<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/NCT04437355</url>
  </required_header>
  <id_info>
    <org_study_id>2018-01124</org_study_id>
    <nct_id>NCT04437355</nct_id>
  </id_info>
  <brief_title>Operative Treatment of Ankle Fractures</brief_title>
  <official_title>Clinical, Functional and Radiological Outcome After Osteosynthesis of Ankle Fractures Using a Specific Provocation Test- a Combined Retro- and Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spital Limmattal Schlieren</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spital Limmattal Schlieren</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Patients who underwent operative treatment of an ankle fracture with or without following&#xD;
      removal of the osteosynthetic material are examined by a specific ankle provocation test, a&#xD;
      questionnaire and X-Rays to evaluate the clinical, functional and radiological outcome&#xD;
      compared to a healthy control group&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study includes all patients operated from 09.12.2012 to 31.12.2020. Patients will undergo&#xD;
      an X-Ray at least two years after primary surgery or at least one year after removal of the&#xD;
      osteosynthetic material. The patients operated from 09.12.2012 to date are therefore a&#xD;
      retrospective cohort, the patients from to date until 31.12.2020 a prospective cohort. This&#xD;
      method is used to achieve the highest possible number of patients in a define period of time&#xD;
      with no alteration of surgical technique.&#xD;
&#xD;
      All patients in the retrospective cohort are contacted at least 2 years after surgery (or 1&#xD;
      year after removal) via phone call or letter, informed about the study and asked to&#xD;
      participate. In case of informed consent, they are invited to the study site. They are asked&#xD;
      to complete the questionnaires and they undergo X-Ray of the affected and the non-affected&#xD;
      ankle.&#xD;
&#xD;
      All patients in the prospective cohort are informed about the study and asked to participate&#xD;
      in the outpatient clinic. In case of informed consent, they are invited to the study site at&#xD;
      least 2 years after surgery. They are asked to complete the questionnaires and they undergo&#xD;
      na X-Ray of the affected and non-affected ankle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional outcome</measure>
    <time_frame>at least two year after surgery or one year after removal of the osteosynthetic material</time_frame>
    <description>This outcome will be compared with a group of adults matching in terms of gender and age. Measured by:&#xD;
- a specific ankle provocation test: Multiple sport test measuring possible movement of the ankle and tolerating stress simulating in sportive movement such as weight bearing, leg press tests etc.&#xD;
The specific provocation test does not have a specific name, because it is self made.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional outcome</measure>
    <time_frame>24 months after initial operation</time_frame>
    <description>This outcome will be compared with a group of adults matching in terms of gender and age. Measured by:&#xD;
- three questionnaires (quality of life, possible movement, restrictions in daily life etc.)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical outcome 1</measure>
    <time_frame>24 months after initial operation</time_frame>
    <description>- VAS: Visual analogue score 1-10&#xD;
Explanation: 1 means almost no pain, 10 is the worst pain one can imagine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical outcome 2</measure>
    <time_frame>24 months after initial operation</time_frame>
    <description>- Quality of life questionnaire&#xD;
Explanation: The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software for the commercial version, but no special software is needed for the RAND-36 version. Pricing depends on the number of scores that the researcher needs to calculate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical outcome 3</measure>
    <time_frame>24 months after initial operation</time_frame>
    <description>Arthrosis compared to the non-affected ankle measured by X-Ray (after an ankle fracture followed by an operative Treatment)&#xD;
The measurement consists of evaluation the joint congruency, quality of the bone and the cartilage and the clear spaces (medial, central, lateral).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Specific ankle provocation test</measure>
    <time_frame>24 months after initial operation</time_frame>
    <description>specific provocation test in our department of physiotherapy supervised by a physiotherapist and one of the investigators. measure of weight bearing, jump on one feet, balance.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Ankle Fracture, Trimalleolar</condition>
  <condition>Ankle Fracture - Lateral Malleolus</condition>
  <condition>Ankle Fracture, Bimalleolar</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Young and healthy Group of People (18-50 years) without any pathology of the lower limb</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ankle Fracture Type Weber B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Young and healthy patients with an operative treated fracture of the ankle (type Weber B)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ankle Fracture Weber C and complex</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Young and healthy patients with an operative treated fracture of the ankle (type Weber C or complex fracture)</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Specific provocation test</intervention_name>
    <description>To compare the results the investigators invite a healthy control group matching in age and gender with the intervention cohort. The control group is informed about the study and asked to participate in the outpatient clinic. In case of informed consent, the participants are invited to the study site. The participants undergo the same provocation test of the ankle, and are asked to complete the specific provocation test. In case of substantial underachievement in the provocation test (&lt;60% of maximum) an X-Ray of both ankles in a.p. and lateral projection is performed. The aim is to radiologically analyse the ankles, and to rule out any morphological reasons for the above mentioned underperformance.</description>
    <arm_group_label>Ankle Fracture Type Weber B</arm_group_label>
    <arm_group_label>Ankle Fracture Weber C and complex</arm_group_label>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age older than 18 and younger than 51 years&#xD;
&#xD;
          -  Operative treatment of an ankle fracture&#xD;
&#xD;
          -  Time operation to follow up: at least 2 years&#xD;
&#xD;
          -  Time removal of osteosynthetic material to follow up: at least 1 year&#xD;
&#xD;
          -  Time operative treatment to removal of the osteosynthetic material: at least 9 months&#xD;
&#xD;
          -  Informed Consent as documented by signature (Appendix: Informed Consent Form)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other pathologies of the lower limb of the affected and/or non-affected side&#xD;
             (fractures, pre-existing arthrosis or operative treatment of the affected and/or&#xD;
             non-affected limb)&#xD;
&#xD;
          -  Pre-existing vascular (peripheral arterial disease, diabetes) or neurological diseases&#xD;
             of the lower extremities&#xD;
&#xD;
          -  Women who are pregnant&#xD;
&#xD;
          -  Prevalence of an infection of the implanted osteosynthetic material&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Urs Zingg</last_name>
    <role>Study Chair</role>
    <affiliation>Spital Limmattal Schlieren</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Spital Limmattal</name>
      <address>
        <city>Schlieren</city>
        <state>Zurich</state>
        <zip>8952</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Spital Limmattal Schlieren</investigator_affiliation>
    <investigator_full_name>Prof Urs Zingg</investigator_full_name>
    <investigator_title>Head of Department of surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Ankle 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/NCT04437355
org study id: 2018-01124
nct id: NCT04437355
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients who underwent operative treatment of an ankle fracture with or without following
      removal of the osteosynthetic material are examined by a specific ankle provocation test, a
      questionnaire and X-Rays to evaluate the clinical, functional and radiological outcome
      compared to a healthy control group
The study includes all patients operated from 09.12.2012 to 31.12.2020. Patients will undergo
      an X-Ray at least two years after primary surgery or at least one year after removal of the
      osteosynthetic material. The patients operated from 09.12.2012 to date are therefore a
      retrospective cohort, the patients from to date until 31.12.2020 a prospective cohort. This
      method is used to achieve the highest possible number of patients in a define period of time
      with no alteration of surgical technique.

      All patients in the retrospective cohort are contacted at least 2 years after surgery (or 1
      year after removal) via phone call or letter, informed about the study and asked to
      participate. In case of informed consent, they are invited to the study site. They are asked
      to complete the questionnaires and they undergo X-Ray of the affected and the non-affected
      ankle.

      All patients in the prospective cohort are informed about the study and asked to participate
      in the outpatient clinic. In case of informed consent, they are invited to the study site at
      least 2 years after surgery. They are asked to complete the questionnaires and they undergo
      na X-Ray of the affected and non-affected ankle.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Functional outcome
time frame: at least two year after surgery or one year after removal of the osteosynthetic material
description: This outcome will be compared with a group of adults matching in terms of gender and age. Measured by:
- a specific ankle provocation test: Multiple sport test measuring possible movement of the ankle and tolerating stress simulating in sportive movement such as weight bearing, leg press tests etc.
The specific provocation test does not have a specific name, because it is self made.
measure: Functional outcome
time frame: 24 months after initial operation
description: This outcome will be compared with a group of adults matching in terms of gender and age. Measured by:
- three questionnaires (quality of life, possible movement, restrictions in daily life etc.)
measure: Clinical outcome 1
time frame: 24 months after initial operation
description: - VAS: Visual analogue score 1-10
Explanation: 1 means almost no pain, 10 is the worst pain one can imagine
measure: Clinical outcome 2
time frame: 24 months after initial operation
description: - Quality of life questionnaire
Explanation: The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software for the commercial version, but no special software is needed for the RAND-36 version. Pricing depends on the number of scores that the researcher needs to calculate.
measure: Clinical outcome 3
time frame: 24 months after initial operation
description: Arthrosis compared to the non-affected ankle measured by X-Ray (after an ankle fracture followed by an operative Treatment)
The measurement consists of evaluation the joint congruency, quality of the bone and the cartilage and the clear spaces (medial, central, lateral).
measure: Specific ankle provocation test
time frame: 24 months after initial operation
description: specific provocation test in our department of physiotherapy supervised by a physiotherapist and one of the investigators. measure of weight bearing, jump on one feet, balance.
arm group label: Control Group
arm group type: Active Comparator
description: Young and healthy Group of People (18-50 years) without any pathology of the lower limb
arm group label: Ankle Fracture Type Weber B
arm group type: Active Comparator
description: Young and healthy patients with an operative treated fracture of the ankle (type Weber B)
arm group label: Ankle Fracture Weber C and complex
arm group type: Active Comparator
description: Young and healthy patients with an operative treated fracture of the ankle (type Weber C or complex fracture)
intervention type: Diagnostic Test
intervention name: Specific provocation test
description: To compare the results the investigators invite a healthy control group matching in age and gender with the intervention cohort. The control group is informed about the study and asked to participate in the outpatient clinic. In case of informed consent, the participants are invited to the study site. The participants undergo the same provocation test of the ankle, and are asked to complete the specific provocation test. In case of substantial underachievement in the provocation test (<60% of maximum) an X-Ray of both ankles in a.p. and lateral projection is performed. The aim is to radiologically analyse the ankles, and to rule out any morphological reasons for the above mentioned underperformance.
arm group label: Ankle Fracture Type Weber B
arm group label: Ankle Fracture Weber C and complex
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Urs Zingg
role: Study Chair
affiliation: Spital Limmattal Schlieren
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Spital Limmattal Schlieren
investigator full name: Prof Urs Zingg
investigator title: Head of Department of surgery
mesh term: Fractures, Bone
mesh term: Ankle Fractures
sharing ipd: No