NCT03779945

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2018

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

December 20, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
Last Updated

December 20, 2018

Status Verified

December 1, 2018

Enrollment Period

1 year

First QC Date

May 17, 2018

Last Update Submit

December 19, 2018

Conditions

Platelet-Rich Plasma

Keywords

PRP

Outcome Measures

Primary Outcomes (1)

  • Lenke classification of posterolateral fusion success

    the degree of bridging bone across the fused vertebral bodies by using xray and CT scan

    6 month to1 year post-operative

Secondary Outcomes (2)

  • modified Oswestry disability index ,

    6 month to 1 year post-operative

  • visual analogue scale

    6 month to 1 year post-operative

Study Arms (2)

posteriolateral lumbar fusion +bone graft+ PRP

ACTIVE COMPARATOR

the addition of autologous platelet rich plasma to the bone graft

Biological: autologous platelet rich plasma

posteriolateral lumbar fusion+bone graft only

ACTIVE COMPARATOR

posteriolateral lumbar fusion with adding autologus bone graft alone posteriolateral lumbar fusion only

Procedure: posteriolateral lumbar fusion only

Interventions

autologous platelet rich plasmaBIOLOGICAL

adding autologous platelet rich plasma to the bone graft harvested from the patient

posteriolateral lumbar fusion +bone graft+ PRP
posteriolateral lumbar fusion onlyPROCEDURE

performing posteriolateral lumbar fusion without using platelet rich plasma

posteriolateral lumbar fusion+bone graft only

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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: 28735763BACKGROUND

  • 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: 27833116BACKGROUND

  • 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: 29238638BACKGROUND

  • 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: 25083353BACKGROUND

Study Officials

  • El Moataz A Zohny El Sabrout, professor

    Assiut University

    STUDY CHAIR

  • Essam M Abdelmoneim Elmorshedy, Lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

  • . Belal O Mohamed Elnady, Lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Micheal B Elia, doctor

CONTACT

01282682989mikelbassem@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
the person performing the statistical analysis shall be masked
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: single center, prospective randomized comparative trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
orthopedics resident

Study Record Dates

First Submitted

May 17, 2018

First Posted

December 19, 2018

Study Start

December 20, 2018

Primary Completion

December 20, 2019

Study Completion

January 20, 2020

Last Updated

December 20, 2018

Record last verified: 2018-12