<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/NCT03830775</url>
  </required_header>
  <id_info>
    <org_study_id>williamBAMC</org_study_id>
    <nct_id>NCT03830775</nct_id>
  </id_info>
  <brief_title>A Prospective Randomized Double Blinded Controlled Trial of Non-Operative Management of TFCC Injuries</brief_title>
  <acronym>TFCC</acronym>
  <official_title>A Prospective Randomized Double Blinded Controlled Trial of Non-Operative Management of TFCC Injuries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>William Beaumont Army Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>William Beaumont Army Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</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>
      Platelet-rich Plasma (PRP) is formed when a patient's blood sample is concentrated by a&#xD;
      commercially available centrifuge. The sample then contains a high concentration of growth&#xD;
      factors and has been used for numerous indications in a number of joints. This process has&#xD;
      not yet been proven for non-operative management of the Triangular FibroCartilage Complex&#xD;
      (TFCC), which is a very commonly injured soft tissue structure in the wrist. This study seeks&#xD;
      to determine the efficacy of PRP for TFCC injuries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Platelet-rich Plasma (PRP) therapy has recently been indicated in the treatment of joint&#xD;
      pain, arthritis, tendonitis, and to augment surgical treatment has become increasingly common&#xD;
      (Hsu) PRP is obtained from obtaining an autologous blood sample, which is then condensed in a&#xD;
      small commercial centrifuge to isolate a concentrated sample of platelets and growth factors.&#xD;
      This sample contains high concentrations of Platelet-derived growth factors (PDGF),&#xD;
      transforming growth factors β (TGFβ), insulin-like growth factor-1 (IGF1), and vascular&#xD;
      endothelial growth factor-1 (VEGF) all of which aid in healing of soft tissues. (Padilla) The&#xD;
      blood sample is autologous, the concentration is prepared in the clinic, and the&#xD;
      complications of the injection are no greater than any other injection given in the clinic.&#xD;
      (Hsu) In addition to being safe, PRP is efficacious. PRP has been well-studied including 10&#xD;
      prospective randomized controlled trials proving the effectiveness of PRP for knee&#xD;
      osteoarthritis alone. (Dai) Strong evidence has also been reported in support of PRP use for&#xD;
      bone healing (Bibbo, Tsai) tendinopathy (Mishra, Peerbooms) cartilage healing (Mei-Dan), and&#xD;
      for augmentation of both ligament reconstruction (Fallouh) and repair (Mazzocca).&#xD;
      Furthermore, the use of PRP has been shown to be a more cost effective treatment as compared&#xD;
      to traditional methods in both chronic wound management and tendonitis (Gosens, Dougherty)&#xD;
      PRP has not been studied in the wrist. Ulnar-sided wrist pain, most commonly involving the&#xD;
      Triangular fibrocartilage complex (TFCC) is both difficult to diagnosis and treat,(Kleinmann,&#xD;
      Fulcher, Graham) The TFCC is a meniscal homologue which acts to stabilize the wrist and to&#xD;
      dissipate compressive forces. Tears within this soft tissue structure are painful and heal&#xD;
      slowly. (Palmer, Palmer). Immobilization, steroid injections, or surgical treatment are the&#xD;
      mainstays of treatment. However, PRP has not been studied as a treatment modality.&#xD;
&#xD;
      The purpose of this analysis is to study the efficacy of PRP injection in the treatment of a&#xD;
      TFCC tear.&#xD;
&#xD;
      The null hypothesis is that there is no difference between injection into the wrist of PRP&#xD;
      and saline (placebo).&#xD;
&#xD;
      The investigators hypothesize that PRP will reduce pain as compared to placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 2, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disability of the Army Shoulder Hand (DASH)</measure>
    <time_frame>Pre-injection</time_frame>
    <description>SCALE: 0-100 (0 being a good result and 100 being complete disability)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability of the Army Shoulder Hand (DASH)</measure>
    <time_frame>2 weeks post injection</time_frame>
    <description>SCALE: 0-100 (0 being a good result and 100 being complete disability)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability of the Army Shoulder Hand (DASH)</measure>
    <time_frame>3 months post injection</time_frame>
    <description>SCALE: 0-100 (0 being a good result and 100 being complete disability)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability of the Army Shoulder Hand (DASH)</measure>
    <time_frame>6 months post injection</time_frame>
    <description>SCALE: 0-100 (0 being a good result and 100 being complete disability)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability of the Army Shoulder Hand (DASH)</measure>
    <time_frame>12 months post injection</time_frame>
    <description>SCALE: 0-100 (0 being a good result and 100 being complete disability)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Michigan Hand Outcome Questionnaire (MHOQ</measure>
    <time_frame>Pre-injection, 2 weeks, 3 months</time_frame>
    <description>SCALE: 0-100 (with 100 being a great result and 0 being considerable pain and dysfunction)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mayo Wrist Score (Mayo)</measure>
    <time_frame>Pre-injection, 2 weeks, 3 months, 6 months, 12 months</time_frame>
    <description>SCALE: 0-100 (with 100 being a great result and 0 being considerable pain and dysfunction)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Anxiety Symptom Scale (PASS)</measure>
    <time_frame>Pre-injection, 2 weeks, 3 months</time_frame>
    <description>SCALE: 0-100 (100 meaning a patient has a high level of anxiety, pain, apprehension; while a lower scale indicates a patient has no concerns or anxiety about pain. The average is about 38 and the standard deviation is 20)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single Assessment Numerical Evaluation (SANE)</measure>
    <time_frame>Pre-injection, 2 weeks, 3 months, 6 months, 12 months</time_frame>
    <description>SCALE: 0-100 (with 100 being a great result and 0 being considerable pain and dysfunction)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Wrist Injuries</condition>
  <condition>PRP</condition>
  <arm_group>
    <arm_group_label>Experimental - PRP injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2cc of PRP is injected into the ulnocarpal joint</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control - Saline injection</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2cc of 0.9% sterile saline is injected into the ulnocarpal joint</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Platelet-rich plasma (PRP)</intervention_name>
    <description>PRP is obtained from obtaining an autologous blood sample, which is then condensed in a small commercial centrifuge to isolate a concentrated sample of platelets and growth factors. This sample contains high concentrations of Platelet-derived growth factors (PDGF), transforming growth factors β (TGFβ), insulin-like growth factor-1 (IGF1), and vascular endothelial growth factor-1 (VEGF) all of which aid in healing of soft tissues. (Padilla) The blood sample is autologous, the concentration is prepared in the clinic, and the complications of the injection are no greater than any other injection given in the clinic.&#xD;
All patients will have a blood sample prepared for PRP. The patient will then be blinded and half will randomly be assigned to PRP injection (2cc) and half will be randomly assigned to placebo (2cc of 0.9% sterile saline)</description>
    <arm_group_label>Experimental - PRP injection</arm_group_label>
    <arm_group_label>control - Saline injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Adult patients consenting for wrist injection, who additionally consent to participate&#xD;
             in this study.&#xD;
&#xD;
          2. MRI which indicates a TFCC tear or Scapho-lunate ligament tear (SL)&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Patients who do not choose to participate in the study or who do not wish to have an&#xD;
             injection&#xD;
&#xD;
          2. Patients who want an injection - but do not want to be randomized.&#xD;
&#xD;
          3. Patients who do not complete one of the follow up documentations.&#xD;
&#xD;
          4. Patients who would like to know their injection (unblinded) may be informed but the&#xD;
             investigators will still attempt to collect data as per protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John C Dunn</last_name>
    <role>Principal Investigator</role>
    <affiliation>WBAMC Staff Hand Surgeon</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael Polmear</last_name>
    <phone>(303) 910-8665</phone>
    <email>michael.polmear@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Lola Norton</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Larissa Schmersal</last_name>
      <phone>915-742-9502</phone>
      <email>larissa.a.schmersal.civ@mail.mil</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Padilla S, Orive G, Sanchez M, Anitua E, Hsu WK. Platelet-rich plasma in orthopaedic applications: evidence-based recommendations for treatment. J Am Acad Orthop Surg. 2014 Aug;22(8):469-70. doi: 10.5435/JAAOS-22-08-469. No abstract available.</citation>
    <PMID>25063744</PMID>
  </results_reference>
  <results_reference>
    <citation>Hsu WK, Mishra A, Rodeo SR, Fu F, Terry MA, Randelli P, Canale ST, Kelly FB. Platelet-rich plasma in orthopaedic applications: evidence-based recommendations for treatment. J Am Acad Orthop Surg. 2013 Dec;21(12):739-48. doi: 10.5435/JAAOS-21-12-739.</citation>
    <PMID>24292930</PMID>
  </results_reference>
  <results_reference>
    <citation>Dai WL, Zhou AG, Zhang H, Zhang J. Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Trials. Arthroscopy. 2017 Mar;33(3):659-670.e1. doi: 10.1016/j.arthro.2016.09.024. Epub 2016 Dec 22.</citation>
    <PMID>28012636</PMID>
  </results_reference>
  <results_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>
  </results_reference>
  <results_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>
  </results_reference>
  <results_reference>
    <citation>Palmer AK, Werner FW. The triangular fibrocartilage complex of the wrist--anatomy and function. J Hand Surg Am. 1981 Mar;6(2):153-62. doi: 10.1016/s0363-5023(81)80170-0.</citation>
    <PMID>7229292</PMID>
  </results_reference>
  <results_reference>
    <citation>Heyworth BE, Lee JH, Kim PD, Lipton CB, Strauch RJ, Rosenwasser MP. Hylan versus corticosteroid versus placebo for treatment of basal joint arthritis: a prospective, randomized, double-blinded clinical trial. J Hand Surg Am. 2008 Jan;33(1):40-8. doi: 10.1016/j.jhsa.2007.10.009.</citation>
    <PMID>18261664</PMID>
  </results_reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>October 19, 2020</last_update_submitted>
  <last_update_submitted_qc>October 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>William Beaumont Army Medical Center</investigator_affiliation>
    <investigator_full_name>John C. Dunn</investigator_full_name>
    <investigator_title>Hand Surgeon</investigator_title>
  </responsible_party>
  <keyword>TFCC</keyword>
  <keyword>PRP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Wrist Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03830775
org study id: williamBAMC
nct id: NCT03830775
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Platelet-rich Plasma (PRP) is formed when a patient's blood sample is concentrated by a
      commercially available centrifuge. The sample then contains a high concentration of growth
      factors and has been used for numerous indications in a number of joints. This process has
      not yet been proven for non-operative management of the Triangular FibroCartilage Complex
      (TFCC), which is a very commonly injured soft tissue structure in the wrist. This study seeks
      to determine the efficacy of PRP for TFCC injuries.
Platelet-rich Plasma (PRP) therapy has recently been indicated in the treatment of joint
      pain, arthritis, tendonitis, and to augment surgical treatment has become increasingly common
      (Hsu) PRP is obtained from obtaining an autologous blood sample, which is then condensed in a
      small commercial centrifuge to isolate a concentrated sample of platelets and growth factors.
      This sample contains high concentrations of Platelet-derived growth factors (PDGF),
      transforming growth factors β (TGFβ), insulin-like growth factor-1 (IGF1), and vascular
      endothelial growth factor-1 (VEGF) all of which aid in healing of soft tissues. (Padilla) The
      blood sample is autologous, the concentration is prepared in the clinic, and the
      complications of the injection are no greater than any other injection given in the clinic.
      (Hsu) In addition to being safe, PRP is efficacious. PRP has been well-studied including 10
      prospective randomized controlled trials proving the effectiveness of PRP for knee
      osteoarthritis alone. (Dai) Strong evidence has also been reported in support of PRP use for
      bone healing (Bibbo, Tsai) tendinopathy (Mishra, Peerbooms) cartilage healing (Mei-Dan), and
      for augmentation of both ligament reconstruction (Fallouh) and repair (Mazzocca).
      Furthermore, the use of PRP has been shown to be a more cost effective treatment as compared
      to traditional methods in both chronic wound management and tendonitis (Gosens, Dougherty)
      PRP has not been studied in the wrist. Ulnar-sided wrist pain, most commonly involving the
      Triangular fibrocartilage complex (TFCC) is both difficult to diagnosis and treat,(Kleinmann,
      Fulcher, Graham) The TFCC is a meniscal homologue which acts to stabilize the wrist and to
      dissipate compressive forces. Tears within this soft tissue structure are painful and heal
      slowly. (Palmer, Palmer). Immobilization, steroid injections, or surgical treatment are the
      mainstays of treatment. However, PRP has not been studied as a treatment modality.

      The purpose of this analysis is to study the efficacy of PRP injection in the treatment of a
      TFCC tear.

      The null hypothesis is that there is no difference between injection into the wrist of PRP
      and saline (placebo).

      The investigators hypothesize that PRP will reduce pain as compared to placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Disability of the Army Shoulder Hand (DASH)
time frame: Pre-injection
description: SCALE: 0-100 (0 being a good result and 100 being complete disability)
measure: Disability of the Army Shoulder Hand (DASH)
time frame: 2 weeks post injection
description: SCALE: 0-100 (0 being a good result and 100 being complete disability)
measure: Disability of the Army Shoulder Hand (DASH)
time frame: 3 months post injection
description: SCALE: 0-100 (0 being a good result and 100 being complete disability)
measure: Disability of the Army Shoulder Hand (DASH)
time frame: 6 months post injection
description: SCALE: 0-100 (0 being a good result and 100 being complete disability)
measure: Disability of the Army Shoulder Hand (DASH)
time frame: 12 months post injection
description: SCALE: 0-100 (0 being a good result and 100 being complete disability)
measure: Michigan Hand Outcome Questionnaire (MHOQ
time frame: Pre-injection, 2 weeks, 3 months
description: SCALE: 0-100 (with 100 being a great result and 0 being considerable pain and dysfunction)
measure: Mayo Wrist Score (Mayo)
time frame: Pre-injection, 2 weeks, 3 months, 6 months, 12 months
description: SCALE: 0-100 (with 100 being a great result and 0 being considerable pain and dysfunction)
measure: Pain Anxiety Symptom Scale (PASS)
time frame: Pre-injection, 2 weeks, 3 months
description: SCALE: 0-100 (100 meaning a patient has a high level of anxiety, pain, apprehension; while a lower scale indicates a patient has no concerns or anxiety about pain. The average is about 38 and the standard deviation is 20)
measure: Single Assessment Numerical Evaluation (SANE)
time frame: Pre-injection, 2 weeks, 3 months, 6 months, 12 months
description: SCALE: 0-100 (with 100 being a great result and 0 being considerable pain and dysfunction)
arm group label: Experimental - PRP injection
arm group type: Experimental
description: 2cc of PRP is injected into the ulnocarpal joint
arm group label: control - Saline injection
arm group type: Placebo Comparator
description: 2cc of 0.9% sterile saline is injected into the ulnocarpal joint
intervention type: Procedure
intervention name: Platelet-rich plasma (PRP)
description: PRP is obtained from obtaining an autologous blood sample, which is then condensed in a small commercial centrifuge to isolate a concentrated sample of platelets and growth factors. This sample contains high concentrations of Platelet-derived growth factors (PDGF), transforming growth factors β (TGFβ), insulin-like growth factor-1 (IGF1), and vascular endothelial growth factor-1 (VEGF) all of which aid in healing of soft tissues. (Padilla) The blood sample is autologous, the concentration is prepared in the clinic, and the complications of the injection are no greater than any other injection given in the clinic.
All patients will have a blood sample prepared for PRP. The patient will then be blinded and half will randomly be assigned to PRP injection (2cc) and half will be randomly assigned to placebo (2cc of 0.9% sterile saline)
arm group label: Experimental - PRP injection
arm group label: control - Saline injection
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: John C Dunn
role: Principal Investigator
affiliation: WBAMC Staff Hand Surgeon
last name: Michael Polmear
phone: (303) 910-8665
email: michael.polmear@gmail.com
facility: 
status: Recruiting
contact: 
country: United States
citation: Padilla S, Orive G, Sanchez M, Anitua E, Hsu WK. Platelet-rich plasma in orthopaedic applications: evidence-based recommendations for treatment. J Am Acad Orthop Surg. 2014 Aug;22(8):469-70. doi: 10.5435/JAAOS-22-08-469. No abstract available.
PMID: 25063744
citation: Hsu WK, Mishra A, Rodeo SR, Fu F, Terry MA, Randelli P, Canale ST, Kelly FB. Platelet-rich plasma in orthopaedic applications: evidence-based recommendations for treatment. J Am Acad Orthop Surg. 2013 Dec;21(12):739-48. doi: 10.5435/JAAOS-21-12-739.
PMID: 24292930
citation: Dai WL, Zhou AG, Zhang H, Zhang J. Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Trials. Arthroscopy. 2017 Mar;33(3):659-670.e1. doi: 10.1016/j.arthro.2016.09.024. Epub 2016 Dec 22.
PMID: 28012636
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: 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: Palmer AK, Werner FW. The triangular fibrocartilage complex of the wrist--anatomy and function. J Hand Surg Am. 1981 Mar;6(2):153-62. doi: 10.1016/s0363-5023(81)80170-0.
PMID: 7229292
citation: Heyworth BE, Lee JH, Kim PD, Lipton CB, Strauch RJ, Rosenwasser MP. Hylan versus corticosteroid versus placebo for treatment of basal joint arthritis: a prospective, randomized, double-blinded clinical trial. J Hand Surg Am. 2008 Jan;33(1):40-8. doi: 10.1016/j.jhsa.2007.10.009.
PMID: 18261664
responsible party type: Principal Investigator
investigator affiliation: William Beaumont Army Medical Center
investigator full name: John C. Dunn
investigator title: Hand Surgeon
mesh term: Wounds and Injuries
mesh term: Wrist Injuries
sharing ipd: No