This single blind clinical trial was aimed to evaluate the clinical and radiographic results of using peek cage and acrylic cage in the patients with cervical discectomy. Sixty-four patients, who had indications of cervical disc surgery and had been treated with discectomy, were randomly allocated to one of two groups. After discectomy was perfomed, peek cage and acrylic cage were used in the control and study groups, respectively. The patients were followed at 2, 6, and 12 months postoperatively. The patients' clinical improvement was evaluated by the amount of pain reduction and the patients' paraclinical findings were measured by dynamic radiological graphs and CT images which were used to evaluate sagittal angle and amount of subsidence, fusion and subluxation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138807132193N3
Registration date:2011-06-01, 1390/03/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-06-01, 1390/03/11
Registrant information
Name
Majid Reza Farrokhi
Name of organization / entity
Shiraz Neurosciences Research Center, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1623 4508
Email address
neuroscien@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz Neurosciences Research Center, Vice-chancellor for Research Affairs of Shiraz University of Medical Sciences
Expected recruitment start date
2011-06-02, 1390/03/12
Expected recruitment end date
2012-07-29, 1391/05/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the results of using peek cage and acrylic cage polymers
Public title
Evaluation of the results of using peek cage and acrylic cage in cervical fusion after cervical discectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: indications of cervical disc surgery with anterior approach
Exclusion criteria: history of trauma, anterior fixation with cervical plate, posterior approach (Laminectomy), cervical fusion in cases of infection including brucellae, TB and spinal tumors, severe osteoporosis, cervical deformity
Age
From 32 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
7194815644
Approval date
2011-05-14, 1390/02/24
Ethics committee reference number
CT-89-5523
Health conditions studied
1
Description of health condition studied
the herniation of intervertebral cervical disc
ICD-10 code
D.21.o
ICD-10 code description
Connective and other soft tissue of head, face and neck
Primary outcomes
1
Description
clinical improvement including cervical pain and radicular pain
Timepoint
Before the operation, 2 and 6 months, 1 and 2 years after the operation
Method of measurement
Patient's clinical examination, Patient's history and performing cervical radiography
Secondary outcomes
1
Description
Evaluation of sagittal angle
Timepoint
Before the operation,2 and 6 months,1 and 2 years after the operation
Method of measurement
Patient's clinical examination and history,using ODOM'S criterion,dynamic radiographs and CTS based on sagittal index criteria
2
Description
Amount of subsidence of cages
Timepoint
Before the operation,2 and 6 months, 1 and 2 years after the operation
Method of measurement
Clinical examination, the patient's history, using ODOM'S criterion, dynamic radiographs and CTS based on sagittal index criteria.
3
Description
Fusion rate
Timepoint
Before the operation,2 and 6 months, 1 and 2 years after the operation
Method of measurement
Patient's clinical examination and history, using ODOM'S criterion, dynamic radiographs and CTS based on sagittal index criteria
4
Description
Subluxation of cage
Timepoint
Before the operation,2 and 6 months, 1 and 2 years after the operation
Method of measurement
Patient's clinical examination and history, using ODOM'S criterion, dynamic radiographs and CTS based on sagittal index criteria
5
Description
Arthrosis formation in lateral segments
Timepoint
Before the operation,2 and 6 months, 1 and 2 years after the operation
Method of measurement
Patient's clinical examination and history, using ODOM'S criterion, dynamic radiographs and CTS based on sagittal index criteria
6
Description
Possible fracture of cage
Timepoint
Before the operation,2 and 6 months, 1 and 2 years after the operation
Method of measurement
Patient's clinical examination and history, using ODOM'S criterion, dynamic radiographs and CTS based on sagittal index criteria
Intervention groups
1
Description
Using peek cage in 32 patients as the control group during 1 year.
Category
Treatment - Surgery
2
Description
Using acrylic cage in 32 patients as the intervention group during 1 year.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Dr. Majid Reza Farrokhi
Street address
Shiraz Neurosciences Research Center-Chamran Hospital
City
Shiraz
2
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Dr. Majid Reza Farrokhi
Street address
Shiraz Neurosciences Research Center-Chamran Hospital
City
Shiraz
3
Recruitment center
Name of recruitment center
Chamran out-patient Clinic
Full name of responsible person
Dr. Majid Reza Farrokhi
Street address
Shiraz Neurosciences Research Center-Chamran Hospital
City
Shiraz
4
Recruitment center
Name of recruitment center
Motahari Clinic
Full name of responsible person
Dr. Majid Reza Farrokhi
Street address
Shiraz Neurosciences Research Center-Chamran Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research Affairs of Shiraz University of Medical Sciences
Street address
Vice-chancellor for Research Affairs-Central Building of Shiraz University of Medical Sciences-Zand boulevard-Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz Neurosciences Research Center-Shiraz University of Medical Sciences
Full name of responsible person
Dr. Majid Reza Farrokhi
Position
Neurosurgeon-Fellowship of spinal surgery-Dean of Shiraz Neurosciences Research Center
Other areas of specialty/work
Street address
Shiraz Neurosciences Research Center-Chamran Hospital
City
Shiraz
Postal code
7194815644
Phone
+98 71 1623 4508
Fax
+98 71 1623 4508
Email
farokhim@sums.ac.ir,farrokhi_drmr@yahoo.com
Web page address
http://www.shiraz-neuroscience.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz Neurosciences Research Center-Shiraz University of Medical Sciences
Full name of responsible person
Dr. Majid Reza Farrokhi
Position
Neurosergeon-Fellowship of Spinal Surgery
Other areas of specialty/work
Street address
Shiraz Neurosciences Research Center-Chamran Hospital
City
Shiraz
Postal code
7194815644
Phone
+98 71 1623 4508
Fax
+98 71 1623 4508
Email
farokhim@sums.ac.ir,farrokhi_drmr@yahoo.com
Web page address
http://www.shiraz-neuroscience.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz Neurosciences Research Center-Shiraz University of Medical Sciences
Full name of responsible person
Mahshid Hosseini
Position
The Expert of Research Affairs of the Center
Other areas of specialty/work
Street address
Shiraz Neurosciences Research Center-Chamran Hospital
City
Shiraz
Postal code
7194815644
Phone
+98 71 1623 4508
Fax
+98 71 1623 4508
Email
neuroscien@sums.ac.ir, hosseini_2m@yahoo.com
Web page address
http://www.shiraz-neuroscience.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)