<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/NCT03289416</url>
  </required_header>
  <id_info>
    <org_study_id>EmCyte</org_study_id>
    <nct_id>NCT03289416</nct_id>
  </id_info>
  <brief_title>Bone Marrow Aspirate Compared to Platelet Rich Plasma for Treating Knee Osteoarthritis</brief_title>
  <acronym>EmCyte</acronym>
  <official_title>Efficacy of Bone Marrow Aspirate Concentrate Compared With Platelet Rich Plasma for the Treatment of Symptomatic Knee Osteoarthritis: A Randomized, Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Andrews Research &amp; Education Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>EmCyte Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>BioSciences Research Associates, Inc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Andrews Research &amp; Education Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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>
      This study is intended to compare whether bone marrow aspirate concentrate or platelet rich&#xD;
      plasma injections is more effective in treating knee osteoarthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While PRP shows promise in helping restore function to these patients, there are still&#xD;
      concerns with PRP's long term outcomes. Another option that has become more popular for&#xD;
      physicians treating this debilitation condition is bone marrow aspirate concentrate (BMA),&#xD;
      which use's undifferentiated cells found in the bone marrow to promote healing and tissue&#xD;
      regeneration. These cells have the ability to replicate into a multiple different tissue&#xD;
      types. With BMA, the marrow is concentrated provide better healing of the damaged tissue and&#xD;
      aid in growth and repair. The full benefits of BMA are still unknown, but studies have shown&#xD;
      the treatment can reduce swelling, relieve pain, and improve healing in articular cartilage&#xD;
      and bone grafts.&#xD;
&#xD;
      Autologous BMA has shown promising clinical potential as a therapeutic agent in regenerative&#xD;
      medicine, including the treatment of osteoarthritis and cartilage defects, and the clinical&#xD;
      efficacy platelet rich plasma has been documented to alleviate symptoms related to knee&#xD;
      osteoarthritis. However, randomized, prospective comparison of the two techniques has not&#xD;
      been reported in the literature and long term follow-up for both treatments is limited, and&#xD;
      especially limited in the use of BMA for osteoarthritis treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2013</start_date>
  <completion_date type="Actual">February 2020</completion_date>
  <primary_completion_date type="Actual">February 2020</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>Patients will be randomly assigned to either a PRP intervention group or the BMC intervention group. Knee pain and function outcomes of enrolled patients in the two groups will be compared to determine which treatment is more effective in treating knee osteoarthritis.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)</measure>
    <time_frame>Screen, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month and 24 month</time_frame>
    <description>Change in pain score measurements utilizing patient surveys</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Subjective International Knee Documentation Committee Subjective Score (IKDC)</measure>
    <time_frame>Screen, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month and 24 month</time_frame>
    <description>Change in pain score measurement utilizing patient surveys</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Platelet Rich Plasma (PRP)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Blood will be drawn from the patient using the Pure PRP II system into a syringe with anticoagulant (sodium citrate). 1 mL of blood will be separated and sent to a lab for analysis. Remaining blood will be separated into a single concentrating device and centrifuged to separate red blood cells from plasma and platelets. The plasma and platelets will be separated off with a syringe and re-centrifuged to separate the platelets from the plasma. 1 mL will be separated and sent to a lab for analysis leaving 6 mL for injection. Both the 1 mL of blood and the 1 mL of PRP will be sent to an independent lab to undergo analysis for CBC, TNC, human CD34+ hematopoietic stem/progenitor cell assay and CFU-F. Physician will then inject the PRP into the affected knee joint.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bone Marrow Concentrate (BMC)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Bone marrow will be harvested from the posterior iliac crest using the PureBMC system. 50 mL of bone marrow will be drawn into one syringe containing 10 mL of sodium citrate. Marrow will be filtered and centrifuged for separation of the bone marrow concentrate. Plasma and cell concentrate will be separated off with two syringes and re-centrifuged to separate the cell concentrate from the plasma. After plasma is drawn off, BMC will be drawn into a syringe for injection into affected knee. BMC production procedure results in 7 mL of product and 1 mL will be separated and sent to a lab for analysis. Both 1 mL of BMA and 1 mL of BMC will be sent to an independent lab to undergo analysis for CBC, TNC, human CD34+ hematopoietic stem/progenitor cell assay and CFU-F.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Pure PRP II</intervention_name>
    <description>The Pure PRP II system will be used to collect and concentrate blood into platelet rich plasma that will be injected into the knee.</description>
    <arm_group_label>Platelet Rich Plasma (PRP)</arm_group_label>
    <other_name>GS60-PURE-II</other_name>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>PureBMC</intervention_name>
    <description>The PureBMC system will be used to collect and concentrate bone marrow aspirate into bone marrow concentrate that will be injected into the knee.</description>
    <arm_group_label>Bone Marrow Concentrate (BMC)</arm_group_label>
    <other_name>BC60-PURE</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female age 18-80 years&#xD;
&#xD;
          -  Knee osteoarthritis&#xD;
&#xD;
          -  Subjects must present with pain or swelling to target knee for at least 4 months&#xD;
&#xD;
          -  Kellgren-Lawrence score between 1 and 3 upon x-ray evaluation&#xD;
&#xD;
          -  Must be willing and able to provide informed consent&#xD;
&#xD;
          -  Willing and able to return for scheduled follow-up visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major mechanical axis deviation of more than 50% into either compartment (varus or&#xD;
             valgus )&#xD;
&#xD;
          -  Have had a corticosteroid injection within 3 months or a hyaluronic acid injection&#xD;
             within 6 months&#xD;
&#xD;
          -  History of the following medical conditions:&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  autoimmune disorders&#xD;
&#xD;
          -  disorders requiring immunosuppression&#xD;
&#xD;
          -  rheumatoid arthritis&#xD;
&#xD;
          -  hemophilic arthropathy&#xD;
&#xD;
          -  infectious arthritis&#xD;
&#xD;
          -  Charcot's knee&#xD;
&#xD;
          -  Paget's disease of the femur or tibia&#xD;
&#xD;
          -  Cancer&#xD;
&#xD;
          -  Ongoing infectious disease&#xD;
&#xD;
          -  Significant cardiovascular, renal or hepatic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joshua Hackel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Andrews Institute for Orthopaedic &amp; Sports Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Andrews Research &amp; Education Foundation</name>
      <address>
        <city>Gulf Breeze</city>
        <state>Florida</state>
        <zip>32561</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hootman JM, Helmick CG. Projections of US prevalence of arthritis and associated activity limitations. Arthritis Rheum. 2006 Jan;54(1):226-9. doi: 10.1002/art.21562.</citation>
    <PMID>16385518</PMID>
  </reference>
  <reference>
    <citation>Spakova T, Rosocha J, Lacko M, Harvanova D, Gharaibeh A. Treatment of knee joint osteoarthritis with autologous platelet-rich plasma in comparison with hyaluronic acid. Am J Phys Med Rehabil. 2012 May;91(5):411-7. doi: 10.1097/PHM.0b013e3182aab72.</citation>
    <PMID>22513879</PMID>
  </reference>
  <reference>
    <citation>Kon E, Mandelbaum B, Buda R, Filardo G, Delcogliano M, Timoncini A, Fornasari PM, Giannini S, Marcacci M. Platelet-rich plasma intra-articular injection versus hyaluronic acid viscosupplementation as treatments for cartilage pathology: from early degeneration to osteoarthritis. Arthroscopy. 2011 Nov;27(11):1490-501. doi: 10.1016/j.arthro.2011.05.011. Epub 2011 Aug 10.</citation>
    <PMID>21831567</PMID>
  </reference>
  <reference>
    <citation>Cerza F, Carni S, Carcangiu A, Di Vavo I, Schiavilla V, Pecora A, De Biasi G, Ciuffreda M. Comparison between hyaluronic acid and platelet-rich plasma, intra-articular infiltration in the treatment of gonarthrosis. Am J Sports Med. 2012 Dec;40(12):2822-7. doi: 10.1177/0363546512461902. Epub 2012 Oct 25.</citation>
    <PMID>23104611</PMID>
  </reference>
  <reference>
    <citation>Patel S, Dhillon MS, Aggarwal S, Marwaha N, Jain A. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. Am J Sports Med. 2013 Feb;41(2):356-64. doi: 10.1177/0363546512471299. Epub 2013 Jan 8.</citation>
    <PMID>23299850</PMID>
  </reference>
  <reference>
    <citation>Li M, Zhang C, Ai Z, Yuan T, Feng Y, Jia W. [Therapeutic effectiveness of intra-knee-articular injection of platelet-rich plasma on knee articular cartilage degeneration]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2011 Oct;25(10):1192-6. Chinese.</citation>
    <PMID>22069972</PMID>
  </reference>
  <reference>
    <citation>Filardo G, Kon E, Di Martino A, Di Matteo B, Merli ML, Cenacchi A, Fornasari PM, Marcacci M. Platelet-rich plasma vs hyaluronic acid to treat knee degenerative pathology: study design and preliminary results of a randomized controlled trial. BMC Musculoskelet Disord. 2012 Nov 23;13:229. doi: 10.1186/1471-2474-13-229.</citation>
    <PMID>23176112</PMID>
  </reference>
  <reference>
    <citation>Vaquerizo V, Plasencia MA, Arribas I, Seijas R, Padilla S, Orive G, Anitua E. Comparison of intra-articular injections of plasma rich in growth factors (PRGF-Endoret) versus Durolane hyaluronic acid in the treatment of patients with symptomatic osteoarthritis: a randomized controlled trial. Arthroscopy. 2013 Oct;29(10):1635-43. doi: 10.1016/j.arthro.2013.07.264.</citation>
    <PMID>24075613</PMID>
  </reference>
  <reference>
    <citation>Convery PN, Milligan KR, Quinn P, Scott K, Clarke RC. Low-dose intra-articular ketorolac for pain relief following arthroscopy of the knee joint. Anaesthesia. 1998 Nov;53(11):1125-9. doi: 10.1046/j.1365-2044.1998.00582.x.</citation>
    <PMID>10023285</PMID>
  </reference>
  <reference>
    <citation>Ng HP, Nordstrom U, Axelsson K, Perniola AD, Gustav E, Ryttberg L, Gupta A. Efficacy of intra-articular bupivacaine, ropivacaine, or a combination of ropivacaine, morphine, and ketorolac on postoperative pain relief after ambulatory arthroscopic knee surgery: a randomized double-blind study. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):26-33. doi: 10.1016/j.rapm.2005.09.009.</citation>
    <PMID>16418021</PMID>
  </reference>
  <reference>
    <citation>Gupta A, Axelsson K, Allvin R, Liszka-Hackzell J, Rawal N, Althoff B, Augustini BG. Postoperative pain following knee arthroscopy: the effects of intra-articular ketorolac and/or morphine. Reg Anesth Pain Med. 1999 May-Jun;24(3):225-30. doi: 10.1016/s1098-7339(99)90132-3.</citation>
    <PMID>10338172</PMID>
  </reference>
  <reference>
    <citation>Beitzel K, McCarthy MB, Cote MP, Apostolakos J, Russell RP, Bradley J, ElAttrache NS, Romeo AA, Arciero RA, Mazzocca AD. The effect of ketorolac tromethamine, methylprednisolone, and platelet-rich plasma on human chondrocyte and tenocyte viability. Arthroscopy. 2013 Jul;29(7):1164-74. doi: 10.1016/j.arthro.2013.04.006.</citation>
    <PMID>23809450</PMID>
  </reference>
  <reference>
    <citation>Hauser RA, Orlofsky A. Regenerative injection therapy with whole bone marrow aspirate for degenerative joint disease: a case series. Clin Med Insights Arthritis Musculoskelet Disord. 2013 Sep 4;6:65-72. doi: 10.4137/CMAMD.S10951. eCollection 2013.</citation>
    <PMID>24046512</PMID>
  </reference>
  <reference>
    <citation>Saw KY, Hussin P, Loke SC, Azam M, Chen HC, Tay YG, Low S, Wallin KL, Ragavanaidu K. Articular cartilage regeneration with autologous marrow aspirate and hyaluronic Acid: an experimental study in a goat model. Arthroscopy. 2009 Dec;25(12):1391-400. doi: 10.1016/j.arthro.2009.07.011. Epub 2009 Sep 17.</citation>
    <PMID>19962065</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>March 4, 2020</last_update_submitted>
  <last_update_submitted_qc>March 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>knee</keyword>
  <keyword>osteoarthritis</keyword>
  <keyword>platelet rich plasma (PRP)</keyword>
  <keyword>bone marrow concentrate (BMC)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 30, 2023</submitted>
    <returned>February 24, 2023</returned>
  </pending_results>
  <!-- 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/NCT03289416
org study id: EmCyte
nct id: NCT03289416
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study is intended to compare whether bone marrow aspirate concentrate or platelet rich
      plasma injections is more effective in treating knee osteoarthritis.
While PRP shows promise in helping restore function to these patients, there are still
      concerns with PRP's long term outcomes. Another option that has become more popular for
      physicians treating this debilitation condition is bone marrow aspirate concentrate (BMA),
      which use's undifferentiated cells found in the bone marrow to promote healing and tissue
      regeneration. These cells have the ability to replicate into a multiple different tissue
      types. With BMA, the marrow is concentrated provide better healing of the damaged tissue and
      aid in growth and repair. The full benefits of BMA are still unknown, but studies have shown
      the treatment can reduce swelling, relieve pain, and improve healing in articular cartilage
      and bone grafts.

      Autologous BMA has shown promising clinical potential as a therapeutic agent in regenerative
      medicine, including the treatment of osteoarthritis and cartilage defects, and the clinical
      efficacy platelet rich plasma has been documented to alleviate symptoms related to knee
      osteoarthritis. However, randomized, prospective comparison of the two techniques has not
      been reported in the literature and long term follow-up for both treatments is limited, and
      especially limited in the use of BMA for osteoarthritis treatment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomly assigned to either a PRP intervention group or the BMC intervention group. Knee pain and function outcomes of enrolled patients in the two groups will be compared to determine which treatment is more effective in treating knee osteoarthritis.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
time frame: Screen, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month and 24 month
description: Change in pain score measurements utilizing patient surveys
measure: Change in Subjective International Knee Documentation Committee Subjective Score (IKDC)
time frame: Screen, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month and 24 month
description: Change in pain score measurement utilizing patient surveys
arm group label: Platelet Rich Plasma (PRP)
arm group type: Other
description: Blood will be drawn from the patient using the Pure PRP II system into a syringe with anticoagulant (sodium citrate). 1 mL of blood will be separated and sent to a lab for analysis. Remaining blood will be separated into a single concentrating device and centrifuged to separate red blood cells from plasma and platelets. The plasma and platelets will be separated off with a syringe and re-centrifuged to separate the platelets from the plasma. 1 mL will be separated and sent to a lab for analysis leaving 6 mL for injection. Both the 1 mL of blood and the 1 mL of PRP will be sent to an independent lab to undergo analysis for CBC, TNC, human CD34+ hematopoietic stem/progenitor cell assay and CFU-F. Physician will then inject the PRP into the affected knee joint.
arm group label: Bone Marrow Concentrate (BMC)
arm group type: Other
description: Bone marrow will be harvested from the posterior iliac crest using the PureBMC system. 50 mL of bone marrow will be drawn into one syringe containing 10 mL of sodium citrate. Marrow will be filtered and centrifuged for separation of the bone marrow concentrate. Plasma and cell concentrate will be separated off with two syringes and re-centrifuged to separate the cell concentrate from the plasma. After plasma is drawn off, BMC will be drawn into a syringe for injection into affected knee. BMC production procedure results in 7 mL of product and 1 mL will be separated and sent to a lab for analysis. Both 1 mL of BMA and 1 mL of BMC will be sent to an independent lab to undergo analysis for CBC, TNC, human CD34+ hematopoietic stem/progenitor cell assay and CFU-F.
intervention type: Combination Product
intervention name: Pure PRP II
description: The Pure PRP II system will be used to collect and concentrate blood into platelet rich plasma that will be injected into the knee.
arm group label: Platelet Rich Plasma (PRP)
other name: GS60-PURE-II
intervention type: Combination Product
intervention name: PureBMC
description: The PureBMC system will be used to collect and concentrate bone marrow aspirate into bone marrow concentrate that will be injected into the knee.
arm group label: Bone Marrow Concentrate (BMC)
other name: BC60-PURE
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Joshua Hackel, MD
role: Principal Investigator
affiliation: Andrews Institute for Orthopaedic & Sports Medicine
facility: 
country: United States
citation: Hootman JM, Helmick CG. Projections of US prevalence of arthritis and associated activity limitations. Arthritis Rheum. 2006 Jan;54(1):226-9. doi: 10.1002/art.21562.
PMID: 16385518
citation: Spakova T, Rosocha J, Lacko M, Harvanova D, Gharaibeh A. Treatment of knee joint osteoarthritis with autologous platelet-rich plasma in comparison with hyaluronic acid. Am J Phys Med Rehabil. 2012 May;91(5):411-7. doi: 10.1097/PHM.0b013e3182aab72.
PMID: 22513879
citation: Kon E, Mandelbaum B, Buda R, Filardo G, Delcogliano M, Timoncini A, Fornasari PM, Giannini S, Marcacci M. Platelet-rich plasma intra-articular injection versus hyaluronic acid viscosupplementation as treatments for cartilage pathology: from early degeneration to osteoarthritis. Arthroscopy. 2011 Nov;27(11):1490-501. doi: 10.1016/j.arthro.2011.05.011. Epub 2011 Aug 10.
PMID: 21831567
citation: Cerza F, Carni S, Carcangiu A, Di Vavo I, Schiavilla V, Pecora A, De Biasi G, Ciuffreda M. Comparison between hyaluronic acid and platelet-rich plasma, intra-articular infiltration in the treatment of gonarthrosis. Am J Sports Med. 2012 Dec;40(12):2822-7. doi: 10.1177/0363546512461902. Epub 2012 Oct 25.
PMID: 23104611
citation: Patel S, Dhillon MS, Aggarwal S, Marwaha N, Jain A. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. Am J Sports Med. 2013 Feb;41(2):356-64. doi: 10.1177/0363546512471299. Epub 2013 Jan 8.
PMID: 23299850
citation: Li M, Zhang C, Ai Z, Yuan T, Feng Y, Jia W. [Therapeutic effectiveness of intra-knee-articular injection of platelet-rich plasma on knee articular cartilage degeneration]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2011 Oct;25(10):1192-6. Chinese.
PMID: 22069972
citation: Filardo G, Kon E, Di Martino A, Di Matteo B, Merli ML, Cenacchi A, Fornasari PM, Marcacci M. Platelet-rich plasma vs hyaluronic acid to treat knee degenerative pathology: study design and preliminary results of a randomized controlled trial. BMC Musculoskelet Disord. 2012 Nov 23;13:229. doi: 10.1186/1471-2474-13-229.
PMID: 23176112
citation: Vaquerizo V, Plasencia MA, Arribas I, Seijas R, Padilla S, Orive G, Anitua E. Comparison of intra-articular injections of plasma rich in growth factors (PRGF-Endoret) versus Durolane hyaluronic acid in the treatment of patients with symptomatic osteoarthritis: a randomized controlled trial. Arthroscopy. 2013 Oct;29(10):1635-43. doi: 10.1016/j.arthro.2013.07.264.
PMID: 24075613
citation: Convery PN, Milligan KR, Quinn P, Scott K, Clarke RC. Low-dose intra-articular ketorolac for pain relief following arthroscopy of the knee joint. Anaesthesia. 1998 Nov;53(11):1125-9. doi: 10.1046/j.1365-2044.1998.00582.x.
PMID: 10023285
citation: Ng HP, Nordstrom U, Axelsson K, Perniola AD, Gustav E, Ryttberg L, Gupta A. Efficacy of intra-articular bupivacaine, ropivacaine, or a combination of ropivacaine, morphine, and ketorolac on postoperative pain relief after ambulatory arthroscopic knee surgery: a randomized double-blind study. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):26-33. doi: 10.1016/j.rapm.2005.09.009.
PMID: 16418021
citation: Gupta A, Axelsson K, Allvin R, Liszka-Hackzell J, Rawal N, Althoff B, Augustini BG. Postoperative pain following knee arthroscopy: the effects of intra-articular ketorolac and/or morphine. Reg Anesth Pain Med. 1999 May-Jun;24(3):225-30. doi: 10.1016/s1098-7339(99)90132-3.
PMID: 10338172
citation: Beitzel K, McCarthy MB, Cote MP, Apostolakos J, Russell RP, Bradley J, ElAttrache NS, Romeo AA, Arciero RA, Mazzocca AD. The effect of ketorolac tromethamine, methylprednisolone, and platelet-rich plasma on human chondrocyte and tenocyte viability. Arthroscopy. 2013 Jul;29(7):1164-74. doi: 10.1016/j.arthro.2013.04.006.
PMID: 23809450
citation: Hauser RA, Orlofsky A. Regenerative injection therapy with whole bone marrow aspirate for degenerative joint disease: a case series. Clin Med Insights Arthritis Musculoskelet Disord. 2013 Sep 4;6:65-72. doi: 10.4137/CMAMD.S10951. eCollection 2013.
PMID: 24046512
citation: Saw KY, Hussin P, Loke SC, Azam M, Chen HC, Tay YG, Low S, Wallin KL, Ragavanaidu K. Articular cartilage regeneration with autologous marrow aspirate and hyaluronic Acid: an experimental study in a goat model. Arthroscopy. 2009 Dec;25(12):1391-400. doi: 10.1016/j.arthro.2009.07.011. Epub 2009 Sep 17.
PMID: 19962065
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No
submitted: January 30, 2023
returned: February 24, 2023