Effect of Platelet-Rich-Plasma in Spine Fusion

Status Not yet recruiting

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Platelet-Rich Plasma

Clinical Trial Details

NCT number	NCT03779945
Study type	Interventional
Source	Assiut University
Contact	Micheal B Elia, doctor
Phone	01282682989
Email	mikelbassem@hotmail.com
Status	Not yet recruiting
Phase	Phase 4
Start date	December 20, 2018
Completion date	January 20, 2020

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05483634` - Compare Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause
Not yet recruiting	`NCT05096650` - Platelet Rich Plasma for Treatment of Facial Photoaging: A Double-blind, Randomized, Split-face Study	N/A
Completed	`NCT03667638` - Influence of Platelet Concentrates on Wound Healing	N/A
Recruiting	`NCT04972331` - Degenerative Meniscus Without Osteoarthritis : Arthroscopic Partial Menisectomy Versus Platelet Rich Plasma (APM-PRP)	N/A
Completed	`NCT04351087` - Microfragmented Adipose Tissue Versus Platelet-rich Plasma for Knee Osteoarthritis: a Randomized Comparative Trial	N/A
Completed	`NCT03220334` - Healing Effects of Autologous Platelet Rich Plasma on Gastric Ulcer Caused by Endoscopic Submucosal Dissection	Phase 3
Completed	`NCT03197428` - Platelet-rich Plasma for Chronic Lateral Ankle Instability	N/A
Recruiting	`NCT04040283` - Platelet-rich Plasma for Menical Tear
Not yet recruiting	`NCT03859843` - Efficacy and Antimicrobial Activity of Platelet Rich Plasma (PRP) in Acne Vulgaris	Phase 3
Completed	`NCT05585216` - The Efficacy of PRP Combined With Exercise to Treat Knee Osteoarthritisq	N/A
Completed	`NCT05925829` - Stromal Vascular Fraction and Autologous Activated Platelet-Rich Plasma Combination in Treating Treatment of Type 2 Diabetes	Phase 1
Completed	`NCT04350827` - PRP vs PRP Plus IGF for Patellar Tendinosis	N/A
Completed	`NCT04522674` - Platelet-Rich Plasma (PRP) for Treatment of Symptomatic Lumbar Facet Syndrome of the Spine	Early Phase 1
Completed	`NCT03197441` - Platelet Rich Plasma for Knee Osteoarthritis	N/A
Completed	`NCT03176641` - Platelet-rich Plasma for Meniscus Repair	N/A
Completed	`NCT02931149` - Evaluation of the Efficacy of Platelet-rich Plasma (PRP) on Advanced Endoscopic Resection Techniques	Phase 3
Recruiting	`NCT05230667` - Comparison of the Effect of Combined Glenohumeral Joint and Subdeltoid Bursa Injection With Platelet-rich Plasma (PRP), Corticosteroid, and Normal Saline in Addition to Physical Therapy for Treatment of Frozen Shoulder	N/A
Completed	`NCT03197415` - Platelet-rich Plasma for Low Back Pain	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.