CTRI/2017/11/010596
Recruiting
Phase 3
Comparison of medical vs early surgical treatment in spinal tuberculosis and outcome assessment: A randomized study.
King George s Medical University Lucknow UP0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Tuberculosis spine patients on anti tubercular drugs
- Sponsor
- King George s Medical University Lucknow UP
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1All recent ( \< 1 month) newly diagnosed cases of spinal tuberculosis with motor power \<\= 4/5 in at least 2 or more limbs.
- •2Radiological 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).
Exclusion Criteria
- •1Patient already taking ATT for more than 1 month
- •2Patients with other medical illness disease such as uncontrolled diabetes, uremia, hepatic failure
- •3Human immunodeficiency virus disease
- •4Multiple non contagious vertebral involvement
- •5Patients/ 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.
Outcomes
Primary Outcomes
Not specified
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