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Effect of Platelet-Rich-Plasma in Spine Fusion

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ClinicalTrials.gov Identifier: NCT03779945
Recruitment Status : Unknown
Verified December 2018 by Micheal Bassem Elia, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : December 19, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Micheal Bassem Elia, Assiut University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Platelet-Rich Plasma Biological: autologous platelet rich plasma Procedure: posteriolateral lumbar fusion only Phase 4

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: single center, prospective randomized comparative trial
Masking: Single (Outcomes Assessor)
Masking Description: the person performing the statistical analysis shall be masked
Primary Purpose: Treatment
Official Title: Application of Platelet-Rich-Plasma in Posterolateral Lumbar Fusion
Estimated Study Start Date : December 20, 2018
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : January 20, 2020

Arm Intervention/treatment
Active Comparator: posteriolateral lumbar fusion +bone graft+ PRP
the addition of autologous platelet rich plasma to the bone graft
Biological: autologous platelet rich plasma
adding autologous platelet rich plasma to the bone graft harvested from the patient

Active Comparator: posteriolateral lumbar fusion+bone graft only
posteriolateral lumbar fusion with adding autologus bone graft alone posteriolateral lumbar fusion only
Procedure: posteriolateral lumbar fusion only
performing posteriolateral lumbar fusion without using platelet rich plasma




Primary Outcome Measures :
  1. Lenke classification of posterolateral fusion success [ Time Frame: 6 month to1 year post-operative ]
    the degree of bridging bone across the fused vertebral bodies by using xray and CT scan


Secondary Outcome Measures :
  1. modified Oswestry disability index , [ Time Frame: 6 month to 1 year post-operative ]
    the functional outcome on the patient

  2. visual analogue scale [ Time Frame: 6 month to 1 year post-operative ]
    the amount of pain sensed by the patient pre and post-operative



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

degenerative or lytic Spondylolisthesis.

Degenerative disc disease requiring posterior lumbar fusion not responding to medical treatment for 1 year.

Age between 20 & 75 years.

Single level fusion

Exclusion Criteria:

Multiple levels patient Traumatic Spondylolisthesis Previous lumbar spine surgery. Other lumbar spine pathology severe osteoporosis Patients younger than 20 years old. Patients older than 75 years old. Immunocompromised patients (eg. Chronic renal failure)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779945


Contacts
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Contact: Micheal B Elia, doctor 01282682989 ext +2 mikelbassem@hotmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: El Moataz A Zohny El Sabrout, professor Assiut University
Principal Investigator: Essam M Abdelmoneim Elmorshedy, Lecturer Assiut University
Principal Investigator: . Belal O Mohamed Elnady, Lecturer Assiut University
Publications:

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Responsible Party: Micheal Bassem Elia, orthopedics resident, Assiut University
ClinicalTrials.gov Identifier: NCT03779945    
Other Study ID Numbers: PRP in lumbar fusion
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Micheal Bassem Elia, Assiut University:
PRP