<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/NCT01688362</url>
  </required_header>
  <id_info>
    <org_study_id>12-1016</org_study_id>
    <nct_id>NCT01688362</nct_id>
  </id_info>
  <brief_title>Platelet Rich Plasma vs. Corticosteroid Injection in the Treatment of Partial Rotator Cuff Tears</brief_title>
  <official_title>Platelet Rich Plasma vs. Corticosteroid Injection in the Treatment of Partial Thickness Rotator Cuff Tears. A Randomized, Prospective, Double Blinded Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to further define the optimal non-surgical treatment strategy&#xD;
      for partial thickness rotator cuff tears. The specific aim of this study is to determine the&#xD;
      outcomes of treatment of partial thickness rotator cuff tears with corticosteroid or platelet&#xD;
      rich plasma (PRP). Subjects with partial thickness rotator cuff tears will be randomized to&#xD;
      receive an injection of PRP or corticosteroid. Shoulder function and tendon healing will be&#xD;
      evaluated using the patient surveys as well as ultrasound. Subjects will be followed for one&#xD;
      year to determine the outcomes for each treatment. The hypothesis is that there is no&#xD;
      difference in healing rate or functional outcomes in patients treated with corticosteroid&#xD;
      injections vs. PRP injections for the treatment of partial thickness rotator cuff tears.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Did not meet target enrollment deadlines.&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>Phase 1</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH)</measure>
    <time_frame>baseline and one year</time_frame>
    <description>Disabilities of the Arm, Shoulder, and Hand (DASH) is a 30-item self-reported questionnaire used assess shoulder function. The DASH is widely used in orthopaedic research and is considered valid and reliable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH)</measure>
    <time_frame>baseline six weeks, 3 months, 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change in Visual Analog Pain scale (VAS)</measure>
    <time_frame>Baseline, six weeks, three months, six months, one year</time_frame>
    <description>Visual Analog Pain scale (VAS) is a self-reported questionnaire used to measure a patients pain level on a scale from 0 (no pain) to 10 (extreme pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change in American Shoulder and Elbow Surgeons (ASES) scale</measure>
    <time_frame>Baseline, six weeks, three months, six months, one year</time_frame>
    <description>American Shoulder and Elbow Surgeons (ASES) scale is used to measure shoulder function. It is combines both physician assessment and patient self-reported questionnaire date to create the functional score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Size of rotator cuff tear size.</measure>
    <time_frame>Baseline, six months and one year</time_frame>
    <description>Rotator cuff tear size will be determined using ultrasound imaging. The mean size at six months and one year will be compared to baseline per-treatment size.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Rotator Cuff Tear</condition>
  <arm_group>
    <arm_group_label>platelet-rich plasma protein (PRP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group will receive 2 injections with PRP. Each injection separated by two weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Corticosteroid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in this group will receive one injection with corticosteroids and then one injection with local anesthetic two weeks later.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Platelet Rich Plasma (PRP)</intervention_name>
    <description>Subjects in this group will receive 2 injections with PRP. Subjects will have will have 15cc of blood drawn with the Arthrex ACP syringe. The blood will be placed into the Arthrex PRP centrifuge and spun at 1500 rpms for 5 minutes. The platelets will be drawn off to create the PRP for injection. A posterior glenohumeral injection under ultrasound guidance will be performed to inject the PRP solution using a 22g needle. A dry sterile dressing will be placed on the injection site. This injection will Take place at time zero and then two weeks later it will be repeated.</description>
    <arm_group_label>platelet-rich plasma protein (PRP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Corticosteroid</intervention_name>
    <description>Subjects in this group will receive one injection with corticosteroids and then one injection with local anesthetic two weeks later. For the first injection patients will have 15ml of blood drawn. This blood will then be discarded in a biohazard container. A 6ml solution of 4ml 0.25% Bupivacaine, 1ml 40mg Kenalog, and 1ml 4mg Dexamethasone will be prepared. A posterior glenohumeral injection under ultrasound guidance will be performed to inject the steroid solution using a 22g needle. A dry sterile dressing will be placed at the injection site.&#xD;
For the second injection two weeks later patients will have 15 ml of blood drawn. This blood will then be discarded in a biohazard container. Using the same technique as in Visit 2, the investigator will inject a 6 ml solution of 2 ml sterile normal saline with 4 ml 0.25% Bupivacaine to the shoulder using ultrasound. A dry sterile dressing will be placed at the injection site.</description>
    <arm_group_label>Corticosteroid</arm_group_label>
    <other_name>Bupivacaine</other_name>
    <other_name>Kenalog</other_name>
    <other_name>Dexamethasone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Shoulder pain for at least two weeks.&#xD;
&#xD;
          -  Partial thickness articular sided rotator cuff tear diagnosed by MRI and&#xD;
             musculoskeletal ultrasound.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior surgery to the injured shoulder&#xD;
&#xD;
          -  Full thickness rotator cuff tear&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Cancer&#xD;
&#xD;
          -  Current treatment with anticoagulation medication&#xD;
&#xD;
          -  Steroid injection in the past 6 months in the injured shoulder&#xD;
&#xD;
          -  Prior PRP treatment to the injured shoulder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brendan C Mackinnon-Patterson, BS, MPH, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina Department of Orthopaedics</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Berkoff David, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of North Carolina Department of Orthopaedics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina Department of Orthopaedics</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27517</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Wolff AB, Sethi P, Sutton KM, Covey AS, Magit DP, Medvecky M. Partial-thickness rotator cuff tears. J Am Acad Orthop Surg. 2006 Dec;14(13):715-25. doi: 10.5435/00124635-200612000-00003.</citation>
    <PMID>17148619</PMID>
  </reference>
  <reference>
    <citation>Reilly P, Macleod I, Macfarlane R, Windley J, Emery RJ. Dead men and radiologists don't lie: a review of cadaveric and radiological studies of rotator cuff tear prevalence. Ann R Coll Surg Engl. 2006 Mar;88(2):116-21. doi: 10.1308/003588406X94968.</citation>
    <PMID>16551396</PMID>
  </reference>
  <reference>
    <citation>Sher JS, Uribe JW, Posada A, Murphy BJ, Zlatkin MB. Abnormal findings on magnetic resonance images of asymptomatic shoulders. J Bone Joint Surg Am. 1995 Jan;77(1):10-5. doi: 10.2106/00004623-199501000-00002.</citation>
    <PMID>7822341</PMID>
  </reference>
  <reference>
    <citation>Milgrom C, Schaffler M, Gilbert S, van Holsbeeck M. Rotator-cuff changes in asymptomatic adults. The effect of age, hand dominance and gender. J Bone Joint Surg Br. 1995 Mar;77(2):296-8.</citation>
    <PMID>7706351</PMID>
  </reference>
  <reference>
    <citation>Teefey SA, Rubin DA, Middleton WD, Hildebolt CF, Leibold RA, Yamaguchi K. Detection and quantification of rotator cuff tears. Comparison of ultrasonographic, magnetic resonance imaging, and arthroscopic findings in seventy-one consecutive cases. J Bone Joint Surg Am. 2004 Apr;86(4):708-16.</citation>
    <PMID>15069134</PMID>
  </reference>
  <reference>
    <citation>Sheth U, Simunovic N, Klein G, Fu F, Einhorn TA, Schemitsch E, Ayeni OR, Bhandari M. Efficacy of autologous platelet-rich plasma use for orthopaedic indications: a meta-analysis. J Bone Joint Surg Am. 2012 Feb 15;94(4):298-307. doi: 10.2106/JBJS.K.00154.</citation>
    <PMID>22241606</PMID>
  </reference>
  <reference>
    <citation>GlobalData. Platelet rich plasma: a market snapshot. http://www.docstoc.com/docs/47503668/Platelet-Rich-Plasma-A-Market-Snapshot. September 12, 2012.</citation>
  </reference>
  <reference>
    <citation>Jo CH, Kim JE, Yoon KS, Shin S. Platelet-rich plasma stimulates cell proliferation and enhances matrix gene expression and synthesis in tenocytes from human rotator cuff tendons with degenerative tears. Am J Sports Med. 2012 May;40(5):1035-45. doi: 10.1177/0363546512437525. Epub 2012 Feb 23.</citation>
    <PMID>22366517</PMID>
  </reference>
  <reference>
    <citation>Chahal J, Van Thiel GS, Mall N, Heard W, Bach BR, Cole BJ, Nicholson GP, Verma NN, Whelan DB, Romeo AA. The role of platelet-rich plasma in arthroscopic rotator cuff repair: a systematic review with quantitative synthesis. Arthroscopy. 2012 Nov;28(11):1718-27. doi: 10.1016/j.arthro.2012.03.007. Epub 2012 Jun 12.</citation>
    <PMID>22694941</PMID>
  </reference>
  <reference>
    <citation>Randelli P, Arrigoni P, Ragone V, Aliprandi A, Cabitza P. Platelet rich plasma in arthroscopic rotator cuff repair: a prospective RCT study, 2-year follow-up. J Shoulder Elbow Surg. 2011 Jun;20(4):518-28. doi: 10.1016/j.jse.2011.02.008.</citation>
    <PMID>21570659</PMID>
  </reference>
  <reference>
    <citation>Castricini R, Longo UG, De Benedetto M, Panfoli N, Pirani P, Zini R, Maffulli N, Denaro V. Platelet-rich plasma augmentation for arthroscopic rotator cuff repair: a randomized controlled trial. Am J Sports Med. 2011 Feb;39(2):258-65. doi: 10.1177/0363546510390780. Epub 2010 Dec 15.</citation>
    <PMID>21160018</PMID>
  </reference>
  <reference>
    <citation>Peerbooms JC, Sluimer J, Bruijn DJ, Gosens T. Positive effect of an autologous platelet concentrate in lateral epicondylitis in a double-blind randomized controlled trial: platelet-rich plasma versus corticosteroid injection with a 1-year follow-up. Am J Sports Med. 2010 Feb;38(2):255-62. doi: 10.1177/0363546509355445.</citation>
    <PMID>20448192</PMID>
  </reference>
  <reference>
    <citation>Gosens T, Peerbooms JC, van Laar W, den Oudsten BL. Ongoing positive effect of platelet-rich plasma versus corticosteroid injection in lateral epicondylitis: a double-blind randomized controlled trial with 2-year follow-up. Am J Sports Med. 2011 Jun;39(6):1200-8. doi: 10.1177/0363546510397173. Epub 2011 Mar 21.</citation>
    <PMID>21422467</PMID>
  </reference>
  <reference>
    <citation>Wolf JM, Ozer K, Scott F, Gordon MJ, Williams AE. Comparison of autologous blood, corticosteroid, and saline injection in the treatment of lateral epicondylitis: a prospective, randomized, controlled multicenter study. J Hand Surg Am. 2011 Aug;36(8):1269-72. doi: 10.1016/j.jhsa.2011.05.014. Epub 2011 Jun 25.</citation>
    <PMID>21705157</PMID>
  </reference>
  <reference>
    <citation>de Vos RJ, Weir A, van Schie HT, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Tol JL. Platelet-rich plasma injection for chronic Achilles tendinopathy: a randomized controlled trial. JAMA. 2010 Jan 13;303(2):144-9. doi: 10.1001/jama.2009.1986.</citation>
    <PMID>20068208</PMID>
  </reference>
  <reference>
    <citation>de Jonge S, de Vos RJ, Weir A, van Schie HT, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Tol JL. One-year follow-up of platelet-rich plasma treatment in chronic Achilles tendinopathy: a double-blind randomized placebo-controlled trial. Am J Sports Med. 2011 Aug;39(8):1623-9. doi: 10.1177/0363546511404877. Epub 2011 May 21.</citation>
    <PMID>21602565</PMID>
  </reference>
  <reference>
    <citation>Alvarez CM, Litchfield R, Jackowski D, Griffin S, Kirkley A. A prospective, double-blind, randomized clinical trial comparing subacromial injection of betamethasone and xylocaine to xylocaine alone in chronic rotator cuff tendinosis. Am J Sports Med. 2005 Feb;33(2):255-62. doi: 10.1177/0363546504267345.</citation>
    <PMID>15701612</PMID>
  </reference>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>April 13, 2017</last_update_submitted>
  <last_update_submitted_qc>April 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prospective Randomized Controlled Double Blinded Trial</keyword>
  <keyword>Rotator Cuff Tear</keyword>
  <keyword>Platelet Rich Plasma</keyword>
  <keyword>Corticosteroid</keyword>
  <keyword>Ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_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/NCT01688362
org study id: 12-1016
nct id: NCT01688362
lead sponsor: 
has dmc: No
The purpose of this study is to further define the optimal non-surgical treatment strategy
      for partial thickness rotator cuff tears. The specific aim of this study is to determine the
      outcomes of treatment of partial thickness rotator cuff tears with corticosteroid or platelet
      rich plasma (PRP). Subjects with partial thickness rotator cuff tears will be randomized to
      receive an injection of PRP or corticosteroid. Shoulder function and tendon healing will be
      evaluated using the patient surveys as well as ultrasound. Subjects will be followed for one
      year to determine the outcomes for each treatment. The hypothesis is that there is no
      difference in healing rate or functional outcomes in patients treated with corticosteroid
      injections vs. PRP injections for the treatment of partial thickness rotator cuff tears.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH)
time frame: baseline and one year
description: Disabilities of the Arm, Shoulder, and Hand (DASH) is a 30-item self-reported questionnaire used assess shoulder function. The DASH is widely used in orthopaedic research and is considered valid and reliable.
measure: Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH)
time frame: baseline six weeks, 3 months, 6 months
measure: Percent change in Visual Analog Pain scale (VAS)
time frame: Baseline, six weeks, three months, six months, one year
description: Visual Analog Pain scale (VAS) is a self-reported questionnaire used to measure a patients pain level on a scale from 0 (no pain) to 10 (extreme pain).
measure: Percent change in American Shoulder and Elbow Surgeons (ASES) scale
time frame: Baseline, six weeks, three months, six months, one year
description: American Shoulder and Elbow Surgeons (ASES) scale is used to measure shoulder function. It is combines both physician assessment and patient self-reported questionnaire date to create the functional score.
measure: Size of rotator cuff tear size.
time frame: Baseline, six months and one year
description: Rotator cuff tear size will be determined using ultrasound imaging. The mean size at six months and one year will be compared to baseline per-treatment size.
arm group label: platelet-rich plasma protein (PRP)
arm group type: Experimental
description: Subjects in this group will receive 2 injections with PRP. Each injection separated by two weeks.
arm group label: Corticosteroid
arm group type: Active Comparator
description: Subjects in this group will receive one injection with corticosteroids and then one injection with local anesthetic two weeks later.
intervention type: Biological
intervention name: Platelet Rich Plasma (PRP)
description: Subjects in this group will receive 2 injections with PRP. Subjects will have will have 15cc of blood drawn with the Arthrex ACP syringe. The blood will be placed into the Arthrex PRP centrifuge and spun at 1500 rpms for 5 minutes. The platelets will be drawn off to create the PRP for injection. A posterior glenohumeral injection under ultrasound guidance will be performed to inject the PRP solution using a 22g needle. A dry sterile dressing will be placed on the injection site. This injection will Take place at time zero and then two weeks later it will be repeated.
arm group label: platelet-rich plasma protein (PRP)
intervention type: Drug
intervention name: Corticosteroid
description: Subjects in this group will receive one injection with corticosteroids and then one injection with local anesthetic two weeks later. For the first injection patients will have 15ml of blood drawn. This blood will then be discarded in a biohazard container. A 6ml solution of 4ml 0.25% Bupivacaine, 1ml 40mg Kenalog, and 1ml 4mg Dexamethasone will be prepared. A posterior glenohumeral injection under ultrasound guidance will be performed to inject the steroid solution using a 22g needle. A dry sterile dressing will be placed at the injection site.
For the second injection two weeks later patients will have 15 ml of blood drawn. This blood will then be discarded in a biohazard container. Using the same technique as in Visit 2, the investigator will inject a 6 ml solution of 2 ml sterile normal saline with 4 ml 0.25% Bupivacaine to the shoulder using ultrasound. A dry sterile dressing will be placed at the injection site.
arm group label: Corticosteroid
other name: Bupivacaine
other name: Kenalog
other name: Dexamethasone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Brendan C Mackinnon-Patterson, BS, MPH, MD
role: Principal Investigator
affiliation: University of North Carolina Department of Orthopaedics
last name: Berkoff David, MD
role: Study Director
affiliation: University of North Carolina Department of Orthopaedics
facility: 
country: United States
citation: Wolff AB, Sethi P, Sutton KM, Covey AS, Magit DP, Medvecky M. Partial-thickness rotator cuff tears. J Am Acad Orthop Surg. 2006 Dec;14(13):715-25. doi: 10.5435/00124635-200612000-00003.
PMID: 17148619
citation: Reilly P, Macleod I, Macfarlane R, Windley J, Emery RJ. Dead men and radiologists don't lie: a review of cadaveric and radiological studies of rotator cuff tear prevalence. Ann R Coll Surg Engl. 2006 Mar;88(2):116-21. doi: 10.1308/003588406X94968.
PMID: 16551396
citation: Sher JS, Uribe JW, Posada A, Murphy BJ, Zlatkin MB. Abnormal findings on magnetic resonance images of asymptomatic shoulders. J Bone Joint Surg Am. 1995 Jan;77(1):10-5. doi: 10.2106/00004623-199501000-00002.
PMID: 7822341
citation: Milgrom C, Schaffler M, Gilbert S, van Holsbeeck M. Rotator-cuff changes in asymptomatic adults. The effect of age, hand dominance and gender. J Bone Joint Surg Br. 1995 Mar;77(2):296-8.
PMID: 7706351
citation: Teefey SA, Rubin DA, Middleton WD, Hildebolt CF, Leibold RA, Yamaguchi K. Detection and quantification of rotator cuff tears. Comparison of ultrasonographic, magnetic resonance imaging, and arthroscopic findings in seventy-one consecutive cases. J Bone Joint Surg Am. 2004 Apr;86(4):708-16.
PMID: 15069134
citation: Sheth U, Simunovic N, Klein G, Fu F, Einhorn TA, Schemitsch E, Ayeni OR, Bhandari M. Efficacy of autologous platelet-rich plasma use for orthopaedic indications: a meta-analysis. J Bone Joint Surg Am. 2012 Feb 15;94(4):298-307. doi: 10.2106/JBJS.K.00154.
PMID: 22241606
citation: GlobalData. Platelet rich plasma: a market snapshot. http://www.docstoc.com/docs/47503668/Platelet-Rich-Plasma-A-Market-Snapshot. September 12, 2012.
citation: Jo CH, Kim JE, Yoon KS, Shin S. Platelet-rich plasma stimulates cell proliferation and enhances matrix gene expression and synthesis in tenocytes from human rotator cuff tendons with degenerative tears. Am J Sports Med. 2012 May;40(5):1035-45. doi: 10.1177/0363546512437525. Epub 2012 Feb 23.
PMID: 22366517
citation: Chahal J, Van Thiel GS, Mall N, Heard W, Bach BR, Cole BJ, Nicholson GP, Verma NN, Whelan DB, Romeo AA. The role of platelet-rich plasma in arthroscopic rotator cuff repair: a systematic review with quantitative synthesis. Arthroscopy. 2012 Nov;28(11):1718-27. doi: 10.1016/j.arthro.2012.03.007. Epub 2012 Jun 12.
PMID: 22694941
citation: Randelli P, Arrigoni P, Ragone V, Aliprandi A, Cabitza P. Platelet rich plasma in arthroscopic rotator cuff repair: a prospective RCT study, 2-year follow-up. J Shoulder Elbow Surg. 2011 Jun;20(4):518-28. doi: 10.1016/j.jse.2011.02.008.
PMID: 21570659
citation: Castricini R, Longo UG, De Benedetto M, Panfoli N, Pirani P, Zini R, Maffulli N, Denaro V. Platelet-rich plasma augmentation for arthroscopic rotator cuff repair: a randomized controlled trial. Am J Sports Med. 2011 Feb;39(2):258-65. doi: 10.1177/0363546510390780. Epub 2010 Dec 15.
PMID: 21160018
citation: Peerbooms JC, Sluimer J, Bruijn DJ, Gosens T. Positive effect of an autologous platelet concentrate in lateral epicondylitis in a double-blind randomized controlled trial: platelet-rich plasma versus corticosteroid injection with a 1-year follow-up. Am J Sports Med. 2010 Feb;38(2):255-62. doi: 10.1177/0363546509355445.
PMID: 20448192
citation: Gosens T, Peerbooms JC, van Laar W, den Oudsten BL. Ongoing positive effect of platelet-rich plasma versus corticosteroid injection in lateral epicondylitis: a double-blind randomized controlled trial with 2-year follow-up. Am J Sports Med. 2011 Jun;39(6):1200-8. doi: 10.1177/0363546510397173. Epub 2011 Mar 21.
PMID: 21422467
citation: Wolf JM, Ozer K, Scott F, Gordon MJ, Williams AE. Comparison of autologous blood, corticosteroid, and saline injection in the treatment of lateral epicondylitis: a prospective, randomized, controlled multicenter study. J Hand Surg Am. 2011 Aug;36(8):1269-72. doi: 10.1016/j.jhsa.2011.05.014. Epub 2011 Jun 25.
PMID: 21705157
citation: de Vos RJ, Weir A, van Schie HT, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Tol JL. Platelet-rich plasma injection for chronic Achilles tendinopathy: a randomized controlled trial. JAMA. 2010 Jan 13;303(2):144-9. doi: 10.1001/jama.2009.1986.
PMID: 20068208
citation: de Jonge S, de Vos RJ, Weir A, van Schie HT, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Tol JL. One-year follow-up of platelet-rich plasma treatment in chronic Achilles tendinopathy: a double-blind randomized placebo-controlled trial. Am J Sports Med. 2011 Aug;39(8):1623-9. doi: 10.1177/0363546511404877. Epub 2011 May 21.
PMID: 21602565
citation: Alvarez CM, Litchfield R, Jackowski D, Griffin S, Kirkley A. A prospective, double-blind, randomized clinical trial comparing subacromial injection of betamethasone and xylocaine to xylocaine alone in chronic rotator cuff tendinosis. Am J Sports Med. 2005 Feb;33(2):255-62. doi: 10.1177/0363546504267345.
PMID: 15701612
responsible party type: Sponsor
mesh term: Rotator Cuff Injuries
mesh term: Dexamethasone
mesh term: Bupivacaine