<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/NCT03831009</url>
  </required_header>
  <id_info>
    <org_study_id>18/07031-7</org_study_id>
    <secondary_id>2018/1585/REK sør-øst B</secondary_id>
    <nct_id>NCT03831009</nct_id>
  </id_info>
  <brief_title>Weight-bearing Radiographs to Evaluate Stability in Ankles With Isolated Weber Type B Fractures.</brief_title>
  <official_title>Weight-bearing Radiographs to Evaluate Stability in Ankles With Isolated Trans-syndesmotic Lateral Malleolar (Weber Type B) Fractures. A Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ostfold Hospital Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ostfold Hospital Trust</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>
      The investigators will conduct a prospective cohort study on the use of weight-bearing&#xD;
      radiographs to evaluate stability in ankles with isolated, trans-syndesmotic (Weber type B)&#xD;
      fibular fractures. Stable fractures will be treated conservatively using a functional brace,&#xD;
      unstable fractures will undergo surgical fixation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is widely accepted that fractures in stable ankles can be treated non-operatively and&#xD;
      fractures in unstable ankles needs internal fixation surgery (Michelson, Magid &amp; McHale,&#xD;
      2007, Gougoulias, Khanna, Seellariou, Maffulli, 2010). Clinical decision-making is thus based&#xD;
      on ankle stability evaluation. The integrity of medial structures, mainly the deep deltoid&#xD;
      ligament, is considered the most important determinant for stability of the ankle mortise&#xD;
      (Michelson, Magid &amp; McHale, 2007, Gougoulias, Khanna, Seellariou, Maffulli, 2010). Weber B&#xD;
      fractures, with no obvious sign of medial side injury on initial plain radiographs, have to&#xD;
      be considered of uncertain stability until adequate stress testing is performed.&#xD;
&#xD;
      Currently there is no definite consensus on what test(s) best determines stability in ankles&#xD;
      with undisplaced, isolated lateral malleolar fractures. Much used methods comprises manual&#xD;
      stress radiographs and gravity stress radiographs (McConnel, Creevy &amp; Tornetta, 2004).&#xD;
      However recent studies have shown that such methods overestimate the need for surgical&#xD;
      fixation indicating the need for a different method to make up the basis for surgical&#xD;
      indication (Dawe, Shafafy, Quayle, Gougoulias, Wee &amp; Sakellariou, 2015, Hastie, Akhtar, Butt,&#xD;
      Baumann &amp; Barrie, 2015, Holmes, Acker, Murphy, McKinney, Kadakia &amp; Irwin, 2016, Hoshino,&#xD;
      Nomoto, Norheim &amp; Harris, 2012, Koval, Egol, Cheung, Goodwin &amp; Spratt (2007), Seidel et al.,&#xD;
      2017, Weber, Burmeister, Flueckiger &amp; Krause, 2010). Authors of recent studies have proposed&#xD;
      weightbearing radiographs as an alternative method to distinguish stable and unstable&#xD;
      fractures, significantly reducing the need for operative treatment (Dawe et al., 2015, Hastie&#xD;
      et al., 2015, Hoshino et al, 2012, Holmes et al., 2016, Seidel et al., 2017, Weber et al.&#xD;
      2010).&#xD;
&#xD;
      To evaluate weight-bearing radiographs ability to determine stability our primary focus is to&#xD;
      evaluate if conservative treatment for &quot;gravity unstable/weightbearing stable&quot; ankles&#xD;
      produces different outcomes than conservative treatment for &quot;gravity stable/weightbearing&#xD;
      stable&quot; ankles.&#xD;
&#xD;
      Participants will be assigned to non-operative or surgical treatment based on ankle stability&#xD;
      evaluation using results from weightbearing radiographs consistently. Stable ankles will be&#xD;
      treated non-operatively with a functional brace (AirCast) for 6 weeks. Participants will be&#xD;
      instructed to bear weight as tolerated and to actively do standardized range-of-motion&#xD;
      exercises. Standard operative treatment is open reduction and internal fixation of the&#xD;
      fracture using plate and screws.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</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>Two-arm parallel assignment. Based on stability evaluation using weight-bearing adiographs one group recieves surgery, one group recieves non-surgical treatment.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Manchester-Oxford Foot Questionnaire (MOxFQ)</measure>
    <time_frame>24 months</time_frame>
    <description>Ankle/foot specific patient-reported outcome measure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Olerud-Molander Ankle Score (OMAS)</measure>
    <time_frame>24 months</time_frame>
    <description>Ankle/foot specific patient-reported outcome measure. Maximum score (100) = best. Minimum score = 0 (worst). Poor = 0-30, Fair = 31-60, Good = 61-90, Excellent = 91-100. Presented as total score (0-100).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AOFAS ankle-hindfoot</measure>
    <time_frame>24 months</time_frame>
    <description>Ankle/foot specific patient-reported outcome measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS/NRS of pain</measure>
    <time_frame>24 months</time_frame>
    <description>Visual analogue pain scale - patient reported. Scale 0-10. 10 = worst possible pain, 0 = no pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eq-5d</measure>
    <time_frame>24 months</time_frame>
    <description>Genereic health related quality of life patient reported outcome measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fracture healing</measure>
    <time_frame>24 months</time_frame>
    <description>Radiographic result</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Registration of complications</measure>
    <time_frame>24 months</time_frame>
    <description>Yes/No for malalignment, deep vein trobosis, nerve injury, wound infection, delayed wound healing and crossover to surgery (including reason for crossover).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bilateral ankle range-of-motion</measure>
    <time_frame>24 months</time_frame>
    <description>Measured in degrees with a goniometer ad modum Lindsjö.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bilateral calf circumference</measure>
    <time_frame>24 months</time_frame>
    <description>Calf circumference in centimeters measured 10 cm distal to the tibial tubercle Calf circumference in centimeters measured 10 cm distal to the tibial tubercle using measuring tape</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">151</enrollment>
  <condition>Lateral Malleolus Fractures</condition>
  <condition>Ankle Fractures</condition>
  <arm_group>
    <arm_group_label>Weight-bearing stable/Gravity stable</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ankles that are considered stable using weight-bearing radiographs AND gravity stress test will be assigned to conservative treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weight-bearing stable/Gravity unstable</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ankles that are considered stable using weight-bearing radiographs but unstable using gravity stress test will be assigned to conservative treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weight-bearing unstable/Gravity unstable</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ankles that are considered unstable using weight-bearing radiographs AND gravity stress test will be assigned to open reduction internal fixation (ORIF)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weight-bearing unstable/Gravity stable</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ankles that are considered unstable using weight-bearing radiographs but stable using gravity stress test will be assigned to open reduction internal fixation (ORIF)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open reduction internal fixation (ORIF)</intervention_name>
    <description>Open fracture reduction followed by internal fixation using a plate and screws. The goal is an osteosynthesis that allow for early range-of-motion exercises, but weightbearing is usually not tolerated until 6 weeks postoperatively.</description>
    <arm_group_label>Weight-bearing unstable/Gravity stable</arm_group_label>
    <arm_group_label>Weight-bearing unstable/Gravity unstable</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conservative treatment</intervention_name>
    <description>Conservative treatment involves ankle protection with a functional brace (AirCast) for 6 weeks. Participants will be instructed to bear weight as tolerated and to actively do standardized range-of-motion exercises.</description>
    <arm_group_label>Weight-bearing stable/Gravity stable</arm_group_label>
    <arm_group_label>Weight-bearing stable/Gravity unstable</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Isolated Weber type B fractures without radiological signs of medial clear space&#xD;
             widening on initial radiographs. Patients must be 18-80 years of age. Before the&#xD;
             injury patients should be mobilized without walking aids. They should be compliant&#xD;
             with good communication skills in the Norwegian or English languages. Patients must&#xD;
             live in Østfold or nearby areas so they are able to meet to follow-up consultations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients presenting with any of the following will be excluded from the study:&#xD;
             Fracture of the medial malleolus. Information about prehospital fracture closed&#xD;
             reduction. Open fracture. Fracture resulting from high-energy trauma or multi-trauma.&#xD;
             Pathologic fracture. Diabetes Mellitus type 1 and 2. Neuropathies. Cognitive&#xD;
             disorders. Previous history of ankle fracture. Previous history of ankle-/foot&#xD;
             surgery. Generalized joint disease such as RA. Patients with insufficient Norwegian or&#xD;
             English language proficiency or lack of communication skills.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marius Molund</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ostfold Hospital Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Østfold Hospital Trust</name>
      <address>
        <city>Sarpsborg</city>
        <state>Østfold</state>
        <zip>1714</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <link>
    <url>https://helseforskning.etikkom.no/prosjekterirek/prosjektregister/prosjekt?p_document_id=1062903&amp;p_parent_id=1067266&amp;_ikbLanguageCode=n</url>
    <description>REC study registration</description>
  </link>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>January 18, 2023</last_update_submitted>
  <last_update_submitted_qc>January 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  <!-- 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/NCT03831009
org study id: 18/07031-7
secondary id: 2018/1585/REK sør-øst B
nct id: NCT03831009
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators will conduct a prospective cohort study on the use of weight-bearing
      radiographs to evaluate stability in ankles with isolated, trans-syndesmotic (Weber type B)
      fibular fractures. Stable fractures will be treated conservatively using a functional brace,
      unstable fractures will undergo surgical fixation.
It is widely accepted that fractures in stable ankles can be treated non-operatively and
      fractures in unstable ankles needs internal fixation surgery (Michelson, Magid & McHale,
      2007, Gougoulias, Khanna, Seellariou, Maffulli, 2010). Clinical decision-making is thus based
      on ankle stability evaluation. The integrity of medial structures, mainly the deep deltoid
      ligament, is considered the most important determinant for stability of the ankle mortise
      (Michelson, Magid & McHale, 2007, Gougoulias, Khanna, Seellariou, Maffulli, 2010). Weber B
      fractures, with no obvious sign of medial side injury on initial plain radiographs, have to
      be considered of uncertain stability until adequate stress testing is performed.

      Currently there is no definite consensus on what test(s) best determines stability in ankles
      with undisplaced, isolated lateral malleolar fractures. Much used methods comprises manual
      stress radiographs and gravity stress radiographs (McConnel, Creevy & Tornetta, 2004).
      However recent studies have shown that such methods overestimate the need for surgical
      fixation indicating the need for a different method to make up the basis for surgical
      indication (Dawe, Shafafy, Quayle, Gougoulias, Wee & Sakellariou, 2015, Hastie, Akhtar, Butt,
      Baumann & Barrie, 2015, Holmes, Acker, Murphy, McKinney, Kadakia & Irwin, 2016, Hoshino,
      Nomoto, Norheim & Harris, 2012, Koval, Egol, Cheung, Goodwin & Spratt (2007), Seidel et al.,
      2017, Weber, Burmeister, Flueckiger & Krause, 2010). Authors of recent studies have proposed
      weightbearing radiographs as an alternative method to distinguish stable and unstable
      fractures, significantly reducing the need for operative treatment (Dawe et al., 2015, Hastie
      et al., 2015, Hoshino et al, 2012, Holmes et al., 2016, Seidel et al., 2017, Weber et al.
      2010).

      To evaluate weight-bearing radiographs ability to determine stability our primary focus is to
      evaluate if conservative treatment for "gravity unstable/weightbearing stable" ankles
      produces different outcomes than conservative treatment for "gravity stable/weightbearing
      stable" ankles.

      Participants will be assigned to non-operative or surgical treatment based on ankle stability
      evaluation using results from weightbearing radiographs consistently. Stable ankles will be
      treated non-operatively with a functional brace (AirCast) for 6 weeks. Participants will be
      instructed to bear weight as tolerated and to actively do standardized range-of-motion
      exercises. Standard operative treatment is open reduction and internal fixation of the
      fracture using plate and screws.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Two-arm parallel assignment. Based on stability evaluation using weight-bearing adiographs one group recieves surgery, one group recieves non-surgical treatment.
primary purpose: Diagnostic
masking: None (Open Label)
measure: The Manchester-Oxford Foot Questionnaire (MOxFQ)
time frame: 24 months
description: Ankle/foot specific patient-reported outcome measure
measure: Olerud-Molander Ankle Score (OMAS)
time frame: 24 months
description: Ankle/foot specific patient-reported outcome measure. Maximum score (100) = best. Minimum score = 0 (worst). Poor = 0-30, Fair = 31-60, Good = 61-90, Excellent = 91-100. Presented as total score (0-100).
measure: AOFAS ankle-hindfoot
time frame: 24 months
description: Ankle/foot specific patient-reported outcome measure
measure: VAS/NRS of pain
time frame: 24 months
description: Visual analogue pain scale - patient reported. Scale 0-10. 10 = worst possible pain, 0 = no pain
measure: Eq-5d
time frame: 24 months
description: Genereic health related quality of life patient reported outcome measure
measure: Fracture healing
time frame: 24 months
description: Radiographic result
measure: Registration of complications
time frame: 24 months
description: Yes/No for malalignment, deep vein trobosis, nerve injury, wound infection, delayed wound healing and crossover to surgery (including reason for crossover).
measure: Bilateral ankle range-of-motion
time frame: 24 months
description: Measured in degrees with a goniometer ad modum Lindsjö.
measure: Bilateral calf circumference
time frame: 24 months
description: Calf circumference in centimeters measured 10 cm distal to the tibial tubercle Calf circumference in centimeters measured 10 cm distal to the tibial tubercle using measuring tape
arm group label: Weight-bearing stable/Gravity stable
arm group type: Active Comparator
description: Ankles that are considered stable using weight-bearing radiographs AND gravity stress test will be assigned to conservative treatment
arm group label: Weight-bearing stable/Gravity unstable
arm group type: Active Comparator
description: Ankles that are considered stable using weight-bearing radiographs but unstable using gravity stress test will be assigned to conservative treatment
arm group label: Weight-bearing unstable/Gravity unstable
arm group type: Active Comparator
description: Ankles that are considered unstable using weight-bearing radiographs AND gravity stress test will be assigned to open reduction internal fixation (ORIF)
arm group label: Weight-bearing unstable/Gravity stable
arm group type: Active Comparator
description: Ankles that are considered unstable using weight-bearing radiographs but stable using gravity stress test will be assigned to open reduction internal fixation (ORIF)
intervention type: Procedure
intervention name: Open reduction internal fixation (ORIF)
description: Open fracture reduction followed by internal fixation using a plate and screws. The goal is an osteosynthesis that allow for early range-of-motion exercises, but weightbearing is usually not tolerated until 6 weeks postoperatively.
arm group label: Weight-bearing unstable/Gravity stable
arm group label: Weight-bearing unstable/Gravity unstable
intervention type: Other
intervention name: Conservative treatment
description: Conservative treatment involves ankle protection with a functional brace (AirCast) for 6 weeks. Participants will be instructed to bear weight as tolerated and to actively do standardized range-of-motion exercises.
arm group label: Weight-bearing stable/Gravity stable
arm group label: Weight-bearing stable/Gravity unstable
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Marius Molund
role: Principal Investigator
affiliation: Ostfold Hospital Trust
facility: 
country: Norway
url: https://helseforskning.etikkom.no/prosjekterirek/prosjektregister/prosjekt?p_document_id=1062903&p_parent_id=1067266&_ikbLanguageCode=n
description: REC study registration
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Ankle Fractures