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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.

Percutaneous Image guided Interventions in Spine diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023500
Enrollment
100
Registered
2020-02-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A180- Tuberculosis of bones and joints

Interventions

Intervention1: Image guided biopsy from the affected vertebra using 8G needle: After thorough pre-procedural evaluation and preparation, patient will be made to lie in prone position on the table of

Sponsors

Dr Deep N Srivastava
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Histopathological and microbiological evaluation of biopsy sample. Histopathological findings(Present or Absent): 1.Granulomas/Giant cell 2.Necrosis 3.AFB positivity 4.Chronic Inflammation 5.Fibrosis 6.Osteonecrosis Microbiological studies: (Present/Absent) 1.GeneXpert 2.Culture 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 At 4 weeks-Clinical response At 8 weeks-Clinical response and MRI

Secondary

MeasureTime frame
All patients will receive ATT and response would be assessed after 1 month in form of: 1. Clinical (Pain, Fever, Weight gain, Appetite) 2. Biochemical (ESR, CRP) 3. Radiological (MRI)Timepoint: After 1 month of ATT, the clinical, biochemical and radiological assessment would be done

Countries

India

Contacts

Public ContactDr Piyush Aggarwal

All India Institute of Medical sciences

drdeepsrivastava@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026