<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04462172</url>
  </required_header>
  <id_info>
    <org_study_id>PekingUTH ZF FNS</org_study_id>
    <nct_id>NCT04462172</nct_id>
  </id_info>
  <brief_title>A Prospective Multicenter Cohort Study About Internal Fixation Using FNS Versus MCS for Femoral Neck Fracture</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Jishuitan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai 6th People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Fuzhou No 2 Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xi'an Honghui Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University Third Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective multicenter cohort study is to compare the post-operative implant failure&#xD;
      rate between the patients with femoral neck fracture (AO classification 31-B) using Femoral&#xD;
      Neck System (FNS) versus Multiple Cancellous Screws (MCS) at 2-year follow up. The patients&#xD;
      are divided into the FNS group and the MCS group according to the internal fixation they&#xD;
      choose. The internal fixation failure rate (IFFR) and differences in fracture prognosis of&#xD;
      the two groups will be compared. Obtain clinical data of FNS in the Chinese population, and&#xD;
      verify the safety and efficacy of FNS for patients with femoral neck fracture.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective multicenter cohort study. The team leader is Peking University Third&#xD;
      Hospital. All patients are divided into 2 groups according to the internal fixation they&#xD;
      choose. Investigators use FNS for internal fixation in Group 1 and MCS in Group 2. Since FNS&#xD;
      is clinically comparable to the Dynamic Hip Screw (DHS) system, investigators used DHS&#xD;
      clinical data as a statistical reference. The relevant parameters of the sample calculation&#xD;
      are α = 0.05 (one-sided) and β = 0.2. PASS 15 was used for calculation, and the final sample&#xD;
      size was 290. The FNS group and the MCS group each included 145 patients. See the text for&#xD;
      detailed inclusion and exclusion criteria. Patients that meet all the inclusion criteria but&#xD;
      do not meet any exclusion criteria, and who have signed the informed consent will be&#xD;
      recruited, and each patient will be assigned a unique patient identification number, which&#xD;
      will be used throughout the study identify the patient. Investigators will perform&#xD;
      preoperative preparation, intraoperative operation and internal fixation implantation&#xD;
      according to the instructions provided in the product packaging. Investigators only plan to&#xD;
      include cases that can successfully conduct closed reduction, therefore investigators will&#xD;
      exclude cases that require open reduction. For the MCS group, three cancellous screws with an&#xD;
      inverted triangle pattern are used to fix the fracture of femoral neck. After the operation,&#xD;
      the patients will be managed according to the standard nursing and rehabilitation procedures&#xD;
      of the experimental site and the results of laboratory tests will be recorded. Regular&#xD;
      follow-up evaluation will be performed after the operation until the end of the two-year&#xD;
      follow-up or the primary end point of the study. In this study, the internal fixation failure&#xD;
      rate (IFFR) is used as the primary end point of the study, which is defined as the total&#xD;
      incidence of internal plant cut-out and fracture. The results of the radiographic&#xD;
      examination, the lateral X-ray film and computed tomography(CT), will be evaluated by an&#xD;
      independent radiologist to determine whether there are cut-out or fracture of the internal&#xD;
      plant. Secondary endpoints include: 1. Bone nonunion after 36 weeks: evaluate bone healing&#xD;
      according to the lateral X-ray examination. According to the regulations of Food and Drug&#xD;
      Administration of the US, it is defined as nonunion if there are no obvious signs of fracture&#xD;
      healing 9 months after the fracture, or if there is no obvious difference in fracture space&#xD;
      after three consecutive months. 2. Garden classification proportion, and Garden index for&#xD;
      reduction assessment. 3. Clinical prognosis: o A 12-Item Short-Form Health Survey (SF-12) o&#xD;
      Harris hip score. 4. Operation time, from the incision to internal fixation implanted. 5. The&#xD;
      times of intraoperative fluoroscopy, average 25 milliseconds per X-ray shot, record the&#xD;
      number of X-ray shot. 6. Postoperative adverse events within 2 years, including ipsilateral&#xD;
      femoral head avascular necrosis, infection, wound hematoma, ipsilateral coxa vara, and&#xD;
      ipsilateral limb shortening. In this study, it is difficult to blind anyone . Investigators&#xD;
      will try their best to reduce human-induced bias in experimental results. Investigators will&#xD;
      use one-sided α = 0.05 for statistical tests and confidence interval calculations. P value&#xD;
      &lt;0.05 is considered statistically significant. SPSS (latest version: SPSS Inc., Chicago, IL,&#xD;
      USA) will be used to analyze the results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 30, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Internal fixation failure rate</measure>
    <time_frame>from operation to 2-year follow-up after the surgery</time_frame>
    <description>defined as the total incidence of internal plant cut-out and fracture.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Bone nonunion</measure>
    <time_frame>from operation to 2-year follow-up after the surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Harris hip score</measure>
    <time_frame>from operation to 2-year follow-up after the surgery</time_frame>
    <description>the score value is from 0 to 100, and a higher score means a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>operation time</measure>
    <time_frame>intraoperative</time_frame>
    <description>from the incision to internal fixation implanted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The times of intraoperative fluoroscopy</measure>
    <time_frame>intraoperative</time_frame>
    <description>average 25 milliseconds per X-ray shot, record the number of X-ray shot</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Postoperative adverse events</measure>
    <time_frame>from operation to 2-year follow-up after the surgery</time_frame>
    <description>including ipsilateral femoral head avascular necrosis, infection, wound hematoma, ipsilateral coxa vara, and ipsilateral limb shortening</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Garden index</measure>
    <time_frame>from operation to 2-year follow-up after the surgery</time_frame>
    <description>The fracture reduction will be considered unsatisfied if the index is less than 155 degrees or more than 180 degrees.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A 12-Item Short-Form Health Survey (SF-12)</measure>
    <time_frame>from operation to 2-year follow-up after the surgery</time_frame>
    <description>the score value is from 0 to 100, and a higher score means a better outcome</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">290</enrollment>
  <condition>Femoral Neck Fractures</condition>
  <arm_group>
    <arm_group_label>Synthes Femoral Neck System (FNS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple cancellous screws (MCS)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FNS</intervention_name>
    <description>perform preoperative preparation, intraoperative operation and internal fixation implantation according to the instructions provided in the product packaging.</description>
    <arm_group_label>Synthes Femoral Neck System (FNS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MCS</intervention_name>
    <description>three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.</description>
    <arm_group_label>Multiple cancellous screws (MCS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18 years&#xD;
&#xD;
          2. Patients with unilateral femoral neck fractures that will be treated with internal&#xD;
             fixation&#xD;
&#xD;
          3. According to AO fracture classification, subjects with the fracture type (31-B)&#xD;
&#xD;
          4. Subjects (with the help of relatives) can understand the informed documents and&#xD;
             patient questionnaires.&#xD;
&#xD;
          5. Subjects (with the help of relatives) voluntarily provide written informed consent to&#xD;
             participate in the clinical study and authorize the transfer of their information to&#xD;
             the sponsor.&#xD;
&#xD;
          6. The investigator believes that the subject can understand the clinical study, is&#xD;
             willing and able to complete all research procedures and follow-up visits and can&#xD;
             cooperate with the research procedures.&#xD;
&#xD;
          7. In-label use of the MCS and FNS.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject does not provide voluntary consent to participate in the study.&#xD;
&#xD;
          2. The researcher believes that the subjects have conditions that affect the&#xD;
             participation and follow-up of this study. (for example, the patient lives in a remote&#xD;
             area or has difficulty in going back to the hospital for follow-up or does not&#xD;
             cooperate with the medical guidance and suggestions of the surgeon.)&#xD;
&#xD;
          3. The subjects were pregnant or lactating women.&#xD;
&#xD;
          4. The researchers believe that the subjects have psychological disorders, which may&#xD;
             affect the treatment outcome.&#xD;
&#xD;
          5. Garden classification III and IV of femoral neck fracture patients older than 65 years&#xD;
&#xD;
          6. Concurrent hip osteoarthritis.&#xD;
&#xD;
          7. Fractures where the operative treatment will occur more than three weeks after the&#xD;
             primary injury&#xD;
&#xD;
          8. Patients combined with other bone fractures.&#xD;
&#xD;
          9. Pathological fracture (e.g., primary or metastatic tumor)&#xD;
&#xD;
         10. Serious soft tissue injury, judged by the investigator, will impact the union of the&#xD;
             fracture, combined open fractures, vascular injury, and combined osteofascial&#xD;
             compartment syndrome&#xD;
&#xD;
         11. Multiple systemic injuries judged by researchers not suitable for enrollment.&#xD;
&#xD;
         12. Revision surgeries (for example, due to malunion, nonunion or infection)&#xD;
&#xD;
         13. Concurrent medical conditions judged by researchers not suitable for enrollment, such&#xD;
             as: metabolic bone disease, post-polio syndrome, poor bone quality, prior history of&#xD;
             poor fracture healing, etc&#xD;
&#xD;
         14. Patients with anaesthetic and surgical contraindications&#xD;
&#xD;
         15. Patients known to be allergic to implant components&#xD;
&#xD;
         16. Patients who are currently using chemotherapeutics or accepting radiotherapy, use&#xD;
             systematically corticosteroid hormone or growth factor, or long-term use sedative&#xD;
             hypnotics (continuous use over 3 months) or non-steroidal anti-inflammatory drugs&#xD;
             (continuous use over 3 months)&#xD;
&#xD;
         17. Intemperance judged by researchers not suitable for enrollment (e.g., excessive daily&#xD;
             drinking or smoking, drug abuse);&#xD;
&#xD;
         18. Subjects participated in other clinical studies in the past 3 months, which may affect&#xD;
             the outcome and follow-up according to the judgment of researchers.&#xD;
&#xD;
         19. Subjects have significant neurological or musculoskeletal disorders or may have&#xD;
             adverse effects on gait or weight-bearing (e.g., muscular dystrophy, multiple&#xD;
             sclerosis, cerebral infarction, hemiplegia, Charcot arthropathy, avascular necrosis of&#xD;
             the femoral head).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fang Zhou, MD</last_name>
    <role>Study Director</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiangyu Xu, MD</last_name>
    <phone>+86-15210849431</phone>
    <email>307542744@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fang Zhou, MD</last_name>
      <phone>+8610-82267010</phone>
      <email>zhouf@bjmu.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Xiangyu Xu, MD</last_name>
      <phone>+86-15210849431</phone>
      <email>307542744@qq.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>October 20, 2021</last_update_submitted>
  <last_update_submitted_qc>October 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>femoral neck fracture</keyword>
  <keyword>internal fixation</keyword>
  <keyword>FNS and MCS</keyword>
  <keyword>multicenter randomized controlled clinical trial</keyword>
  <keyword>internal fixation failure rate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Femoral Neck Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04462172
org study id: PekingUTH ZF FNS
nct id: NCT04462172
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Treatment
masking: None (Open Label)
measure: Internal fixation failure rate
time frame: from operation to 2-year follow-up after the surgery
description: defined as the total incidence of internal plant cut-out and fracture.
measure: Number of Participants with Bone nonunion
time frame: from operation to 2-year follow-up after the surgery
description: 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.
measure: Harris hip score
time frame: from operation to 2-year follow-up after the surgery
description: the score value is from 0 to 100, and a higher score means a better outcome
measure: operation time
time frame: intraoperative
description: from the incision to internal fixation implanted.
measure: The times of intraoperative fluoroscopy
time frame: intraoperative
description: average 25 milliseconds per X-ray shot, record the number of X-ray shot
measure: Number of Participants with Postoperative adverse events
time frame: from operation to 2-year follow-up after the surgery
description: including ipsilateral femoral head avascular necrosis, infection, wound hematoma, ipsilateral coxa vara, and ipsilateral limb shortening
measure: Garden index
time frame: from operation to 2-year follow-up after the surgery
description: The fracture reduction will be considered unsatisfied if the index is less than 155 degrees or more than 180 degrees.
measure: A 12-Item Short-Form Health Survey (SF-12)
time frame: from operation to 2-year follow-up after the surgery
description: the score value is from 0 to 100, and a higher score means a better outcome
arm group label: Synthes Femoral Neck System (FNS)
arm group type: Experimental
description: 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.
arm group label: Multiple cancellous screws (MCS)
arm group type: Active Comparator
description: 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.
intervention type: Device
intervention name: FNS
description: perform preoperative preparation, intraoperative operation and internal fixation implantation according to the instructions provided in the product packaging.
arm group label: Synthes Femoral Neck System (FNS)
intervention type: Device
intervention name: MCS
description: three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.
arm group label: Multiple cancellous screws (MCS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fang Zhou, MD
role: Study Director
affiliation: Peking University Third Hospital
last name: Xiangyu Xu, MD
phone: +86-15210849431
email: 307542744@qq.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Femoral Neck Fractures
sharing ipd: No