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

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Tuberculosis
• Intervention / Treatment: Procedure: no debridement

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 Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 67 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: spine surgery; The objective was to compare the outcomes of radical debridement versus no debridement under different surgical procedures for the treatment of thoracic and lumbar tuberculosis.	Procedure: no debridement; It is a spinal surgery performed with isolated posterior instrumentation without debridement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The operative time in minutes	5 years
blood loss in milliliter	5 years
erythrocyte sedimentation rate (ESR) in mm/h	5 years
kyphotic angle in degree	5 years

Collaborators and Investigators

• Sponsor: The Second Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: December 9, 2015
• First Submitted That Met QC Criteria: December 18, 2015
• First Posted (Estimate): December 23, 2015

Study Record Updates

• Last Update Posted (Estimate): December 23, 2015
• Last Update Submitted That Met QC Criteria: December 18, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Musculoskeletal Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Spinal Diseases; Bone Diseases; Mycobacterium Infections; Spondylitis; Bone Diseases, Infectious; Tuberculosis, Osteoarticular; Tuberculosis; Tuberculosis, Spinal
• Other Study ID Numbers: 1898