Comparison of cranial and caudal pedicle screw-selective unilateral cemented versus fully reinforced pedicle screws in the lumbar spine of patients with osteoporosis a prospective randomized clinical trial.
Comparative study of selective reinforcement of unilateral cranial and caudal pedicle screws with cement versus full reinforcement of pedicle screws in the osteoporotic spine: a prospective randomized clinical trial
Design
This study is a randomized, prospective, and unblinded clinical trial.
Settings and conduct
This study is a prospective, randomized, unblinded clinical trial that will be conducted in Qom, Iran, in 1403 AH. All surgeries will be performed by a skilled surgeon in a specialized surgical center. In order to control for confounding variables, patients will be standardized from the beginning of anesthesia to the administration of analgesics in the recovery room.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Age over 50 years
• T-score -• 2.5
• BMI between 30-20
• Patient is free from uncontrolled chronic diseases such as diabetes or cardiovascular disorders.
Exclusion criteria:
• Previous surgery in the lumbar region
• Degenerative disorders in other vertebrae
• Use of opioids for pain relief
• Unwillingness to follow up after surgery
Intervention groups
Group A includes patients who will undergo spinal fixation surgery with full reinforcement of pedicle screws with bone cement. Group B includes patients who will undergo spinal fixation surgery without cement reinforcement, and Group C includes patients whose surgical technique involves unilateral reinforcement of the caudal and cranial pedicle screws with bone cement and placement of the other screws without cement reinforcement.
Comparison of cranial and caudal pedicle screw-selective unilateral cemented versus fully reinforced pedicle screws in the lumbar spine of patients with osteoporosis a prospective randomized clinical trial.
Public title
Comparison of cranial and caudal pedicle screw-selective unilateral cemented versus fully reinforced pedicle screws in the lumbar spine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 50 years
T-score < - 2.5
BMI between 30-20
The patient is free of uncontrolled chronic diseases such as diabetes or cardiovascular disorders.
Exclusion criteria:
Previous surgery in the lumbar region
Degenerative disorders in other vertebrae
Taking opioids to relieve pain
Unwillingness to follow up after surgery
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be enrolled using a convenience sampling method and will be divided into three groups A, B, and C based on a randomized block design with rows of six. Group A includes patients who will undergo spinal fixation surgery with full reinforcement of pedicle screws with bone cement. Group B includes patients who will undergo spinal fixation surgery without cement reinforcement, and group C includes patients in whose surgical technique the caudal and cranial pedicle screws will be reinforced unilaterally with bone cement and the other screws will be placed without cement reinforcement.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Hamedan, Shahid Fahmideh Blvd., Research Square, Central Headquarters of University of Medical Sciences, 5th Floor
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Approval date
2025-09-07, 1404/06/16
Ethics committee reference number
IR.UMSHA.REC.1404.449
Health conditions studied
1
Description of health condition studied
Degenerative disease of the lumbar spine
ICD-10 code
G32
ICD-10 code description
Other degenerative disorders of nervous system in diseases classified elsewhere
Primary outcomes
1
Description
Bleeding
Timepoint
During surgery
Method of measurement
Blood, suction bottle and blood gases
2
Description
Time Surgery
Timepoint
During Surgery
Method of measurement
Smartwatch
3
Description
Pain
Timepoint
Before surgery and in the first month after surgery
Method of measurement
Visual analog scale
4
Description
infection
Timepoint
After surgery
Method of measurement
Southampton Scale
5
Description
Functional Disability
Timepoint
Before surgery and in the first month after surgery
Method of measurement
Functional Disability Questionnaire
Secondary outcomes
1
Description
Pain
Timepoint
12th month after surgery
Method of measurement
Visual analog scale
2
Description
Functional Disability
Timepoint
12th month after surgery
Method of measurement
Functional Disability Questionnaire
3
Description
Fution
Timepoint
12th month after surgery
Method of measurement
Radiographic image
4
Description
Loosening of the screw
Timepoint
12th month after surgery
Method of measurement
Radiographic image
5
Description
Adjacent segment damage
Timepoint
12th month after surgery
Method of measurement
Radiographic image
Intervention groups
1
Description
Intervention group: Pedicle Screw Fixation + Cement: Initially, a midline incision was made in the posterior region, and then a decompression procedure including bilateral partial facetectomy was performed for all patients. Before screw placement, two entry holes were made in the vertebral pedicles at the L3-L5 level using an awl, and then a 3-mm guide hole was created with a Lenke probe. The selected screws had a solid core and were made of titanium alloy. Fluoroscopic radiography using a C-arm was used to determine the exact placement of the screws. In the created hole, 2 ml of bone cement with special fillers was injected into each screw (all screws were inserted with cement reinforcement). In the next step, screws with a length of 40 to 50 mm and an outer diameter of 6 to 6.5 mm were placed precisely according to the method described by Weinstein et al. (17).
Category
Treatment - Surgery
2
Description
Intervention group: Pedicle Screw Fixation - Cement: Initially, a posterior incision was made for all patients, followed by decompression including bilateral partial facetectomy. Then, pedicle screws with a length of 40 to 50 mm and an external diameter of 6 to 6.5 mm were placed bilaterally at the L3-L5 level in the designated areas under fluoroscopic guidance. This process was performed without injecting cement into the bilateral guide holes. In the final stage, the screws were connected to each other using a 5.5 mm diameter rod, and the fixation process was fully completed by adjusting the vertebrae.
Category
Treatment - Surgery
3
Description
Intervention group: Pedicle Screw Fixation ± Cement: According to the previous surgical technique, after partial facetectomy, 2 ml of high-viscosity cement was unilaterally injected into the created cavity of the upper and lower screws along with bone fillers. In the next step, screws with a length of 40 to 50 mm and an outer diameter of 6 to 6.5 mm were precisely placed. The other screws were inserted without cement reinforcement. Finally, the rods and nuts were properly assembled and the structure was stabilized. The cement around the nuts was evaluated by CT scan within 72 hours after surgery and was evaluated according to the classification of Yeom et al.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital, Qom
Full name of responsible person
Dr. Ali Mehrafshan
Street address
Jomhuri Street-Vali Asr Hospital
City
Qom
Province
Ghoum
Postal code
371715219
Phone
+98 25 3861 9252
Email
Alimehrafshan2@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Sultanian
Street address
Hamedan, Shahid Fahmideh Blvd., Research Square, Central Headquarters of University of Medical Sciences, 5th Floor
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
parisahajilo73@gmail.com
Grant name
Vice President for Research and Technology, Hamadan University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Ali Mehrafshan
Position
Neurosurgeon
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Jomhuri Street-Vali Asr Hospital
City
Qom
Province
Ghoum
Postal code
371725219
Phone
+98 25 3861 9252
Email
Alimehrafshan2@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Ali mehrafshan
Position
Neurosurgeon
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Jomhuri Street-Vali Asr Hospital
City
Qom
Province
Ghoum
Postal code
371725219
Phone
+98 25 3861 9252
Email
Alimehrafshan2@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Parisa Hajilo
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
371715219
Phone
+98 25 3861 9252
Email
parisahajilo73@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information from all participants without personal information will be published in the form of tables as a general conclusion.
When the data will become available and for how long
After the sampling is completed and the final data analysis is performed
To whom data/document is available
General public
Under which criteria data/document could be used
In order to increase public awareness of unilateral and bilateral surgical methods, and improve the clinical skills of surgeons in choosing the most effective surgical method.
From where data/document is obtainable
Trusted databases
What processes are involved for a request to access data/document
Visit the desired database and use keywords to access the article.