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CTRI Number  CTRI/2020/06/026211 [Registered on: 29/06/2020] Trial Registered Prospectively
Last Modified On: 17/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   This is a clinical trial to study the short term effects in patients with spine fractures without any weakness or loss of sensation in both hands and legs when they are treated with operation versus when they are treated by bed rest. 
Scientific Title of Study   An open labelled randomized control trial comparing short term outcomes in thoracolumbar fractures without neurological deficit and without obvious posterior ligamentous complex injury treated by percutaneous fixation vs no fixation. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Duddukunta Vishal Reddy 
Designation  Doctor 
Affiliation  JIPMER 
Address  Dept of Orthopedics JIPMER Gorimedu puducherry india

Pondicherry
PONDICHERRY
605006
India 
Phone  9502026355  
Fax    
Email  dvishalreddy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Deep Sharma 
Designation  Doctor 
Affiliation  JIPMER 
Address  Head of department dept of orthopedics JIPMER Gorimedu puducherry india

Pondicherry
PONDICHERRY
605006
India 
Phone  9489146554  
Fax    
Email  drdeep_sharma@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Duddukunta Vishal Reddy 
Designation  Doctor 
Affiliation  JIPMER 
Address  Dept of orthopedics JIPMER Gorimedu puducherry india

Pondicherry
PONDICHERRY
605006
India 
Phone  9502026355  
Fax    
Email  dvishalreddy@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education Research Dhanvantri nagar Gorimedu Pondicherry 605006 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education Research 
Address  JIPMER gorimedu dhanvantri nagar pondicherry 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Duddukunta Vishal Reddy  Jawaharlal Institute of Postgraduate Medical Education & Research  Room no. 6, orthopedic duty room Dept of orthopedics Emergency block JIPMER gorimedu danvantri nagar puducherry 605006
Pondicherry
PONDICHERRY 		 9502026355

dvishalreddy@gmail.com 
Duddukunta Vishal Reddy  Jawaharlal Institute of Postgraduate Medical Education & Research  Orthopedic OPD, room no 64 Dept of orthopedics Old OPD Block JIPMER Dhanvantri angar, Gorimedu pondicherry 605006
Pondicherry
PONDICHERRY 		 9502026355

dvishalreddy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S220||Fracture of thoracic vertebra, (2) ICD-10 Condition: S320||Fracture of lumbar vertebra,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Percutaneous pedicle screw fixation for thoracolumbar spine fractures.  Under general anesthesia, patients positioned in prone on a radiolucent table for spine surgery with chest, abdomen, and pelvis supported by gel pads. Under posteroanterior (PA) fluoroscopic guidance, the initial skin incision is made approximately 1–2 cm lateral from the pedicle for screw fixation, and then underlying fascia is split and paraspinal muscle dissection was performed by finger. A “J” type bone marrow needle is positioned to the lateral and slightly cranial margin of the pedicle for instrumentation with the sense of bone touch in the PA view. Under true PA view, the needle is inserted to a slightly medial direction. When the needle tip is located in the medial border of the pedicle in the true PA view, fluoroscopy - turned on in order to see the lateral view. If the needle is passed in the pedicle without violation of the medial border of the pedicle, the needle was slowly advanced into the vertebra body. A guide wire is inserted into the vertebral body through the needle, and the needle removed carefully, The dilation tube is placed through the guide wire, and tapping done for screw insertion. After tapping to the junction of the pedicle and vertebral body, a cannulated percutaneous pedicle screw is advanced through the guide wire into the pedicle and vertebral body; the guide wire was then removed after adequate positioning of the screw. Using the same approach, pedicle screws are inserted into above and below the fractured vertebra including the fractured level. Under PA and lateral fluoroscopic guidance, an adequately sized rod is placed in the percutaneous pedicle screw heads through a small incision made on the thoracic region. If compression is required for spinal alignment, it is performed prior to placement of locking nuts. Incisions for screws and rods placement were irrigated and closed. 
Comparator Agent  thoracolumbar spine fractures without neurodefict and without PLC injury managed conservatively.  patient will be provided with initial period of bed rest and adequate analgesics according to patients liberty and needs following the injury. patient would be encouraged to ambulate at the earliest without the use of brace as and when he can tolerate the pain to do so. patient would then be discharged on the day he would achieve independent ambulation and asked to followup in opd after 3 weeks since date of injury. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adults of both sexes aged 18 years or over, with a radiologically confirmed, recent (less than or at one week) isolated thoracolumbar fracture without neurodeficit and obvious PLC injury. 
 
ExclusionCriteria 
Details  ANY
Patients with a preferred choice of treatment modality
Polytrauma patients
Patients with other associated musculoskeletal trauma
Pathological fractures of vertebral body.
Previous spine surgeries.
Presence of back pain prior to thoracolumbar fractures.
Patients with obvious PLC disruption on radiological evaluation
Pregnant patients.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
In patients of thoracolumbar fractures without obvious PLC injury and without neurological deficit, treated by percutaneous fixation vs no fixation, To compare the intensity of pain (measured by vas score) between the 2 groups at the end of 3 weeks since time of injury.
 		 3 weeks since time of injury.
 
 
Secondary Outcome  
Outcome  TimePoints 
In patients of thoracolumbar fractures without PLC injury and without neurological deficit, treated by percutaneous fixation vs no fixation, to compare between the 2 groups, the extent of disability measured by ODI score, EUROQOL-5D, return to work (Denis work scale), number of days of hospital stay and analgesic usage at end of 3 weeks since time of injury
 		 3 weeks since time of injury. 
In patients of thoracolumbar fractures without PLC injury and without neurological deficit, treated by percutaneous fixation vs no fixation, To compare between the 2 groups the radiological outcome measured by cobbs angle at the end of 3 weeks.  3 weeks since time of injury. 
In patients of thoracolumbar fractures without PLC injury and without neurological deficit, treated by percutaneous fixation vs no fixation, To identify and record any complications arising due to treatment irrespective of which treatment given among the two groups at the end of 3 weeks  3 weeks since time of injury. 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2020 
Date of Study Completion (India) 13/05/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 13/05/2022 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 NIL publications from this trial as of date 21/6/2020 have been published. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  		 This study is a randomized, open labelled , parallel group, single center trial comparing short term outcomes in patients of thoracolumbar fractures without neurodeficit and without posterior ligamentous complex(PLC) treated operatively by percutaneous pedicle screw fixation vs those treated non operatively. patients who satisfy the inclusion criteria will be explained the details of the study and consent taken for participation. following which he will be randomized and respective group will be alloted. patient will then undergo the respective SOP(standard operative procedure - i.e operative management for operative group and conservative management for conservative group) followed for the particular group. thereafter he will be discharged and asked to followup at the end of three weeks since injury, for assessment of outcomes, i.e. primary outcome - pain measure by vas score, secondary outcomes - disability (measured by EUROQOL 5L, ODI score, return to work, analgesic useage), radiological outcomes(cobbs angle), any complications that arise in the two study arms. following the assessment patient will be kept on regular follow up as per institutional guidelines for management of these group of patients.  
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