<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/NCT03036878</url>
  </required_header>
  <id_info>
    <org_study_id>RD-2016-04-02</org_study_id>
    <nct_id>NCT03036878</nct_id>
  </id_info>
  <brief_title>ReNu™ Marrow Stimulation Augmentation</brief_title>
  <official_title>Evaluation of the ReNu™ Amniotic Suspension Allograft After Marrow Stimulation in the Treatment of Osteochondral Defects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NuTech Medical, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Organogenesis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>NuTech Medical, Inc</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>
      To evaluate the use of ReNu™ allograft for the augmentation of marrow stimulation for&#xD;
      osteochondral lesions&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, non-randomized, longitudinal study of up to 8 evaluable participants&#xD;
      recruited from two separate practices. Male and non-pregnant female patients between the ages&#xD;
      of 18 and 55 years of age will be screened for study recruitment. Female patients must be&#xD;
      actively practicing a contraception method, abstinence, be surgically sterilized, or be&#xD;
      postmenopausal. Participants will receive ReNu™ as an adjunct to their standard of care&#xD;
      marrow stimulation for the treatment of osteochondral defects.&#xD;
&#xD;
      At each follow-up visit, concomitant medications and adverse events shall be collected from&#xD;
      each subject, and each subject shall complete the following questionnaires:&#xD;
&#xD;
      IKDC Health Assessment (Includes Short Form-36) Tegner KOOS Knee Survey VAS Pain Scale SANE&#xD;
      score&#xD;
&#xD;
      The subjects will be assessed at Baseline using these scales an again at all subsequent study&#xD;
      follow-up visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Closed for lack of enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">February 7, 2017</start_date>
  <completion_date type="Actual">December 6, 2019</completion_date>
  <primary_completion_date type="Actual">December 6, 2019</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>Change in KOOS score from baseline</measure>
    <time_frame>1 Year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Tegner score from baseline</measure>
    <time_frame>1 Year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in VAS score from baseline</measure>
    <time_frame>6, 12 &amp; 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Tegner score from baseline</measure>
    <time_frame>6 &amp; 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SANE score from baseline</measure>
    <time_frame>6, 12 &amp; 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in KOOS score from baseline</measure>
    <time_frame>6 &amp; 24 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Osteochondral Defect</condition>
  <arm_group>
    <arm_group_label>ReNu Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Injection of ReNu allograft into the joint capsule.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ReNu</intervention_name>
    <description>ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.</description>
    <arm_group_label>ReNu Injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Voluntary signature of the IRB approved Informed Consent&#xD;
&#xD;
          2. Male or female participants between the ages of 18-55&#xD;
&#xD;
          3. If female:&#xD;
&#xD;
               1. Actively practicing a contraception method, or&#xD;
&#xD;
               2. Practicing abstinence, or&#xD;
&#xD;
               3. Surgically sterilized, or&#xD;
&#xD;
               4. Postmenopausal&#xD;
&#xD;
          4. Pretreatment arthroscopic confirmation indicating one or two contained lesion(s) and&#xD;
             equal to an ICRS Grade 3a, 3b, 3c, 3d of the femoral condyle, patella, or trochlear&#xD;
             groove and OCD lesions (Grade 4a) with healed bone base, which is non-sclerotic and no&#xD;
             loss of bone greater then 6mm measured from the surrounding subchondral plate.&#xD;
             Original pretreatment arthroscopic confirmation indicates that one or two lesion(s)&#xD;
             are equal to an ICRS Grade 3a, 3b, 3c, 3d contained lesion(s) that is equivalent to an&#xD;
             Outerbridge Grade III or IV (greater than 50% loss of articular cartilage). OF NOTE:&#xD;
             Patients with need for concomitant procedures such as Anteromedialization of Tibial&#xD;
             Tubercle (AMZ) and lateral lengthening are allowable&#xD;
&#xD;
          5. Has peripheral cartilage debridement to healthy cartilage that results in a lesion (s)&#xD;
             with an area of &gt; or = 1cm ^2 and &lt; or = 4 cm^2.&#xD;
&#xD;
          6. PCL, LCL and MCL in the affected knee are stable and the ACL is stable or can be&#xD;
             stabilized as a concomitant procedure.&#xD;
&#xD;
          7. Ipsilateral knee compartment has intact menisci (or requires partial meniscectomy&#xD;
             resulting in stable menisci). Minimum remnant width of 5mm.&#xD;
&#xD;
          8. The contralateral knee is asymptomatic, stable, and fully functional.&#xD;
&#xD;
          9. Must be physically and mentally willing and able to comply with post-operative&#xD;
             rehabilitation and routinely scheduled clinical and radiographic visits through 24&#xD;
             months.&#xD;
&#xD;
         10. Alignment: Mechanical axis must be no more than 5 degrees from neutral.&#xD;
&#xD;
         11. Must be 3 months post previous surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clinical and/or radiographic disease diagnosis of the indexed affected joint that&#xD;
             Includes:&#xD;
&#xD;
               1. Osteoarthritis or avascular necrosis,&#xD;
&#xD;
               2. Rheumatoid arthritis, or history of septic or reactive arthritis,&#xD;
&#xD;
               3. Gout or history of gout or pseudogout in the affected knee,&#xD;
&#xD;
               4. Osteochondritis dissecans of the knee with significant bone loss (greater than&#xD;
                  6mm deep from the subchondral plate)&#xD;
&#xD;
               5. Associated damage to the underlying subchondral bone requiring a bone graft&#xD;
&#xD;
          2. History of secondary arthropathies (i.e. sickle cell disease, hemochromatosis, or&#xD;
             autoimmune disease).&#xD;
&#xD;
          3. Uncontrolled diabetes.&#xD;
&#xD;
          4. Displays a high surgical risk due to unstable cardiac and/or pulmonary disease.&#xD;
&#xD;
          5. Has HIV or other immunodeficient state including subjects on immunosuppressant&#xD;
             therapies, or has significant illness (metastasis of any type) that decreases the&#xD;
             probability of survival to the 2 year endpoint.&#xD;
&#xD;
          6. Is at substantial risk for the need of organ transplantation, such as renal&#xD;
             insufficiency.&#xD;
&#xD;
          7. Is pregnant or breast-feeding.&#xD;
&#xD;
          8. Body mass index &gt; 35.&#xD;
&#xD;
          9. Has bipolar articular cartilage involvement or kissing lesions of the ipsilateral&#xD;
             compartment, described as tibial or patellar lesions in the same compartment with&#xD;
             greater than ICRS Grade 2 chondrosis.&#xD;
&#xD;
         10. Is participating concurrently in another clinical trial, or has participated in a&#xD;
             clinical trial within 30 days of surgery.&#xD;
&#xD;
         11. Is receiving prescription pain medication other than NSAIDs or acetaminophen for&#xD;
             conditions unrelated to the index knee condition, chronic use of anticoagulants, or&#xD;
             taking corticosteroids.&#xD;
&#xD;
         12. Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the&#xD;
             ability to perform objective functional assessment of either knee.&#xD;
&#xD;
         13. Active joint infection.&#xD;
&#xD;
         14. Prior total meniscectomy of either knee.&#xD;
&#xD;
         15. Radiographically has &gt;5 degrees of malalignment as measured from the hip, knee and&#xD;
             ankle mechanical axis.&#xD;
&#xD;
         16. Has subchondral bone loss of greater than 6mm&#xD;
&#xD;
         17. Has received within the past three months intra-articular platelet rich plasma,&#xD;
             hyaluronic acid therapy, steroid, amniotic-derived or stem cell injections in the&#xD;
             index knee.&#xD;
&#xD;
         18. Prior realignment surgery in the affected knee within the past 6 months.&#xD;
&#xD;
         19. Failed microfracture/marrow stimulation treatment performed less than 12-months before&#xD;
             baseline.&#xD;
&#xD;
         20. Is receiving workman's compensation or currently involved in litigation relating to&#xD;
             the index knee.&#xD;
&#xD;
         21. Has history of alcoholism, medication, or intravenous drug abuse, psychosis, is a&#xD;
             prisoner, has a personality disorder (s), poor motivation, emotional or intellectual&#xD;
             issues that would likely make the subject unreliable for the study, or any combination&#xD;
             of variables in the investigator's judgment that should exclude a potential subject.&#xD;
&#xD;
         22. Any conditions or implants that might affect having MRIs: had or have an aneurysm clip&#xD;
             implanted, intraocular foreign bodies (commonly seen in welders), subcutaneous metal&#xD;
             shards (found in sheet metal workers), or some shrapnel; additionally, no cardiac&#xD;
             pacemaker, defibrillator, implanted neurostimulater (TENS implants) some prosthetic&#xD;
             heart valve (especially mitral valve), cochlear implant or other hearing aide.&#xD;
             Subjects should be excluded if they have a tendency of claustrophobia or have tattoos&#xD;
             that may contain iron-based dyes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jack Farr, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OrthoIndy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orthoindy</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>January 13, 2020</last_update_submitted>
  <last_update_submitted_qc>January 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Osteochondral</keyword>
  <keyword>Marrow Stimulation</keyword>
  <keyword>ReNu</keyword>
  <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/NCT03036878
org study id: RD-2016-04-02
nct id: NCT03036878
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the use of ReNu™ allograft for the augmentation of marrow stimulation for
      osteochondral lesions
This is a prospective, non-randomized, longitudinal study of up to 8 evaluable participants
      recruited from two separate practices. Male and non-pregnant female patients between the ages
      of 18 and 55 years of age will be screened for study recruitment. Female patients must be
      actively practicing a contraception method, abstinence, be surgically sterilized, or be
      postmenopausal. Participants will receive ReNu™ as an adjunct to their standard of care
      marrow stimulation for the treatment of osteochondral defects.

      At each follow-up visit, concomitant medications and adverse events shall be collected from
      each subject, and each subject shall complete the following questionnaires:

      IKDC Health Assessment (Includes Short Form-36) Tegner KOOS Knee Survey VAS Pain Scale SANE
      score

      The subjects will be assessed at Baseline using these scales an again at all subsequent study
      follow-up visits.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in KOOS score from baseline
time frame: 1 Year
measure: Change in Tegner score from baseline
time frame: 1 Year
measure: Change in VAS score from baseline
time frame: 6, 12 & 24 months
measure: Change in Tegner score from baseline
time frame: 6 & 24 months
measure: Change in SANE score from baseline
time frame: 6, 12 & 24 months
measure: Change in KOOS score from baseline
time frame: 6 & 24 months
arm group label: ReNu Injection
arm group type: Experimental
description: Injection of ReNu allograft into the joint capsule.
intervention type: Other
intervention name: ReNu
description: ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.
arm group label: ReNu Injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Jack Farr, MD
role: Principal Investigator
affiliation: OrthoIndy
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteochondrosis
sharing ipd: No