New hip fracture fixation device put to the test against traditional screws
NCT ID NCT04462172
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
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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
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290 people
The number who actually took part.
- Started
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Oct 2021
- Finished
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Nov 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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