<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/NCT03261843</url>
  </required_header>
  <id_info>
    <org_study_id>platelet rich plasma</org_study_id>
    <nct_id>NCT03261843</nct_id>
  </id_info>
  <brief_title>The Effect of Using Autologous Platelet Rich Plasma on Posterior Lumbar Interbody Fusion</brief_title>
  <official_title>The Effect of Using Autologous Platelet Rich Plasma on Posterior Lumbar Interbody Fusion : a Randomized Comparative Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      the study aims to determine the effect of using Autologous platelet rich plasma on both the&#xD;
      quality &amp; rate of posterior lumbar interbody fusion &amp; its outcome on the Patient regarding&#xD;
      postoperative lumbar pain &amp; functional outcome&#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;
      Sixty patients will be selected for the study and will be randomized into two group one&#xD;
      receiving posterior lumbar interbody fusion with Autologous platelet rich plasma and the&#xD;
      other group will receive posterior lumbar interbody fusion without Autologous platelet rich&#xD;
      plasma.&#xD;
&#xD;
      Methodology pre-operative preparation: Prior to the operation the selected patients will&#xD;
      perform lumbar spine Computarised tomography and X ray films. Both the visual analogue scale&#xD;
      of pain and the Oswestry disability index will be collected from the patients&#xD;
&#xD;
      Autologous platelet rich plasma preparation:&#xD;
&#xD;
      Autologous Platelet rich plasma 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 Ethylenediaminetetraacetic 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 immediately before its&#xD;
      application to avoid coagulation of the specimen (for every 1.5 milliliter plasma, 1&#xD;
      milliliter calcium chloride 3% is added).&#xD;
&#xD;
      Surgery:&#xD;
&#xD;
      A posterior lumbar interbody fusion with posterior pedicle screw fixation will be performed&#xD;
      through a midline posterior approach. Trans-pedicular screws will be placed under&#xD;
      fluoroscopic guidance, followed by discectomy. The vertebral body endplates will be prepared&#xD;
      by curetting until point bleeding was seen.&#xD;
&#xD;
      Autologous cancellous bone chips will be harvested unilaterally from the iliac wing,&#xD;
      approached through the midline posterior incision. The bone chips will be steeped in the&#xD;
      plasma solution until clotting occurred visually (approximately 10 minutes). In the control&#xD;
      group, the bone chips will be filled with autologous bone in the same way and were implanted&#xD;
      after approximately 10 minutes without incubation in a plasma solution.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 1, 2017</start_date>
  <completion_date type="Anticipated">May 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 1, 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>bridging trabecular bone scale</measure>
    <time_frame>from 3 to 6 month post-operative</time_frame>
    <description>the degree of bridging bone across the fused vertebral bodies</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>visual analogue of pain</measure>
    <time_frame>from 3 to 6 month post-operative</time_frame>
    <description>the amount of pain sensed by the patient pre and post-operative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the Oswestry disability index</measure>
    <time_frame>from 3 to 6 month post-operative</time_frame>
    <description>the functional outcome on the patient</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Autologous Platelet Rich Plasma Effect on Bone Healing</condition>
  <arm_group>
    <arm_group_label>posterior lumbar interbody fusion + platelet rich plasma</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>posterior lumbar interbody fusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>bone graft alone</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>posterior lumbar interbody fusion + platelet rich plasma</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>posterior lumbar interbody fusion without autologous platelet rich plasma</intervention_name>
    <description>performing posterior lumbar interbody fusion without using platelet rich plasma</description>
    <arm_group_label>posterior lumbar interbody fusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Spondylolisthesis.&#xD;
&#xD;
          -  Degenerative disc disease requiring posterior lumbar interbody fusion not responding&#xD;
             to medical treatment for 1 year.&#xD;
&#xD;
          -  Age between 20 &amp; 70 years.&#xD;
&#xD;
          -  Single or multiple level fusions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous lumbar spine surgery.&#xD;
&#xD;
          -  Other lumbar spine pathology&#xD;
&#xD;
          -  severe osteoporosis&#xD;
&#xD;
          -  Chronic use of steroid or non-steroidal anti-inflammatory drugs (more than one year)&#xD;
&#xD;
          -  Patients younger than 20 years old.&#xD;
&#xD;
          -  Patients older than 70 years old.&#xD;
&#xD;
          -  Immunocompromised patients (eg. Chronic renal failure)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ahmed A A Hassan, M.B.B.ch</last_name>
    <phone>+201288103657</phone>
    <email>ahmedabdelazim2014@yahoo.com</email>
  </overall_contact>
  <results_reference>
    <citation>Smith PA. Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial. Am J Sports Med. 2016 Apr;44(4):884-91. doi: 10.1177/0363546515624678. Epub 2016 Feb 1.</citation>
    <PMID>26831629</PMID>
  </results_reference>
  <results_reference>
    <citation>Sys J, Weyler J, Van Der Zijden T, Parizel P, Michielsen J. Platelet-rich plasma in mono-segmental posterior lumbar interbody fusion. Eur Spine J. 2011 Oct;20(10):1650-7. doi: 10.1007/s00586-011-1897-0. Epub 2011 Jul 10.</citation>
    <PMID>21744284</PMID>
  </results_reference>
  <results_reference>
    <citation>Weiner BK, Walker M. Efficacy of autologous growth factors in lumbar intertransverse fusions. Spine (Phila Pa 1976). 2003 Sep 1;28(17):1968-70; discussion 1971. doi: 10.1097/01.BRS.0000083141.02027.48.</citation>
    <PMID>12973143</PMID>
  </results_reference>
  <results_reference>
    <citation>Hee HT, Majd ME, Holt RT, Myers L. Do autologous growth factors enhance transforaminal lumbar interbody fusion? Eur Spine J. 2003 Aug;12(4):400-7. doi: 10.1007/s00586-003-0548-5. Epub 2003 May 22.</citation>
    <PMID>12761669</PMID>
  </results_reference>
  <results_reference>
    <citation>Kaux JF, Le Goff C, Seidel L, Peters P, Gothot A, Albert A, Crielaard JM. [Comparative study of five techniques of preparation of platelet-rich plasma]. Pathol Biol (Paris). 2011 Jun;59(3):157-60. doi: 10.1016/j.patbio.2009.04.007. Epub 2009 May 28. French.</citation>
    <PMID>19481375</PMID>
  </results_reference>
  <results_reference>
    <citation>Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available.</citation>
    <PMID>15085519</PMID>
  </results_reference>
  <results_reference>
    <citation>Ferrari M, Zia S, Valbonesi M, Henriquet F, Venere G, Spagnolo S, Grasso MA, Panzani I. A new technique for hemodilution, preparation of autologous platelet-rich plasma and intraoperative blood salvage in cardiac surgery. Int J Artif Organs. 1987 Jan;10(1):47-50.</citation>
    <PMID>3570542</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Abdelazim Abdelrahim Hassan</investigator_full_name>
    <investigator_title>resident of orthopedics and trauma surgery</investigator_title>
  </responsible_party>
  <keyword>platelet rich plasma , posterior lumbar interbody fusion</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03261843
org study id: platelet rich plasma
nct id: NCT03261843
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
the study aims to determine the effect of using Autologous platelet rich plasma on both the
      quality & rate of posterior lumbar interbody fusion & its outcome on the Patient regarding
      postoperative lumbar pain & functional outcome
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.

      Sixty patients will be selected for the study and will be randomized into two group one
      receiving posterior lumbar interbody fusion with Autologous platelet rich plasma and the
      other group will receive posterior lumbar interbody fusion without Autologous platelet rich
      plasma.

      Methodology pre-operative preparation: Prior to the operation the selected patients will
      perform lumbar spine Computarised tomography and X ray films. Both the visual analogue scale
      of pain and the Oswestry disability index will be collected from the patients

      Autologous platelet rich plasma preparation:

      Autologous Platelet rich plasma 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 Ethylenediaminetetraacetic 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 immediately before its
      application to avoid coagulation of the specimen (for every 1.5 milliliter plasma, 1
      milliliter calcium chloride 3% is added).

      Surgery:

      A posterior lumbar interbody fusion with posterior pedicle screw fixation will be performed
      through a midline posterior approach. Trans-pedicular screws will be placed under
      fluoroscopic guidance, followed by discectomy. The vertebral body endplates will be prepared
      by curetting until point bleeding was seen.

      Autologous cancellous bone chips will be harvested unilaterally from the iliac wing,
      approached through the midline posterior incision. The bone chips will be steeped in the
      plasma solution until clotting occurred visually (approximately 10 minutes). In the control
      group, the bone chips will be filled with autologous bone in the same way and were implanted
      after approximately 10 minutes without incubation in a plasma solution.
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: bridging trabecular bone scale
time frame: from 3 to 6 month post-operative
description: the degree of bridging bone across the fused vertebral bodies
measure: visual analogue of pain
time frame: from 3 to 6 month post-operative
description: the amount of pain sensed by the patient pre and post-operative
measure: the Oswestry disability index
time frame: from 3 to 6 month post-operative
description: the functional outcome on the patient
arm group label: posterior lumbar interbody fusion + platelet rich plasma
arm group type: Active Comparator
description: the addition of autologous platelet rich plasma to the bone graft
arm group label: posterior lumbar interbody fusion
arm group type: Active Comparator
description: bone graft alone
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: posterior lumbar interbody fusion + platelet rich plasma
intervention type: Procedure
intervention name: posterior lumbar interbody fusion without autologous platelet rich plasma
description: performing posterior lumbar interbody fusion without using platelet rich plasma
arm group label: posterior lumbar interbody fusion
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ahmed A A Hassan, M.B.B.ch
phone: +201288103657
email: ahmedabdelazim2014@yahoo.com
citation: Smith PA. Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial. Am J Sports Med. 2016 Apr;44(4):884-91. doi: 10.1177/0363546515624678. Epub 2016 Feb 1.
PMID: 26831629
citation: Sys J, Weyler J, Van Der Zijden T, Parizel P, Michielsen J. Platelet-rich plasma in mono-segmental posterior lumbar interbody fusion. Eur Spine J. 2011 Oct;20(10):1650-7. doi: 10.1007/s00586-011-1897-0. Epub 2011 Jul 10.
PMID: 21744284
citation: Weiner BK, Walker M. Efficacy of autologous growth factors in lumbar intertransverse fusions. Spine (Phila Pa 1976). 2003 Sep 1;28(17):1968-70; discussion 1971. doi: 10.1097/01.BRS.0000083141.02027.48.
PMID: 12973143
citation: Hee HT, Majd ME, Holt RT, Myers L. Do autologous growth factors enhance transforaminal lumbar interbody fusion? Eur Spine J. 2003 Aug;12(4):400-7. doi: 10.1007/s00586-003-0548-5. Epub 2003 May 22.
PMID: 12761669
citation: Kaux JF, Le Goff C, Seidel L, Peters P, Gothot A, Albert A, Crielaard JM. [Comparative study of five techniques of preparation of platelet-rich plasma]. Pathol Biol (Paris). 2011 Jun;59(3):157-60. doi: 10.1016/j.patbio.2009.04.007. Epub 2009 May 28. French.
PMID: 19481375
citation: Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available.
PMID: 15085519
citation: Ferrari M, Zia S, Valbonesi M, Henriquet F, Venere G, Spagnolo S, Grasso MA, Panzani I. A new technique for hemodilution, preparation of autologous platelet-rich plasma and intraoperative blood salvage in cardiac surgery. Int J Artif Organs. 1987 Jan;10(1):47-50.
PMID: 3570542
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Abdelazim Abdelrahim Hassan
investigator title: resident of orthopedics and trauma surgery
sharing ipd: Undecided