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/NCT06003101</url>
    </required_header>
    <id_info>
      <org_study_id>2023P001436</org_study_id>
      <nct_id>NCT06003101</nct_id>
    </id_info>
    <brief_title>Effect of PRP, PPP, &amp; BMAC on Functional Outcomes Following Hip Arthroscopy for Acetabular Labral Pathologies</brief_title>
    <acronym>PRP; PPP; BMAC</acronym>
    <official_title>Effect of Platelet-Rich Plasma, Platelet-Poor Plasma, &amp; Bone Marrow Aspirate Concentrate Application on Functional Outcomes Following Hip Arthroscopy for Acetabular Labral Pathologies: A Prospective Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Massachusetts General Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to assess the effect of PRP/PPP/BMAC application on&#xD;
        functional outcomes after hip arthroscopy to address acetabular labral pathologies. The main&#xD;
        questions it aims to answer are:&#xD;
  &#xD;
          1. Does PRP/PPP/BMAC application improve functional outcomes after hip arthroscopy to&#xD;
             address acetabular labral pathologies?&#xD;
  &#xD;
          2. Does PRP/PPP/BMAC application reduce the arthritic burden as measured by functional&#xD;
             outcomes following hip arthroscopy to address labral pathologies with concomitant&#xD;
             PRP/PPP/BMAC application?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. Background Surgical management of labral pathology has evolved to reflect our current&#xD;
             understanding of mechanism of injury and resulting hip dysfunction. Correction of labral&#xD;
             pathology presents a technical challenge, and many techniques currently exist. Initial&#xD;
             management of labral tears included complete resection or debridement to the bony&#xD;
             acetabular surface of the affected region. This had the advantage of acutely reducing&#xD;
             hip pain but was later shown by seminal biomechanical studies to compromise the&#xD;
             mechanical integrity of the hip. With the exception of cases found to have profound&#xD;
             degenerative changes to the labral and adjacent articular cartilage, labral&#xD;
             resection/debridement has largely been replaced by techniques that emphasize labral&#xD;
             tissue and blood flow preservation (i.e., repair, augmentation, reconstruction) due to a&#xD;
             growing body of evidence reporting improved functional outcomes.&#xD;
  &#xD;
             Repair techniques focus on restoring functional anatomy by re-establishing the labrum's&#xD;
             native position and contour on the rim of the acetabulum. Similar to repairing a torn&#xD;
             meniscus in the knee, restoring the anatomic footprint of a torn labrum will&#xD;
             reconstitute normal joint biomechanics. Labral injuries are often seen in the setting of&#xD;
             femoroacetabular impingement and are a common source of early symptomatology. Therefore,&#xD;
             during labral repair, concomitant correction of bony cam lesions, pincer lesions, or&#xD;
             both may be necessary to prevent reinjury of the labrum. Correction of cam and pincer&#xD;
             lesions requires femoral neck osteoplasty (trimming of femoral neck) and acetabuloplasty&#xD;
             (trimming of the bony acetabular rim), respectively.&#xD;
  &#xD;
             Articular cartilage has limited intrinsic healing capacity and pathology frequently&#xD;
             results in gradual and progressive tissue deterioration. Moreover, many patients&#xD;
             presenting with hip pain in the third and fourth decade of life already have&#xD;
             osteoarthritic changes observed at the time of arthroscopy. It has been proposed that&#xD;
             altered biomechanics of the hip resulting from a labral tear can increase the stresses&#xD;
             through the hip causing faster progression of cartilage wear. Moreover, previous&#xD;
             literature has illustrated the significant association between patients with moderate to&#xD;
             severe osteoarthritis undergoing hip arthroscopy and inferior postoperative outcomes&#xD;
             when compared to similar patients with less osteoarthritis. Thus, while there have been&#xD;
             notable advances in acetabular labral repair techniques, there continues to be demand&#xD;
             for an innovation that can preserve the acetabular cartilage and chondrolabral junction&#xD;
             in order to improve outcomes in these patients.&#xD;
  &#xD;
             Recently, given the properties of the isolated components, bone marrow aspirate&#xD;
             concentrate (BMAC) has gained attention for its theoretical potential to treat OA and&#xD;
             slow the progression of cartilage deterioration. BMAC contains marrow elements including&#xD;
             mesenchymal stromal cells (MSCs), platelets, red and white blood cells, and&#xD;
             hematopoietic precursors. Bone-marrow derived platelets contain growth factors,&#xD;
             cytokines, and chemokines, which can promote wound healing, collagen synthesis,&#xD;
             suppression of pro-inflammatory cytokines, production of extracellular matrix, and&#xD;
             chondrocyte proliferation. MSCs are multipotent, non-hematopoietic stromal cells with&#xD;
             the capacity to self-renew, proliferate, and differentiate into cartilage, bone, or fat.&#xD;
             Numerous tissue sources can be used to isolate MSC cells, including bone marrow, adipose&#xD;
             tissue, synovial membrane, bursa, umbilical cord blood, and periosteum. Within&#xD;
             orthopaedic procedures, bone marrow derived MSCs (BMSCs) have been reported to be an&#xD;
             excellent source of MSCs and are often harvested from the iliac crest, distal femur,&#xD;
             proximal humerus, and vertebrae.&#xD;
  &#xD;
             Currently, the PI has adopted the use of a combined mixture of platelet-rich plasma&#xD;
             (PRP), platelet-poor plasma (PPP), and BMAC that are harvested, processed, and applied&#xD;
             during arthroscopic acetabular labral repair as his standard of care when encountering&#xD;
             mild to moderate cartilage damage, chondrolabral junction breakdown, and isolated&#xD;
             chondral lesions/flaps. Previous studies performed by the PI have demonstrated that&#xD;
             harvesting bone marrow aspirate from the body of the ilium is not only a safe procedure,&#xD;
             but also provides a concentration of connective tissue progenitor cells that is&#xD;
             comparable to other harvest sites in the body. Furthermore, harvesting bone marrow&#xD;
             aspirate from the body of the ilium concomitantly with arthroscopic acetabular labral&#xD;
             repair is efficient, limits the harvesting and repair of the labrum to one procedure,&#xD;
             and limits the procedure to only one procedural site. Regarding clinical outcomes, the&#xD;
             PI recently published a foundational study that demonstrated that augmenting the&#xD;
             acetabular labral repair site with bone marrow aspirate concentrate harvested from the&#xD;
             body of the ilium resulted in significantly greater functional improvements in patients&#xD;
             with moderate osteoarthritis compared to similar patients without BMAC application.&#xD;
             Additionally, Kucharik et al. reported that patients with full-thickness chondral flaps&#xD;
             treated with BMAC at the time of arthroscopic labral repair, compared to microfracture,&#xD;
             experienced significantly greater improvements in functional outcomes at 12 months&#xD;
             follow-up. Thus, demonstrating the possible benefits and potential of BMAC application&#xD;
             during arthroscopic labral repair in the first randomized controlled trial (RCT) is&#xD;
             necessary.&#xD;
  &#xD;
             The investigators are proposing the initiation of RCT) to provide Level I evidence for&#xD;
             the investigation of the effect of PRP/PPP/BMAC application during arthroscopic&#xD;
             acetabular labral repair. The RCT will compare postoperative outcomes between subjects&#xD;
             that do and do not receive PRP/PPP/BMAC application during hip arthroscopy for&#xD;
             acetabular labral pathologies using current, evidence-based, standard of care&#xD;
             techniques. The outcomes of this study have the potential to fundamentally change the&#xD;
             practice of hip arthroscopy across the world and lead to the improvement of countless&#xD;
             lives. From an administrative perspective, this study could also result in future&#xD;
             insurance coverage for the PRP/PPP/BMAC harvesting/processing/application procedure -&#xD;
             something that is unlikely to occur from retrospective studies alone. On the other hand,&#xD;
             if this study yields evidence that BMAC does not significantly improve the functional&#xD;
             outcomes of patients undergoing hip arthroscopy for acetabular labral repair, it will&#xD;
             provide critical insight to prevent patients from undergoing an additional procedure&#xD;
             that confers minimal or no benefit at an additional cost.&#xD;
  &#xD;
          2. Specific Aims and Objectives Study Aim 1: To assess the effect of PRP/PPP/BMAC&#xD;
             application on functional outcomes after hip arthroscopy to address acetabular labral&#xD;
             pathologies.&#xD;
  &#xD;
             Hypothesis 1.1: Subjects treated with BMAC will have significantly improved&#xD;
             patient-reported outcome measures (PROMs) at 12 months compared to baseline.&#xD;
  &#xD;
             Hypothesis 1.2: Subjects treated without BMAC will have significantly improved PROMs at&#xD;
             12 months compared to baseline.&#xD;
  &#xD;
             Hypothesis 1.3: Subjects treated with BMAC will have significantly greater improvements&#xD;
             in PROMs compared to subjects who did not receive BMAC application at 12 months compared&#xD;
             to baseline.&#xD;
  &#xD;
             Hypothesis 1.4: Hypothesis 1.1-1.3 will hold true at 24 months and beyond.&#xD;
  &#xD;
             Study Aim 2: To evaluate the effect of arthritic burden on functional outcomes following&#xD;
             hip arthroscopy to address labral pathologies with concomitant PRP/PPP/BMAC application.&#xD;
  &#xD;
             Hypothesis 2.1: Subjects with severe osteoarthritis (Outerbridge Grade 4, graded&#xD;
             arthroscopically) will have inferior PROMs improvements 12 months after arthroscopic&#xD;
             treatment of labral pathology without PRP/PPP/BMAC application, as compared to similar&#xD;
             subjects with less severe osteoarthritis (Outerbridge Grade &lt; or equal to 3).&#xD;
  &#xD;
             Hypothesis 2.2: Subjects with severe osteoarthritis (Outerbridge Grade 4, graded&#xD;
             arthroscopically) will have inferior PROMs improvements 12 months after arthroscopic&#xD;
             treatment of labral pathology with PRP/PPP/BMAC application, as compared to similar&#xD;
             subjects with less severe osteoarthritis (Outerbridge Grade &lt; or equal to 3).&#xD;
  &#xD;
             Hypothesis. 2.3: Hypothesis 2.1-2.3 will hold true at 24 months and beyond.&#xD;
  &#xD;
             Exploratory Hypothesis: Subjects with moderate osteoarthritis (Outerbridge Grade 2-3)&#xD;
             treated with PRP/PPP/BMAC application will have significantly greater improvements in&#xD;
             PROMs compared to similar subjects who did not receive PRP/PPP/BMAC application.&#xD;
  &#xD;
          3. General Description of Study Design Single-blind, prospective randomized controlled&#xD;
             trial (RCT) of patients with acetabular labral pathologies undergoing hip arthroscopy&#xD;
             comparing outcomes of subjects receiving treatment of the labrum alone versus subjects&#xD;
             receiving treatment of the labrum with concomitant PRP/PPP/BMAC application. Regardless&#xD;
             of treatment allocation, no alterations will be made to the PI's surgical technique,&#xD;
             including but not limited to initial portal placement, capsular management, addressment&#xD;
             of the labral lesions (i.e., debridement, repair, augmentation, reconstruction), or the&#xD;
             need to perform femoral and/or acetabular osteoplasties.&#xD;
  &#xD;
        Subjects with symptomatic acetabular labral pathologies and clinically indicated for surgical&#xD;
        intervention will be appropriately consented for hip arthroscopy by the PI. The PI routinely&#xD;
        discusses his use of PRP/PPP/BMAC application and will briefly mention that this intervention&#xD;
        is available, if clinically indicated during the time of surgery.&#xD;
  &#xD;
        Following the surgical consenting process, potential subjects will be introduced to the study&#xD;
        by a member of the research team. Patients not interested in participating in the study may&#xD;
        still be offered PRP/PPP/BMAC application but will be informed that the associated&#xD;
        cost/hospital charge must be covered out-of-pocket (i.e., direct cost to patient). Patients&#xD;
        interested and willing to participate in the study will have their surgical consents verified&#xD;
        to include the possible application of PRP/PPP/BMAC.&#xD;
  &#xD;
        Subjects will be tracked using validated patient-reported outcomes measures (PROMs - see&#xD;
        below), along with review of the medical record for physical exam and radiographic/advanced&#xD;
        imaging findings to track their progress throughout the study and will continue for as long&#xD;
        as they are a patient of the PI. Study procedures will be complete when the last enrolled&#xD;
        subject completes 20-year follow-up and completes the corresponding surveys.&#xD;
  &#xD;
        Subjects will undergo the procedure under general anesthesia and will be positioned supine on&#xD;
        a hip distraction table. Following portal placement and establishing intra-articular access,&#xD;
        the PI will evaluate the extent of damage and tissue quality of the labrum, chondral&#xD;
        surfaces, transition zone cartilage, and chondrolabral junction intraoperatively, under&#xD;
        direct arthroscopic visualization.&#xD;
  &#xD;
        For patients with limited damage or degenerative changes to the labrum, articular surfaces,&#xD;
        transition zone cartilage, and chondrolabral junction, the procedure will be carried out in&#xD;
        standard fashion (void of any study-specific intraoperative procedures/interventions) - as&#xD;
        PRP/PPP/BMAC application is not clinically indicated in these patients. These patients that&#xD;
        do not meet the clinical indications for PRP/PPP/BMAC application will be stratified into a&#xD;
        tertiary cohort to serve as 'controls' (randomization will not apply to these patients), but&#xD;
        will continue to receive subsequent surveys via REDCap to track their functional progress and&#xD;
        outcomes.&#xD;
  &#xD;
        Conversely, for patients with evidence of damage or degenerative changes to the labrum (i.e.,&#xD;
        Beck Labral Tear Classification ≥ 1), articular surfaces (i.e., Outerbridge Grade ≥ 2),&#xD;
        transition zone cartilage (i.e., ALAD Classification ≥ 2), and/or chondrolabral junction&#xD;
        (i.e., Beck Chondrolabral Junction Classification ≥ 1), subsequent treatment will be&#xD;
        dependent on their treatment allocation (outlined below). Patients will be randomized into&#xD;
        treatment arms using a computer algorithm.&#xD;
  &#xD;
          -  NO TREATMENT Arm: Patients will undergo hip arthroscopy for the treatment of their&#xD;
             labral pathology.&#xD;
  &#xD;
          -  TREATMENT Arm: Patients randomly allocated to receive BMAC will undergo hip arthroscopy&#xD;
             and will receive PRP/PPP/BMAC application through the PI's standardized method of&#xD;
             harvest, processing, and application.&#xD;
  &#xD;
        Notably, bone marrow aspiration from the body of the ilium will be performed through one of&#xD;
        the arthroscopic portals. In certain situations, pending anatomical constraints, an&#xD;
        additional arthroscopic portal may be created to safely harvest bone marrow. However, given&#xD;
        the normal variation in the number of arthroscopy portals created, it would be unknown to the&#xD;
        patient, thus blinded, to whether bone marrow was harvested.&#xD;
  &#xD;
        Additionally, as outlined in the informed consent document, patients will be blinded to what&#xD;
        treatment arm they are randomized to avoid confounding the results of the PROMs they&#xD;
        complete. Regardless of research study arm, patients will be blinded to the treatment they&#xD;
        receive during the study period.&#xD;
  &#xD;
        This off-label* use of PRP/PPP/BMAC application during hip arthroscopy has been adopted to&#xD;
        become the PI's standard of care to date. However, to date, it has not been proven to be&#xD;
        superior to the absence of its use in clinical practice, and thus it is being investigated as&#xD;
        a research-specific intervention in comparison to standard of care hip arthroscopy without&#xD;
        PRP/PPP/BMAC. Upon initiation of this proposed RCT, the PI's research fund will pay for the&#xD;
        associated costs of the PRP/PPP/BMAC procedure if subjects are enrolled and randomized into&#xD;
        the treatment arm of this present study. Patients that wish to receive PRP/PPP/BMAC&#xD;
        application during their hip arthroscopy (if clinically indicated intraoperatively - upon&#xD;
        arthroscopic visualization/assessment of the labrum/chondral surfaces/chondrolabral&#xD;
        junction), but are not amenable to randomization/study enrollment, may opt to pay for this&#xD;
        intervention out-of-pocket (i.e., direct charge to the patient).&#xD;
  &#xD;
        By agreeing to participate in this RCT, subjects will be consenting to:&#xD;
  &#xD;
          -  Be randomized into a treatment arm that either will or will not receive PRP/PPP/BMAC&#xD;
             application, if clinically indicated at the time of surgery.&#xD;
  &#xD;
          -  Agree to be 'blinded' to their assigned treatment allocation (i.e., subjects will not be&#xD;
             told what treatment group they were randomized to)&#xD;
  &#xD;
          -  Agree to complete outcome and PROM surveys prior to surgery and at regularly scheduled&#xD;
             intervals up until 20 years postoperatively.&#xD;
  &#xD;
          -  Agree to be contacted via email/phone by the study team for survey distribution, follow&#xD;
             up with questions about survey responses, and possible reminders about survey&#xD;
             completion.&#xD;
  &#xD;
               -  The PRP/PPP/BMAC application technique is in accordance with the Federal Drug&#xD;
                  Administrations' (FDA) guidelines/considerations under section 361 of the Public&#xD;
                  Health Service (PHS) Act and Title 21 Code of Federal Regulations (CFR) Part 1271&#xD;
                  for criterion of minimal manipulation and homologous use. Thus, the difference&#xD;
                  between un-enrolled patients and enrolled study participants is the possibility&#xD;
                  (pending randomization) for of PRP/PPP/BMAC harvest, processing, and application.&#xD;
                  Outside of the study, patients may request PRP/PPP/BMAC application during hip&#xD;
                  arthroscopy with Dr. Martin. However, these patients will be responsible for the&#xD;
                  associated out-of-pocket costs of the procedure if Dr. Martin deems PRP/PPP/BMAC&#xD;
                  application to be clinically indicated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2045</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2027</primary_completion_date>
    <phase>Phase 3</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>Pain Level</measure>
      <time_frame>Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months</time_frame>
      <description>Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. Range: 0-10, with 0 being no pain and 10 being the worst pain imaginable.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Modified Harris Hip Score (mHHS)</measure>
      <time_frame>Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months</time_frame>
      <description>Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. Scores range from 0 (poor) to 100 (ideal).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>International Hip Outcome Tool-12 (iHOT-12)</measure>
      <time_frame>Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months</time_frame>
      <description>Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. The total score is calculated as a simple mean of these responses ranging from 0 to 100, with 100 representing the best possible quality-of-life score.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Non-Arthritic Hip Score (NAHS)</measure>
      <time_frame>Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months</time_frame>
      <description>Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. Scores range from 0 (poor) to 100 (ideal).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hip Outcome Score (HOS)</measure>
      <time_frame>Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months</time_frame>
      <description>Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. Scores range from 0 (poor) to 100 (ideal).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Kerlan-Jobe Orthopaedic Clinic Athletic Hip Score</measure>
      <time_frame>Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months</time_frame>
      <description>Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. Scores range from 0 (poor) to 100 (ideal).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Visual Analog Scale (VAS) Pain Score</measure>
      <time_frame>Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months</time_frame>
      <description>Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. Range: 0-10, with 0 being no pain and 10 being the worst pain imaginable.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Oswestry Low Back Disability Questionnaire (aka Oswestry Disability Index, ODI)</measure>
      <time_frame>Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months</time_frame>
      <description>Validated PROM to assess low back pain. Scores range from 0 to 50, with 0 being no disability and 50 being completed disabled.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tegner Lysholm Knee Scoring Scale</measure>
      <time_frame>Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months</time_frame>
      <description>Validated PROM to assess knee pain. . Scores range from 0 (worse disability) to 100 (less disability).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10)</measure>
      <time_frame>Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months</time_frame>
      <description>Designed to be a &quot;bottom-line&quot; assessment of a patient's health that can be used for a wide variety of diseases. The PROMIS-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the &quot;T-Score&quot;. The average &quot;T-Score&quot; for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Pittsburgh Sleep Quality Index (PSQI):</measure>
      <time_frame>Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months</time_frame>
      <description>The PQSI is a validated and widely used 9-question survey that is broken down into 7 scored subcomponents that measure the quality and patterns of sleep. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Satisfaction, Postoperative Protocol Compliance, &amp; Subsequent Surgeries</measure>
      <time_frame>Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months</time_frame>
      <description>A ten-question survey will be used to assess patient satisfaction with their treatment, compliance with the post-operative rehabilitation program, and track subsequent surgeries on the ipsilateral hip (i.e., revision hip arthroscopy or conversion to total hip arthroplasty) and/or lumbosacral spine.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Acetabular Labrum Tear</condition>
    <condition>Femoro Acetabular Impingement</condition>
    <condition>Chondral Defect</condition>
    <condition>Bone Marrow Aspirate Concentrate</condition>
    <arm_group>
      <arm_group_label>Bone marrow aspirate concentrate (BMAC)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients randomly allocated to receive BMAC will undergo hip arthroscopy and will receive PRP/PPP/BMAC application through the PI's standardized method of harvest, processing, and application.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patients allocated to the control cohort will receive standard of care hip arthroscopy without PRP/PPP/BMAC application.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Bone marrow aspirate concentrate (BMAC)</intervention_name>
      <description>Bone marrow aspiration from the body of the ilium will be performed through one of the arthroscopic portals.</description>
      <arm_group_label>Bone marrow aspirate concentrate (BMAC)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Control</intervention_name>
      <description>Standard of care hip arthroscopy without bone marrow aspiration will be performed in these patients.</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age: &gt; or equal to 18 years&#xD;
  &#xD;
            -  Clinically indicated for hip arthroscopy (by the study PI) to address a labral&#xD;
               pathology&#xD;
  &#xD;
            -  Willingness to participate, amenable to randomization into either treatment arm of the&#xD;
               research study, and the ability to understand &amp; sign the informed consent document&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-English speaking (PROM surveys are only validated in English)&#xD;
  &#xD;
            -  Prior same site (i.e., ipsilateral hip) surgery, including but not limited to previous&#xD;
               hip arthroscopy, core decompression, or periacetabular osteotomies&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Scott D. Martin, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Massachusetts General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Scott D. Martin, MD</last_name>
      <phone>617-732-5329</phone>
      <email>sdmartin@mgh.harvard.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Massachusetts General Hospital</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02114</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Scott D. Martin, MD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Bedi A, Kelly BT. Femoroacetabular impingement. J Bone Joint Surg Am. 2013 Jan 2;95(1):82-92. doi: 10.2106/JBJS.K.01219.</citation>
      <PMID>23283377</PMID>
    </reference>
    <reference>
      <citation>Kelly BT, Weiland DE, Schenker ML, Philippon MJ. Arthroscopic labral repair in the hip: surgical technique and review of the literature. Arthroscopy. 2005 Dec;21(12):1496-504. doi: 10.1016/j.arthro.2005.08.013.</citation>
      <PMID>16376242</PMID>
    </reference>
    <reference>
      <citation>McCarthy JC, Jarrett BT, Ojeifo O, Lee JA, Bragdon CR. What factors influence long-term survivorship after hip arthroscopy? Clin Orthop Relat Res. 2011 Feb;469(2):362-71. doi: 10.1007/s11999-010-1559-2.</citation>
      <PMID>20872105</PMID>
    </reference>
    <reference>
      <citation>McCarthy JC, Noble PC, Schuck MR, Wright J, Lee J. The Otto E. Aufranc Award: The role of labral lesions to development of early degenerative hip disease. Clin Orthop Relat Res. 2001 Dec;(393):25-37. doi: 10.1097/00003086-200112000-00004.</citation>
      <PMID>11764355</PMID>
    </reference>
    <reference>
      <citation>Ferguson SJ, Bryant JT, Ganz R, Ito K. The acetabular labrum seal: a poroelastic finite element model. Clin Biomech (Bristol, Avon). 2000 Jul;15(6):463-8. doi: 10.1016/s0268-0033(99)00099-6.</citation>
      <PMID>10771126</PMID>
    </reference>
    <reference>
      <citation>Ferguson SJ, Bryant JT, Ganz R, Ito K. An in vitro investigation of the acetabular labral seal in hip joint mechanics. J Biomech. 2003 Feb;36(2):171-8. doi: 10.1016/s0021-9290(02)00365-2.</citation>
      <PMID>12547354</PMID>
    </reference>
    <reference>
      <citation>Ferguson SJ, Bryant JT, Ganz R, Ito K. The influence of the acetabular labrum on hip joint cartilage consolidation: a poroelastic finite element model. J Biomech. 2000 Aug;33(8):953-60. doi: 10.1016/s0021-9290(00)00042-7.</citation>
      <PMID>10828325</PMID>
    </reference>
    <reference>
      <citation>Larson CM, Giveans MR. Arthroscopic management of femoroacetabular impingement: early outcomes measures. Arthroscopy. 2008 May;24(5):540-6. doi: 10.1016/j.arthro.2007.11.007. Epub 2008 Jan 7.</citation>
      <PMID>18442686</PMID>
    </reference>
    <reference>
      <citation>Larson CM, Dean RS, McGaver RS, Seiffert KJ, Giveans MR. Arthroscopic Debridement Versus Refixation of the Acetabular Labrum Associated With Femoroacetabular Impingement: Updated Mean 7-Year Follow-up. Am J Sports Med. 2022 Mar;50(3):731-738. doi: 10.1177/03635465211067818. Epub 2022 Jan 31.</citation>
      <PMID>35099305</PMID>
    </reference>
    <reference>
      <citation>Larson CM, Giveans MR, Stone RM. Arthroscopic debridement versus refixation of the acetabular labrum associated with femoroacetabular impingement: mean 3.5-year follow-up. Am J Sports Med. 2012 May;40(5):1015-21. doi: 10.1177/0363546511434578. Epub 2012 Feb 3.</citation>
      <PMID>22307078</PMID>
    </reference>
    <reference>
      <citation>Espinosa N, Rothenfluh DA, Beck M, Ganz R, Leunig M. Treatment of femoro-acetabular impingement: preliminary results of labral refixation. J Bone Joint Surg Am. 2006 May;88(5):925-35. doi: 10.2106/JBJS.E.00290.</citation>
      <PMID>16651565</PMID>
    </reference>
    <reference>
      <citation>Kucharik MP, Abraham PF, Nazal MR, Varady NH, Eberlin CT, Meek WM, Martin SD. Arthroscopic Acetabular Labral Repair Versus Labral Debridement: Long-term Survivorship and Functional Outcomes. Orthop J Sports Med. 2022 Jul 7;10(7):23259671221109012. doi: 10.1177/23259671221109012. eCollection 2022 Jul.</citation>
      <PMID>35837442</PMID>
    </reference>
    <reference>
      <citation>Kucharik MP, Abraham PF, Nazal MR, Varady NH, Meek WM, Martin SD. Minimum 2-Year Functional Outcomes of Patients Undergoing Capsular Autograft Hip Labral Reconstruction. Am J Sports Med. 2021 Aug;49(10):2659-2667. doi: 10.1177/03635465211026666. Epub 2021 Jul 2.</citation>
      <PMID>34213975</PMID>
    </reference>
    <reference>
      <citation>Martin SD, Kucharik MP, Abraham PF, Nazal MR, Meek WM, Varady NH. Functional Outcomes of Arthroscopic Acetabular Labral Repair with and without Bone Marrow Aspirate Concentrate. J Bone Joint Surg Am. 2022 Jan 5;104(1):4-14. doi: 10.2106/JBJS.20.01740.</citation>
      <PMID>34648479</PMID>
    </reference>
    <reference>
      <citation>Nazal MR, McCarthy MBR, Mazzocca AD, Martin SD. Connective Tissue Progenitor Analysis of Bone Marrow Aspirate Concentrate Harvested From the Body of the Ilium During Arthroscopic Acetabular Labral Repair. Arthroscopy. 2020 May;36(5):1311-1320. doi: 10.1016/j.arthro.2019.11.125. Epub 2020 Jan 17.</citation>
      <PMID>31958539</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
      <investigator_full_name>Scott D Martin</investigator_full_name>
      <investigator_title>Principal Investigator; Director, Joint Preservation Service; Director, MGH Sports Medicine Fellowship</investigator_title>
    </responsible_party>
    <keyword>Acetabular Labrum Tear</keyword>
    <keyword>Femoro Acetabular Impingement</keyword>
    <keyword>Chondral Defect</keyword>
    <keyword>Bone Marrow Aspirate Concentrate</keyword>
    <keyword>Chondrolabral Junction</keyword>
    <keyword>Osteoarthritis</keyword>
    <keyword>Hip Arthroscopy</keyword>
    <keyword>BMAC</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Femoracetabular Impingement</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/NCT06003101
  org study id: 2023P001436
  nct id: NCT06003101
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial is to assess the effect of PRP/PPP/BMAC application on
        functional outcomes after hip arthroscopy to address acetabular labral pathologies. The main
        questions it aims to answer are:
  
          1. Does PRP/PPP/BMAC application improve functional outcomes after hip arthroscopy to
             address acetabular labral pathologies?
  
          2. Does PRP/PPP/BMAC application reduce the arthritic burden as measured by functional
             outcomes following hip arthroscopy to address labral pathologies with concomitant
             PRP/PPP/BMAC application?
  1. Background Surgical management of labral pathology has evolved to reflect our current
             understanding of mechanism of injury and resulting hip dysfunction. Correction of labral
             pathology presents a technical challenge, and many techniques currently exist. Initial
             management of labral tears included complete resection or debridement to the bony
             acetabular surface of the affected region. This had the advantage of acutely reducing
             hip pain but was later shown by seminal biomechanical studies to compromise the
             mechanical integrity of the hip. With the exception of cases found to have profound
             degenerative changes to the labral and adjacent articular cartilage, labral
             resection/debridement has largely been replaced by techniques that emphasize labral
             tissue and blood flow preservation (i.e., repair, augmentation, reconstruction) due to a
             growing body of evidence reporting improved functional outcomes.
  
             Repair techniques focus on restoring functional anatomy by re-establishing the labrum's
             native position and contour on the rim of the acetabulum. Similar to repairing a torn
             meniscus in the knee, restoring the anatomic footprint of a torn labrum will
             reconstitute normal joint biomechanics. Labral injuries are often seen in the setting of
             femoroacetabular impingement and are a common source of early symptomatology. Therefore,
             during labral repair, concomitant correction of bony cam lesions, pincer lesions, or
             both may be necessary to prevent reinjury of the labrum. Correction of cam and pincer
             lesions requires femoral neck osteoplasty (trimming of femoral neck) and acetabuloplasty
             (trimming of the bony acetabular rim), respectively.
  
             Articular cartilage has limited intrinsic healing capacity and pathology frequently
             results in gradual and progressive tissue deterioration. Moreover, many patients
             presenting with hip pain in the third and fourth decade of life already have
             osteoarthritic changes observed at the time of arthroscopy. It has been proposed that
             altered biomechanics of the hip resulting from a labral tear can increase the stresses
             through the hip causing faster progression of cartilage wear. Moreover, previous
             literature has illustrated the significant association between patients with moderate to
             severe osteoarthritis undergoing hip arthroscopy and inferior postoperative outcomes
             when compared to similar patients with less osteoarthritis. Thus, while there have been
             notable advances in acetabular labral repair techniques, there continues to be demand
             for an innovation that can preserve the acetabular cartilage and chondrolabral junction
             in order to improve outcomes in these patients.
  
             Recently, given the properties of the isolated components, bone marrow aspirate
             concentrate (BMAC) has gained attention for its theoretical potential to treat OA and
             slow the progression of cartilage deterioration. BMAC contains marrow elements including
             mesenchymal stromal cells (MSCs), platelets, red and white blood cells, and
             hematopoietic precursors. Bone-marrow derived platelets contain growth factors,
             cytokines, and chemokines, which can promote wound healing, collagen synthesis,
             suppression of pro-inflammatory cytokines, production of extracellular matrix, and
             chondrocyte proliferation. MSCs are multipotent, non-hematopoietic stromal cells with
             the capacity to self-renew, proliferate, and differentiate into cartilage, bone, or fat.
             Numerous tissue sources can be used to isolate MSC cells, including bone marrow, adipose
             tissue, synovial membrane, bursa, umbilical cord blood, and periosteum. Within
             orthopaedic procedures, bone marrow derived MSCs (BMSCs) have been reported to be an
             excellent source of MSCs and are often harvested from the iliac crest, distal femur,
             proximal humerus, and vertebrae.
  
             Currently, the PI has adopted the use of a combined mixture of platelet-rich plasma
             (PRP), platelet-poor plasma (PPP), and BMAC that are harvested, processed, and applied
             during arthroscopic acetabular labral repair as his standard of care when encountering
             mild to moderate cartilage damage, chondrolabral junction breakdown, and isolated
             chondral lesions/flaps. Previous studies performed by the PI have demonstrated that
             harvesting bone marrow aspirate from the body of the ilium is not only a safe procedure,
             but also provides a concentration of connective tissue progenitor cells that is
             comparable to other harvest sites in the body. Furthermore, harvesting bone marrow
             aspirate from the body of the ilium concomitantly with arthroscopic acetabular labral
             repair is efficient, limits the harvesting and repair of the labrum to one procedure,
             and limits the procedure to only one procedural site. Regarding clinical outcomes, the
             PI recently published a foundational study that demonstrated that augmenting the
             acetabular labral repair site with bone marrow aspirate concentrate harvested from the
             body of the ilium resulted in significantly greater functional improvements in patients
             with moderate osteoarthritis compared to similar patients without BMAC application.
             Additionally, Kucharik et al. reported that patients with full-thickness chondral flaps
             treated with BMAC at the time of arthroscopic labral repair, compared to microfracture,
             experienced significantly greater improvements in functional outcomes at 12 months
             follow-up. Thus, demonstrating the possible benefits and potential of BMAC application
             during arthroscopic labral repair in the first randomized controlled trial (RCT) is
             necessary.
  
             The investigators are proposing the initiation of RCT) to provide Level I evidence for
             the investigation of the effect of PRP/PPP/BMAC application during arthroscopic
             acetabular labral repair. The RCT will compare postoperative outcomes between subjects
             that do and do not receive PRP/PPP/BMAC application during hip arthroscopy for
             acetabular labral pathologies using current, evidence-based, standard of care
             techniques. The outcomes of this study have the potential to fundamentally change the
             practice of hip arthroscopy across the world and lead to the improvement of countless
             lives. From an administrative perspective, this study could also result in future
             insurance coverage for the PRP/PPP/BMAC harvesting/processing/application procedure -
             something that is unlikely to occur from retrospective studies alone. On the other hand,
             if this study yields evidence that BMAC does not significantly improve the functional
             outcomes of patients undergoing hip arthroscopy for acetabular labral repair, it will
             provide critical insight to prevent patients from undergoing an additional procedure
             that confers minimal or no benefit at an additional cost.
  
          2. Specific Aims and Objectives Study Aim 1: To assess the effect of PRP/PPP/BMAC
             application on functional outcomes after hip arthroscopy to address acetabular labral
             pathologies.
  
             Hypothesis 1.1: Subjects treated with BMAC will have significantly improved
             patient-reported outcome measures (PROMs) at 12 months compared to baseline.
  
             Hypothesis 1.2: Subjects treated without BMAC will have significantly improved PROMs at
             12 months compared to baseline.
  
             Hypothesis 1.3: Subjects treated with BMAC will have significantly greater improvements
             in PROMs compared to subjects who did not receive BMAC application at 12 months compared
             to baseline.
  
             Hypothesis 1.4: Hypothesis 1.1-1.3 will hold true at 24 months and beyond.
  
             Study Aim 2: To evaluate the effect of arthritic burden on functional outcomes following
             hip arthroscopy to address labral pathologies with concomitant PRP/PPP/BMAC application.
  
             Hypothesis 2.1: Subjects with severe osteoarthritis (Outerbridge Grade 4, graded
             arthroscopically) will have inferior PROMs improvements 12 months after arthroscopic
             treatment of labral pathology without PRP/PPP/BMAC application, as compared to similar
             subjects with less severe osteoarthritis (Outerbridge Grade < or equal to 3).
  
             Hypothesis 2.2: Subjects with severe osteoarthritis (Outerbridge Grade 4, graded
             arthroscopically) will have inferior PROMs improvements 12 months after arthroscopic
             treatment of labral pathology with PRP/PPP/BMAC application, as compared to similar
             subjects with less severe osteoarthritis (Outerbridge Grade < or equal to 3).
  
             Hypothesis. 2.3: Hypothesis 2.1-2.3 will hold true at 24 months and beyond.
  
             Exploratory Hypothesis: Subjects with moderate osteoarthritis (Outerbridge Grade 2-3)
             treated with PRP/PPP/BMAC application will have significantly greater improvements in
             PROMs compared to similar subjects who did not receive PRP/PPP/BMAC application.
  
          3. General Description of Study Design Single-blind, prospective randomized controlled
             trial (RCT) of patients with acetabular labral pathologies undergoing hip arthroscopy
             comparing outcomes of subjects receiving treatment of the labrum alone versus subjects
             receiving treatment of the labrum with concomitant PRP/PPP/BMAC application. Regardless
             of treatment allocation, no alterations will be made to the PI's surgical technique,
             including but not limited to initial portal placement, capsular management, addressment
             of the labral lesions (i.e., debridement, repair, augmentation, reconstruction), or the
             need to perform femoral and/or acetabular osteoplasties.
  
        Subjects with symptomatic acetabular labral pathologies and clinically indicated for surgical
        intervention will be appropriately consented for hip arthroscopy by the PI. The PI routinely
        discusses his use of PRP/PPP/BMAC application and will briefly mention that this intervention
        is available, if clinically indicated during the time of surgery.
  
        Following the surgical consenting process, potential subjects will be introduced to the study
        by a member of the research team. Patients not interested in participating in the study may
        still be offered PRP/PPP/BMAC application but will be informed that the associated
        cost/hospital charge must be covered out-of-pocket (i.e., direct cost to patient). Patients
        interested and willing to participate in the study will have their surgical consents verified
        to include the possible application of PRP/PPP/BMAC.
  
        Subjects will be tracked using validated patient-reported outcomes measures (PROMs - see
        below), along with review of the medical record for physical exam and radiographic/advanced
        imaging findings to track their progress throughout the study and will continue for as long
        as they are a patient of the PI. Study procedures will be complete when the last enrolled
        subject completes 20-year follow-up and completes the corresponding surveys.
  
        Subjects will undergo the procedure under general anesthesia and will be positioned supine on
        a hip distraction table. Following portal placement and establishing intra-articular access,
        the PI will evaluate the extent of damage and tissue quality of the labrum, chondral
        surfaces, transition zone cartilage, and chondrolabral junction intraoperatively, under
        direct arthroscopic visualization.
  
        For patients with limited damage or degenerative changes to the labrum, articular surfaces,
        transition zone cartilage, and chondrolabral junction, the procedure will be carried out in
        standard fashion (void of any study-specific intraoperative procedures/interventions) - as
        PRP/PPP/BMAC application is not clinically indicated in these patients. These patients that
        do not meet the clinical indications for PRP/PPP/BMAC application will be stratified into a
        tertiary cohort to serve as 'controls' (randomization will not apply to these patients), but
        will continue to receive subsequent surveys via REDCap to track their functional progress and
        outcomes.
  
        Conversely, for patients with evidence of damage or degenerative changes to the labrum (i.e.,
        Beck Labral Tear Classification ≥ 1), articular surfaces (i.e., Outerbridge Grade ≥ 2),
        transition zone cartilage (i.e., ALAD Classification ≥ 2), and/or chondrolabral junction
        (i.e., Beck Chondrolabral Junction Classification ≥ 1), subsequent treatment will be
        dependent on their treatment allocation (outlined below). Patients will be randomized into
        treatment arms using a computer algorithm.
  
          -  NO TREATMENT Arm: Patients will undergo hip arthroscopy for the treatment of their
             labral pathology.
  
          -  TREATMENT Arm: Patients randomly allocated to receive BMAC will undergo hip arthroscopy
             and will receive PRP/PPP/BMAC application through the PI's standardized method of
             harvest, processing, and application.
  
        Notably, bone marrow aspiration from the body of the ilium will be performed through one of
        the arthroscopic portals. In certain situations, pending anatomical constraints, an
        additional arthroscopic portal may be created to safely harvest bone marrow. However, given
        the normal variation in the number of arthroscopy portals created, it would be unknown to the
        patient, thus blinded, to whether bone marrow was harvested.
  
        Additionally, as outlined in the informed consent document, patients will be blinded to what
        treatment arm they are randomized to avoid confounding the results of the PROMs they
        complete. Regardless of research study arm, patients will be blinded to the treatment they
        receive during the study period.
  
        This off-label* use of PRP/PPP/BMAC application during hip arthroscopy has been adopted to
        become the PI's standard of care to date. However, to date, it has not been proven to be
        superior to the absence of its use in clinical practice, and thus it is being investigated as
        a research-specific intervention in comparison to standard of care hip arthroscopy without
        PRP/PPP/BMAC. Upon initiation of this proposed RCT, the PI's research fund will pay for the
        associated costs of the PRP/PPP/BMAC procedure if subjects are enrolled and randomized into
        the treatment arm of this present study. Patients that wish to receive PRP/PPP/BMAC
        application during their hip arthroscopy (if clinically indicated intraoperatively - upon
        arthroscopic visualization/assessment of the labrum/chondral surfaces/chondrolabral
        junction), but are not amenable to randomization/study enrollment, may opt to pay for this
        intervention out-of-pocket (i.e., direct charge to the patient).
  
        By agreeing to participate in this RCT, subjects will be consenting to:
  
          -  Be randomized into a treatment arm that either will or will not receive PRP/PPP/BMAC
             application, if clinically indicated at the time of surgery.
  
          -  Agree to be 'blinded' to their assigned treatment allocation (i.e., subjects will not be
             told what treatment group they were randomized to)
  
          -  Agree to complete outcome and PROM surveys prior to surgery and at regularly scheduled
             intervals up until 20 years postoperatively.
  
          -  Agree to be contacted via email/phone by the study team for survey distribution, follow
             up with questions about survey responses, and possible reminders about survey
             completion.
  
               -  The PRP/PPP/BMAC application technique is in accordance with the Federal Drug
                  Administrations' (FDA) guidelines/considerations under section 361 of the Public
                  Health Service (PHS) Act and Title 21 Code of Federal Regulations (CFR) Part 1271
                  for criterion of minimal manipulation and homologous use. Thus, the difference
                  between un-enrolled patients and enrolled study participants is the possibility
                  (pending randomization) for of PRP/PPP/BMAC harvest, processing, and application.
                  Outside of the study, patients may request PRP/PPP/BMAC application during hip
                  arthroscopy with Dr. Martin. However, these patients will be responsible for the
                  associated out-of-pocket costs of the procedure if Dr. Martin deems PRP/PPP/BMAC
                  application to be clinically indicated.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Pain Level
  time frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
  description: Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. Range: 0-10, with 0 being no pain and 10 being the worst pain imaginable.
  measure: Modified Harris Hip Score (mHHS)
  time frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
  description: Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. Scores range from 0 (poor) to 100 (ideal).
  measure: International Hip Outcome Tool-12 (iHOT-12)
  time frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
  description: Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. The total score is calculated as a simple mean of these responses ranging from 0 to 100, with 100 representing the best possible quality-of-life score.
  measure: Non-Arthritic Hip Score (NAHS)
  time frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
  description: Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. Scores range from 0 (poor) to 100 (ideal).
  measure: Hip Outcome Score (HOS)
  time frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
  description: Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. Scores range from 0 (poor) to 100 (ideal).
  measure: Kerlan-Jobe Orthopaedic Clinic Athletic Hip Score
  time frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
  description: Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. Scores range from 0 (poor) to 100 (ideal).
  measure: Visual Analog Scale (VAS) Pain Score
  time frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
  description: Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. Range: 0-10, with 0 being no pain and 10 being the worst pain imaginable.
  measure: Oswestry Low Back Disability Questionnaire (aka Oswestry Disability Index, ODI)
  time frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
  description: Validated PROM to assess low back pain. Scores range from 0 to 50, with 0 being no disability and 50 being completed disabled.
  measure: Tegner Lysholm Knee Scoring Scale
  time frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
  description: Validated PROM to assess knee pain. . Scores range from 0 (worse disability) to 100 (less disability).
  measure: Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10)
  time frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
  description: Designed to be a "bottom-line" assessment of a patient's health that can be used for a wide variety of diseases. The PROMIS-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
  measure: The Pittsburgh Sleep Quality Index (PSQI):
  time frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
  description: The PQSI is a validated and widely used 9-question survey that is broken down into 7 scored subcomponents that measure the quality and patterns of sleep. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
  measure: Patient Satisfaction, Postoperative Protocol Compliance, & Subsequent Surgeries
  time frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
  description: A ten-question survey will be used to assess patient satisfaction with their treatment, compliance with the post-operative rehabilitation program, and track subsequent surgeries on the ipsilateral hip (i.e., revision hip arthroscopy or conversion to total hip arthroplasty) and/or lumbosacral spine.
  arm group label: Bone marrow aspirate concentrate (BMAC)
  arm group type: Experimental
  description: Patients randomly allocated to receive BMAC will undergo hip arthroscopy and will receive PRP/PPP/BMAC application through the PI's standardized method of harvest, processing, and application.
  arm group label: Control
  arm group type: Placebo Comparator
  description: Patients allocated to the control cohort will receive standard of care hip arthroscopy without PRP/PPP/BMAC application.
  intervention type: Biological
  intervention name: Bone marrow aspirate concentrate (BMAC)
  description: Bone marrow aspiration from the body of the ilium will be performed through one of the arthroscopic portals.
  arm group label: Bone marrow aspirate concentrate (BMAC)
  intervention type: Procedure
  intervention name: Control
  description: Standard of care hip arthroscopy without bone marrow aspiration will be performed in these patients.
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Scott D. Martin, MD
  role: Principal Investigator
  affiliation: Massachusetts General Hospital
  last name: Scott D. Martin, MD
  phone: 617-732-5329
  email: sdmartin@mgh.harvard.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  citation: Bedi A, Kelly BT. Femoroacetabular impingement. J Bone Joint Surg Am. 2013 Jan 2;95(1):82-92. doi: 10.2106/JBJS.K.01219.
  PMID: 23283377
  citation: Kelly BT, Weiland DE, Schenker ML, Philippon MJ. Arthroscopic labral repair in the hip: surgical technique and review of the literature. Arthroscopy. 2005 Dec;21(12):1496-504. doi: 10.1016/j.arthro.2005.08.013.
  PMID: 16376242
  citation: McCarthy JC, Jarrett BT, Ojeifo O, Lee JA, Bragdon CR. What factors influence long-term survivorship after hip arthroscopy? Clin Orthop Relat Res. 2011 Feb;469(2):362-71. doi: 10.1007/s11999-010-1559-2.
  PMID: 20872105
  citation: McCarthy JC, Noble PC, Schuck MR, Wright J, Lee J. The Otto E. Aufranc Award: The role of labral lesions to development of early degenerative hip disease. Clin Orthop Relat Res. 2001 Dec;(393):25-37. doi: 10.1097/00003086-200112000-00004.
  PMID: 11764355
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  responsible party type: Principal Investigator
  investigator affiliation: Massachusetts General Hospital
  investigator full name: Scott D Martin
  investigator title: Principal Investigator; Director, Joint Preservation Service; Director, MGH Sports Medicine Fellowship
  mesh term: Femoracetabular Impingement
  sharing ipd: No