<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/NCT03303690</url>
  </required_header>
  <id_info>
    <org_study_id>GK2017AS</org_study_id>
    <nct_id>NCT03303690</nct_id>
  </id_info>
  <brief_title>AS: Ankle Spacer for Talar Osteochondral Defects</brief_title>
  <acronym>AS</acronym>
  <official_title>A Prospective Trial on the Clinical Efficacy of the Ankle Spacer for the Surgical Treatment of Large, Multiple, Cystic and Secondary or Tertiary Osteochondral Defects of the Talus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      By means of the Ankle Spacer patients will be implanted, the clinical and radiological&#xD;
      results of which will be prospectively recorded and analyzed at different points in time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ankle sprains can result in talar osteochondral defects (OCDs) which have a significant&#xD;
      impact on the quality of life of patients. When these OCDs are of large nature&#xD;
      (anterior-posterior or medial-lateral diameter &gt;1.5cm in diameter), cystic, have failed prior&#xD;
      surgical treatment, or when there are multiple present on the talar articular surface,&#xD;
      surgical care by means of fixation or bone marrow stimulation is contra-indicated. An ankle&#xD;
      arthrodesis or fusion can be considered, but this results in functional limitation due to a&#xD;
      decreased range of motion (ROM). In order to serve for a bone sparing prosthesis procedure,&#xD;
      preserve range of motion, optimize physical functioning and to resurface the talus, the Ankle&#xD;
      Spacer has been developed. It is a one-piece implant system that replaces the articulating&#xD;
      upper talus surface of the tibio-talar joint, and offers several implant sizes in order to&#xD;
      fit to the different talus sizes. It is anatomically designed to the native upper talus&#xD;
      surface to provide an optimal fit to the distal articular surface. It has a rough titanium&#xD;
      plasma spray (TPS) coated under surface with two posts and spikes for implant fixation. The&#xD;
      rough surface enables secondary fixation by means of bone ingrowth and the spikes at the&#xD;
      posterior part of the prosthesis allowing for optimal adherence of the implant and for&#xD;
      minimal iatrogenic damage upon fixation. By these means, the anatomical situation and the&#xD;
      natural congruency of the ankle joint are mirrored to a optimal extent. Despite the fact that&#xD;
      no clinical trials have been published on this specific implant, it is hypothesized that the&#xD;
      5-year postoperative clinical outcomes concerning pain and prosthesis survival will be&#xD;
      considered good.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Arthrex stopped manufacturing the device&#xD;
  </why_stopped>
  <start_date type="Actual">December 5, 2017</start_date>
  <completion_date type="Actual">March 11, 2020</completion_date>
  <primary_completion_date type="Actual">March 11, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>NRS during walking/weightbearing</measure>
    <time_frame>2 years postoperatively</time_frame>
    <description>The primary study parameter is the measurement of the NRS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NRS at rest and during stairclimbing</measure>
    <time_frame>pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.</time_frame>
    <description>Other outcome measures will include pain evaluation using the NRS pain at rest and during stair climbing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS during stairclimbing</measure>
    <time_frame>pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.</time_frame>
    <description>Other outcome measures will include pain evaluation using the NRS pain at rest and during stair climbing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AOFAS (American Orthopedic Foot and Ankle Score)</measure>
    <time_frame>pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.</time_frame>
    <description>Other outcome measures will include the AOFAS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FAOS (Foot and Ankle Outcome Score)</measure>
    <time_frame>pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.</time_frame>
    <description>Other outcome measures will include FAOS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 (Short-Form 36) Physical Component Scale</measure>
    <time_frame>pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.</time_frame>
    <description>Other outcome measures will include SF-36 Physical Component Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 (Short-Form 36) Mental Component Scale</measure>
    <time_frame>pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.</time_frame>
    <description>Other outcome measures will include SF-36 Mental Component Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ROM (range of motion)</measure>
    <time_frame>pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.</time_frame>
    <description>Other outcome measures will include Range of Motion (ROM) in degrees of dorsi- and plantarflexion and will be measured using a goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>demographic data: sex</measure>
    <time_frame>pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.</time_frame>
    <description>Other study parameters that will be recorded are demographic data and also radiographic evaluations to evaluate loosening and subsidence (radiographs). Complications, implant survivorship (revision rate), operation time, adverse events, and length of hospital stay will also be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>demographic data: age</measure>
    <time_frame>pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.</time_frame>
    <description>Other study parameters that will be recorded are demographic data and also radiographic evaluations to evaluate loosening and subsidence (radiographs). Complications, implant survivorship (revision rate), operation time, adverse events, and length of hospital stay will also be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic evaluation</measure>
    <time_frame>pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.</time_frame>
    <description>Radiographic evaluations to evaluate loosening and subsidence (radiographs). Complications, implant survivorship (revision rate), operation time, adverse events, and length of hospital stay will also be recorded.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Osteochondral Defect of Talus</condition>
  <arm_group>
    <arm_group_label>Ankle Spacer (AS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will surgically receive the to be implanted ankle spacer in their ankle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ankle Spacer (AS)</intervention_name>
    <description>All included patients will be treated by means of surgical implantation of the Ankle Spacer prosthesis in an open manner replacing the talar side of the tibiotalar joint.</description>
    <arm_group_label>Ankle Spacer (AS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ranging from 18 to 80 years&#xD;
&#xD;
          -  talar osteochondral defect (multiple degenerative talar cysts present, and/or prior&#xD;
             failed surgical treatment and/or multiple defects and/or large (&gt;15mm))&#xD;
&#xD;
          -  willing to receive surgical implantation of the Ankle Spacer&#xD;
&#xD;
          -  has been informed of the nature of the study and provided written consent&#xD;
&#xD;
          -  The subject and treating physician agree that the subject will return for all required&#xD;
             post-procedure follow-up visits&#xD;
&#xD;
          -  failed previous conservative treatment&#xD;
&#xD;
          -  complaints for at least 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  -severe ankle malalignement.(&gt; 5° varus/valgus).&#xD;
&#xD;
          -  fracture &lt; 6 months - tendinitis - diabetes mellitus / rheumathoid arthritis&#xD;
&#xD;
          -  advanced osteoporosis&#xD;
&#xD;
          -  grade two or higher (Kellgren-Lawrence-Score) ankle joint degeneration on the tibia&#xD;
             side.&#xD;
&#xD;
          -  any ankle deformation that does not allow proper rasping of the cartilage and/or&#xD;
             proper seating of the desired sized implant, as described in the surgical technique.&#xD;
&#xD;
          -  blood supply limitations and previous infections, which may retard healing.&#xD;
&#xD;
          -  foreign-body sensitivity. Where material sensitivity is suspected, appropriate tests&#xD;
             should be made and sensitivity ruled out prior to implantation.&#xD;
&#xD;
          -  active infection or blood supply limitations.&#xD;
&#xD;
          -  conditions that tend to limit the patient's ability or willingness to restrict&#xD;
             activities or follow directions during the healing period, including severe&#xD;
             neuro-arthropathy.&#xD;
&#xD;
          -  pathological conditions, such as insufficient quantity or quality of bone (e.g.,&#xD;
             cystic changes or severe osteopenia), which may compromise implant fixation.&#xD;
&#xD;
          -  currently participating in an investigational drug or another device study that&#xD;
             clinically interferes with the current study endpoints.&#xD;
&#xD;
          -  Inability to be brought back to the surgery site for long term follow-up evaluations&#xD;
             or the subject is unwilling to fill out the appropriate evaluation forms&#xD;
&#xD;
          -  adiposity grade I (BMI &gt; 30 kg/m2)&#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>G.M.M.J. Kerkhoffs, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Academic Medical Center (AMC Amsterdam)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Academic Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord Holland</state>
        <zip>1105AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 17, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>Jari Dahmen</investigator_full_name>
    <investigator_title>Local Study Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteochondrosis</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/NCT03303690
org study id: GK2017AS
nct id: NCT03303690
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
By means of the Ankle Spacer patients will be implanted, the clinical and radiological
      results of which will be prospectively recorded and analyzed at different points in time.
Ankle sprains can result in talar osteochondral defects (OCDs) which have a significant
      impact on the quality of life of patients. When these OCDs are of large nature
      (anterior-posterior or medial-lateral diameter >1.5cm in diameter), cystic, have failed prior
      surgical treatment, or when there are multiple present on the talar articular surface,
      surgical care by means of fixation or bone marrow stimulation is contra-indicated. An ankle
      arthrodesis or fusion can be considered, but this results in functional limitation due to a
      decreased range of motion (ROM). In order to serve for a bone sparing prosthesis procedure,
      preserve range of motion, optimize physical functioning and to resurface the talus, the Ankle
      Spacer has been developed. It is a one-piece implant system that replaces the articulating
      upper talus surface of the tibio-talar joint, and offers several implant sizes in order to
      fit to the different talus sizes. It is anatomically designed to the native upper talus
      surface to provide an optimal fit to the distal articular surface. It has a rough titanium
      plasma spray (TPS) coated under surface with two posts and spikes for implant fixation. The
      rough surface enables secondary fixation by means of bone ingrowth and the spikes at the
      posterior part of the prosthesis allowing for optimal adherence of the implant and for
      minimal iatrogenic damage upon fixation. By these means, the anatomical situation and the
      natural congruency of the ankle joint are mirrored to a optimal extent. Despite the fact that
      no clinical trials have been published on this specific implant, it is hypothesized that the
      5-year postoperative clinical outcomes concerning pain and prosthesis survival will be
      considered good.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: NRS during walking/weightbearing
time frame: 2 years postoperatively
description: The primary study parameter is the measurement of the NRS
measure: NRS at rest and during stairclimbing
time frame: pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.
description: Other outcome measures will include pain evaluation using the NRS pain at rest and during stair climbing
measure: NRS during stairclimbing
time frame: pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.
description: Other outcome measures will include pain evaluation using the NRS pain at rest and during stair climbing
measure: AOFAS (American Orthopedic Foot and Ankle Score)
time frame: pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.
description: Other outcome measures will include the AOFAS.
measure: FAOS (Foot and Ankle Outcome Score)
time frame: pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.
description: Other outcome measures will include FAOS
measure: SF-36 (Short-Form 36) Physical Component Scale
time frame: pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.
description: Other outcome measures will include SF-36 Physical Component Scale
measure: SF-36 (Short-Form 36) Mental Component Scale
time frame: pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.
description: Other outcome measures will include SF-36 Mental Component Scale
measure: ROM (range of motion)
time frame: pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.
description: Other outcome measures will include Range of Motion (ROM) in degrees of dorsi- and plantarflexion and will be measured using a goniometer
measure: demographic data: sex
time frame: pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.
description: Other study parameters that will be recorded are demographic data and also radiographic evaluations to evaluate loosening and subsidence (radiographs). Complications, implant survivorship (revision rate), operation time, adverse events, and length of hospital stay will also be recorded.
measure: demographic data: age
time frame: pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.
description: Other study parameters that will be recorded are demographic data and also radiographic evaluations to evaluate loosening and subsidence (radiographs). Complications, implant survivorship (revision rate), operation time, adverse events, and length of hospital stay will also be recorded.
measure: Radiographic evaluation
time frame: pre-operatively, follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 1,2,3,4,5 year postop.
description: Radiographic evaluations to evaluate loosening and subsidence (radiographs). Complications, implant survivorship (revision rate), operation time, adverse events, and length of hospital stay will also be recorded.
arm group label: Ankle Spacer (AS)
arm group type: Experimental
description: This arm will surgically receive the to be implanted ankle spacer in their ankle.
intervention type: Procedure
intervention name: Ankle Spacer (AS)
description: All included patients will be treated by means of surgical implantation of the Ankle Spacer prosthesis in an open manner replacing the talar side of the tibiotalar joint.
arm group label: Ankle Spacer (AS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: G.M.M.J. Kerkhoffs, MD PhD
role: Principal Investigator
affiliation: Academic Medical Center (AMC Amsterdam)
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: Jari Dahmen
investigator title: Local Study Investigator
mesh term: Osteochondrosis
sharing ipd: No