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Effect of Platelet-Rich-Plasma in Spine Fusion

Application of Platelet-Rich-Plasma in Posterolateral Lumbar Fusion

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03779945
Enrollment
60
Registered
2018-12-19
Start date
2018-12-20
Completion date
2020-01-20
Last updated
2018-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Platelet-Rich Plasma

Keywords

PRP

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

Interventions

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

PROCEDUREposteriolateral lumbar fusion only

performing posteriolateral lumbar fusion without using platelet rich plasma

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

the person performing the statistical analysis shall be masked

Intervention model description

single center, prospective randomized comparative trial

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Lenke classification of posterolateral fusion success6 month to1 year post-operativethe degree of bridging bone across the fused vertebral bodies by using xray and CT scan

Secondary

MeasureTime frameDescription
modified Oswestry disability index ,6 month to 1 year post-operativethe functional outcome on the patient
visual analogue scale6 month to 1 year post-operativethe amount of pain sensed by the patient pre and post-operative

Contacts

Primary ContactMicheal B Elia, doctor
mikelbassem@hotmail.com01282682989

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026