A study comparing the 8G (wider bore) and 11G(smaller bore) needle in their ability to obtain adequate sample for making diagnosis in patients suffering from tuberculosis of the spine.
Not Applicable
- Conditions
- Health Condition 1: A180- Tuberculosis of bones and joints
- Registration Number
- CTRI/2020/02/023500
- Lead Sponsor
- Dr Deep N Srivastava
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients suspected to have TB spondylitis clinically, biochemically and radiologically and are treatment naive will be included in the trial. However patients who are subsequently found to have no evidence of tubercular infection on biopsy and further show no response to empirical ATT 1 month after the treatment will be excluded from the study.
Exclusion Criteria
Patients younger than 18 years of age, those not willing to give consent for the procedure and those having underlying bleeding. diathesis will be excluded from the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Histopathological and microbiological evaluation of biopsy sample. <br/ ><br> <br/ ><br>Histopathological findings(Present or Absent): <br/ ><br>1.Granulomas/Giant cell <br/ ><br>2.Necrosis <br/ ><br>3.AFB positivity <br/ ><br>4.Chronic Inflammation <br/ ><br>5.Fibrosis <br/ ><br>6.Osteonecrosis <br/ ><br> <br/ ><br>Microbiological studies: (Present/Absent) <br/ ><br>1.GeneXpert <br/ ><br>2.Culture <br/ ><br> <br/ ><br>All patients will receive ATT and response would be assessed after 4 weeks and 8 weeks using clinical, biochemical and radiological parameters.Timepoint: Baseline (within 7 days of acquiring biopsy)- Histopathology and microbiogical findings <br/ ><br>At 4 weeks-Clinical response <br/ ><br>At 8 weeks-Clinical response and MRI
- Secondary Outcome Measures
Name Time Method All patients will receive ATT and response would be assessed after 1 month in form of: <br/ ><br>1. Clinical (Pain, Fever, Weight gain, Appetite) <br/ ><br>2. Biochemical (ESR, CRP) <br/ ><br>3. Radiological (MRI)Timepoint: After 1 month of ATT, the clinical, biochemical and radiological assessment would be done