| CTRI Number |
CTRI/2017/11/010596 [Registered on: 23/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
22/11/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of medical vs early surgical treatment in spinal tuberculosis |
|
Scientific Title of Study
|
Comparison of medical vs early surgical treatment in spinal tuberculosis and outcome assessment: A randomized study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Somil Jaiswal |
| Designation |
Assistant Professor |
| Affiliation |
King George s Medical University |
| Address |
Department of Neurosurgery
5th floor Shatabdi hospital King George s Medical University Lucknow 226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7755075630 |
| Fax |
|
| Email |
dr.somil26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Somil Jaiswal |
| Designation |
Assistant Professor |
| Affiliation |
King George s Medical University |
| Address |
Department of Neurosurgery
5th floor Shatabdi hospital King George s Medical University Lucknow 226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7755075630 |
| Fax |
|
| Email |
dr.somil26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Somil Jaiswal |
| Designation |
Assistant Professor |
| Affiliation |
King George s Medical University |
| Address |
Department of Neurosurgery
5th floor Shatabdi hospital King George s Medical University Lucknow 226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7755075630 |
| Fax |
|
| Email |
dr.somil26@gmail.com |
|
|
Source of Monetary or Material Support
|
| King George s Medical University Lucknow UP |
|
|
Primary Sponsor
|
| Name |
King George s Medical University Lucknow UP |
| Address |
KGMU Lucknow |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Somil Jaiswal |
KGMU Lucknow |
Department of Neurosurgery 5th floor Phase 2 Shatabdi Hospital
Lucknow
UTTAR PRADESH |
7755075630
dr.somil26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KGMU Instutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Tuberculosis spine patients on anti tubercular drugs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
medical treatment |
Anti tubercular drugs |
| Intervention |
Surgical Treatment |
Surgical procedures + Anti tubercular drugs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 All recent (< 1 month) newly diagnosed cases of spinal tuberculosis with motor power ≤ 4/5 in at least 2 or more limbs.
2 Radiological features of central spinal canal narrowing (Anterior-posterior diameter or Area) of 25-50% (in cervical and thoracic region) and 50-75% (in lumbar region).
|
|
| ExclusionCriteria |
| Details |
1 Patient already taking ATT for more than 1 month
2 Patients with other medical illness disease such as uncontrolled diabetes, uremia, hepatic failure
3 Human immunodeficiency virus disease
4 Multiple non contagious vertebral involvement
5 Patients/ attendants refusing consent
6. Absolute surgical criteria
• Central spinal canal narrowing > 50% (in cervical and thoracic region) and >50-75% (in lumbar region).
• Greater than 2 vertebral collapse with or without spinal canal narrowing.
• Clinical deterioration of 2 or more power grade with features of compression.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Modified Barthel index
Modified Japenese Orthopaedic Association Score |
Modified Barthel index
Modified Japenese Orthopaedic Association Score at 1,3,6,12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of anti tubercular treatment
|
Duration of anti tubercular treatment6,12,18,24 months |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2017 |
| 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="2"
Months="11"
Days="20" |
|
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
|
Tuberculosis (TB) is a severe infectious disease. In 2012, about 8.6
million new cases were diagnosed, and 1.3 million deaths occurred globally. Spinal tuberculosis (TB) is the most common form of
extrapulmonary tuberculosis, accounting for approximately 1 to 3 % of all
tuberculosis cases. Spinal tuberculosis, first
described by Sir Percival Pott in the Eighteenth century, accounts for 50%of
these cases and results in immense morbidity and mortality. Although spinal TB
presents clinically with a multitude of symptoms, back pain is the major
symptom. Spinal TB can lead to bone destruction and vertebral colÂlapse
resulting in paravertebral abscesses and deformity. If prompt management is not
employed, severe neuroÂlogical symptoms ensue, which can lead to a debilitating
consequence. In fact, spinal TB still remains the leading cause of
non-traumatic paraplegia in developing nations. Anti-tubercuÂlar chemotherapy
along with immobilization is usually effecÂtive.It’s still a topic of debate whether patient to be administered medical
therapy only or surgical intervention too. The clear indication for surgery is
not available and most decisions are taken once neurological deterioration has
occurred. This study intends to assess impact of early surgical intervention on
outcome. The outcome will be assessed in the form of neurological recovery,
quality of life and time to cure |