The Effect of Using Autologous Platelet Rich Plasma on Posterior Lumbar Interbody Fusion
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|ClinicalTrials.gov Identifier: NCT03261843|
Recruitment Status : Unknown
Verified August 2017 by Ahmed Abdelazim Abdelrahim Hassan, Assiut University.
Recruitment status was: Not yet recruiting
First Posted : August 25, 2017
Last Update Posted : August 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Autologous Platelet Rich Plasma Effect on Bone Healing||Biological: autologous platelet rich plasma Procedure: posterior lumbar interbody fusion without autologous platelet rich plasma||Phase 4|
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).
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||single center, prospective randomized comparative trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||the person performing the statistical analysis shall be masked|
|Official Title:||The Effect of Using Autologous Platelet Rich Plasma on Posterior Lumbar Interbody Fusion : a Randomized Comparative Trial|
|Estimated Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||January 1, 2019|
|Estimated Study Completion Date :||May 1, 2019|
Active Comparator: posterior lumbar interbody fusion + platelet rich plasma
the addition of autologous platelet rich plasma to the bone graft
Biological: autologous platelet rich plasma
adding autologous platelet rich plasma to the bone graft harvested from the patient
Active Comparator: posterior lumbar interbody fusion
bone graft alone
Procedure: posterior lumbar interbody fusion without autologous platelet rich plasma
performing posterior lumbar interbody fusion without using platelet rich plasma
- bridging trabecular bone scale [ Time Frame: from 3 to 6 month post-operative ]the degree of bridging bone across the fused vertebral bodies
- visual analogue of pain [ Time Frame: from 3 to 6 month post-operative ]the amount of pain sensed by the patient pre and post-operative
- the Oswestry disability index [ Time Frame: from 3 to 6 month post-operative ]the functional outcome on the patient
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261843
|Contact: Ahmed A A Hassan, M.B.B.email@example.com|