xml: <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/NCT06028763</url>
    </required_header>
    <id_info>
      <org_study_id>AP19679620</org_study_id>
      <nct_id>NCT06028763</nct_id>
    </id_info>
    <brief_title>Comparative Study of Heparin-Conjugated Gel vs. Microfracture for Surgical Treatment of Ankle Joint Cartilage Lesions</brief_title>
    <official_title>Development of Biomedical Technology for the Treatment of Ankle Cartilage Using Injectable Biocomposite Hydrogel</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Scientific Center of Traumatology and Orthopedics named after academician N.D. Batpenov</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Scientific Center of Traumatology and Orthopedics named after academician N.D. Batpenov</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>
        This study aims to evaluate the effectiveness of heparin-conjugated gel for treating ankle&#xD;
        joint cartilage lesions compared to the conventional microfracture method. It involves 40&#xD;
        participants aged 18 to 65 with localized cartilage defects (Outerbridge II-IV) in the&#xD;
        ankle's talus bone.&#xD;
  &#xD;
        Participants will be divided into two groups: the main group and the control group. The main&#xD;
        group will undergo a two-stage process. Initially, adipose tissue will be collected via&#xD;
        lipoaspiration from osteoarthritis patients. This tissue will be used to isolate mesenchymal&#xD;
        stem cells (MSCs) and extract growth factors, resulting in a biocomposite hydrogel. In the&#xD;
        second stage, arthroscopy will be performed to apply the hydrogel for cartilage treatment.&#xD;
  &#xD;
        The control group will undergo standard microfracture surgery, a known cartilage repair&#xD;
        method.&#xD;
  &#xD;
        The study's main objective is to compare heparin-conjugated gel treatment to microfracture in&#xD;
        terms of cartilage repair and patient outcomes. A 12-month follow-up will assess short-term&#xD;
        and potential mid-term effects.&#xD;
  &#xD;
        Data will be analyzed using Microsoft Excel and Statistica 13.0 for descriptive and&#xD;
        comprehensive statistical analysis. Quantitative indicators will be assessed using&#xD;
        appropriate tests (Mann-Whitney, Wilcoxon T, χ2) to determine significant differences between&#xD;
        groups.&#xD;
  &#xD;
        The study addresses key questions: Does heparin-conjugated gel offer better cartilage repair,&#xD;
        functional improvement, and pain reduction than microfracture? Does the hydrogel approach&#xD;
        better preserve joint integrity and slow degeneration? Are there complications with either&#xD;
        method? This study combines cellular and surgical components to explore innovative cartilage&#xD;
        lesion treatments. Comparing with microfracture and using a thorough follow-up, it aims to&#xD;
        enhance cartilage repair techniques and patient outcomes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Introduction:&#xD;
  &#xD;
        This prospective clinical study aims to investigate the effectiveness of heparin-conjugated&#xD;
        gel in treating patients with ankle joint cartilage lesions and to compare its outcomes with&#xD;
        the traditional method of microfracture. The study aims to provide valuable insights into&#xD;
        novel treatment options for cartilage repair.&#xD;
  &#xD;
        Study Design and Participants:&#xD;
  &#xD;
        The study plans to enroll 40 male and female patients aged 18 to 65 years with localized&#xD;
        defects in the articular cartilage of the talus bone (Outerbridge II-IV) within the ankle&#xD;
        joint. Participants will be evenly divided into two groups: the main group and the control&#xD;
        group, each comprising 20 participants.&#xD;
  &#xD;
        Interventions:&#xD;
  &#xD;
        Main Group:&#xD;
  &#xD;
        In the main group, participants will undergo a comprehensive two-stage treatment approach:&#xD;
  &#xD;
        Stage 1 - Biocomposite Hydrogel Preparation:&#xD;
  &#xD;
        Subcutaneous adipose tissue will be collected from patients with signs of ankle joint&#xD;
        osteoarthritis through lipoaspiration. The extracted tissue will be transferred to the Kazakh&#xD;
        National Center of Biotechnology (Astana, Kazakhstan) for the isolation and cultivation of&#xD;
        mesenchymal stromal cells (MSCs). A biocomposite hydrogel, containing MSCs and growth factors&#xD;
        (TGF-β1 and BMP-4), will be obtained.&#xD;
  &#xD;
        Stage 2 - Arthroscopic Cartilage Therapy:&#xD;
  &#xD;
        Participants will undergo arthroscopy of the ankle joint. A heparin-conjugated fibrin&#xD;
        hydrogel enriched with MSCs and growth factors will be applied to treat cartilage pathology.&#xD;
  &#xD;
        Control Group:&#xD;
  &#xD;
        The control group will receive the standard microfracture procedure for ankle cartilage&#xD;
        lesion under arthroscopic control.&#xD;
  &#xD;
        Follow-Up and Safety Assessment:&#xD;
  &#xD;
        A 12-month follow-up period will be implemented to assess short-term and potential mid-term&#xD;
        effects. Safety assessment of the heparin-conjugated hydrogel will be based on clinical wound&#xD;
        healing assessment, local joint changes, and laboratory data (ESR, white blood cell count,&#xD;
        C-reactive protein) 5-7 days post-surgery.&#xD;
  &#xD;
        Clinical Evaluation:&#xD;
  &#xD;
        The therapeutic efficacy of the heparin-conjugated hydrogel will be evaluated using clinical&#xD;
        scales and questionnaires, including the American Orthopedic Foot and Ankle Score (AOFAS) and&#xD;
        Visual Analogue Scale (VAS) for joint function and quality of life assessment.&#xD;
  &#xD;
        Imaging and Rehabilitation:&#xD;
  &#xD;
        Prior to surgery, patients will undergo magnetic resonance imaging (MRI) for defect&#xD;
        confirmation and dimension assessment using The Magnetic Resonance Observation of Cartage&#xD;
        Repair Tissue (MOCART) scale. Postoperative rehabilitation will be tailored individually&#xD;
        based on defect characteristics and patient progress. Axial load on the operated limb will be&#xD;
        limited for 6 weeks. Gradual weight-bearing will occur from the 6th to the 12th week.&#xD;
  &#xD;
        Postoperative Monitoring:&#xD;
  &#xD;
        Cartilage condition and joint health will be monitored postoperatively. Hydrogel survival and&#xD;
        cartilage defect closure will be observed using MRI at 6 and 12 months.&#xD;
  &#xD;
        Data Analysis:&#xD;
  &#xD;
        Statistical analysis will use Microsoft Excel and Statistica 13.0. Descriptive statistics&#xD;
        methods will calculate means (M) for parametric indicators, medians (Me) and interquartile&#xD;
        ranges (Q25-Q75) for non-parametric indicators, and standard deviations (SD). The&#xD;
        Mann-Whitney and Wilcoxon T criteria will assess quantitative differences. The χ2 criterion&#xD;
        will assess qualitative parameters. Significance will be considered at p&lt;0.05.&#xD;
  &#xD;
        Conclusion:&#xD;
  &#xD;
        This study's rigorous design aims to contribute to understanding the effectiveness of&#xD;
        heparin-conjugated gel for ankle cartilage repair, offering potential improvements over&#xD;
        traditional microfracture. Insights gained from this study may lead to enhanced treatment&#xD;
        options for patients with cartilage lesions in the ankle joint.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 29, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>40 participants will divide into 2 groups main and control. Main group (n=20): implantation of heparin-conjugated fibrin hydrogel with autologous MSCs and growth factors (TGF-β1 and BMP-4) into the cartilage defect during arthroscopy.&#xD;
  Control group (n=20): arthroscopic debridement of the joint with microfracturing (traditional method of treatment).</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The American Orthopedic Foot and Ankle Score</measure>
      <time_frame>6; 12 months after surgery</time_frame>
      <description>The American Orthopedic Foot and Ankle Score (AOFAS) is a widely used outcome measure designed to assess the functional status and pain levels of patients with foot and ankle disorders. It provides a standardized way to quantify the impact of musculoskeletal conditions on patients' daily lives. The AOFAS score involves a questionnaire that includes various domains related to pain, function, and alignment of the foot and ankle. Patients provide responses to questions about their ability to perform specific activities, their pain levels, and their overall satisfaction with the function of their foot and ankle. The AOFAS score is calculated based on the patient's responses, with higher scores indicating better functional status, less pain, and higher satisfaction. This outcome measure is commonly used in clinical research and practice to assess the effectiveness of interventions and treatments for foot and ankle conditions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Visual Analogue Scale</measure>
      <time_frame>6; 12 months after surgery</time_frame>
      <description>The Visual Analogue Scale (VAS) is a simple and commonly used method to assess the intensity or severity of subjective experiences, such as pain or discomfort. It involves a horizontal line with endpoints representing different levels of the experience being measured. Participants are asked to place a mark on the line to indicate the intensity of their experience, with one endpoint indicating no experience (e.g., no pain) and the other endpoint indicating the maximum possible experience (e.g., worst imaginable pain). The distance from the &quot;no experience&quot; end of the line to the participant's mark is then measured to quantify the intensity on a continuous scale. VAS provides a quick and easy way to gather subjective information and is often used in clinical settings and research studies to assess various sensations and perceptions.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Magnetic resonance imaging of ankle</measure>
      <time_frame>6; 12 months after surgery</time_frame>
      <description>To confirm the presence of a cartilage tissue defect, determine its localization and preliminary dimensions, and interpret the results according to The Magnetic Resonance Observation of Cartage Repair Tissue (MOCART) scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complete Blood Count</measure>
      <time_frame>5 days after surgery</time_frame>
      <description>A Complete Blood Count (CBC) is a comprehensive blood test that evaluates various components of blood, including red blood cells, white blood cells, and platelets. It provides essential information about the health and composition of the blood. In your case, you're particularly interested in assessing the level of erythrocyte sedimentation rate (ESR) and white blood cell count. The ESR measures the rate at which red blood cells settle in a tube of blood and is often used as a marker of inflammation. The white blood cell count measures the number of white blood cells in a given volume of blood and can indicate immune system function and potential infections. By including these specific parameters in the CBC, you aim to gain insights into inflammation levels and immune responses in the body</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>C-reactive protein</measure>
      <time_frame>5 days after surgery</time_frame>
      <description>C-reactive protein (CRP) test plays a crucial role in monitoring the body's response to the surgical procedure. CRP is a protein produced by the liver in response to inflammation. After surgery, the body's immune system reacts to the surgical trauma, causing inflammation at the surgical site. Elevated CRP levels suggest that inflammation is present, which is a normal part of the healing process following surgery. However, extremely high or prolonged CRP levels could indicate excessive or prolonged inflammation, which might raise concerns about potential complications such as infection or poor wound healing.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Ankle Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>Group 1 (main)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Treatment consists of 2 stages. 1 stage starts with lipoaspiration of subcutaneous adipose tissue from patients. This tissue will then undergo Mesenchymal Stem Cells (MSC) isolation, cultivation and become a biocomposite hydrogel with growth factors. The 2 stage involves ankle joint arthroscopy using the hydrogel for cartilage therapy. To ensure proper hydrogel fixation, we'll clean cartilage remnants, remove fibrous tissue, and create 10mm deep, 2.5mm diameter microperforations. Cartilage donor site prep during arthroscopy will remove non-viable tissue and establish communication with underlying bone marrow. After stopping bleeding, heparin-conjugated fibrin hydrogel with MSCs and growth factors (TGF-β1 and BMP-4) will be implanted using epinephrine-soaked gauze. Hydrogel gels in 3-5 mins. Ankle joint movement tests will confirm successful implantation. Joint stability, articular congruence, and joint condition will be inspected.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2 (control)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients from control group will undergo arthroscopic debridement of the joint with microfracturing (traditional method of treatment).</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Injection of biocomposite hydrogel into ankle's cartilage lesion under arthroscopic control</intervention_name>
      <description>Surgical treatment involves the use of an injectable biocomposite hydrogel containing autologous mesenchymal stem cells (MSCs), adipose tissue-derived cells, and chondroinductive growth factors (TGF-β1 and BMP-4) under arthroscopic control</description>
      <arm_group_label>Group 1 (main)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Microfracture of ankle's cartilage lesion under arthroscopic control</intervention_name>
      <description>Microfracture involves creating tiny perforations in the damaged cartilage, exposing the underlying bone. This encourages the formation of a healing response, where blood and bone marrow cells fill the holes, forming a repair tissue known as fibrocartilage. This newly formed tissue aims to improve joint function and alleviate symptoms associated with cartilage damage. The procedure is performed under arthroscopic guidance, allowing for precise targeting of the lesion while minimizing trauma to the surrounding tissues.</description>
      <arm_group_label>Group 2 (control)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with a local defect of articular cartilage of the talus bone (Outerbridge&#xD;
               II-IV) of the ankle joint;&#xD;
  &#xD;
            -  an area of no more than 3 cm2 for a single defect or 20 cm2 for multiple defects of&#xD;
               the cartilaginous tissue of the talus bone of the ankle joint;&#xD;
  &#xD;
            -  voluntary consent to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  age 18&lt; and &gt;65&#xD;
  &#xD;
            -  progressive osteoarthritis of the ankle joint in the late stages;&#xD;
  &#xD;
            -  synovitis of the ankle joint;&#xD;
  &#xD;
            -  instability of the ankle joint;&#xD;
  &#xD;
            -  BMI&lt;29.9;&#xD;
  &#xD;
            -  presence of non-sanitized foci of chronic infection;&#xD;
  &#xD;
            -  severe mental illnesses (schizophrenia, psycho-organic syndrome);&#xD;
  &#xD;
            -  hormonal osteopathy;&#xD;
  &#xD;
            -  hemiparesis on the side of the proposed operation;&#xD;
  &#xD;
            -  neoplasms of other localizations with or without metastases;&#xD;
  &#xD;
            -  absence (refusal) of voluntary consent to participate in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Dina Saginova, PhD</last_name>
      <phone>+77015998758</phone>
      <email>sa_dina@mail.ru</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Meruyert Makhmetova, PhD Student</last_name>
      <phone>+77011675975</phone>
      <email>meruert1995@mail.ru</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Center of National Scientific center Of Traumatology and Orthopedics named after academician N.D. Batpenov</name>
        <address>
          <city>Astana</city>
          <zip>Z00P5Y5</zip>
          <country>Kazakhstan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Olzhas Bekarissov, PhD</last_name>
        <phone>+77172547717</phone>
        <email>bekarisov_o@nscto.kz</email>
      </contact>
    </location>
    <location_countries>
      <country>Kazakhstan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Cartilage lesions</keyword>
    <keyword>Osteoarthritis</keyword>
    <keyword>Mesenchymal stem cells</keyword>
    <keyword>Ankle arthroscopy</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>
  
  
text: 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/NCT06028763
  org study id: AP19679620
  nct id: NCT06028763
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to evaluate the effectiveness of heparin-conjugated gel for treating ankle
        joint cartilage lesions compared to the conventional microfracture method. It involves 40
        participants aged 18 to 65 with localized cartilage defects (Outerbridge II-IV) in the
        ankle's talus bone.
  
        Participants will be divided into two groups: the main group and the control group. The main
        group will undergo a two-stage process. Initially, adipose tissue will be collected via
        lipoaspiration from osteoarthritis patients. This tissue will be used to isolate mesenchymal
        stem cells (MSCs) and extract growth factors, resulting in a biocomposite hydrogel. In the
        second stage, arthroscopy will be performed to apply the hydrogel for cartilage treatment.
  
        The control group will undergo standard microfracture surgery, a known cartilage repair
        method.
  
        The study's main objective is to compare heparin-conjugated gel treatment to microfracture in
        terms of cartilage repair and patient outcomes. A 12-month follow-up will assess short-term
        and potential mid-term effects.
  
        Data will be analyzed using Microsoft Excel and Statistica 13.0 for descriptive and
        comprehensive statistical analysis. Quantitative indicators will be assessed using
        appropriate tests (Mann-Whitney, Wilcoxon T, χ2) to determine significant differences between
        groups.
  
        The study addresses key questions: Does heparin-conjugated gel offer better cartilage repair,
        functional improvement, and pain reduction than microfracture? Does the hydrogel approach
        better preserve joint integrity and slow degeneration? Are there complications with either
        method? This study combines cellular and surgical components to explore innovative cartilage
        lesion treatments. Comparing with microfracture and using a thorough follow-up, it aims to
        enhance cartilage repair techniques and patient outcomes.
  Introduction:
  
        This prospective clinical study aims to investigate the effectiveness of heparin-conjugated
        gel in treating patients with ankle joint cartilage lesions and to compare its outcomes with
        the traditional method of microfracture. The study aims to provide valuable insights into
        novel treatment options for cartilage repair.
  
        Study Design and Participants:
  
        The study plans to enroll 40 male and female patients aged 18 to 65 years with localized
        defects in the articular cartilage of the talus bone (Outerbridge II-IV) within the ankle
        joint. Participants will be evenly divided into two groups: the main group and the control
        group, each comprising 20 participants.
  
        Interventions:
  
        Main Group:
  
        In the main group, participants will undergo a comprehensive two-stage treatment approach:
  
        Stage 1 - Biocomposite Hydrogel Preparation:
  
        Subcutaneous adipose tissue will be collected from patients with signs of ankle joint
        osteoarthritis through lipoaspiration. The extracted tissue will be transferred to the Kazakh
        National Center of Biotechnology (Astana, Kazakhstan) for the isolation and cultivation of
        mesenchymal stromal cells (MSCs). A biocomposite hydrogel, containing MSCs and growth factors
        (TGF-β1 and BMP-4), will be obtained.
  
        Stage 2 - Arthroscopic Cartilage Therapy:
  
        Participants will undergo arthroscopy of the ankle joint. A heparin-conjugated fibrin
        hydrogel enriched with MSCs and growth factors will be applied to treat cartilage pathology.
  
        Control Group:
  
        The control group will receive the standard microfracture procedure for ankle cartilage
        lesion under arthroscopic control.
  
        Follow-Up and Safety Assessment:
  
        A 12-month follow-up period will be implemented to assess short-term and potential mid-term
        effects. Safety assessment of the heparin-conjugated hydrogel will be based on clinical wound
        healing assessment, local joint changes, and laboratory data (ESR, white blood cell count,
        C-reactive protein) 5-7 days post-surgery.
  
        Clinical Evaluation:
  
        The therapeutic efficacy of the heparin-conjugated hydrogel will be evaluated using clinical
        scales and questionnaires, including the American Orthopedic Foot and Ankle Score (AOFAS) and
        Visual Analogue Scale (VAS) for joint function and quality of life assessment.
  
        Imaging and Rehabilitation:
  
        Prior to surgery, patients will undergo magnetic resonance imaging (MRI) for defect
        confirmation and dimension assessment using The Magnetic Resonance Observation of Cartage
        Repair Tissue (MOCART) scale. Postoperative rehabilitation will be tailored individually
        based on defect characteristics and patient progress. Axial load on the operated limb will be
        limited for 6 weeks. Gradual weight-bearing will occur from the 6th to the 12th week.
  
        Postoperative Monitoring:
  
        Cartilage condition and joint health will be monitored postoperatively. Hydrogel survival and
        cartilage defect closure will be observed using MRI at 6 and 12 months.
  
        Data Analysis:
  
        Statistical analysis will use Microsoft Excel and Statistica 13.0. Descriptive statistics
        methods will calculate means (M) for parametric indicators, medians (Me) and interquartile
        ranges (Q25-Q75) for non-parametric indicators, and standard deviations (SD). The
        Mann-Whitney and Wilcoxon T criteria will assess quantitative differences. The χ2 criterion
        will assess qualitative parameters. Significance will be considered at p<0.05.
  
        Conclusion:
  
        This study's rigorous design aims to contribute to understanding the effectiveness of
        heparin-conjugated gel for ankle cartilage repair, offering potential improvements over
        traditional microfracture. Insights gained from this study may lead to enhanced treatment
        options for patients with cartilage lesions in the ankle joint.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: 40 participants will divide into 2 groups main and control. Main group (n=20): implantation of heparin-conjugated fibrin hydrogel with autologous MSCs and growth factors (TGF-β1 and BMP-4) into the cartilage defect during arthroscopy.
  Control group (n=20): arthroscopic debridement of the joint with microfracturing (traditional method of treatment).
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The American Orthopedic Foot and Ankle Score
  time frame: 6; 12 months after surgery
  description: The American Orthopedic Foot and Ankle Score (AOFAS) is a widely used outcome measure designed to assess the functional status and pain levels of patients with foot and ankle disorders. It provides a standardized way to quantify the impact of musculoskeletal conditions on patients' daily lives. The AOFAS score involves a questionnaire that includes various domains related to pain, function, and alignment of the foot and ankle. Patients provide responses to questions about their ability to perform specific activities, their pain levels, and their overall satisfaction with the function of their foot and ankle. The AOFAS score is calculated based on the patient's responses, with higher scores indicating better functional status, less pain, and higher satisfaction. This outcome measure is commonly used in clinical research and practice to assess the effectiveness of interventions and treatments for foot and ankle conditions.
  measure: Visual Analogue Scale
  time frame: 6; 12 months after surgery
  description: The Visual Analogue Scale (VAS) is a simple and commonly used method to assess the intensity or severity of subjective experiences, such as pain or discomfort. It involves a horizontal line with endpoints representing different levels of the experience being measured. Participants are asked to place a mark on the line to indicate the intensity of their experience, with one endpoint indicating no experience (e.g., no pain) and the other endpoint indicating the maximum possible experience (e.g., worst imaginable pain). The distance from the "no experience" end of the line to the participant's mark is then measured to quantify the intensity on a continuous scale. VAS provides a quick and easy way to gather subjective information and is often used in clinical settings and research studies to assess various sensations and perceptions.
  measure: Magnetic resonance imaging of ankle
  time frame: 6; 12 months after surgery
  description: To confirm the presence of a cartilage tissue defect, determine its localization and preliminary dimensions, and interpret the results according to The Magnetic Resonance Observation of Cartage Repair Tissue (MOCART) scale.
  measure: Complete Blood Count
  time frame: 5 days after surgery
  description: A Complete Blood Count (CBC) is a comprehensive blood test that evaluates various components of blood, including red blood cells, white blood cells, and platelets. It provides essential information about the health and composition of the blood. In your case, you're particularly interested in assessing the level of erythrocyte sedimentation rate (ESR) and white blood cell count. The ESR measures the rate at which red blood cells settle in a tube of blood and is often used as a marker of inflammation. The white blood cell count measures the number of white blood cells in a given volume of blood and can indicate immune system function and potential infections. By including these specific parameters in the CBC, you aim to gain insights into inflammation levels and immune responses in the body
  measure: C-reactive protein
  time frame: 5 days after surgery
  description: C-reactive protein (CRP) test plays a crucial role in monitoring the body's response to the surgical procedure. CRP is a protein produced by the liver in response to inflammation. After surgery, the body's immune system reacts to the surgical trauma, causing inflammation at the surgical site. Elevated CRP levels suggest that inflammation is present, which is a normal part of the healing process following surgery. However, extremely high or prolonged CRP levels could indicate excessive or prolonged inflammation, which might raise concerns about potential complications such as infection or poor wound healing.
  arm group label: Group 1 (main)
  arm group type: Experimental
  description: Treatment consists of 2 stages. 1 stage starts with lipoaspiration of subcutaneous adipose tissue from patients. This tissue will then undergo Mesenchymal Stem Cells (MSC) isolation, cultivation and become a biocomposite hydrogel with growth factors. The 2 stage involves ankle joint arthroscopy using the hydrogel for cartilage therapy. To ensure proper hydrogel fixation, we'll clean cartilage remnants, remove fibrous tissue, and create 10mm deep, 2.5mm diameter microperforations. Cartilage donor site prep during arthroscopy will remove non-viable tissue and establish communication with underlying bone marrow. After stopping bleeding, heparin-conjugated fibrin hydrogel with MSCs and growth factors (TGF-β1 and BMP-4) will be implanted using epinephrine-soaked gauze. Hydrogel gels in 3-5 mins. Ankle joint movement tests will confirm successful implantation. Joint stability, articular congruence, and joint condition will be inspected.
  arm group label: Group 2 (control)
  arm group type: Active Comparator
  description: Patients from control group will undergo arthroscopic debridement of the joint with microfracturing (traditional method of treatment).
  intervention type: Procedure
  intervention name: Injection of biocomposite hydrogel into ankle's cartilage lesion under arthroscopic control
  description: Surgical treatment involves the use of an injectable biocomposite hydrogel containing autologous mesenchymal stem cells (MSCs), adipose tissue-derived cells, and chondroinductive growth factors (TGF-β1 and BMP-4) under arthroscopic control
  arm group label: Group 1 (main)
  intervention type: Procedure
  intervention name: Microfracture of ankle's cartilage lesion under arthroscopic control
  description: Microfracture involves creating tiny perforations in the damaged cartilage, exposing the underlying bone. This encourages the formation of a healing response, where blood and bone marrow cells fill the holes, forming a repair tissue known as fibrocartilage. This newly formed tissue aims to improve joint function and alleviate symptoms associated with cartilage damage. The procedure is performed under arthroscopic guidance, allowing for precise targeting of the lesion while minimizing trauma to the surrounding tissues.
  arm group label: Group 2 (control)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Dina Saginova, PhD
  phone: +77015998758
  email: sa_dina@mail.ru
  last name: Meruyert Makhmetova, PhD Student
  phone: +77011675975
  email: meruert1995@mail.ru
  facility: 
  status: Recruiting
  contact: 
  country: Kazakhstan
  responsible party type: Sponsor
  mesh term: Osteoarthritis
  sharing ipd: No