<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/NCT04455763</url>
  </required_header>
  <id_info>
    <org_study_id>1866/2020</org_study_id>
    <nct_id>NCT04455763</nct_id>
  </id_info>
  <brief_title>Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis</brief_title>
  <acronym>REMEDY SVF</acronym>
  <official_title>Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis - ReMeDY SVF -Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Töölö Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Töölö Hospital</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>
      Trial purpose is to research the outcome after thumb carpometacarpal injection with stromal&#xD;
      vascular fraction (SVF) derived from adipose tissue. The study compares SVF injection therapy&#xD;
      with thumb splinting vs. splinting only.&#xD;
&#xD;
      Patients with radiologically and clinically confirmed Eaton-Glickel II osteoarthritis are&#xD;
      randomized (1:1 computer generated sequence with random block size) to two parallel groups&#xD;
      and will undergo SVF injection and splinting vs. splinting only.&#xD;
&#xD;
      Baseline data is collected preoperatively and patients are followed at 1, 3 and 6 months&#xD;
      after enrollment. The primary end-point is 6 months and the primary outcome is pain visual&#xD;
      analogue scale and patient-rated wrist evaluation (PRWE).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 14, 2021</start_date>
  <completion_date type="Anticipated">March 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2022</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>Pain (Visual Analogue Scale)</measure>
    <time_frame>6 months</time_frame>
    <description>The VAS is derived by health care professional question of pain in scale 0 to 100 mm (0 mm =no pain, 100 mm =worst possible pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-Rated Wrist Evaluation (PRWE)</measure>
    <time_frame>6 months</time_frame>
    <description>The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global improvement</measure>
    <time_frame>6 months</time_frame>
    <description>Global rating to treatment effect will be evaluated by question: &quot;How would you rate the function of your hand compared to the situation before the treatment?&quot;. The options are in 5-step Likert scale from (-2) Much worse to (+2) Much better</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grip strength</measure>
    <time_frame>6 months</time_frame>
    <description>Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Key pinch strength</measure>
    <time_frame>6 months</time_frame>
    <description>Key pinch strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Michigan Hand Outcomes Questionnaire (MHQ)</measure>
    <time_frame>6 months</time_frame>
    <description>The MHQ comprises of 37 core questions to measure hand-specific outcomes containing six distinct scales: overall hand function, activities of daily living, pain, work performance, aesthetics and patient satisfaction with hand function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>6 months</time_frame>
    <description>Incidence of complications (hemaetoma, injection site infection etc.)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Thumb Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>SVF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thumb carpometacarpal injection with adipose-derived SVF combined with splinting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Splint</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Thumb carpometacarpal osteoarthrosis treated with splinting only</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SVF</intervention_name>
    <description>Adipose-derived stromal vascular fraction</description>
    <arm_group_label>SVF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Splint</intervention_name>
    <description>Thumb brace (Actimove® Rhizo Forte)</description>
    <arm_group_label>SVF</arm_group_label>
    <arm_group_label>Splint</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 40-70 years&#xD;
&#xD;
          -  Eaton-Glickel II thumb CMC osteoarthrosis&#xD;
&#xD;
          -  Symptom duration &gt; 3 months&#xD;
&#xD;
          -  Pain visual analogue score &gt; 30 mm&#xD;
&#xD;
          -  &lt; 3 months of treatment with thumb splinting&#xD;
&#xD;
          -  American Society of Anaesthesiologists physical status (ASA) I-III&#xD;
&#xD;
          -  Fluent in written and spoken Finnish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;40 or &gt;70 years&#xD;
&#xD;
          -  Eaton-Glickel I, III-IV&#xD;
&#xD;
          -  Symptom duration &lt; 3 months&#xD;
&#xD;
          -  Pain VAS &lt; 30 mm&#xD;
&#xD;
          -  Post-traumatic osteoarthrosis of thumb CMC I&#xD;
&#xD;
          -  Rheumatoid arthritis or other inflammatory joint disease&#xD;
&#xD;
          -  The use of per oral corticosteroids or other immunomodulatory drugs&#xD;
&#xD;
          -  Less than 6 months after another operation of the same upper limb&#xD;
&#xD;
          -  Other condition of the same upper limb requiring surgery&#xD;
&#xD;
          -  Malnutrition&#xD;
&#xD;
          -  Neurological condition affecting upper limb function&#xD;
&#xD;
          -  Heavy smoking (&gt; 20 cigarettes per day)&#xD;
&#xD;
          -  Alcohol or drug abuse&#xD;
&#xD;
          -  Previous history or active cancer&#xD;
&#xD;
          -  Previous history of allergic reaction to local anaesthetic&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samuli Aspinen, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>HUS Töölö Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Samuli Aspinen, M.D., Ph.D.</last_name>
    <phone>+358406360546</phone>
    <email>samuli.aspinen@hus.fi</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jussi Kosola, M.D., Ph.D.</last_name>
    <email>jussi.kosola@helsinki.fi</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Töölö Hospital (Helsinki University Hospital)</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samuli Aspinen, M.D., Ph.D.</last_name>
      <phone>+358406360546</phone>
      <email>samuli.aspinen@hus.fi</email>
    </contact>
    <contact_backup>
      <last_name>Jorma Ryhänen, adj. prof</last_name>
      <email>jorma.ryhanen@hus.fi</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>January 14, 2021</last_update_submitted>
  <last_update_submitted_qc>January 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Töölö Hospital</investigator_affiliation>
    <investigator_full_name>Samuli Aspinen</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Thumb Osteoarthrosis</keyword>
  <keyword>Stromal Vascular Fraction</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/NCT04455763
org study id: 1866/2020
nct id: NCT04455763
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Trial purpose is to research the outcome after thumb carpometacarpal injection with stromal
      vascular fraction (SVF) derived from adipose tissue. The study compares SVF injection therapy
      with thumb splinting vs. splinting only.

      Patients with radiologically and clinically confirmed Eaton-Glickel II osteoarthritis are
      randomized (1:1 computer generated sequence with random block size) to two parallel groups
      and will undergo SVF injection and splinting vs. splinting only.

      Baseline data is collected preoperatively and patients are followed at 1, 3 and 6 months
      after enrollment. The primary end-point is 6 months and the primary outcome is pain visual
      analogue scale and patient-rated wrist evaluation (PRWE).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain (Visual Analogue Scale)
time frame: 6 months
description: The VAS is derived by health care professional question of pain in scale 0 to 100 mm (0 mm =no pain, 100 mm =worst possible pain)
measure: Patient-Rated Wrist Evaluation (PRWE)
time frame: 6 months
description: The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)
measure: Global improvement
time frame: 6 months
description: Global rating to treatment effect will be evaluated by question: "How would you rate the function of your hand compared to the situation before the treatment?". The options are in 5-step Likert scale from (-2) Much worse to (+2) Much better
measure: Grip strength
time frame: 6 months
description: Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side
measure: Key pinch strength
time frame: 6 months
description: Key pinch strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side
measure: Michigan Hand Outcomes Questionnaire (MHQ)
time frame: 6 months
description: The MHQ comprises of 37 core questions to measure hand-specific outcomes containing six distinct scales: overall hand function, activities of daily living, pain, work performance, aesthetics and patient satisfaction with hand function.
measure: Complications
time frame: 6 months
description: Incidence of complications (hemaetoma, injection site infection etc.)
arm group label: SVF
arm group type: Experimental
description: Thumb carpometacarpal injection with adipose-derived SVF combined with splinting
arm group label: Splint
arm group type: Active Comparator
description: Thumb carpometacarpal osteoarthrosis treated with splinting only
intervention type: Procedure
intervention name: SVF
description: Adipose-derived stromal vascular fraction
arm group label: SVF
intervention type: Other
intervention name: Splint
description: Thumb brace (Actimove® Rhizo Forte)
arm group label: SVF
arm group label: Splint
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Samuli Aspinen, M.D., Ph.D.
role: Principal Investigator
affiliation: HUS Töölö Hospital
last name: Samuli Aspinen, M.D., Ph.D.
phone: +358406360546
email: samuli.aspinen@hus.fi
last name: Jussi Kosola, M.D., Ph.D.
email: jussi.kosola@helsinki.fi
facility: 
status: Recruiting
contact: 
contact backup: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Töölö Hospital
investigator full name: Samuli Aspinen
investigator title: Principal investigator
mesh term: Osteoarthritis
sharing ipd: No