Early Outcomes of Radical Debridement Versus no Debridement Under Different Surgical Procedures

Spinal Tuberculosis Clinical Trial

Official title:

Outcomes of Radical Debridement Versus no Debridement Under Different Surgical Procedures for the Treatment of Thoracic and Lumbar Spinal Tuberculosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02638272
• Other study ID #: 1898
• Status: Completed
• Phase: N/A
• First received: December 9, 2015
• Last updated: December 18, 2015
• Start date: January 2009
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: The Second Hospital of Anhui Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Chinese Medical Association
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: September 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 67 Years

Eligibility

Inclusion Criteria:

1. Frankel grading was grade D and E

2. Severe back pain

3. Abscess combined with high pressure symptoms

4. Larger sequestrum formation or sinus

5. Significant spinal instability.

Exclusion Criteria:

1. Frankel grading was grade A,B and C

2. Conservative treatment

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Tuberculosis
• Tuberculosis
• Tuberculosis, Spinal

Intervention

Procedure:
• no debridement
It is a spinal surgery performed with isolated posterior instrumentation without debridement.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Anhui Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The operative time in minutes		5 years	Yes
Primary	blood loss in milliliter		5 years	Yes
Primary	erythrocyte sedimentation rate (ESR) in mm/h		5 years	No
Primary	kyphotic angle in degree		5 years	No