Comparison of the efficacy of pedicle screw fixation with cement augmentation versus without in the treatment of spinal stenosis following posterior spinal fusion surgery, superiority according to bone mineral density: A three-arm randomized open clinical trial
Evaluation of the effectiveness of pedicle screw fixation with and without cement on clinical and radiological outcomes in osteoporotic patients, as well as determine whether cement augmentation performance can be comparable to regular bone density.
Design
A three-arm parallel randomized interventional trial without blinding, but with a control group and a sample size of 92 patients with a one-year follow-up of patients.
Settings and conduct
The present study will conduct on 92 patients in Shohada Tajrish Hospital. patients will be stratified into intervention groups (T-score ≤ -1.5) and a control group (T-score > -1.5). Afterward, the osteoporotic group will be randomized into: Group II-A = osteoporosis without cement augmentation or Group II-B =osteoporosis+ cement augmentation. The intervention will be performed by a senior spine surgeon.
Participants/Inclusion and exclusion criteria
Patients >= 40 with spinal canal stenosis who are candidates for posterior spinal fusion surgery via pedicle screws fixation.
Absence of other vertebral disorders such as tumors or infections- Absence of serious medical problems, such as congestive heart failure and cirrhosis, calcium absorption disorder, hyperparathyroid disease-Absence of spine abnormalities, including sagittal and coronal deformities.
Intervention groups
Intervention group 1)patients with T-score ≤ -1.5 and spinal canal stenosis who will undergo pedicle screw fixation without cement augmentation. Intervention group 2)patients with T-score ≤ -1.5 and spinal canal stenosis who will undergo pedicle screw fixation with cement augmentation. Control group: patients with T-score > -1.5 and spinal canal stenosis who will undergo pedicle screw fixation without cement augmentation.
Main outcome variables
Evaluation of changes in VAS score and radiological parameters before and after one year of surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190126042496N2
Registration date:2023-01-19, 1401/10/29
Registration timing:registered_while_recruiting
Last update:2023-01-19, 1401/10/29
Update count:0
Registration date
2023-01-19, 1401/10/29
Registrant information
Name
Mohammadrez Shahmohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8001
Email address
mr_shahmohammadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-18, 1401/10/28
Expected recruitment end date
2024-01-18, 1402/10/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of pedicle screw fixation with cement augmentation versus without in the treatment of spinal stenosis following posterior spinal fusion surgery, superiority according to bone mineral density: A three-arm randomized open clinical trial
Public title
pedicle screw fixation with cement augmentation versus without in the treatment of spinal stenosis following posterior spinal fusion surgery, superiority according to bone mineral density: A three-arm randomized open clinical trial.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
diagnosed with spinal stenosis by symptoms, signs, and imaging examinations
advised for PSF surgery through pedicle screw fixation
older than 40 years old
Exclusion criteria:
diagnosed with other vertebral disorders such as tumors or infections
serious medical problems such as congestive heart failure and cirrhosis, calcium absorption disorder, hyperparathyroid disease
diagnosed with spinal deformities including sagittal plane deformity and coronal imbalance
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Informed consent will be obtained from each participant before patient enrolment in the study. Patients who meet all the inclusion criteria and none of the exclusion criteria will be consecutively included and stratified into two groups according to T-score: Group I= non-osteoporotic (T-score >-1.5) and Group II= osteoporotic (T-score ≤-1.5). Afterward, the osteoporotic group will be randomized into one of the following study arms by the statistician according to a random allocation sequence by a random number table: Group II-A = osteoporosis without cement augmentation or Group II-B =osteoporosis+ cement augmentation. The intervention will be communicated to the patient by a surgeon.
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
Institutional Research Ethics Committee - Shahid Beheshti University of Medical Sciences
Street address
3rth floor, Faculty of Medicine, next to Taleghani Hospital, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717434 - 1939547
Approval date
2022-05-10, 1401/02/20
Ethics committee reference number
IR.SBMU.MSP.REC.1401.086
Health conditions studied
1
Description of health condition studied
Patients with spinal canal stenosis are candidates for posterior spinal fusion surgery
ICD-10 code
M48.0
ICD-10 code description
Spinal stenosis
2
Description of health condition studied
Osteoporosis is defined as a mean adjusted T-score of -1.5 or below
ICD-10 code
M81
ICD-10 code description
Osteoporosis without current pathological fracture
Primary outcomes
1
Description
Changes in VAS score before and after posterior spinal fusion surgery
Timepoint
The VAS score will be measured before and after one year of surgery to determine the degree of pain reduction.
Method of measurement
The patient's pain level is assessed on a horizontal line of 100 mm that its left end represents no pain, and the right end corresponds to the most severe pain that can be experienced. The patient is asked to mark the pain intensity they are experiencing currently.
Secondary outcomes
1
Description
Proximal junctional kyphosis (PJK): A rise of over 20° in the Cobbs' angle between the lower endplate of the upper instrumented vertebra (UIV) and the upper endplates of two super-adjacent vertebrae between the immediate postoperative and after one year follow-up
Timepoint
Immediately after surgery and after one year follow-up
Method of measurement
Through upright lateral radiographs
2
Description
Proximal junctional vertebral fracture (PJVF): The fracture of UIV or UIV +1
Timepoint
Immediately after surgery and after one year follow-up
Method of measurement
Anteroposterior and lateral plain radiographs, and computed tomography (CT)
3
Description
Adjacent segment disease (ASD):Degeneration of the mobile spinal segments above or below a fused spinal segment
Timepoint
Immediately after surgery and after one year follow-up
Method of measurement
Anteroposterior and lateral plain radiographs, and computed tomography (CT)
4
Description
Screw fracture: Fracture of rod following pedicle screw fixation surgery
Timepoint
Immediately after surgery and after one year follow-up
Method of measurement
Anteroposterior and lateral plain radiographs, and computed tomography (CT)
5
Description
Rod fracture: Fracture of rod following pedicle screw fixation surgery
Timepoint
Immediately after surgery and after one year follow-up
Method of measurement
Anteroposterior and lateral plain radiographs, and computed tomography (CT)
6
Description
Screw loosening: The appearance of a radiolucent rim >1 mm (a halo) around at least one screw on radiography or CT scan
Timepoint
Immediately after surgery and after one year follow-up
Method of measurement
Anteroposterior and lateral plain radiographs, and computed tomography (CT)
Intervention groups
1
Description
Intervention group: (Group II-A) A group of osteoporotic patients with T-score ≤ -1.5 and spinal canal stenosis who will undergo pedicle screw fixation without cement augmentation.
Category
Treatment - Surgery
2
Description
Intervention group: (Group II-B) A group of osteoporotic patients with T-score ≤ -1.5 and spinal canal stenosis who will undergo pedicle screw fixation with cement augmentation (0.8-1 cc of polymethylmethacrylate (PMMA) per screw, bilaterally into each vertebra with a viscosity slightly thinner than toothpaste. The screw is implanted into the vertebra prior to the complete solidification of the cement, and the rod is attached following solidification.)
Category
Treatment - Surgery
3
Description
Control group: A group of non-osteoporotic patients with T-score > -1.5 and spinal canal stenosis who will undergo pedicle screw fixation without cement augmentation.