| CTRI Number |
CTRI/2017/03/008119 [Registered on: 16/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
16/03/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Operation for spine fractures |
|
Scientific Title of Study
|
MANAGEMENT OF THORACOLUMBAR FRACTURES AS PER
TLICS GUIDELINES –AND MINI OPEN THORACOTOMY
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Brig MN Swamy |
| Designation |
Professor and HOD |
| Affiliation |
AFMC Pune |
| Address |
Department of Neurosurgery
Command Hospital
Southern Command
AFMC
Pune
Department of Neurosurgery
Command Hospital
Southern Command
AFMC
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9960780134 |
| Fax |
|
| Email |
drnarayanswamy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Brig MN Swamy |
| Designation |
Professor and HOD |
| Affiliation |
AFMC Pune |
| Address |
Department of Neurosurgery
Command Hospital
Southern Command
AFMC
Pune
Department of Neurosurgery
Command Hospital
Southern Command
AFMC
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9960780134 |
| Fax |
|
| Email |
drnarayanswamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Brig MN Swamy |
| Designation |
Professor and HOD |
| Affiliation |
AFMC Pune |
| Address |
Department of Neurosurgery
Command Hospital
Southern Command
AFMC
Pune
Department of Neurosurgery
Command Hospital
Southern Command
AFMC
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9960780134 |
| Fax |
|
| Email |
drnarayanswamy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Command Hospital Southern Command, Wanawadi, Pune-411040
Affiliated to Armed Forces Medical College |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Brig MN Swamy |
Command Hospital |
Ward no-16
Dept of Neurosurgery
Pune
MAHARASHTRA |
9960780134
drnarayanswamy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Armed Forces Medical College, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
The patients with single level Traumatic fractures(T11, T12 & L1), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Miniopen thoracotomy |
The patients who fall in surgical group will undergo mini open-thoracotomy,diaphragm sparing corpectomy with end plated expandable titanium cage and screw rod construct fixation. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Single level Traumatic fractures(T11, T12 & L1).
Thoraco lumbar fractures who were treated elsewhere without proper workup upto 3 months.
Patients who were unwilling initially for surgery who later developed instability up to one year.
|
|
| ExclusionCriteria |
| Details |
Pathological fractures.
Concomitant fractures in the vertebral column.
Long standing fractures with pseudoarthrosis.
Disabling co morbidities like lung pathology which would interfere with post op assessment of pulmonary function.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post operatively these patients will be examined for
1) Restoration of saggital and coronal balance by digital X ray
2) Kyphotic correction, neurological deterioration by CT and MRI
3) Pulmonary function tests by mechanical spirometry
4) Restoration of diaphragmatic movements by Fluroscopy and USG
on 12th post operative day, after 3 months, after 6 months and yearly thereafter upto 5 years.
|
upto 5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Restoration of saggital and coronal balance |
5 years |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this prospective study, 40 consecutive patients with single level traumatic fracture of T11, T 12, LV1. Age (20-80 years), Sex (Males and Females) will
be studied. CLASSIFICATION As per TLICS
SCALE into CONSERVATIVE (TLICS
score ≤ 3), OBSERVANT ( TLICS SCORE =4) who will be operated on deterioration, OPERATIVE--- (TLICS SCORE >4). Conservative group will
be managed with 4 weeks strict bed rest. Partial mobilisation with Taylor’s
brace 8 wks. Guarded mobility without Taylor’s brace. Imaging for parameters of
instability at 3 and 6 months then yearly. The patients who fall in surgical
group will undergo mini open-thoracotomy, corpectomy with end plated expandable
titanium cage and screw rod construct
fixation. Postoperatively all the patients will be mobilised on the same post
op evening. Bedside portable x ray will be done on post op evening. Digital
x-ray, Bed side PFT will be done on 3rd
day. Diaphragmatic movement by USG will be assessed on 7th day. VAS score will be recorded
from post operative evening to 10 days. Mechanical spirometer
and fluoroscopic diaphragmatic movement will be done on 12th day. CT/MRI will be done on 14th
day. Post operatively these patients will be examined for
restoration of saggital and coronal balance, kyphotic correction,
neurological deterioration, pulmonary function tests and restoration of
diaphragamatic movements.
|