<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/NCT03772236</url>
  </required_header>
  <id_info>
    <org_study_id>ARP2</org_study_id>
    <nct_id>NCT03772236</nct_id>
  </id_info>
  <brief_title>Phi Angle and Antero-medial Pain in Total Ankle Replacement Follow-up</brief_title>
  <official_title>Evaluation of the Relation Between the Rotation Angle of the Talar Component and the Antero-medial Pain in Patients Underwent Total Ankle Replacement, at Least One Year After Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Ortopedico Galeazzi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Ortopedico Galeazzi</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 study evaluates the relation between the rotational alignment of the talar component (phi&#xD;
      angle) and the antero-medial ankle pain in patients underwent total ankle replacement, at&#xD;
      least one year after surgery.&#xD;
&#xD;
      Moreover, the study aims to define a range of the phi angle associated with a lower frequency&#xD;
      of antero-medial pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      In case of total ankle prosthesis surgery, the correct positioning of the talar component is&#xD;
      one of the most challenging tasks. When performing total ankle replacement, the primary goal&#xD;
      for long-term implant survival is to restore a physiological alignment of the prosthesis in&#xD;
      the lateral and frontal planes. In fact, an incorrect alignment can alter joint mechanics and&#xD;
      joint reactive forces that can lead to implant failure (Saltzman, 2004).&#xD;
&#xD;
      Regarding the rotation in the dorsoplantar plane, the prosthesis is aligned taking as&#xD;
      reference the axis of the second metatarsal bone, with the foot in neutral position (Roukis,&#xD;
      2015). In this regard, there are no specific mechanical-articular considerations as for the&#xD;
      lateral and frontal planes. However, it is expected that misalignments of the prosthesis in&#xD;
      the dorsoplantar plane may involve the presence of antero-medial pain in the ankle in the&#xD;
      long term (at least 1 year after surgery).&#xD;
&#xD;
      At present, no previous studies have verified whether there is a relation between the&#xD;
      rotational alignment of the talar component in the dorsoplantar plane and the frequency of&#xD;
      antero-medial ankle pain, at least 1 year after surgery. This evaluation can provide useful&#xD;
      information for a more advantageous placement of the implant during the intervention.&#xD;
&#xD;
      Aim of the Study:&#xD;
&#xD;
      The aim of the study is to evaluate the relation between the rotational alignment of the&#xD;
      talar component (phi angle) and the antero-medial ankle pain, in patients underwent total&#xD;
      ankle replacement, at least one year after surgery.&#xD;
&#xD;
      Moreover, the study aims to define a range of the phi angle associated with a lower frequency&#xD;
      of the antero-medial pain.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      A sample of 100 subjects in the follow-up period after total ankle replacement (minimum 12&#xD;
      months after surgery, maximum 36 months) will be enrolled. Age range will be 18 to 60 years.&#xD;
      Each subject will be evaluated once, in occasion of the routine follow-up examination. The&#xD;
      subjects will be enrolled consecutively and differentiated according to the time passed since&#xD;
      the intervention (at least 12 months), with incremental windows of 6 months, up to a maximum&#xD;
      of 36 months. This will lead to define 4 time windows (12-18 months, 18-24, 24-30, 30-36). A&#xD;
      number of 25 subjects will be enrolled for each time window. Once a time window will be&#xD;
      completed, only subjects belonging to the remaining not completed windows will be enrolled.&#xD;
&#xD;
      Outcomes:&#xD;
&#xD;
      The phi angle will be measured according to that described by Manzi et al., 2017.&#xD;
      Specifically, the phi angle will be obtained by the orthopaedist on the standard dorsoplantar&#xD;
      radiograph of the foot, which is routinely performed for the follow-up examination. The phi&#xD;
      angle is the relative angle between the alignment of the talar component of the implant, and&#xD;
      the axis passing through the second metatarsal bone, in the dorsoplantar plane. The phi angle&#xD;
      is defined as negative when the talar component is aligned in an abducted position to the&#xD;
      second metatarsal axis; similarly, the angle is defined as positive when the talar component&#xD;
      is aligned in an adducted position.&#xD;
&#xD;
      The rate of postoperative pain will be assessed during the follow-up examination by a&#xD;
      recently distributed pain monitoring web-based app: 'NavigatePain' (NavigatePain, Aglance&#xD;
      Solutions, Denmark). The app is used in a simple and intuitive manner by exploiting tablet&#xD;
      device (Boudreau, 2016; Matthews, 2018). It is used only for data collection, without&#xD;
      therapeutic or diagnostic purposes. In few minutes, it allows the patient to draw the pain&#xD;
      areas in the frontal and lateral planes, automatically providing an index that quantifies the&#xD;
      percentage of anterior and medial areas affected by pain (with respect to the whole body area&#xD;
      in the considered plane).&#xD;
&#xD;
      The antero-medial ankle pain will be obtain as the sum of the anterior and medial pain&#xD;
      indexes provided by the app.&#xD;
&#xD;
      The strength of the relation between the phi angle and the antero-medial ankle pain will be&#xD;
      evaluated according to Pearson correlation coefficient, or Spearman rank correlation in case&#xD;
      of not normal distribution. Statistical significance of the coefficients will be tested&#xD;
      according to two-tailed t-test or permutation distribution test assessing Pearson and&#xD;
      Spearman coefficients, respectively. Linear regression analysis will be performed as well.&#xD;
&#xD;
      Correlation coefficient and linear regression will be evaluated in each time window. The&#xD;
      results will be compared among the consecutive windows in order to assess the potential&#xD;
      dependence on the follow-up time.&#xD;
&#xD;
      The sample size of 25 subjects per time window has been verified to guarantee identifying as&#xD;
      significantly different from zero a correlation value larger than 0.7 (i.e. strong&#xD;
      correlation), by t-test at 0.05 level alpha and power 95% (G*Power software, Universitat&#xD;
      Dusseldorf, Germany).&#xD;
&#xD;
      The distribution of the pain rate will be evaluated in function of the phi angle. Potential&#xD;
      threshold values of phi associated with lower pain rates will be identified, in order to&#xD;
      define a range of phi associated with a lower frequency of the antero-medial pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 4, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Phi angle</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Relative angle (measured in degrees) between the alignment of the talar component of the implant, and the axis passing through the second metatarsal bone, in the dorsoplantar plane.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Antero-medial ankle pain</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Sum of the antero and medial pain areas, measured as percentage with respect to the total body area in the considered plane.</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Ankle Osteoarthritis</condition>
  <condition>Prostheses and Implants</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing follow-up examination at a third-level hospital after total ankle&#xD;
        replacement&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  previous intervention of first implant of total ankle replacement, with at least 12&#xD;
             months of follow up and maximum 36 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  more than 36 months from the surgery of first implant of total ankle replacement&#xD;
&#xD;
          -  previous revision surgery of ankle prosthesis&#xD;
&#xD;
          -  previous intervention of ankle disarthrodesis and ankle prosthesis implant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Federico Usuelli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Istituto Ortopedico Galeazzi</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tito Bassani, PhD</last_name>
    <phone>+39‭0266214939</phone>
    <email>tito.bassani@grupposandonato.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Federico Usuelli, MD</last_name>
    <phone>+39‭3357351838</phone>
    <email>fusuelli@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Irccs Istituto Ortopedico Galeazzi</name>
      <address>
        <city>Milan</city>
        <state>Milano</state>
        <zip>20156</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Federico Usuelli, MD</last_name>
      <phone>+39‭3357351838‬</phone>
      <email>fusuelli@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Federico Usuelli, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Boudreau SA, Badsberg S, Christensen SW, Egsgaard LL. Digital Pain Drawings: Assessing Touch-Screen Technology and 3D Body Schemas. Clin J Pain. 2016 Feb;32(2):139-45. doi: 10.1097/AJP.0000000000000230.</citation>
    <PMID>25756558</PMID>
  </reference>
  <reference>
    <citation>Manzi L, Villafane JH, Indino C, Tamini J, Berjano P, Usuelli FG. Reliability of the Phi angle to assess rotational alignment of the talar component in total ankle replacement. Foot Ankle Surg. 2019 Apr;25(2):169-173. doi: 10.1016/j.fas.2017.10.009. Epub 2017 Nov 8.</citation>
    <PMID>29409284</PMID>
  </reference>
  <reference>
    <citation>Matthews M, Rathleff MS, Vicenzino B, Boudreau SA. Capturing patient-reported area of knee pain: a concurrent validity study using digital technology in patients with patellofemoral pain. PeerJ. 2018 Mar 8;6:e4406. doi: 10.7717/peerj.4406. eCollection 2018.</citation>
    <PMID>29568700</PMID>
  </reference>
  <reference>
    <citation>Roukis TS. The Salto Talaris XT Revision Ankle Prosthesis. Clin Podiatr Med Surg. 2015 Oct;32(4):551-67. doi: 10.1016/j.cpm.2015.06.019. Epub 2015 Jul 31.</citation>
    <PMID>26407741</PMID>
  </reference>
  <reference>
    <citation>Saltzman CL, Tochigi Y, Rudert MJ, McIff TE, Brown TD. The effect of agility ankle prosthesis misalignment on the peri-ankle ligaments. Clin Orthop Relat Res. 2004 Jul;(424):137-42. doi: 10.1097/01.blo.0000132463.80467.65.</citation>
    <PMID>15241155</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 12, 2018</last_update_submitted>
  <last_update_submitted_qc>December 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Total Ankle Replacement; Pain Measurement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</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/NCT03772236
org study id: ARP2
nct id: NCT03772236
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study evaluates the relation between the rotational alignment of the talar component (phi
      angle) and the antero-medial ankle pain in patients underwent total ankle replacement, at
      least one year after surgery.

      Moreover, the study aims to define a range of the phi angle associated with a lower frequency
      of antero-medial pain.
Background:

      In case of total ankle prosthesis surgery, the correct positioning of the talar component is
      one of the most challenging tasks. When performing total ankle replacement, the primary goal
      for long-term implant survival is to restore a physiological alignment of the prosthesis in
      the lateral and frontal planes. In fact, an incorrect alignment can alter joint mechanics and
      joint reactive forces that can lead to implant failure (Saltzman, 2004).

      Regarding the rotation in the dorsoplantar plane, the prosthesis is aligned taking as
      reference the axis of the second metatarsal bone, with the foot in neutral position (Roukis,
      2015). In this regard, there are no specific mechanical-articular considerations as for the
      lateral and frontal planes. However, it is expected that misalignments of the prosthesis in
      the dorsoplantar plane may involve the presence of antero-medial pain in the ankle in the
      long term (at least 1 year after surgery).

      At present, no previous studies have verified whether there is a relation between the
      rotational alignment of the talar component in the dorsoplantar plane and the frequency of
      antero-medial ankle pain, at least 1 year after surgery. This evaluation can provide useful
      information for a more advantageous placement of the implant during the intervention.

      Aim of the Study:

      The aim of the study is to evaluate the relation between the rotational alignment of the
      talar component (phi angle) and the antero-medial ankle pain, in patients underwent total
      ankle replacement, at least one year after surgery.

      Moreover, the study aims to define a range of the phi angle associated with a lower frequency
      of the antero-medial pain.

      Methods:

      A sample of 100 subjects in the follow-up period after total ankle replacement (minimum 12
      months after surgery, maximum 36 months) will be enrolled. Age range will be 18 to 60 years.
      Each subject will be evaluated once, in occasion of the routine follow-up examination. The
      subjects will be enrolled consecutively and differentiated according to the time passed since
      the intervention (at least 12 months), with incremental windows of 6 months, up to a maximum
      of 36 months. This will lead to define 4 time windows (12-18 months, 18-24, 24-30, 30-36). A
      number of 25 subjects will be enrolled for each time window. Once a time window will be
      completed, only subjects belonging to the remaining not completed windows will be enrolled.

      Outcomes:

      The phi angle will be measured according to that described by Manzi et al., 2017.
      Specifically, the phi angle will be obtained by the orthopaedist on the standard dorsoplantar
      radiograph of the foot, which is routinely performed for the follow-up examination. The phi
      angle is the relative angle between the alignment of the talar component of the implant, and
      the axis passing through the second metatarsal bone, in the dorsoplantar plane. The phi angle
      is defined as negative when the talar component is aligned in an abducted position to the
      second metatarsal axis; similarly, the angle is defined as positive when the talar component
      is aligned in an adducted position.

      The rate of postoperative pain will be assessed during the follow-up examination by a
      recently distributed pain monitoring web-based app: 'NavigatePain' (NavigatePain, Aglance
      Solutions, Denmark). The app is used in a simple and intuitive manner by exploiting tablet
      device (Boudreau, 2016; Matthews, 2018). It is used only for data collection, without
      therapeutic or diagnostic purposes. In few minutes, it allows the patient to draw the pain
      areas in the frontal and lateral planes, automatically providing an index that quantifies the
      percentage of anterior and medial areas affected by pain (with respect to the whole body area
      in the considered plane).

      The antero-medial ankle pain will be obtain as the sum of the anterior and medial pain
      indexes provided by the app.

      The strength of the relation between the phi angle and the antero-medial ankle pain will be
      evaluated according to Pearson correlation coefficient, or Spearman rank correlation in case
      of not normal distribution. Statistical significance of the coefficients will be tested
      according to two-tailed t-test or permutation distribution test assessing Pearson and
      Spearman coefficients, respectively. Linear regression analysis will be performed as well.

      Correlation coefficient and linear regression will be evaluated in each time window. The
      results will be compared among the consecutive windows in order to assess the potential
      dependence on the follow-up time.

      The sample size of 25 subjects per time window has been verified to guarantee identifying as
      significantly different from zero a correlation value larger than 0.7 (i.e. strong
      correlation), by t-test at 0.05 level alpha and power 95% (G*Power software, Universitat
      Dusseldorf, Germany).

      The distribution of the pain rate will be evaluated in function of the phi angle. Potential
      threshold values of phi associated with lower pain rates will be identified, in order to
      define a range of phi associated with a lower frequency of the antero-medial pain.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Phi angle
time frame: Through study completion, an average of 18 months
description: Relative angle (measured in degrees) between the alignment of the talar component of the implant, and the axis passing through the second metatarsal bone, in the dorsoplantar plane.
measure: Antero-medial ankle pain
time frame: Through study completion, an average of 18 months
description: Sum of the antero and medial pain areas, measured as percentage with respect to the total body area in the considered plane.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Federico Usuelli, MD
role: Principal Investigator
affiliation: IRCCS Istituto Ortopedico Galeazzi
last name: Tito Bassani, PhD
phone: +39‭0266214939
email: tito.bassani@grupposandonato.it
last name: Federico Usuelli, MD
phone: +39‭3357351838
email: fusuelli@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
citation: Boudreau SA, Badsberg S, Christensen SW, Egsgaard LL. Digital Pain Drawings: Assessing Touch-Screen Technology and 3D Body Schemas. Clin J Pain. 2016 Feb;32(2):139-45. doi: 10.1097/AJP.0000000000000230.
PMID: 25756558
citation: Manzi L, Villafane JH, Indino C, Tamini J, Berjano P, Usuelli FG. Reliability of the Phi angle to assess rotational alignment of the talar component in total ankle replacement. Foot Ankle Surg. 2019 Apr;25(2):169-173. doi: 10.1016/j.fas.2017.10.009. Epub 2017 Nov 8.
PMID: 29409284
citation: Matthews M, Rathleff MS, Vicenzino B, Boudreau SA. Capturing patient-reported area of knee pain: a concurrent validity study using digital technology in patients with patellofemoral pain. PeerJ. 2018 Mar 8;6:e4406. doi: 10.7717/peerj.4406. eCollection 2018.
PMID: 29568700
citation: Roukis TS. The Salto Talaris XT Revision Ankle Prosthesis. Clin Podiatr Med Surg. 2015 Oct;32(4):551-67. doi: 10.1016/j.cpm.2015.06.019. Epub 2015 Jul 31.
PMID: 26407741
citation: Saltzman CL, Tochigi Y, Rudert MJ, McIff TE, Brown TD. The effect of agility ankle prosthesis misalignment on the peri-ankle ligaments. Clin Orthop Relat Res. 2004 Jul;(424):137-42. doi: 10.1097/01.blo.0000132463.80467.65.
PMID: 15241155
responsible party type: Sponsor
mesh term: Osteoarthritis
sharing ipd: No