subjects have significant neurological or musculoskeletal disorders or may have adverse effects on gait or weight-bearing (e.g., muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot arthropathy, avascular necrosis of the femoral head).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191, China

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