<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/NCT02998333</url>
  </required_header>
  <id_info>
    <org_study_id>2016_136#B2016709</org_study_id>
    <secondary_id>NL55707.018.16</secondary_id>
    <nct_id>NCT02998333</nct_id>
  </id_info>
  <brief_title>Chronic Ankle Instability, Surgical Repair: Open Versus Closed</brief_title>
  <acronym>CAISR</acronym>
  <official_title>Does Arthroscopic Anatomic Repair of the Anterior Talofibular Ligament Provide Better Functional Outcome Compared to Open Anatomic Repair in Patients With Chronic Ankle Instability: a Multicentre Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gwendolyn Vuurberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zimmer Biomet</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centro Hospitalar do Porto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Site Hôpital orthopédique</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Amphia Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Albert Schweitzer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</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>
      Rationale: Lateral ankle ligament injuries may be a result of ankle sprains. In 10-30% of&#xD;
      patients with lateral ankle ligament injuries, chronic lateral ankle instability may be&#xD;
      present. If conservative treatment fails, instability is treated surgically. Anatomic repair&#xD;
      (also known as the Bröstrom procedure) is the current golden standard for surgical treatment&#xD;
      of chronic ankle instability. The Bröstrom started out as an open technique and is now also&#xD;
      performed arthroscopically. Both approaches are considered standard care and provide good&#xD;
      results. Which approach is best, has not yet been researched. In this study it is&#xD;
      hypothesized arthroscopic repair provides better functional outcome compared to open repair&#xD;
      during short term follow-up.&#xD;
&#xD;
      Objective: The main objective of this study is to compare the functional outcome after&#xD;
      arthroscopic and open anatomic repair in patients with chronic lateral ankle instability, and&#xD;
      secondly to assess ankle stability and ankle Range of Motion (ROM) after arthroscopic and&#xD;
      open ligament repair.&#xD;
&#xD;
      Study design: A Non-Blinded Prospective Randomized Controlled Trial Study population: All&#xD;
      patients willing to participate, from an age of 18 years old, with persisting ankle&#xD;
      instability for at least 6 months, eligible for anatomic repair.&#xD;
&#xD;
      Intervention: Both groups of patients are surgically treated with anatomic repair of the&#xD;
      anterior talofibular ligament (ATFL). One group is treated arthroscopically and the other by&#xD;
      the open approach.&#xD;
&#xD;
      Main study parameters/endpoints: The primary outcome measure is functional outcome 6 months&#xD;
      after surgery measured using the Foot and Ankle Outcome Score. The main study parameter is a&#xD;
      difference of ≥10 2 points per FAOS subscale between both treatment groups (Minimal Important&#xD;
      Change = 10 points; 2 per subscale).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">January 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional outcome</measure>
    <time_frame>6 months</time_frame>
    <description>The primary outcome measures is a difference in pain and disability between both treatment groups as measured a Functional Ankle Outcome Score (FAOS) score change of ≥2 points per subscale measured at 6 months follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional outcome FAOS</measure>
    <time_frame>3- and 6 months</time_frame>
    <description>For assessment disablement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional outcome Numeric Rating Scale (NRS) pain</measure>
    <time_frame>3- and 6 months</time_frame>
    <description>For pain assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional outcome Cumberland Ankle Instability Tool (CAIT)</measure>
    <time_frame>3- and 6 months</time_frame>
    <description>For instability assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anterior Drawer Test (ADT)</measure>
    <time_frame>Pre-operative, instraoperative, 3- and 6 months postoperative</time_frame>
    <description>The anterior drawer test is registered per mm (range 0-15mm) displacement and according to the manual anterior drawer test (M-ATT) categories (grade 0-3).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion (ROM)</measure>
    <time_frame>Pre-operative, instraoperative, 3- and 6 months postoperative</time_frame>
    <description>ROM is registered in degrees of dorsi- and plantarflexion and is measured using a goniometer. Assessment is performed pre-operatively, and at 3- and 6-months postoperatively.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Chronic Ankle Instability</condition>
  <arm_group>
    <arm_group_label>Open surgical ankle stabilization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>These patients will receive open surgical stabilization of the ankle joint after failed conservative treatment with complaints for at least 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arthroscopic surgical ankle stabilization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>These patients will receive arthroscopic surgical stabilization of the ankle joint after failed conservative treatment with complaints for at least 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical stabilization</intervention_name>
    <description>Surgical stabilization of the ankle joint, performed as an open or arthroscopic procedure.</description>
    <arm_group_label>Arthroscopic surgical ankle stabilization</arm_group_label>
    <arm_group_label>Open surgical ankle stabilization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients are 18 years or older;&#xD;
&#xD;
          -  Experience pain and/or a sensation of instability during sports and/or daily activity;&#xD;
&#xD;
          -  Isolated lateral ankle instability;&#xD;
&#xD;
          -  Planned for surgical repair of the ATFL;&#xD;
&#xD;
          -  At least one previous episode of an ankle inversion sprain;&#xD;
&#xD;
          -  Complaints for at least 6 months;&#xD;
&#xD;
          -  Failed previous conservative treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious concomitant injury (like arthrosis, ruled out using an AP and lateral x-ray&#xD;
             according to standard protocol);&#xD;
&#xD;
          -  Foot or ankle fracture in past;&#xD;
&#xD;
          -  Previous foot or ankle surgery;&#xD;
&#xD;
          -  ROM restriction of &gt;10 degrees;&#xD;
&#xD;
          -  Medial instability;&#xD;
&#xD;
          -  Severe misalignment;&#xD;
&#xD;
          -  Ankle/foot deformities (e.g. severe flat foot);&#xD;
&#xD;
          -  Systemic comorbidity leading to delayed recovery (e.g. Diabetes Mellitus, Rheumatoid&#xD;
             Arthritis)&#xD;
&#xD;
          -  (general) Hyper laxity&#xD;
&#xD;
          -  Inability or unwillingness to provide consent&#xD;
&#xD;
          -  Present factors that may cause difficulty of follow-up&#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>G.M.M.J. Kerkhoffs, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Orthopaedic Surgery, AMC, Amsterdam, The Netherlands</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gwendolyn Vuurberg</last_name>
    <phone>+31(0)205662474</phone>
    <email>g.vuurberg@amc.uva.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>AMC</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>G. Vuurberg</last_name>
      <email>g.vuurberg@amc.uva.nl</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Povoa deVarzim</name>
      <address>
        <city>Porto</city>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>H.D. Pereira, MD</last_name>
      <email>helderduartepereira@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Site Hôpital orthopédique</name>
      <address>
        <city>Lausanne</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>R. Baalbaki, MD</last_name>
      <email>rayan.baalbaki@chuv.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
    <country>Portugal</country>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Kobayashi T, Gamada K. Lateral Ankle Sprain and Chronic Ankle Instability: A Critical Review. Foot Ankle Spec. 2014 Aug 1;7(4):298-326. doi: 10.1177/1938640014539813. Epub 2014 Jun 24.</citation>
    <PMID>24962695</PMID>
  </reference>
  <reference>
    <citation>Brostrom L. Sprained ankles. VI. Surgical treatment of &quot;chronic&quot; ligament ruptures. Acta Chir Scand. 1966 Nov;132(5):551-65. No abstract available.</citation>
    <PMID>5339635</PMID>
  </reference>
  <reference>
    <citation>Mabit, C.C., J.M.; Fiorenza, F.; Huc, H.; Pecout, C., Lateral ligament reconstruction of the ankle: comparative study of peroneus brevis tenodesis versus periosteal ligamentoplasty. Foot and Ankle Surgery, 1998. 4(2): p. 6.</citation>
  </reference>
  <reference>
    <citation>Pereira H, Vuurberg G, Gomes N, Oliveira JM, Ripoll PL, Reis RL, Espregueira-Mendes J, Niek van Dijk C. Arthroscopic Repair of Ankle Instability With All-Soft Knotless Anchors. Arthrosc Tech. 2016 Feb 1;5(1):e99-e107. doi: 10.1016/j.eats.2015.10.010. eCollection 2016 Feb.</citation>
    <PMID>27073785</PMID>
  </reference>
  <reference>
    <citation>Drakos MC, Behrens SB, Paller D, Murphy C, DiGiovanni CW. Biomechanical Comparison of an Open vs Arthroscopic Approach for Lateral Ankle Instability. Foot Ankle Int. 2014 Aug;35(8):809-815. doi: 10.1177/1071100714535765. Epub 2014 May 21.</citation>
    <PMID>24850160</PMID>
  </reference>
  <reference>
    <citation>Matsui K, Takao M, Miyamoto W, Matsushita T. Early recovery after arthroscopic repair compared to open repair of the anterior talofibular ligament for lateral instability of the ankle. Arch Orthop Trauma Surg. 2016 Jan;136(1):93-100. doi: 10.1007/s00402-015-2342-3. Epub 2015 Oct 14.</citation>
    <PMID>26467354</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>January 31, 2021</last_update_submitted>
  <last_update_submitted_qc>January 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>Gwendolyn Vuurberg</investigator_full_name>
    <investigator_title>PhD Candidate</investigator_title>
  </responsible_party>
  <keyword>Instability</keyword>
  <keyword>Ankle</keyword>
  <keyword>Surgical stabilization</keyword>
  <!-- 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/NCT02998333
org study id: 2016_136#B2016709
secondary id: NL55707.018.16
nct id: NCT02998333
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rationale: Lateral ankle ligament injuries may be a result of ankle sprains. In 10-30% of
      patients with lateral ankle ligament injuries, chronic lateral ankle instability may be
      present. If conservative treatment fails, instability is treated surgically. Anatomic repair
      (also known as the Bröstrom procedure) is the current golden standard for surgical treatment
      of chronic ankle instability. The Bröstrom started out as an open technique and is now also
      performed arthroscopically. Both approaches are considered standard care and provide good
      results. Which approach is best, has not yet been researched. In this study it is
      hypothesized arthroscopic repair provides better functional outcome compared to open repair
      during short term follow-up.

      Objective: The main objective of this study is to compare the functional outcome after
      arthroscopic and open anatomic repair in patients with chronic lateral ankle instability, and
      secondly to assess ankle stability and ankle Range of Motion (ROM) after arthroscopic and
      open ligament repair.

      Study design: A Non-Blinded Prospective Randomized Controlled Trial Study population: All
      patients willing to participate, from an age of 18 years old, with persisting ankle
      instability for at least 6 months, eligible for anatomic repair.

      Intervention: Both groups of patients are surgically treated with anatomic repair of the
      anterior talofibular ligament (ATFL). One group is treated arthroscopically and the other by
      the open approach.

      Main study parameters/endpoints: The primary outcome measure is functional outcome 6 months
      after surgery measured using the Foot and Ankle Outcome Score. The main study parameter is a
      difference of ≥10 2 points per FAOS subscale between both treatment groups (Minimal Important
      Change = 10 points; 2 per subscale).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Functional outcome
time frame: 6 months
description: The primary outcome measures is a difference in pain and disability between both treatment groups as measured a Functional Ankle Outcome Score (FAOS) score change of ≥2 points per subscale measured at 6 months follow-up.
measure: Functional outcome FAOS
time frame: 3- and 6 months
description: For assessment disablement
measure: Functional outcome Numeric Rating Scale (NRS) pain
time frame: 3- and 6 months
description: For pain assessment
measure: Functional outcome Cumberland Ankle Instability Tool (CAIT)
time frame: 3- and 6 months
description: For instability assessment
measure: Anterior Drawer Test (ADT)
time frame: Pre-operative, instraoperative, 3- and 6 months postoperative
description: The anterior drawer test is registered per mm (range 0-15mm) displacement and according to the manual anterior drawer test (M-ATT) categories (grade 0-3).
measure: Range of Motion (ROM)
time frame: Pre-operative, instraoperative, 3- and 6 months postoperative
description: ROM is registered in degrees of dorsi- and plantarflexion and is measured using a goniometer. Assessment is performed pre-operatively, and at 3- and 6-months postoperatively.
arm group label: Open surgical ankle stabilization
arm group type: Active Comparator
description: These patients will receive open surgical stabilization of the ankle joint after failed conservative treatment with complaints for at least 6 months.
arm group label: Arthroscopic surgical ankle stabilization
arm group type: Active Comparator
description: These patients will receive arthroscopic surgical stabilization of the ankle joint after failed conservative treatment with complaints for at least 6 months.
intervention type: Procedure
intervention name: Surgical stabilization
description: Surgical stabilization of the ankle joint, performed as an open or arthroscopic procedure.
arm group label: Arthroscopic surgical ankle stabilization
arm group label: Open surgical ankle stabilization
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: G.M.M.J. Kerkhoffs, Professor
role: Principal Investigator
affiliation: Department of Orthopaedic Surgery, AMC, Amsterdam, The Netherlands
last name: Gwendolyn Vuurberg
phone: +31(0)205662474
email: g.vuurberg@amc.uva.nl
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: Netherlands
country: Portugal
country: Switzerland
citation: Kobayashi T, Gamada K. Lateral Ankle Sprain and Chronic Ankle Instability: A Critical Review. Foot Ankle Spec. 2014 Aug 1;7(4):298-326. doi: 10.1177/1938640014539813. Epub 2014 Jun 24.
PMID: 24962695
citation: Brostrom L. Sprained ankles. VI. Surgical treatment of "chronic" ligament ruptures. Acta Chir Scand. 1966 Nov;132(5):551-65. No abstract available.
PMID: 5339635
citation: Mabit, C.C., J.M.; Fiorenza, F.; Huc, H.; Pecout, C., Lateral ligament reconstruction of the ankle: comparative study of peroneus brevis tenodesis versus periosteal ligamentoplasty. Foot and Ankle Surgery, 1998. 4(2): p. 6.
citation: Pereira H, Vuurberg G, Gomes N, Oliveira JM, Ripoll PL, Reis RL, Espregueira-Mendes J, Niek van Dijk C. Arthroscopic Repair of Ankle Instability With All-Soft Knotless Anchors. Arthrosc Tech. 2016 Feb 1;5(1):e99-e107. doi: 10.1016/j.eats.2015.10.010. eCollection 2016 Feb.
PMID: 27073785
citation: Drakos MC, Behrens SB, Paller D, Murphy C, DiGiovanni CW. Biomechanical Comparison of an Open vs Arthroscopic Approach for Lateral Ankle Instability. Foot Ankle Int. 2014 Aug;35(8):809-815. doi: 10.1177/1071100714535765. Epub 2014 May 21.
PMID: 24850160
citation: Matsui K, Takao M, Miyamoto W, Matsushita T. Early recovery after arthroscopic repair compared to open repair of the anterior talofibular ligament for lateral instability of the ankle. Arch Orthop Trauma Surg. 2016 Jan;136(1):93-100. doi: 10.1007/s00402-015-2342-3. Epub 2015 Oct 14.
PMID: 26467354
responsible party type: Sponsor-Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: Gwendolyn Vuurberg
investigator title: PhD Candidate