Autologous Platelet Rich Plasma Effect on Bone Healing Clinical Trial
Official title:
The Effect of Using Autologous Platelet Rich Plasma on Posterior Lumbar Interbody Fusion : a Randomized Comparative Trial
the study aims to determine the effect of using Autologous platelet rich plasma on both the quality & rate of posterior lumbar interbody fusion & its outcome on the Patient regarding postoperative lumbar pain & functional outcome
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.
Sixty patients will be selected for the study and will be randomized into two group one
receiving posterior lumbar interbody fusion with Autologous platelet rich plasma and the
other group will receive posterior lumbar interbody fusion without Autologous platelet rich
plasma.
Methodology pre-operative preparation: Prior to the operation the selected patients will
perform lumbar spine Computarised tomography and X ray films. Both the visual analogue scale
of pain and the Oswestry disability index will be collected from the patients
Autologous platelet rich plasma preparation:
Autologous Platelet rich plasma 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 Ethylenediaminetetraacetic 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 immediately before its
application to avoid coagulation of the specimen (for every 1.5 milliliter plasma, 1
milliliter calcium chloride 3% is added).
Surgery:
A posterior lumbar interbody fusion with posterior pedicle screw fixation will be performed
through a midline posterior approach. Trans-pedicular screws will be placed under
fluoroscopic guidance, followed by discectomy. The vertebral body endplates will be prepared
by curetting until point bleeding was seen.
Autologous cancellous bone chips will be harvested unilaterally from the iliac wing,
approached through the midline posterior incision. The bone chips will be steeped in the
plasma solution until clotting occurred visually (approximately 10 minutes). In the control
group, the bone chips will be filled with autologous bone in the same way and were implanted
after approximately 10 minutes without incubation in a plasma solution.
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