<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/NCT03779945</url>
  </required_header>
  <id_info>
    <org_study_id>PRP in lumbar fusion</org_study_id>
    <nct_id>NCT03779945</nct_id>
  </id_info>
  <brief_title>Effect of Platelet-Rich-Plasma in Spine Fusion</brief_title>
  <official_title>Application of Platelet-Rich-Plasma in Posterolateral Lumbar Fusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the fusion rate after the use of platelet rich&#xD;
      plasma with autolgus bone graft and comparing it with bone graft alone&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be submitted for approval by the Ethics Committee of Faculty of Medicine,&#xD;
      Assiut University, and written informed consent will be obtained from all patients prior to&#xD;
      enrollment. The study population will be selected from patients attending the Department of&#xD;
      Orthopedics and Trauma surgery, Assiut University hospitals.&#xD;
&#xD;
      A total of 104 patients treated with single level degenerative or lytic lumbar&#xD;
      Spondylolisthesis indicated for PLF will be included ,patients will be classified into 2&#xD;
      groups Group A:Of 52 patients PLF + autologus bone graft+ PRP Group B: Of 52 patients treated&#xD;
      with PLF + autologus bone graft only without adding PRP&#xD;
&#xD;
      Methods of evaluation&#xD;
&#xD;
        -  History taking.&#xD;
&#xD;
        -  Full clinical and neurological examination&#xD;
&#xD;
        -  Radiological evaluation by x-ray (antero posterior, lateral, and, CT scans provide&#xD;
           excellent views of bony detail) and MRI if needed Method of randomization By shuffling&#xD;
           cards method the candidate patient will choose one card from104 cards 52 of them&#xD;
           containing fusion with PRP and the other 52 contaning Fusion without PRP&#xD;
&#xD;
      Platelet-rich plasma (PRP is obtained using a two-stage centrifugation process:&#xD;
&#xD;
      Whole blood sample will be drawn from the participant and be collected in a sterile tube&#xD;
      containing anticoagulant (sodium citrate 3.8% or Ethylenediaminetetra acetic acid). The tube&#xD;
      will be centrifuged at 160xg relative centrifugal force (about 1000 round per minute) for 10&#xD;
      min in a centrifugal apparatus. The first spin will separate platelet poor plasma at the top&#xD;
      from red blood cells at the bottom and platelet rich plasma above (mixed with the white blood&#xD;
      cells in the buffy coat). The Platelet poor plasma, Platelet rich plasma and a few red blood&#xD;
      cells will be aspirated into a new tube, mixed and in the second spin, the tube will be&#xD;
      centrifuged at 400xg relative centrifugal form (about 1500 round per minute) for another 10&#xD;
      minutes. The upper section will consist of Platelet poor plasma and the Platelet rich plasma&#xD;
      will be collected at the bottom of the tube in the form of pellet. Then, Platelet poor plasma&#xD;
      and Platelet rich plasma will be aspirated and mixed (discarding the upper portion). Prior to&#xD;
      treatment calcium chloride 3% will be added to activate platelets specimen&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 20, 2018</start_date>
  <completion_date type="Anticipated">January 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 20, 2019</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>single center, prospective randomized comparative trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>the person performing the statistical analysis shall be masked</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Lenke classiﬁcation of posterolateral fusion success</measure>
    <time_frame>6 month to1 year post-operative</time_frame>
    <description>the degree of bridging bone across the fused vertebral bodies by using xray and CT scan</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>modified Oswestry disability index ,</measure>
    <time_frame>6 month to 1 year post-operative</time_frame>
    <description>the functional outcome on the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>visual analogue scale</measure>
    <time_frame>6 month to 1 year post-operative</time_frame>
    <description>the amount of pain sensed by the patient pre and post-operative</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Platelet-Rich Plasma</condition>
  <arm_group>
    <arm_group_label>posteriolateral lumbar fusion +bone graft+ PRP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the addition of autologous platelet rich plasma to the bone graft</description>
  </arm_group>
  <arm_group>
    <arm_group_label>posteriolateral lumbar fusion+bone graft only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>posteriolateral lumbar fusion with adding autologus bone graft alone posteriolateral lumbar fusion only</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>autologous platelet rich plasma</intervention_name>
    <description>adding autologous platelet rich plasma to the bone graft harvested from the patient</description>
    <arm_group_label>posteriolateral lumbar fusion +bone graft+ PRP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>posteriolateral lumbar fusion only</intervention_name>
    <description>performing posteriolateral lumbar fusion without using platelet rich plasma</description>
    <arm_group_label>posteriolateral lumbar fusion+bone graft only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        degenerative or lytic Spondylolisthesis.&#xD;
&#xD;
        Degenerative disc disease requiring posterior lumbar fusion not responding to medical&#xD;
        treatment for 1 year.&#xD;
&#xD;
        Age between 20 &amp; 75 years.&#xD;
&#xD;
        Single level fusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Multiple levels patient Traumatic Spondylolisthesis Previous lumbar spine surgery. Other&#xD;
        lumbar spine pathology severe osteoporosis Patients younger than 20 years old. Patients&#xD;
        older than 75 years old. Immunocompromised patients (eg. Chronic renal failure)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>El Moataz A Zohny El Sabrout, professor</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Essam M Abdelmoneim Elmorshedy, Lecturer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>. Belal O Mohamed Elnady, Lecturer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Micheal B Elia, doctor</last_name>
    <phone>01282682989</phone>
    <phone_ext>+2</phone_ext>
    <email>mikelbassem@hotmail.com</email>
  </overall_contact>
  <reference>
    <citation>Kubota G, Kamoda H, Orita S, Yamauchi K, Sakuma Y, Oikawa Y, Inage K, Sainoh T, Sato J, Ito M, Yamashita M, Nakamura J, Suzuki T, Takahashi K, Ohtori S. Platelet-rich plasma enhances bone union in posterolateral lumbar fusion: A prospective randomized controlled trial. Spine J. 2019 Feb;19(2):e34-e40. doi: 10.1016/j.spinee.2017.07.167. Epub 2017 Jul 20.</citation>
    <PMID>28735763</PMID>
  </reference>
  <reference>
    <citation>Shiga Y, Orita S, Kubota G, Kamoda H, Yamashita M, Matsuura Y, Yamauchi K, Eguchi Y, Suzuki M, Inage K, Sainoh T, Sato J, Fujimoto K, Abe K, Kanamoto H, Inoue M, Kinoshita H, Aoki Y, Toyone T, Furuya T, Koda M, Takahashi K, Ohtori S. Freeze-Dried Platelet-Rich Plasma Accelerates Bone Union with Adequate Rigidity in Posterolateral Lumbar Fusion Surgery Model in Rats. Sci Rep. 2016 Nov 11;6:36715. doi: 10.1038/srep36715.</citation>
    <PMID>27833116</PMID>
  </reference>
  <reference>
    <citation>Imagama S, Ando K, Kobayashi K, Ishikawa Y, Nakamura H, Hida T, Ito K, Tsushima M, Matsumoto A, Morozumi M, Tanaka S, Machino M, Ota K, Nakashima H, Takamatsu J, Matsushita T, Nishida Y, Ishiguro N, Matsuyama Y. Efficacy of Early Fusion With Local Bone Graft and Platelet-Rich Plasma in Lumbar Spinal Fusion Surgery Followed Over 10 Years. Global Spine J. 2017 Dec;7(8):749-755. doi: 10.1177/2192568217696690. Epub 2017 Apr 11.</citation>
    <PMID>29238638</PMID>
  </reference>
  <reference>
    <citation>Tarantino R, Donnarumma P, Mancarella C, Rullo M, Ferrazza G, Barrella G, Martini S, Delfini R. Posterolateral arthrodesis in lumbar spine surgery using autologous platelet-rich plasma and cancellous bone substitute: an osteoinductive and osteoconductive effect. Global Spine J. 2014 Aug;4(3):137-42. doi: 10.1055/s-0034-1376157. Epub 2014 May 3.</citation>
    <PMID>25083353</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>May 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 15, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 19, 2018</last_update_submitted>
  <last_update_submitted_qc>December 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Micheal Bassem Elia</investigator_full_name>
    <investigator_title>orthopedics resident</investigator_title>
  </responsible_party>
  <keyword>PRP</keyword>
  <!-- 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/NCT03779945
org study id: PRP in lumbar fusion
nct id: NCT03779945
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to evaluate the fusion rate after the use of platelet rich
      plasma with autolgus bone graft and comparing it with bone graft alone
The study will be submitted for approval by the Ethics Committee of Faculty of Medicine,
      Assiut University, and written informed consent will be obtained from all patients prior to
      enrollment. The study population will be selected from patients attending the Department of
      Orthopedics and Trauma surgery, Assiut University hospitals.

      A total of 104 patients treated with single level degenerative or lytic lumbar
      Spondylolisthesis indicated for PLF will be included ,patients will be classified into 2
      groups Group A:Of 52 patients PLF + autologus bone graft+ PRP Group B: Of 52 patients treated
      with PLF + autologus bone graft only without adding PRP

      Methods of evaluation

        -  History taking.

        -  Full clinical and neurological examination

        -  Radiological evaluation by x-ray (antero posterior, lateral, and, CT scans provide
           excellent views of bony detail) and MRI if needed Method of randomization By shuffling
           cards method the candidate patient will choose one card from104 cards 52 of them
           containing fusion with PRP and the other 52 contaning Fusion without PRP

      Platelet-rich plasma (PRP is obtained using a two-stage centrifugation process:

      Whole blood sample will be drawn from the participant and be collected in a sterile tube
      containing anticoagulant (sodium citrate 3.8% or Ethylenediaminetetra acetic acid). The tube
      will be centrifuged at 160xg relative centrifugal force (about 1000 round per minute) for 10
      min in a centrifugal apparatus. The first spin will separate platelet poor plasma at the top
      from red blood cells at the bottom and platelet rich plasma above (mixed with the white blood
      cells in the buffy coat). The Platelet poor plasma, Platelet rich plasma and a few red blood
      cells will be aspirated into a new tube, mixed and in the second spin, the tube will be
      centrifuged at 400xg relative centrifugal form (about 1500 round per minute) for another 10
      minutes. The upper section will consist of Platelet poor plasma and the Platelet rich plasma
      will be collected at the bottom of the tube in the form of pellet. Then, Platelet poor plasma
      and Platelet rich plasma will be aspirated and mixed (discarding the upper portion). Prior to
      treatment calcium chloride 3% will be added to activate platelets specimen
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: single center, prospective randomized comparative trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: the person performing the statistical analysis shall be masked
measure: Lenke classiﬁcation of posterolateral fusion success
time frame: 6 month to1 year post-operative
description: the degree of bridging bone across the fused vertebral bodies by using xray and CT scan
measure: modified Oswestry disability index ,
time frame: 6 month to 1 year post-operative
description: the functional outcome on the patient
measure: visual analogue scale
time frame: 6 month to 1 year post-operative
description: the amount of pain sensed by the patient pre and post-operative
arm group label: posteriolateral lumbar fusion +bone graft+ PRP
arm group type: Active Comparator
description: the addition of autologous platelet rich plasma to the bone graft
arm group label: posteriolateral lumbar fusion+bone graft only
arm group type: Active Comparator
description: posteriolateral lumbar fusion with adding autologus bone graft alone posteriolateral lumbar fusion only
intervention type: Biological
intervention name: autologous platelet rich plasma
description: adding autologous platelet rich plasma to the bone graft harvested from the patient
arm group label: posteriolateral lumbar fusion +bone graft+ PRP
intervention type: Procedure
intervention name: posteriolateral lumbar fusion only
description: performing posteriolateral lumbar fusion without using platelet rich plasma
arm group label: posteriolateral lumbar fusion+bone graft only
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: El Moataz A Zohny El Sabrout, professor
role: Study Chair
affiliation: Assiut University
last name: Essam M Abdelmoneim Elmorshedy, Lecturer
role: Principal Investigator
affiliation: Assiut University
last name: . Belal O Mohamed Elnady, Lecturer
role: Principal Investigator
affiliation: Assiut University
last name: Micheal B Elia, doctor
phone: 01282682989
phone ext: +2
email: mikelbassem@hotmail.com
citation: Kubota G, Kamoda H, Orita S, Yamauchi K, Sakuma Y, Oikawa Y, Inage K, Sainoh T, Sato J, Ito M, Yamashita M, Nakamura J, Suzuki T, Takahashi K, Ohtori S. Platelet-rich plasma enhances bone union in posterolateral lumbar fusion: A prospective randomized controlled trial. Spine J. 2019 Feb;19(2):e34-e40. doi: 10.1016/j.spinee.2017.07.167. Epub 2017 Jul 20.
PMID: 28735763
citation: Shiga Y, Orita S, Kubota G, Kamoda H, Yamashita M, Matsuura Y, Yamauchi K, Eguchi Y, Suzuki M, Inage K, Sainoh T, Sato J, Fujimoto K, Abe K, Kanamoto H, Inoue M, Kinoshita H, Aoki Y, Toyone T, Furuya T, Koda M, Takahashi K, Ohtori S. Freeze-Dried Platelet-Rich Plasma Accelerates Bone Union with Adequate Rigidity in Posterolateral Lumbar Fusion Surgery Model in Rats. Sci Rep. 2016 Nov 11;6:36715. doi: 10.1038/srep36715.
PMID: 27833116
citation: Imagama S, Ando K, Kobayashi K, Ishikawa Y, Nakamura H, Hida T, Ito K, Tsushima M, Matsumoto A, Morozumi M, Tanaka S, Machino M, Ota K, Nakashima H, Takamatsu J, Matsushita T, Nishida Y, Ishiguro N, Matsuyama Y. Efficacy of Early Fusion With Local Bone Graft and Platelet-Rich Plasma in Lumbar Spinal Fusion Surgery Followed Over 10 Years. Global Spine J. 2017 Dec;7(8):749-755. doi: 10.1177/2192568217696690. Epub 2017 Apr 11.
PMID: 29238638
citation: Tarantino R, Donnarumma P, Mancarella C, Rullo M, Ferrazza G, Barrella G, Martini S, Delfini R. Posterolateral arthrodesis in lumbar spine surgery using autologous platelet-rich plasma and cancellous bone substitute: an osteoinductive and osteoconductive effect. Global Spine J. 2014 Aug;4(3):137-42. doi: 10.1055/s-0034-1376157. Epub 2014 May 3.
PMID: 25083353
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Micheal Bassem Elia
investigator title: orthopedics resident