Clinical trial NCT03779945: Effect of Platelet-Rich-Plasma in Spine Fusion
Official title: Application of Platelet-Rich-Plasma in Posterolateral Lumbar Fusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Platelet-Rich Plasma
Keywords: PRP
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single center, prospective randomized comparative trial
Primary purpose: TREATMENT

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

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

Eligibility 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)

Primary outcomes:
measure: Lenke classiﬁcation of posterolateral fusion success
timeFrame: 6 month to1 year post-operative
Secondary outcomes:
measure: modified Oswestry disability index ,
timeFrame: 6 month to 1 year post-operative
measure: visual analogue scale
timeFrame: 6 month to 1 year post-operative
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: El Moataz A Zohny El Sabrout, professor
role: STUDY_CHAIR
affiliation: Assiut University
name: Essam M Abdelmoneim Elmorshedy, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: . Belal O Mohamed Elnady, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.