spinopelvic alignment in patients with lumbospinal stenosis and out come after simple decompression surgery
Design
Clinical trial without control group and evaluation of pre- and postoperative outcomes in patient group
Settings and conduct
At the beginning of the study, all patients with lumbar spinal stenosis referred to Imam Reza Clinic and candidate for decompression surgery after surgery were compared and compared with two surgical methods without consent and after obtaining consent form. Patients will be asked to complete VAS-index and back pain (VAS-Leg) questionnaires for VAS foot pain and ODI (Oswestry.Disability back) questionnaire, then undergo surgery by unilateral laminectomy and bilateral decompression by a surgeon. It will be performed with the same instrument (Crisson Punch No. 3.45) (and at Imam Reza Medical Complex) in Kermanshah
Participants/Inclusion and exclusion criteria
Patients with severe central canal stenosis who can be followed for 6 months and with coronary deformity less than ̊◌10 without severe foraminal stenosis who are stable on dynamic X-rays.
Patients with coronary deformity based on SRS-Schwab classification, Patients with spondylolisthesis and Patients with spondylolysis will be excluded.
Intervention groups
In the selected group, surgery will be performed by unilateral laminectomy and bilateral decompression by a surgeon with the same instrument.
Main outcome variables
Pelvic Incidence, Pelvic Tilt, Sacral Slope
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190708044145N1
Registration date:2019-11-02, 1398/08/11
Registration timing:registered_while_recruiting
Last update:2019-11-02, 1398/08/11
Update count:0
Registration date
2019-11-02, 1398/08/11
Registrant information
Name
Mohamad reza Akrami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6475
Email address
mr_akrami@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Spinopelvic alignment in patients with lumbospinal stenosis and out come after simple decompression surgery
Public title
Spinopelvic alignment in patients with lumbospinal stenosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Severe central canal stricture
Coronal deformity scoliosis lumbar
Lack of instability dynamics in graphs
Patients without severe foraminal stenosis
Exclusion criteria:
Patients with coronary deformity based on SRS-Schwab classification
Patients with spondylolisthesis
Patients with spondylolysis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
29
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Science, Shahid Beheshti Boulevard, Kermanshah
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-03-19, 1397/12/28
Ethics committee reference number
IR.KUMS.REC.1397.1068
Health conditions studied
1
Description of health condition studied
lumbosacral stenosis
ICD-10 code
M48.07
ICD-10 code description
Spinal stenosis, lumbosacral region
Primary outcomes
1
Description
Spinopelvic alignment
Timepoint
Spinopelvic alignment will be measured at baseline (before surgery), first month, three month, and 6 month after surgery.
Method of measurement
In all patients, spine x-rays are performed from the T12 to the first 10 cm of the femoral head, with the hip and knee joint fully extended. ODI (Oswestry.Disability Index) and VAS-Leg (VAS-Leg) and VAS-Back (VAS-Back) questionnaires will also be completed for all patients.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Decompression surgery. The surgical procedure will be performed with unilateral laminectomy and bilateral decompression by a surgeon with the same tool (Crisson Punch 3.45 °) and in Imam Reza (AS) Kermanshah Therapeutic Complex. Patients will be ambulated the day after surgery and discharged without a brace on the third day of surgery. Patients will be allowed light daily activities on the day of discharge and allowed to remove heavy objects 3 months after surgery. Patients will be referred to the outpatient clinic at 1, 3, and 6 months after surgery by the same surgeon, and pelvic and lumbar radiographs in each Bat diseased repeated visits will be followed for 6 months.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
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
All potential data will be shared after people are unrecognizable.
When the data will become available and for how long
The access period will start 6 months after the results are published
To whom data/document is available
All academic researchers will have access to the data.
Under which criteria data/document could be used
The data will be available for new data analysis purposes.
From where data/document is obtainable
To access the study data corresponded author should be contacted.
Mohammad Reza Akrami, Imam Reza Hospital, Parastar Boulevard , Kermanshah. Phone:
00988334276300. Email: mr_akrami@kums.ac.ir
What processes are involved for a request to access data/document
Data will be shared after contacting the corresponder author and submission of the request, and after signing the data use agreement.