<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/NCT04427657</url>
  </required_header>
  <id_info>
    <org_study_id>LipoOA</org_study_id>
    <nct_id>NCT04427657</nct_id>
  </id_info>
  <brief_title>Use of Lipogems for Knee Osteoarthritis</brief_title>
  <official_title>Adipose Microfragmented Autologous Tissue for the Treatment of Knee Osteoarthritis</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Lipogems system consist in the use of a monouse kit for liposuction, processing and&#xD;
      administration of adipose tissue. The use of the final product (microfragmented adipose&#xD;
      tissue,not expanded) shoud promote the natural joint homeostasis, associated with a clinical&#xD;
      improvement&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Objectiveof the study is to analyse the therapeutic role of microfragmented autologous&#xD;
      tissue for the treatment of the knee osteoarthritis (OA).&#xD;
&#xD;
      Main purpose: Symptomatic and functional evaluation at 6 months by comparison of the Knee&#xD;
      Injury and Osteoarthritis Outcome Score(KOOS) recorded between two groups (6±1 months)&#xD;
      undergoing arthroscopic debridement ± injection of autologous microfragmented lipoaspirate&#xD;
      tissue (Lipogems®).&#xD;
&#xD;
      Secondary Purposes: Evaluation of possible radiological changes pre-operative and after 6±1&#xD;
      months by means of MagneticResonanceImage analysis. Symptomatic and functional evaluation at&#xD;
      6±1 months by means of VisualAnalogueScale, KneeSocietyScore, Western Ontario and McMaster&#xD;
      Universities Osteoarthritis Index(WOMAC). Reduction of anti-inflammatory drugs&#xD;
      (pre-intervention versus 6±1 months). Evaluation &quot;quality-adjusted life years&quot; (QUALY) in&#xD;
      relation to the questionnaire SatisfactioForm-12 (pre-intervention vs 6±1 months). Check for&#xD;
      any adverse effects directly related to the use of micro-fragmented adipose tissue. Changes&#xD;
      in serum levels of biomarkers related to OA (CollagenType II C-Telopeptide (CTX-II), collagen&#xD;
      type III N-propeptide (PIIINP)) will be evaluated (pre-intervention vs 6±1 months).&#xD;
&#xD;
      The study is an interventional, prospective, randomized, controlled trial. Controls: n = 39&#xD;
      patients with knee osteoarthritis undergoing arthroscopic debridement. Cases: n = 39 patients&#xD;
      with knee osteoarthritis undergoing arthroscopic debridement surgery + intrarticular&#xD;
      injection of autologous microfragmented lipoaspirate tissue (Lipogems®).&#xD;
&#xD;
      Surgical technique: patient in supine position. A double contemporary operating fields is&#xD;
      made under sedation. During arthroscopic debridement is made an injection of local anesthetic&#xD;
      at the dermal level with a subcutaneous infiltration of Klein solution. The plastic surgeon&#xD;
      wait for about 5 minutes for vasoconstriction and then start with liposuction of about 60 ml&#xD;
      of adipose tissue. Then lipoaspirate was processed with Lipogems® technique that consist in a&#xD;
      mechanical fragmentation, physiological washing and filter passage of the lipoaspirate. A&#xD;
      volume of 8-9 ml of microfragmented adipose tissue was injected intra-articulary after&#xD;
      arthroscopic debridement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 8, 2018</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Symptomatic and functional evaluation at 6 months by comparison of the KOOS score recorded between the two groups</measure>
    <time_frame>6 month</time_frame>
    <description>Symptomatic and functional evaluation at 6 months by comparison of the KOOS score recorded between two groups (6±1 months) undergoing arthroscopic debridement ± injection of autologous microfragmented lipoaspirate tissue (Lipogems®).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiological changes at 6 month recorded between the two groups</measure>
    <time_frame>6 month</time_frame>
    <description>Evaluation of possible radiological changes pre-operative and after 6±1 months by means of MagneticResonanceImaging analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional changes at 6 month recorded between the two groups</measure>
    <time_frame>6 month</time_frame>
    <description>Symptomatic and functional evaluation at 6±1 months by means of Proms that inclued questionnaire about quality of life (SF-12, WOMAC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum changes at 6 month recorded between the two groups</measure>
    <time_frame>6 month</time_frame>
    <description>Changes in serum levels of biomarkers related to Osteoarthritis (collagen type II C-telopeptide(CTx-II),collagen type III N-propeptide( PIIINP)) will be evaluated (pre-intervention vs 6±1 months).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>39 patients with knee osteoarthritis undergoing arthroscopic debridement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cases</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>39 patients with knee osteoarthritis undergoing arthroscopic debridement surgery + intrarticular injection of autologous microfragmented lipoaspirate tissue (Lipogems®).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>autologous microfragmented lipoaspirate tissue (Lipogems®).</intervention_name>
    <description>patient in supine position. A double contemporary operating fields is made under sedation. During arthroscopic debridement is made an injection of local anesthetic at the dermal level with a subcutaneous infiltration of Klein solution. The plastic surgeon wait for about 5 minutes for vasoconstriction and then start with liposuction of about 60 ml of adipose tissue. Then lipoaspirate was processed with Lipogems® technique that consist in a mechanical fragmentation, physiological washing and filter passage of the lipoaspirate. A volume of 8-9 ml of microfragmented adipose tissue was injected intra-articulary after arthroscopic debridement.</description>
    <arm_group_label>Cases</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>arthroscopic debridment</intervention_name>
    <description>patient in supine position. Under sedation is perform an arthroscopic debridement</description>
    <arm_group_label>Controls</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with knee osteoarthritis grade III e IV Kellgren-Lawrence,&#xD;
&#xD;
          -  age between 45 and 75,&#xD;
&#xD;
          -  pain ≥ 6 VAS scale,&#xD;
&#xD;
          -  no ligamentous instability,axial deviation less than 10°&#xD;
&#xD;
          -  BMI between 18 and 30,&#xD;
&#xD;
          -  International Normalized Ratio (INR) &lt; 1.5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous traumatic lesion (tibial fracture, osteothomy) of the knee&#xD;
&#xD;
          -  osteonecrosis&#xD;
&#xD;
          -  meniscal surgery in the previous 6 weeks&#xD;
&#xD;
          -  chemiotherapy, radioteherapy&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  alchoolism, psichiatric disease,drug addiction&#xD;
&#xD;
          -  coagulation disorders&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>michele ulivi</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Istituto Ortopedico GaleazziMilano</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istituto Ortopedico Galeazzi</name>
      <address>
        <city>Milano</city>
        <zip>20161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Istituto Ortopedico Galeazzi</name>
      <address>
        <city>Milan</city>
        <zip>20161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>April 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 2, 2021</last_update_submitted>
  <last_update_submitted_qc>July 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2021</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>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</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/NCT04427657
org study id: LipoOA
nct id: NCT04427657
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Lipogems system consist in the use of a monouse kit for liposuction, processing and
      administration of adipose tissue. The use of the final product (microfragmented adipose
      tissue,not expanded) shoud promote the natural joint homeostasis, associated with a clinical
      improvement
The Objectiveof the study is to analyse the therapeutic role of microfragmented autologous
      tissue for the treatment of the knee osteoarthritis (OA).

      Main purpose: Symptomatic and functional evaluation at 6 months by comparison of the Knee
      Injury and Osteoarthritis Outcome Score(KOOS) recorded between two groups (6±1 months)
      undergoing arthroscopic debridement ± injection of autologous microfragmented lipoaspirate
      tissue (Lipogems®).

      Secondary Purposes: Evaluation of possible radiological changes pre-operative and after 6±1
      months by means of MagneticResonanceImage analysis. Symptomatic and functional evaluation at
      6±1 months by means of VisualAnalogueScale, KneeSocietyScore, Western Ontario and McMaster
      Universities Osteoarthritis Index(WOMAC). Reduction of anti-inflammatory drugs
      (pre-intervention versus 6±1 months). Evaluation "quality-adjusted life years" (QUALY) in
      relation to the questionnaire SatisfactioForm-12 (pre-intervention vs 6±1 months). Check for
      any adverse effects directly related to the use of micro-fragmented adipose tissue. Changes
      in serum levels of biomarkers related to OA (CollagenType II C-Telopeptide (CTX-II), collagen
      type III N-propeptide (PIIINP)) will be evaluated (pre-intervention vs 6±1 months).

      The study is an interventional, prospective, randomized, controlled trial. Controls: n = 39
      patients with knee osteoarthritis undergoing arthroscopic debridement. Cases: n = 39 patients
      with knee osteoarthritis undergoing arthroscopic debridement surgery + intrarticular
      injection of autologous microfragmented lipoaspirate tissue (Lipogems®).

      Surgical technique: patient in supine position. A double contemporary operating fields is
      made under sedation. During arthroscopic debridement is made an injection of local anesthetic
      at the dermal level with a subcutaneous infiltration of Klein solution. The plastic surgeon
      wait for about 5 minutes for vasoconstriction and then start with liposuction of about 60 ml
      of adipose tissue. Then lipoaspirate was processed with Lipogems® technique that consist in a
      mechanical fragmentation, physiological washing and filter passage of the lipoaspirate. A
      volume of 8-9 ml of microfragmented adipose tissue was injected intra-articulary after
      arthroscopic debridement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Symptomatic and functional evaluation at 6 months by comparison of the KOOS score recorded between the two groups
time frame: 6 month
description: Symptomatic and functional evaluation at 6 months by comparison of the KOOS score recorded between two groups (6±1 months) undergoing arthroscopic debridement ± injection of autologous microfragmented lipoaspirate tissue (Lipogems®).
measure: Radiological changes at 6 month recorded between the two groups
time frame: 6 month
description: Evaluation of possible radiological changes pre-operative and after 6±1 months by means of MagneticResonanceImaging analysis.
measure: Functional changes at 6 month recorded between the two groups
time frame: 6 month
description: Symptomatic and functional evaluation at 6±1 months by means of Proms that inclued questionnaire about quality of life (SF-12, WOMAC)
measure: Serum changes at 6 month recorded between the two groups
time frame: 6 month
description: Changes in serum levels of biomarkers related to Osteoarthritis (collagen type II C-telopeptide(CTx-II),collagen type III N-propeptide( PIIINP)) will be evaluated (pre-intervention vs 6±1 months).
arm group label: Controls
arm group type: Active Comparator
description: 39 patients with knee osteoarthritis undergoing arthroscopic debridement
arm group label: Cases
arm group type: Experimental
description: 39 patients with knee osteoarthritis undergoing arthroscopic debridement surgery + intrarticular injection of autologous microfragmented lipoaspirate tissue (Lipogems®).
intervention type: Procedure
intervention name: autologous microfragmented lipoaspirate tissue (Lipogems®).
description: patient in supine position. A double contemporary operating fields is made under sedation. During arthroscopic debridement is made an injection of local anesthetic at the dermal level with a subcutaneous infiltration of Klein solution. The plastic surgeon wait for about 5 minutes for vasoconstriction and then start with liposuction of about 60 ml of adipose tissue. Then lipoaspirate was processed with Lipogems® technique that consist in a mechanical fragmentation, physiological washing and filter passage of the lipoaspirate. A volume of 8-9 ml of microfragmented adipose tissue was injected intra-articulary after arthroscopic debridement.
arm group label: Cases
intervention type: Procedure
intervention name: arthroscopic debridment
description: patient in supine position. Under sedation is perform an arthroscopic debridement
arm group label: Controls
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: michele ulivi
role: Principal Investigator
affiliation: IRCCS Istituto Ortopedico GaleazziMilano
facility: 
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee