<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/NCT04471259</url>
  </required_header>
  <id_info>
    <org_study_id>M2018151</org_study_id>
    <nct_id>NCT04471259</nct_id>
  </id_info>
  <brief_title>Functional Follow-up After Endoscopic Calcaneoplasty for Haglund's Deformity</brief_title>
  <official_title>Functional Follow-up After Endoscopic Calcaneoplasty for Haglund's Deformity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Isokinetic muscle strength test implemented by the Biodex system is a method used for&#xD;
      evaluating muscle function that has been applied clinically in the field of sports and&#xD;
      rehabilitation medicine. However, information on its application on Haglund's deformity&#xD;
      remain insufficient. Therefore, the present study is designed to examine the effectiveness of&#xD;
      the muscle strength test using the Biodex system in evaluating the recovery of athletic&#xD;
      capacity in patients with Haglund's deformity following endoscopic surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients. A retrospective (medical records), level 3 evidence study was designed to evaluate&#xD;
      the outcomes of patients who underwent endoscopic surgery for Haglund's deformity. The&#xD;
      present study was approved by the Peking University Third Hospital's ethics committee.&#xD;
      Written informed consent was obtained from all patients, parents or guardians of the patients&#xD;
      prior to the present study. The rights of the patients were protected.&#xD;
&#xD;
      Diagnosis. Patients were designed to be diagnosed based on subjective complaints, combined&#xD;
      with clinical and radiological examinations. Radiological measurements for this disease&#xD;
      include the Fowler-Phillip angle, calcaneal pith angle, parallel pitch lines, Chauveaux-Liet&#xD;
      angle and the X/Y ratio.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 22, 2012</start_date>
  <completion_date type="Actual">March 21, 2020</completion_date>
  <primary_completion_date type="Actual">December 22, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Biodex results on both sides before surgery</measure>
    <time_frame>pre-surgery</time_frame>
    <description>Biodex isokinetic muscle testing system was applied in this research. Isokinetic muscle strength test is a kind of muscle function evaluation and test method, which has been applied in the research and clinical work of sports medicine and rehabilitation medicine but never on Haglund's disease before. The isokinetic muscle strength test of the flexor and dorsiflexion of the ankle joint can evaluate the muscle strength and endurance to reflect the postoperative patient's capacity for action, providing reliable clinical evidence for postoperative rehabilitation of patients after endoscopic calcaneoplasties. Isokinetic strength test conducted on both the injured and uninjured sides of the patients using the Biodex system before surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biodex results on both sides at 3 months</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>Isokinetic strength test conducted on both the injured and uninjured sides of the patients using the Biodex system 3 months after surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biodex results on both sides at 6 months</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Isokinetic strength test conducted on both the injured and uninjured sides of the patients using the Biodex system 6 months after surgery.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">42</enrollment>
  <condition>Haglund's Deformity</condition>
  <arm_group>
    <arm_group_label>Patients' injured side</arm_group_label>
    <description>The Biodex, AOFAS, VAS were tested on the patients' injured side</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients' uninjured side</arm_group_label>
    <description>The Biodex, AOFAS, VAS were tested on the patients' uninjured side</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Classification statistics</intervention_name>
    <description>We classified patients by gender, age, recovery time,etc</description>
    <arm_group_label>Patients' injured side</arm_group_label>
    <arm_group_label>Patients' uninjured side</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study included 42 cases of 37 patients diagnosed with Haglund disease treated by the&#xD;
        author from 2012 to 2018 treated with endoscopic surgery (5 of whom were patients with left&#xD;
        and right feet, 33 men, 4 women, average age 32.3 (range:15 to 62, SD=13.6) years, 2 of&#xD;
        whom are professional athletes.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who underwent endoscopic surgery for Haglund's deformity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Haglund's Deformity</keyword>
  <keyword>Biodex System</keyword>
  <keyword>Isokinetic muscle testing</keyword>
  <keyword>Endoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bursitis</mesh_term>
    <mesh_term>Exostoses</mesh_term>
    <mesh_term>Congenital Abnormalities</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/NCT04471259
org study id: M2018151
nct id: NCT04471259
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Isokinetic muscle strength test implemented by the Biodex system is a method used for
      evaluating muscle function that has been applied clinically in the field of sports and
      rehabilitation medicine. However, information on its application on Haglund's deformity
      remain insufficient. Therefore, the present study is designed to examine the effectiveness of
      the muscle strength test using the Biodex system in evaluating the recovery of athletic
      capacity in patients with Haglund's deformity following endoscopic surgery.
Patients. A retrospective (medical records), level 3 evidence study was designed to evaluate
      the outcomes of patients who underwent endoscopic surgery for Haglund's deformity. The
      present study was approved by the Peking University Third Hospital's ethics committee.
      Written informed consent was obtained from all patients, parents or guardians of the patients
      prior to the present study. The rights of the patients were protected.

      Diagnosis. Patients were designed to be diagnosed based on subjective complaints, combined
      with clinical and radiological examinations. Radiological measurements for this disease
      include the Fowler-Phillip angle, calcaneal pith angle, parallel pitch lines, Chauveaux-Liet
      angle and the X/Y ratio.
observational model: Case-Control
time perspective: Retrospective
measure: Biodex results on both sides before surgery
time frame: pre-surgery
description: Biodex isokinetic muscle testing system was applied in this research. Isokinetic muscle strength test is a kind of muscle function evaluation and test method, which has been applied in the research and clinical work of sports medicine and rehabilitation medicine but never on Haglund's disease before. The isokinetic muscle strength test of the flexor and dorsiflexion of the ankle joint can evaluate the muscle strength and endurance to reflect the postoperative patient's capacity for action, providing reliable clinical evidence for postoperative rehabilitation of patients after endoscopic calcaneoplasties. Isokinetic strength test conducted on both the injured and uninjured sides of the patients using the Biodex system before surgery.
measure: Biodex results on both sides at 3 months
time frame: 3 months after surgery
description: Isokinetic strength test conducted on both the injured and uninjured sides of the patients using the Biodex system 3 months after surgery.
measure: Biodex results on both sides at 6 months
time frame: 6 months after surgery
description: Isokinetic strength test conducted on both the injured and uninjured sides of the patients using the Biodex system 6 months after surgery.
arm group label: Patients' injured side
description: The Biodex, AOFAS, VAS were tested on the patients' injured side
arm group label: Patients' uninjured side
description: The Biodex, AOFAS, VAS were tested on the patients' uninjured side
intervention type: Other
intervention name: Classification statistics
description: We classified patients by gender, age, recovery time,etc
arm group label: Patients' injured side
arm group label: Patients' uninjured side
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Bursitis
mesh term: Exostoses
mesh term: Congenital Abnormalities
sharing ipd: No