The aim of the current study is to compare the functional recovery between early kyphoplasty and conservative care in paratroopers with stable thoracolumbar fractures. We will include 70 paratroopers aging 18 to 45 years with stable thoracolumbar fractures presenting less than 30 days after trauma. Old fractures and those requiring surgery will be excluded. Patients would be randomly assigned to two study groups to undergo percutaneous balloon kyphoplasty (n=35) or conservative care (n=35) by applying orthosis for 3 months. Patients would be followed for 6 months and would be evaluated clinically using visual analogue scale and Oswestry disability index.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201611172445N3
Registration date:2016-12-06, 1395/09/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-06, 1395/09/16
Registrant information
Name
Fariborz Ghaffarpasand
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4259
Email address
ghafarf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-03-01, 1390/12/11
Expected recruitment end date
2015-01-01, 1393/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Functional Recovery following Early Kyphoplasty versus Conservative Management in Stable Thoracuolumbar Fractures in Parachute Jumpers
Public title
Kyphoplasty versus Conservative Therapy with Brace for Vertebral Fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Military parachute jumper; age between 18 and 45 years; acute stable thoracolumbar fractures (T10-L2); stable fractures classifying as A1 and A2 according to AOSpine thoracolumbar spine injury classification system; intact posterior ligamentous complex (PLC); intact neurological exam; acute fracture being confirmed by hypo- and hyper-intense signal change in the vertebral body in T1- and T2-weighted MRI, respectively.
Exclusion criteria: Unstable thoracolumbar fractures; ruptured PLC; neurological deficit; being referred later than 30-days of the injury; vertebral angulation of more than 35 degrees; decreased vertebral height of more than 50%; pre-injury neurological deficits; previous thoracolumbar fractures; previous spinal procedures; metabolic bone diseases; history of anaphylactic or drug reactions.
Age
From 18 years old to 45 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
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 Shiraz University of Medical Sciences
Street address
Ethics Committee of Shiraz University of Medical Sciences, Vice Chancellor of Research, Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
Postal code
Approval date
2016-09-02, 1395/06/12
Ethics committee reference number
IR.SUMS.MED.REC.1395.578
Health conditions studied
1
Description of health condition studied
Fracture of thoracic vertebra
ICD-10 code
S22.0
ICD-10 code description
Fracture of thoracic vertebra
2
Description of health condition studied
Fracture of lumbar vertebra
ICD-10 code
S32.0
ICD-10 code description
Fracture of lumbar vertebra
Primary outcomes
1
Description
Pain intensity
Timepoint
Baseline, 1 month, 3 months, 6 months
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Disability
Timepoint
Baseline, 1 month, 3 months, 6 months
Method of measurement
Oswestry disability index (ODI)
Secondary outcomes
1
Description
Days absence from work
Timepoint
6 months
Method of measurement
Days
2
Description
Duration for starting parachute jumping
Timepoint
6 months
Method of measurement
Days
Intervention groups
1
Description
Percutaneous Baloon Kyphoplasty of the fracture level and injection of 5cc bone cement
Category
Treatment - Surgery
2
Description
Conservative therapy by applying thoracolumabr orthosis for 3 months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital of AJA University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Masoudi
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Shiraz 576 Artesh Hospital
Full name of responsible person
Mohammad Sadegh Masoodi
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research, Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Vice Chancellor of Research, Floor 7, Shiraz University of Medical Sciences, Zand Avenue, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fariborz Ghaffarpasand
Position
Resident
Other areas of specialty/work
Street address
Neurosurgery Department Office, Namazi Hospital, Namazi Square
City
Shiraz
Postal code
Phone
+98 71 3627 4259
Fax
Email
ghafarf@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fariborz Ghaffarpasand
Position
Resident
Other areas of specialty/work
Street address
Neurosurgery Department Office, Namazi Hospital, Namazi Square
City
Shiraz
Postal code
Phone
+98 71 3627 4259
Fax
Email
ghafarf@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fariborz Ghaffarpasand
Position
Resident
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
ghafarf@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)