A Phase 4 interventional study of autologous platelet rich plasma and posteriolateral lumbar fusion only in Platelet-Rich Plasma, sponsored by Assiut University. Status unknown. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-12-20.
Sponsored by Assiut University · Phase 4, Interventional, and Treatment
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
Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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)
the addition of autologous platelet rich plasma to the bone graft
Biological: autologous platelet rich plasma
posteriolateral lumbar fusion with adding autologus bone graft alone posteriolateral lumbar fusion only
Procedure: posteriolateral lumbar fusion only
adding autologous platelet rich plasma to the bone graft harvested from the patient
performing posteriolateral lumbar fusion without using platelet rich plasma
Lenke classification of posterolateral fusion success
the degree of bridging bone across the fused vertebral bodies by using xray and CT scan
Time frame: 6 month to1 year post-operative
modified Oswestry disability index ,
the functional outcome on the patient
Time frame: 6 month to 1 year post-operative
visual analogue scale
the amount of pain sensed by the patient pre and post-operative
Time frame: 6 month to 1 year post-operative
No study locations are listed for this record.
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assiut University