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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
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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| posteriolateral lumbar fusion +bone graft+ PRP | Active Comparator | the addition of autologous platelet rich plasma to the bone graft |
|
| posteriolateral lumbar fusion+bone graft only | Active Comparator | posteriolateral lumbar fusion with adding autologus bone graft alone posteriolateral lumbar fusion only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous platelet rich plasma | Biological | adding autologous platelet rich plasma to the bone graft harvested from the patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| modified Oswestry disability index , | the functional outcome on the patient | 6 month to 1 year post-operative |
| visual analogue scale | the amount of pain sensed by the patient pre and post-operative |
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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)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Micheal B Elia, doctor | Contact | 01282682989 | +2 | mikelbassem@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| El Moataz A Zohny El Sabrout, professor | Assiut University | Study Chair |
| Essam M Abdelmoneim Elmorshedy, Lecturer | Assiut University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28735763 | Background | 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. | |
| 27833116 |
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single center, prospective randomized comparative trial
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the person performing the statistical analysis shall be masked
| posteriolateral lumbar fusion only | Procedure | performing posteriolateral lumbar fusion without using platelet rich plasma |
|
| 6 month to 1 year post-operative |
| . Belal O Mohamed Elnady, Lecturer |
| Assiut University |
| Principal Investigator |
| 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. |
| 29238638 | Background | 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. |
| 25083353 | Background | 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. |