Outcomes of Radical Debridement Versus no Debridement Under Different Surgical Procedures for the Treatment of Thoracic and Lumbar Spinal Tuberculosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 74
- Primary Endpoint
- blood loss in milliliter
Study Overview
Brief Summary
Whether radical debridement is necessary for the treatment of thoracic and lumbar tuberculosis is still questionable. The objective of this prospective randomized study was to compare the outcomes of radical debridement versus no debridement under different surgical procedures for the treatment of thoracic and lumbar tuberculosis.
Detailed Description
Seventy-four thoracic and lumbar tuberculosis patients with a neurological function of grade D and E underwent surgeries from January 2009 to January 2014. All patients were divided into group A and group B by taking the drawing of lots. In group A, radical debridement, bone graft and instrumentation were performed. In group B, isolated posterior instrumentation without debridement were performed in all cases and drainage of iliopsoas abscess via laparoscopy in 2 cases. The operative time, blood loss, visual analogue score (VAS), erythrocyte sedimentation rate (ESR), kyphotic angle, Frankel grading, fusion rate and complications were evaluated.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 67 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Frankel grading was grade D and E
- •Severe back pain
- •Abscess combined with high pressure symptoms
- •Larger sequestrum formation or sinus
- •Significant spinal instability.
Exclusion Criteria
- •Frankel grading was grade A,B and C
- •Conservative treatment
Outcomes
Primary Outcomes
blood loss in milliliter
Time Frame: 5 years
The operative time in minutes
Time Frame: 5 years
erythrocyte sedimentation rate (ESR) in mm/h
Time Frame: 5 years
kyphotic angle in degree
Time Frame: 5 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Qian Jun
Principal Investigator
The Second Hospital of Anhui Medical University