Comparison of two methods of vertebral fixation through pedicle screwing and pedicle screwing with kyphoplasty during recovery and pain and pull out screws in patients with lumbar or dorsal vertebral fracture
Comparison of two methods of vertebral fixation through pedicle screwing and pedicle screwing with kyphoplasty during recovery and pain and pull out screws in patients with lumbar or dorsal vertebral fracture
Design
The study will be double blind and clinical trial.40 patients will be randomly divided into 2 groups. The groups are parallel. The trial phase is 3
Settings and conduct
Patients with lumbar or dorsal vertebral fracture in valiasr Hospital in Arak are divided into 2 groups by simple randomization with blocks.The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:All patients candidates for lumbar or back fracture surgery, absence of underlying diseases, no history of thromboembolism, age 18 years and above, absence of pathological fracture, no history of underlying bone disease
Exclusion criteria:Unwillingness to participate in the study, death
Intervention groups
Intervention group 1: In this group, pedicle screw placement is performed. At the beginning of the surgery, the fixation level should reach a level so that the spine is exposed.
Intervention group 2: Kyphoplasty will be performed along with pedicle screw placement
Main outcome variables
The average rate of Proximal Junction Kyphosis and Proximal Junction Failure, the average rate of screw loosening, the average pain, the average recovery time and return to normal life, the rate of pseudo-arthrosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N177
Registration date:2022-11-24, 1401/09/03
Registration timing:registered_while_recruiting
Last update:2022-11-24, 1401/09/03
Update count:0
Registration date
2022-11-24, 1401/09/03
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of vertebral fixation through pedicle screwing and pedicle screwing with kyphoplasty during recovery and pain and pull out screws in patients with lumbar or dorsal vertebral fracture
Public title
Comparison of two methods of vertebral fixation through pedicle screwing and pedicle screwing with kyphoplasty during recovery and pain and pull out screws in patients with lumbar or dorsal vertebral fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients candidates for lumbar or back fracture surgery
Age 18 years and above
Exclusion criteria:
underlying diseases
history of thromboembolism
pathological fracture
underlying bone disease
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into 2 groups using a permuted balanced block randomization method with the size of blocks 4 and 8. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Surgery is performed by a neurosurgeon and follow-up and examination of patients is performed by a resident. And the analyzer will also be unaware of groups. The study is double-blind.
It should be noted that in order to be a double-blind study, the data is collected by a specialized assistant who was unaware of the groupings.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2022-04-03, 1401/01/14
Ethics committee reference number
IR.ARAKMU.REC.1401.006
Health conditions studied
1
Description of health condition studied
lumbar or dorsal vertebral fracture
ICD-10 code
S32.0
ICD-10 code description
Fracture of lumbar vertebra
Primary outcomes
1
Description
Average amount (Proximal Junctional Kyphosis)
Timepoint
6 months and one year after the operation
Method of measurement
Radiography
2
Description
The average rate of Proximal Junctional Failure
Timepoint
6 months and one year after the operation
Method of measurement
Radiography
3
Description
Average wear of screws
Timepoint
6 months and one year after the operation
Method of measurement
Radiography
4
Description
Mean of pain
Timepoint
1.5, 3, 6 and 12 months after surgery
Method of measurement
Pain Visual Analog Questionnaire
5
Description
average time of recovery and return to normal life
Timepoint
After surgery
Method of measurement
Physical examination
6
Description
The amount of pseudoarthrosis
Timepoint
6 months and one year after the operation
Method of measurement
Radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group, pedicle screw placement is done. At the beginning of the surgery, the fixation level should reach a level so that the spine is exposed. The entry point of the pedicle screw in the vertebrae of the lumbar arch is determined based on the intersection point of each of the four lines: • Pars interarticularis • Mamillary process • Lateral border of the superior articular facet • Mid transverse process The entry point of the pedicle screw in the sections The bottom of the thoracic arch is determined after determining the intersection of the middle part of the facet joint (the joint between the vertebrae) and the upper edge of the transverse process. The entry point of the screw is in the lateral and end part of this intersection. Guide points: • Lateral border of the superior facet • Lateral border of the inferior facet • Ridge of the pars interarticularis • Transverse process To split the cortex surface as an entry point, you can use drill and rongeur used. Terminal angle of the skull: a pedicle rod is used to guide the path towards the vertebral body. The correct progress of the pedicle rod in the final path of the skull depends on the contralateral transverse process and causes the hole to be created in a direction parallel to the original surface. Medial-lateral tilt: Medial-lateral tilt depends on the rotation of the vertebra and its location up to 45 degrees in L5 or 0 degrees It is approved in T5. In the case of deep insertion, the important point is to prevent penetration into the inner part of the spinal canal and lateral or anterior penetration into the cortex of the vertebral body. Ideally, the path of the two screws should be close to each other, while only being placed in the cortex of the pedicle and its body. Screw placement: The pedicle screw with the appropriate diameter and length is selected by the surgeon using a special device completely. It is placed in the created channel and fills the entire channel. Throughout this process, radiographic images can be used to ensure the correct placement of the screw. Depending on the surgeon, a single or multi-axis screw is selected for the operation.
Category
Treatment - Surgery
2
Description
Intervention group 2: Kyphoplasty will be performed along with pedicle screw placement. After the pedicle screw placement is done, two small and special needles are inserted into the broken area using anesthesia. Then, with the help of a balloon, the structure of the spine and vertebrae is formed, and then bone cement is poured into the vertebrae to harden them. This surgery takes one hour for each broken vertebra.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Ali Nazemi Rafi
Street address
Valiasr Hospital, Valiasr square, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3417 3645
Fax
+98 86 3222 2003
Email
nazemi@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mehdi Salehi
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
salehi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 68 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Ali Nazemi Rafie
Position
Assistant
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street