Comparative study of lumbar spine stabilization with 2-stage surgery and cement reinforcement in osteoporotic patients
Design
The clinical trial has 2 intervention groups with parallel groups. Randomized and without blinding, randomization was done with permutation block design
Settings and conduct
Valiasr Hospital, Qom - patients were operated with 2-stage surgery and cement reinforcement and were evaluated for 12 months.
Participants/Inclusion and exclusion criteria
Patients with osteoporosis, age over 50 years, BMI between 20-30, with degenerative lumbar spine at the level of L1-S1 vertebrae.
Intervention groups
Group A: There are patients who will use bone cement as part of their treatment protocol to strengthen the pedicle screw.
Group B: There are patients whose treatment protocol is 2-stage surgery
A comparative study of lumbar spine stabilization with 2-stage surgery and cement augmentation in osteoporosis patients: a randomized clinical trial
Public title
Comparative study of lumbar spine stabilization with 2-stage surgery and cement augmentation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Osteoporosis patients with pre-surgery bone density in the range (T-Score->2.5)
age range over 50 years
body mass index between 20-30
with degenerative lumbar spine complications at L1-S1 level is
Exclusion criteria:
Patients who could not be reached or lived outside the province
pationts did not want to enter the study
The presence of other pathological factors (cysts or tumors)
discopathy in other vertebrae
performing any re-surgery during the past year
using narcotics or narcotic drugs and smoking
suffering from underlying diseases affecting Osteoporosis (rheumatoid arthritis, thyroid disorders...)
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly entered into the study and will be divided into 2 groups A and B based on permutation block design with rows of 4. Group A are patients in whom bone cement will be used as part of their treatment protocol to reinforce the pedicle screw. Group B are patients whose treatment protocol is 2-stage surgery
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
5th floor, Shahid Fahmideh Blvd., University of Medical Sciences, Central Headquarters, Research Square
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Approval date
2024-01-27, 1402/11/07
Ethics committee reference number
IR.UMSHA.REC.1402.667
Health conditions studied
1
Description of health condition studied
Lumbar spine degeneration
ICD-10 code
G30-G32
ICD-10 code description
Other degenerative diseases of the nervous system
Primary outcomes
1
Description
Pain
Timepoint
Before surgery - one month after surgery
Method of measurement
VAS visual analog scale
2
Description
Disability of patients
Timepoint
Before surgery - one month after surgery
Method of measurement
Oswestry Disability Index (ODI)
Secondary outcomes
1
Description
Fution
Timepoint
12 months after surgery
Method of measurement
BSF classification scale
2
Description
Pedicle Screw loosing
Timepoint
12 months after surgery
Method of measurement
Dynamic radiography and CT scan images
Intervention groups
1
Description
Intervention group first; First intervention group: Lumbar spine stabilization surgery in one step along with pedicle screw reinforcement with bone cement
Category
Treatment - Surgery
2
Description
Intervention group second: Spine stabilization surgery is performed in 2 stages, first pedicle screws are installed and 6 months after that, the rod and other attachments are installed.