<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/NCT02183896</url>
  </required_header>
  <id_info>
    <org_study_id>14-0080</org_study_id>
    <nct_id>NCT02183896</nct_id>
  </id_info>
  <brief_title>Efficacy of PRP (Platelet Rich Plasma) Following Arthroscopic Microfracture of Chondral Lesions of the Hip</brief_title>
  <official_title>Efficacy of PRP (Platelet Rich Plasma) Following Arthroscopic Microfracture of Chondral Lesions of the Hip</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research project is to assess the effectiveness of intra-articular&#xD;
      injections of autologous platelet-rich plasma (PRP) after arthroscopic microfracture. Our&#xD;
      hypothesis is that platelet-rich plasma will improve patient's clinical outcomes and chondral&#xD;
      healing following microfracture performed during femoroacetabular impingement (FAI) hip&#xD;
      arthroscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this research project is to assess the effectiveness of intra-articular&#xD;
      injections of autologous platelet-rich plasma (PRP) after arthroscopic microfracture. Our&#xD;
      hypothesis is that platelet-rich plasma will improve patient's clinical outcomes and chondral&#xD;
      healing following microfracture performed during femoroacetabular impingement (FAI) hip&#xD;
      arthroscopy.&#xD;
&#xD;
      This study has two aims:&#xD;
&#xD;
        1. Evaluate clinical efficacy of intra-articular injections of platelet-rich plasma (PRP)&#xD;
           following arthroscopic microfracture.&#xD;
&#xD;
        2. Evaluate if microfracture followed by PRP injections improves chondral healing.&#xD;
&#xD;
      Microfracture has shown good results with chondral lesions of the hip. However, microfracture&#xD;
      does not regenerate normal hyaline cartilage. There is growing evidence that PRP can improve&#xD;
      articular cartilage healing. Injection of PRP following microfracture may help regeneration&#xD;
      to normal hyaline like articular cartilage together with soft tissue healing, thereby&#xD;
      improving patients' early and long-term outcomes of chondral healing.&#xD;
&#xD;
      Patients will be randomized to one of two study arms - microfracture with PRP (treatment arm)&#xD;
      and microfracture with saline (control arm) in a 1:1 ratio.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI left&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MRI dGEMRIC</measure>
    <time_frame>12 and 24 months post-operative</time_frame>
    <description>MRI dGEMRIC will be utilized to assess chondral healing. Change is being assessed between measurement time points.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PA Hip X-Ray</measure>
    <time_frame>Baseline, 12 and 24 months post-operative</time_frame>
    <description>Change is being assessed between measurement time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Hip Outcome Tool (IHOT)</measure>
    <time_frame>Pre-operative; and 3, 6, 12, and 24 month post-operative</time_frame>
    <description>Patient reported outcomes assessed from patient completed surveys. Change is being assessed between measurement time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Western Ontario and McMaster (WOMAC) osteoarthritis index</measure>
    <time_frame>Pre-operative; and 3, 6, 12, and 24 month post-operative</time_frame>
    <description>Patient reported outcomes assessed with patient completed survey.Change is being assessed between measurement time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-arthritic hip score</measure>
    <time_frame>Pre-operative; and 3, 6, 12, and 24 month post-operative</time_frame>
    <description>Patient reported outcomes assessed with patient completed survey. Change is being assessed between measurement time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion (ROM)</measure>
    <time_frame>Pre-operative; prior to injections at week 1 and 2 post-operative; 6 week, and 3, 6, 12, and 24 months post-operative</time_frame>
    <description>ROM assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flexion Abduction and External Rotation (FABER)</measure>
    <time_frame>Pre-operative; prior to injections at week 1 and 2 post-operative; 6 week, and 3, 6, 12, and 24 months post-operative</time_frame>
    <description>FABER assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bicycle Kicks</measure>
    <time_frame>Pre-operative; prior to injections at week 1 and 2 post-operative; 6 week, and 3, 6, 12, and 24 months post-operative</time_frame>
    <description>Bicycle kicks assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Femoroacetabular Impingement</condition>
  <condition>Chondral Lesions</condition>
  <arm_group>
    <arm_group_label>Platelet-rich plasma (PRP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intra-articular injections in the hip of autologous platelet-rich plasma (PRP) at week 1 and 2 post-operatively. Dose 5 mL. PRP is derived from the patient's own blood.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intra-articular injections in the hip of saline, solution week 1 and 2 post-operatively. Dose: 5 mL at each injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Platelet-rich plasma (PRP)</intervention_name>
    <arm_group_label>Platelet-rich plasma (PRP)</arm_group_label>
    <other_name>PRP</other_name>
    <other_name>Autologous platelet-rich plasma</other_name>
    <other_name>Autologous PRP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <arm_group_label>Saline</arm_group_label>
    <other_name>0.9% Sodium Chloride</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients aged 18-50, inclusive.&#xD;
&#xD;
          2. Healthy patients undergoing hip arthroscopy due to FAI.&#xD;
&#xD;
          3. No OA according to X-Ray, defined by the presence of joint space narrowing,&#xD;
             osteophytes, sclerosis and subchondral cysts and surgery observation (Tonnis grade&#xD;
             0-1).&#xD;
&#xD;
          4. No other influential disabilities in lower limbs, which could alter the post-operative&#xD;
             therapy.&#xD;
&#xD;
          5. No chronic use of NSAIDs, steroids, or chemotherapy drugs during the last 6 months&#xD;
             before enrollment.&#xD;
&#xD;
          6. Women of childbearing potential will be allowed to enroll but must be willing to&#xD;
             practice one highly effective method of contraception (oral, injectable or implanted&#xD;
             hormonal methods of contraception, placement of an intrauterine device [IUD] or&#xD;
             intrauterine system [IUS] condom or occlusive cap with spermicidal&#xD;
             foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout&#xD;
             the study.&#xD;
&#xD;
          7. Intra-articular cartilage lesion grade 2-3-4-5 of Beck Classification or III-IV of&#xD;
             Outerbridge.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with autoimmune concomitant disease(s) that may affect joints, such as&#xD;
             rheumatoid arthritis (RA), psoriatic arthritis and lupus arthritis.&#xD;
&#xD;
          2. Patients with polyarticular disease.&#xD;
&#xD;
          3. Patients with major conditions, such as poorly controlled diabetes, congestive heart&#xD;
             failure (CHF), chronic obstructive pulmonary disease (COPD) or untreated depression.&#xD;
&#xD;
          4. Patients with blood disorders (thrombopathy, thrombocytopenia, anemia with hemoglobin&#xD;
             &lt;9g/dL).&#xD;
&#xD;
          5. Patients who had intra-articular treatment with steroids within 6 months of enrollment&#xD;
             in this study or received more than 3 previous intra-articular steroid injections to&#xD;
             the effected hip.&#xD;
&#xD;
          6. Patients who are pregnant or nursing at the time of consent.&#xD;
&#xD;
          7. Non-English speaking patients. (Scores used for evaluation have not been validated in&#xD;
             Spanish).&#xD;
&#xD;
          8. Patients who had previous hip surgery.&#xD;
&#xD;
          9. Additional disabilities in any of the lower limbs that would interfere with any of the&#xD;
             clinical assessments.&#xD;
&#xD;
         10. Chronic use of NSAIDs (defined as taking NSAID regularly every week for the last 6&#xD;
             months), steroids or chemotherapy drugs.&#xD;
&#xD;
         11. Patients with a BMI over 30. Due to the fact that this study utilizes an injection&#xD;
             technique, which may be inaccurate in obese subjects.&#xD;
&#xD;
         12. Patients with pacemakers or metal implants who are unable to get an MRI.&#xD;
&#xD;
         13. Non-adherence according to inclusion criteria.&#xD;
&#xD;
         14. Patients allergic to lidocaine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cecilia Pascual-Garrido, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Denver, CU Sports Medicine</name>
      <address>
        <city>Boulder</city>
        <state>Colorado</state>
        <zip>80304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>July 1, 2014</study_first_submitted>
  <study_first_submitted_qc>July 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>December 26, 2018</last_update_submitted>
  <last_update_submitted_qc>December 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Femoroacetabular impingement (FAI)</keyword>
  <keyword>Chondral lesions</keyword>
  <keyword>Hip</keyword>
  <keyword>Microfracture</keyword>
  <keyword>Platelet-rich plasma (PRP)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Femoracetabular Impingement</mesh_term>
    <mesh_term>Fractures, Stress</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/NCT02183896
org study id: 14-0080
nct id: NCT02183896
lead sponsor: 
has dmc: No
is fda regulated device: No
The purpose of this research project is to assess the effectiveness of intra-articular
      injections of autologous platelet-rich plasma (PRP) after arthroscopic microfracture. Our
      hypothesis is that platelet-rich plasma will improve patient's clinical outcomes and chondral
      healing following microfracture performed during femoroacetabular impingement (FAI) hip
      arthroscopy.
The purpose of this research project is to assess the effectiveness of intra-articular
      injections of autologous platelet-rich plasma (PRP) after arthroscopic microfracture. Our
      hypothesis is that platelet-rich plasma will improve patient's clinical outcomes and chondral
      healing following microfracture performed during femoroacetabular impingement (FAI) hip
      arthroscopy.

      This study has two aims:

        1. Evaluate clinical efficacy of intra-articular injections of platelet-rich plasma (PRP)
           following arthroscopic microfracture.

        2. Evaluate if microfracture followed by PRP injections improves chondral healing.

      Microfracture has shown good results with chondral lesions of the hip. However, microfracture
      does not regenerate normal hyaline cartilage. There is growing evidence that PRP can improve
      articular cartilage healing. Injection of PRP following microfracture may help regeneration
      to normal hyaline like articular cartilage together with soft tissue healing, thereby
      improving patients' early and long-term outcomes of chondral healing.

      Patients will be randomized to one of two study arms - microfracture with PRP (treatment arm)
      and microfracture with saline (control arm) in a 1:1 ratio.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: MRI dGEMRIC
time frame: 12 and 24 months post-operative
description: MRI dGEMRIC will be utilized to assess chondral healing. Change is being assessed between measurement time points.
measure: PA Hip X-Ray
time frame: Baseline, 12 and 24 months post-operative
description: Change is being assessed between measurement time points.
measure: International Hip Outcome Tool (IHOT)
time frame: Pre-operative; and 3, 6, 12, and 24 month post-operative
description: Patient reported outcomes assessed from patient completed surveys. Change is being assessed between measurement time points.
measure: Western Ontario and McMaster (WOMAC) osteoarthritis index
time frame: Pre-operative; and 3, 6, 12, and 24 month post-operative
description: Patient reported outcomes assessed with patient completed survey.Change is being assessed between measurement time points.
measure: Non-arthritic hip score
time frame: Pre-operative; and 3, 6, 12, and 24 month post-operative
description: Patient reported outcomes assessed with patient completed survey. Change is being assessed between measurement time points.
measure: Range of Motion (ROM)
time frame: Pre-operative; prior to injections at week 1 and 2 post-operative; 6 week, and 3, 6, 12, and 24 months post-operative
description: ROM assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points.
measure: Flexion Abduction and External Rotation (FABER)
time frame: Pre-operative; prior to injections at week 1 and 2 post-operative; 6 week, and 3, 6, 12, and 24 months post-operative
description: FABER assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points.
measure: Bicycle Kicks
time frame: Pre-operative; prior to injections at week 1 and 2 post-operative; 6 week, and 3, 6, 12, and 24 months post-operative
description: Bicycle kicks assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points.
arm group label: Platelet-rich plasma (PRP)
arm group type: Experimental
description: Intra-articular injections in the hip of autologous platelet-rich plasma (PRP) at week 1 and 2 post-operatively. Dose 5 mL. PRP is derived from the patient's own blood.
arm group label: Saline
arm group type: Placebo Comparator
description: Intra-articular injections in the hip of saline, solution week 1 and 2 post-operatively. Dose: 5 mL at each injection.
intervention type: Biological
intervention name: Platelet-rich plasma (PRP)
arm group label: Platelet-rich plasma (PRP)
other name: PRP
other name: Autologous platelet-rich plasma
other name: Autologous PRP
intervention type: Drug
intervention name: Saline
arm group label: Saline
other name: 0.9% Sodium Chloride
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Cecilia Pascual-Garrido, M.D.
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Femoracetabular Impingement
mesh term: Fractures, Stress