Efficacy of autologous platelet-rich plasma in arthrodesis after lumbar spine posterior stabilization surgery
Design
Two arm parallel group non randomised control trial, double-blind, phase 3 on 20 patients.
Settings and conduct
20 patients who are candidates for lumbar spine stabilization surgery referred to Rasoul Akram Hospital, on the day of operation, venous blood is taken from the patient in a special tube to prepare Platelet Rich Plasma (PRP) and transferred to the laboratory. PRP is prepared in the laboratory by the double spin method. Then, at the end of the operation, 2 cc of PRP per vertebra along with the allograft bone in the posterolateral space on the right or left side of the vertebral column and then the combination of 2cc of normal saline serum per each vertebra along with the allograft bone in the posterolateral space on the opposite side Placed. Then, the patient is followed up with CT scan images in the third, sixth, and twelfth months after the operation, and bone formation is evaluated by two radiologists who are unaware of the intervention site.
Participants/Inclusion and exclusion criteria
inclusion criteria: patients in the age range of 16 to 69 years who are candidates for posterior stabilization surgery of the lumbar spine.
Exclusion criteria: Patients who have malignancy, blood diseases and osteoporosis, or have a history of spine surgery.
Intervention groups
Intervention group: Platelet-rich plasma is placed in combination with allograft bone in the posterolateral space on the right or left side of the patient's vertebral column.
Control group: On the opposite side of the intervention group (right or left), the combination of allograft bone with normal saline (placebo) is placed in the posterolateral space of the patient's vertebral column..
Main outcome variables
arthrodesis rate in CT scan images
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171124037606N4
Registration date:2023-05-08, 1402/02/18
Registration timing:retrospective
Last update:2023-05-08, 1402/02/18
Update count:0
Registration date
2023-05-08, 1402/02/18
Registrant information
Name
Alireza Tabibkhooei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2228
Email address
tabibkhooei.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-01, 1400/07/09
Expected recruitment end date
2022-12-24, 1401/10/03
Actual recruitment start date
2021-10-01, 1400/07/09
Actual recruitment end date
2022-12-24, 1401/10/03
Trial completion date
2022-12-24, 1401/10/03
Scientific title
Comparing the effectiveness of autologous PRP in postrolateral arthrodesis of lumbar spine surgery
Public title
The effect of autologous platelet-rich plasma on spinal arthrodesis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with lumbar spine fracture
Patients with lumbar canal stenosis
Patients with lumbar spondylolisthesis
Exclusion criteria:
Patients with a history of spine surgery
Patients suspected of local infection of the spine
Patients with canal stenosis or fractures of cervical and thoracic vertebrae
Patients with malignancy
Patients treated with immunosuppressive drugs
Patients with platelet disorders
Patients with severe osteoporosis
Age
From 16 years old to 69 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
One side of the patient's lumbar spine (right or left) is used as an intervention sample and the other side of the patient's spine is used as a control sample.
Actual sample size reached:
20
More than 1 sample in each individual
Actual sample size in each individual:
2
One side of the patient's lumbar spine (right or left) is used as an intervention sample and the other side of the patient's spine is used as a control sample.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome evaluators, who are two radiologists, entered their evaluations in separate questionnaires and numerically, and considering that the interventional material is not visible in the imaging, in relation to which side of the patient's spine (right or left) They are completely unaware of the intervention.
The data analyst, who is a statistician, also receives the data numerically and is unaware of which side of the patient's spine (right or left) the intervention took place.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-09-26, 1400/07/04
Ethics committee reference number
IR.IUMS.FMD.REC.1400.492
Health conditions studied
1
Description of health condition studied
Postrolateral arthrodesis after lumbar spine fixation
ICD-10 code
M96.0
ICD-10 code description
Pseudarthrosis after fusion or arthrodesis
Primary outcomes
1
Description
Arthrodesis rate based on Hounsfield index in CT scan images
Timepoint
Evaluation of posterolateral arthrodesis in the third, sixth and twelfth months after surgery
Method of measurement
Helical 16-slice CT scan machine
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: On the day of surgery, 26 cc of venous blood was taken from the patient under sterile conditions and placed in 3 special tubes for the preparation of platelet-rich plasma (manufactured by Becton Dickinson) containing 1.5 cc of Acid Citrate Dextrose (ACD) with a volume of 8.5 cc. are poured and transferred to the laboratory. In the laboratory, platelet-rich plasma is prepared by the double spin method, in this way, first all 3 tubes are placed in a centrifuge (Pars Azma model SH.13) with 1600 rpm for 12 minutes and after finishing the layer work The plasma is separated under sterile conditions and enters the test tube without anticoagulant. Then it is placed again in the centrifuge with 2700 rpm for 5 minutes. After finishing the work, the upper two-thirds of the plasma is separated from the tube and the remaining one-third is gently shaken in a pendulum after a 5-minute rest so that the concentrated platelets merge with the plasma. Then the platelet-rich plasma was transferred to the operating room and at the end of the operation, 2 cc per vertebra in combination with allograft bone (manufactured by Ceno Bone Company) in the posterolateral space on the right or left side of the vertebral column and then the combination of allograft bone with 2 CC of normal saline serum is placed for each vertebra in the posterolateral space on the opposite side of the vertebral column. Then, the patient was followed up for one year with CT scan imaging in the third, sixth and twelfth months after the operation, and the amount of arthrodesis based on the Hounsfield index was numerically calculated in separate questionnaires by two radiologists who did not know about the side of the intervention. will be recorded. Then the average of the reported numbers is delivered to the statistician for statistical calculations.
Category
Treatment - Drugs
2
Description
Control group: the posterolateral space of the vertebral column on the opposite side in the patients of the intervention group, where the combination of 2 cc of normal saline serum is placed for each vertebra along with the bone graft. Then, the patient was followed up for one year with CT scan imaging in the third, sixth and twelfth months after the operation, and the amount of arthrodesis based on the Hounsfield index was numerically calculated in separate questionnaires by two radiologists who did not know about the side of the intervention. will be recorded. Then the average of the reported numbers is delivered to the statistician for statistical calculations.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After de-identifying people, the information about the main outcome will be accessible
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For research purposes, descriptive raw data is made available at the discretion of the University Research Committee
From where data/document is obtainable
by Email:
tabibkhooei.a@iums.ac.ir
What processes are involved for a request to access data/document
After receiving the email about making the information available after checking the qualification of the researcher by the research committee, the information will be sent to the academic email address of the person within a week.