Femoral Neck FracturesNCT04462172
A Prospective Multicenter Cohort Study About Internal Fixation Using FNS Versus MCS for Femoral Neck Fracture
A study testing FNS and MCS in people with Femoral Neck Fractures, run by Peking University Third Hospital at 1 site in China.
Trial summary
This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral neck fracture (AO classification 31-B) using Femoral Neck System (FNS) versus Multiple Cancellous Screws (MCS) at 2-year follow up. 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?
- FNS and MCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2021to 23 Nov 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age ≥18 years
- Patients with unilateral femoral neck fractures that will be treated with internal fixation
- According to AO fracture classification, subjects with the fracture type (31-B)
- Subjects (with the help of relatives) can understand the informed documents and patient questionnaires.
- 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.
- 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.
- In-label use of the MCS and FNS.
Who cannot join
- Subject does not provide voluntary consent to participate in the study.
- 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.)
- The subjects were pregnant or lactating women.
- The researchers believe that the subjects have psychological disorders, which may affect the treatment outcome.
- Garden classification III and IV of femoral neck fracture patients older than 65 years
- Concurrent hip osteoarthritis.
Show all 19Show fewer
- Fractures where the operative treatment will occur more than three weeks after the primary injury
- Patients combined with other bone fractures.
- Pathological fracture (e.g., primary or metastatic tumor)
- 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
- Multiple systemic injuries judged by researchers not suitable for enrollment.
- Revision surgeries (for example, due to malunion, nonunion or infection)
- 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
- Patients with anaesthetic and surgical contraindications
- Patients known to be allergic to implant components
- 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)
- Intemperance judged by researchers not suitable for enrollment (e.g., excessive daily drinking or smoking, drug abuse);
- 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.
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: A Prospective Multicenter Cohort Study About Internal Fixation Using Synthes Femoral Neck System (FNS) Versus Multiple Cancellous Screws (MCS) for Femoral Neck Fracture
This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral neck fracture (AO classification 31-B) using Femoral Neck System (FNS) versus Multiple Cancellous Screws (MCS) at 2-year follow up. The patients are divided into the FNS group and the MCS group according to the internal fixation they choose. The internal fixation failure rate (IFFR) and differences in fracture prognosis of the two groups will be compared. Obtain clinical data of FNS in the Chinese population, and verify the safety and efficacy of FNS for patients with femoral neck fracture.
Read the detailed description
This is a prospective multicenter cohort study. The team leader is Peking University Third Hospital. All patients are divided into 2 groups according to the internal fixation they choose. Investigators use FNS for internal fixation in Group 1 and MCS in Group 2. Since FNS is clinically comparable to the Dynamic Hip Screw (DHS) system, investigators used DHS clinical data as a statistical reference. The relevant parameters of the sample calculation are α = 0.05 (one-sided) and β = 0.2. PASS 15 was used for calculation, and the final sample size was 290. The FNS group and the MCS group each included 145 patients. See the text for detailed inclusion and exclusion criteria. Patients that meet all the inclusion criteria but do not meet any exclusion criteria, and who have signed the informed consent will be recruited, and each patient will be assigned a unique patient identification number, which will be used throughout the study identify the patient. Investigators will perform preoperative preparation, intraoperative operation and internal fixation implantation according to the instructions provided in the product packaging. Investigators only plan to include cases that can successfully conduct closed reduction, therefore investigators will exclude cases that require open reduction. For the MCS group, three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck. After the operation, the patients will be managed according to the standard nursing and rehabilitation procedures of the experimental site and the results of laboratory tests will be recorded. Regular follow-up evaluation will be performed after the operation until the end of the two-year follow-up or the primary end point of the study. In this study, the internal fixation failure rate (IFFR) is used as the primary end point of the study, which is defined as the total incidence of internal plant cut-out and fracture. The results of the radiographic examination, the lateral X-ray film and computed tomography(CT), will be evaluated by an independent radiologist to determine whether there are cut-out or fracture of the internal plant. Secondary endpoints include: 1. Bone nonunion after 36 weeks: evaluate bone healing according to the lateral X-ray examination. According to the regulations of Food and Drug Administration of the US, it is defined as nonunion if there are no obvious signs of fracture healing 9 months after the fracture, or if there is no obvious difference in fracture space after three consecutive months. 2. Garden classification proportion, and Garden index for reduction assessment. 3. Clinical prognosis: o A 12-Item Short-Form Health Survey (SF-12) o Harris hip score. 4. Operation time, from the incision to internal fixation implanted. 5. The times of intraoperative fluoroscopy, average 25 milliseconds per X-ray shot, record the number of X-ray shot. 6. Postoperative adverse events within 2 years, including ipsilateral femoral head avascular necrosis, infection, wound hematoma, ipsilateral coxa vara, and ipsilateral limb shortening. In this study, it is difficult to blind anyone . Investigators will try their best to reduce human-induced bias in experimental results. Investigators will use one-sided α = 0.05 for statistical tests and confidence interval calculations. P value <0.05 is considered statistically significant. SPSS (latest version: SPSS Inc., Chicago, IL, USA) will be used to analyze the results.
- Conditions
- Femoral Neck Fractures
- Being tested
- FNS, MCS
- Keywords
- femoral neck fracture, internal fixation, FNS and MCS, multicenter randomized controlled clinical trial, internal fixation failure rate
- 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.
FNSDevice
perform preoperative preparation, intraoperative operation and internal fixation implantation according to the instructions provided in the product packaging.
MCSDevice
three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.
| Study group | Role | What they receive |
|---|---|---|
| Synthes Femoral Neck System (FNS) | Experimental | Synthes Femoral Neck System (FNS) was developed with the intention to combine advantages of DHS (dynamic hip screw) and MCS (multiple cancellous screw). The FNS implants consist of plates, bolts, locking screws and antirotating-screws. The plate consists of a small base plate with one or two locking holes and a barrel portion. The barrel allows for gliding of the head elements while restricting rotation around the head-neck axis, so FNS is a fixed-angle gliding fixation device that allows for controlled collapse of the femoral neck, like DHS. The FNS was also designed to minimize implant footprint on the bone with its compact design, like MCS. Furthermore, the FNS was designed to reduce the length of incision necessary for implant insertion when compared to DHS. This new concept of femoral neck fracture fixation still emphasizes the biology of fracture healing by initial fracture compression. Receives: Device: FNS |
| Multiple cancellous screws (MCS) | Active comparator | Multiple cancellous screws (MCS) fixation is the most common and classic method to deal with femoral neck fractures which is less invasive and retains more viable bone, compared with dynamic hip screw (DHS) fixation that appears biomechanically more stable. In this study, three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck. Receives: Device: MCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal Fixation Failure Rate
defined as the total incidence of internal plant cut-out and fracture.
Measured: from operation to 1-year follow-up after the surgery
Secondary outcomes (7)
Number of Participants With Bone Nonunion
evaluate bone healing according to the lateral X-ray examination. According to the regulations of Food and Drug Administration of the US, if there are no obvious signs of fracture healing 9 months after the fracture, or if there is no obvious difference in fracture space after three consecutive months, it is defined as nonunion.
Measured: from operation to 1-year follow-up after the surgery
Harris Hip Score
the scale of the score value is from 0 to 100, and a higher score means a better outcome
Measured: At 1 year after the surgery
Operation Time
from the incision to internal fixation implanted.
Measured: intraoperative
The Times of Intraoperative Fluoroscopy
average 25 milliseconds per X-ray shot, record the number of X-ray shot
Measured: intraoperative
Number of Participants With Postoperative Adverse Events
including ipsilateral femoral head avascular necrosis, infection, wound hematoma, ipsilateral coxa vara, and ipsilateral limb shortening
Measured: from operation to 1-year follow-up after the surgery
Reduction Quality
Routine radiographs were taken to assess fracture reduction quality, which was categorized neutral, positive or negative support. Neutral Support: the medial cortex of the head-neck fragment is continuous with the medial cortex of the femoral shaft. Positive support: the medial cortex of the head-neck fragment lies medial to the medial cortex of the femoral shaft. Negative support: the medial cortex of the head-neck fragment lies lateral to the medial cortex of the femoral shaft.
Measured: from operation to 1-year follow-up after the surgery
Femoral Neck Shortening
Since both implants are designed to allow for femoral neck shortening to allow fragment contact and bone healing. The amount of shortening primarily depends on the fracture configuration and bone quality.
Measured: from operation to 1-year follow-up after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start30 Oct 2021
- Primary completion23 Nov 2025
- Study completion23 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- 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
- Model description
- This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral neck fracture (AO classification 31-B) using Femoral Neck System (FNS) versus Multiple Cancellous Screws (MCS) at 2-year follow up.The patients are divided into the FNS group and the MCS group according to the internal fixation they choose.
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Tianjin Hospital, West China Hospital, Hospital of Chinese Medicine of the Xinjiang Uygur Autonomous Region, Xi'an Honghui Hospital, The Fuzhou No 2 Hospital
- Responsible party
- Sponsor
- Investigators
- Fang Zhou, MD, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462172
- Sponsor's protocol ID
- PekingUTH ZF FNS
- Status last verified
- Mar 2026
- First submitted
- 28 Jun 2020
- Last updated
- 20 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Cohort Study About Internal Fixation Using Synthes Femoral Neck System (FNS) Versus Multiple Cancellous Screws (MCS) for Femoral Neck Fracture
- ClinicalTrials.gov ID
- NCT04462172
- Acronym / sponsor ID
- PekingUTH ZF FNS
- Conditions
- Femoral Neck Fractures
- Keywords
- femoral neck fracture, internal fixation, FNS and MCS, multicenter randomized controlled clinical trial, internal fixation failure rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Tianjin Hospital, West China Hospital, Hospital of Chinese Medicine of the Xinjiang Uygur Autonomous Region, Xi'an Honghui Hospital, The Fuzhou No 2 Hospital
- Study start
- 30 Oct 2021 (actual)
- Primary completion
- 23 Nov 2025 (actual)
- Study completion
- 23 Nov 2025 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Posted 20 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral neck fracture (AO classification 31-B) using Femoral Neck System (FNS) versus Multiple Cancellous Screws (MCS) at 2-year follow up. The patients are divided into the FNS group and the MCS group according to the internal fixation they choose. The internal fixation failure rate (IFFR) and differences in fracture prognosis of the two groups will be compared. Obtain clinical data of FNS in the Chinese population, and verify the safety and efficacy of FNS for patients with femoral neck fracture.
Detailed description
This is a prospective multicenter cohort study. The team leader is Peking University Third Hospital. All patients are divided into 2 groups according to the internal fixation they choose. Investigators use FNS for internal fixation in Group 1 and MCS in Group 2. Since FNS is clinically comparable to the Dynamic Hip Screw (DHS) system, investigators used DHS clinical data as a statistical reference. The relevant parameters of the sample calculation are α = 0.05 (one-sided) and β = 0.2. PASS 15 was used for calculation, and the final sample size was 290. The FNS group and the MCS group each included 145 patients. See the text for detailed inclusion and exclusion criteria. Patients that meet all the inclusion criteria but do not meet any exclusion criteria, and who have signed the informed consent will be recruited, and each patient will be assigned a unique patient identification number, which will be used throughout the study identify the patient. Investigators will perform preoperative preparation, intraoperative operation and internal fixation implantation according to the instructions provided in the product packaging. Investigators only plan to include cases that can successfully conduct closed reduction, therefore investigators will exclude cases that require open reduction. For the MCS group, three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck. After the operation, the patients will be managed according to the standard nursing and rehabilitation procedures of the experimental site and the results of laboratory tests will be recorded. Regular follow-up evaluation will be performed after the operation until the end of the two-year follow-up or the primary end point of the study. In this study, the internal fixation failure rate (IFFR) is used as the primary end point of the study, which is defined as the total incidence of internal plant cut-out and fracture. The results of the radiographic examination, the lateral X-ray film and computed tomography(CT), will be evaluated by an independent radiologist to determine whether there are cut-out or fracture of the internal plant. Secondary endpoints include: 1. Bone nonunion after 36 weeks: evaluate bone healing according to the lateral X-ray examination. According to the regulations of Food and Drug Administration of the US, it is defined as nonunion if there are no obvious signs of fracture healing 9 months after the fracture, or if there is no obvious difference in fracture space after three consecutive months. 2. Garden classification proportion, and Garden index for reduction assessment. 3. Clinical prognosis: o A 12-Item Short-Form Health Survey (SF-12) o Harris hip score. 4. Operation time, from the incision to internal fixation implanted. 5. The times of intraoperative fluoroscopy, average 25 milliseconds per X-ray shot, record the number of X-ray shot. 6. Postoperative adverse events within 2 years, including ipsilateral femoral head avascular necrosis, infection, wound hematoma, ipsilateral coxa vara, and ipsilateral limb shortening. In this study, it is difficult to blind anyone . Investigators will try their best to reduce human-induced bias in experimental results. Investigators will use one-sided α = 0.05 for statistical tests and confidence interval calculations. P value <0.05 is considered statistically significant. SPSS (latest version: SPSS Inc., Chicago, IL, USA) will be used to analyze the results.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral neck fracture (AO classification 31-B) using Femoral Neck System (FNS) versus Multiple Cancellous Screws (MCS) at 2-year follow up.The patients are divided into the FNS group and the MCS group according to the internal fixation they choose.
| Arm | Type | Receives |
|---|---|---|
| Synthes Femoral Neck System (FNS) | Experimental | Device: FNSSynthes Femoral Neck System (FNS) was developed with the intention to combine advantages of DHS (dynamic hip screw) and MCS (multiple cancellous screw). The FNS implants consist of plates, bolts, locking screws and antirotating-screws. The plate consists of a small base plate with one or two locking holes and a barrel portion. The barrel allows for gliding of the head elements while restricting rotation around the head-neck axis, so FNS is a fixed-angle gliding fixation device that allows for controlled collapse of the femoral neck, like DHS. The FNS was also designed to minimize implant footprint on the bone with its compact design, like MCS. Furthermore, the FNS was designed to reduce the length of incision necessary for implant insertion when compared to DHS. This new concept of femoral neck fracture fixation still emphasizes the biology of fracture healing by initial fracture compression. |
| Multiple cancellous screws (MCS) | Active comparator | Device: MCSMultiple cancellous screws (MCS) fixation is the most common and classic method to deal with femoral neck fractures which is less invasive and retains more viable bone, compared with dynamic hip screw (DHS) fixation that appears biomechanically more stable. In this study, three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- Patients with unilateral femoral neck fractures that will be treated with internal fixation
- According to AO fracture classification, subjects with the fracture type (31-B)
- Subjects (with the help of relatives) can understand the informed documents and patient questionnaires.
- 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.
Key exclusion criteria (19 listed)
- Subject does not provide voluntary consent to participate in the study.
- 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.)
- The subjects were pregnant or lactating women.
- The researchers believe that the subjects have psychological disorders, which may affect the treatment outcome.
- Garden classification III and IV of femoral neck fracture patients older than 65 years
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 |
|---|---|---|
| FNSperform preoperative preparation, intraoperative operation and internal fixation implantation according to the instructions provided in the product packaging. | Device | Synthes Femoral Neck System (FNS) |
| MCSthree cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck. | Device | Multiple cancellous screws (MCS) |
Primary outcome
Internal Fixation Failure Rate
Time frame: from operation to 1-year follow-up after the surgery
defined as the total incidence of internal plant cut-out and fracture.
7 secondary outcomes
Number of Participants With Bone Nonunion
Time frame: from operation to 1-year follow-up after the surgery
Harris Hip Score
Time frame: At 1 year after the surgery
Operation Time
Time frame: intraoperative
The Times of Intraoperative Fluoroscopy
Time frame: intraoperative
Number of Participants With Postoperative Adverse Events
Time frame: from operation to 1-year follow-up after the surgery
Reduction Quality
Time frame: from operation to 1-year follow-up after the surgery
Femoral Neck Shortening
Time frame: from operation to 1-year follow-up after the surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Fang Zhou, MD study director
Peking University Third 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 FNS and MCS in people with Femoral Neck Fractures, run by Peking University Third Hospital at 1 site in China.
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 7 inclusion and 19 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: finished, as of the sponsor's last update on 20 Jul 2026. 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 China. 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?
Yes. Results are posted in the registry (first posted 20 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Internal Fixation Failure Rate (time frame: from operation to 1-year follow-up after the surgery). 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 20 Jul 2026.