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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spinal Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Bone Diseases Bone Diseases, Infectious Gram-Positive Bacterial Infections Infections Musculoskeletal Diseases Mycobacterium Infections Spinal Diseases Spondylitis Tuberculosis Tuberculosis, Extrapulmonary Tuberculosis, Osteoarticular Tuberculosis, Spinal

Age range

14 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

no debridement

Procedure

It is a spinal surgery performed with isolated posterior instrumentation without debridement.

Primary outcomes

The operative time in minutes

Time frame: 5 years
blood loss in milliliter

Time frame: 5 years
erythrocyte sedimentation rate (ESR) in mm/h

Time frame: 5 years
kyphotic angle in degree

Time frame: 5 years

Sponsors and collaborators

Lead sponsor

The Second Hospital of Anhui Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2015
First posted: Dec 23, 2015
Registry last updated: Dec 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting