NCT03261843

Brief Summary

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

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 Nov 2017

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

August 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

August 25, 2017

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

August 23, 2017

Last Update Submit

August 24, 2017

Conditions

Autologous Platelet Rich Plasma Effect on Bone Healing

Keywords

platelet rich plasma , posterior lumbar interbody fusion

Outcome Measures

Primary Outcomes (1)

  • bridging trabecular bone scale

    the degree of bridging bone across the fused vertebral bodies

    from 3 to 6 month post-operative

Secondary Outcomes (2)

  • visual analogue of pain

    from 3 to 6 month post-operative

  • the Oswestry disability index

    from 3 to 6 month post-operative

Study Arms (2)

posterior lumbar interbody fusion + platelet rich plasma

ACTIVE COMPARATOR

the addition of autologous platelet rich plasma to the bone graft

Biological: autologous platelet rich plasma

posterior lumbar interbody fusion

ACTIVE COMPARATOR

bone graft alone

Procedure: posterior lumbar interbody fusion without autologous platelet rich plasma

Interventions

autologous platelet rich plasmaBIOLOGICAL

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

posterior lumbar interbody fusion + platelet rich plasma
posterior lumbar interbody fusion without autologous platelet rich plasmaPROCEDURE

performing posterior lumbar interbody fusion without using platelet rich plasma

posterior lumbar interbody fusion

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spondylolisthesis.
  • Degenerative disc disease requiring posterior lumbar interbody fusion not responding to medical treatment for 1 year.
  • Age between 20 \& 70 years.
  • Single or multiple level fusions.

You may not qualify if:

  • Previous lumbar spine surgery.
  • Other lumbar spine pathology
  • severe osteoporosis
  • Chronic use of steroid or non-steroidal anti-inflammatory drugs (more than one year)
  • Patients younger than 20 years old.
  • Patients older than 70 years old.
  • Immunocompromised patients (eg. Chronic renal failure)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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: 26831629RESULT

  • 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: 21744284RESULT

  • 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: 12973143RESULT

  • 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: 12761669RESULT

  • 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: 19481375RESULT

  • 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: 15085519RESULT

  • 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: 3570542RESULT

Central Study Contacts

Ahmed A A Hassan, M.B.B.ch

CONTACT

+201288103657ahmedabdelazim2014@yahoo.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
resident of orthopedics and trauma surgery

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 25, 2017

Study Start

November 1, 2017

Primary Completion

January 1, 2019

Study Completion

May 1, 2019

Last Updated

August 25, 2017

Record last verified: 2017-08