The Effect of Using Autologous Platelet Rich Plasma on Posterior Lumbar Interbody Fusion

The Effect of Using Autologous Platelet Rich Plasma on Posterior Lumbar Interbody Fusion : a Randomized Comparative Trial

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

Study Overview

• Status: Unknown
• Conditions: Autologous Platelet Rich Plasma Effect on Bone Healing
• Intervention / Treatment: Biological: autologous platelet rich plasma; Procedure: posterior lumbar interbody fusion without autologous platelet rich plasma

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.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ahmed A A Hassan, M.B.B.ch; Phone Number: +201288103657; Email: ahmedabdelazim2014@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: posterior lumbar interbody fusion + platelet rich plasma; 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: posterior lumbar interbody fusion; bone graft alone	Procedure: posterior lumbar interbody fusion without autologous platelet rich plasma; performing posterior lumbar interbody fusion without using platelet rich plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bridging trabecular bone scale	the degree of bridging bone across the fused vertebral bodies	from 3 to 6 month post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue of pain	the amount of pain sensed by the patient pre and post-operative	from 3 to 6 month post-operative
the Oswestry disability index	the functional outcome on the patient	from 3 to 6 month post-operative

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2017
• Primary Completion (ANTICIPATED): January 1, 2019
• Study Completion (ANTICIPATED): May 1, 2019

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 24, 2017
• First Posted (ACTUAL): August 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2017
• Last Update Submitted That Met QC Criteria: August 24, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: platelet rich plasma , posterior lumbar interbody fusion
• Other Study ID Numbers: Platelet rich plasma

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No