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

NCT ID: NCT02638272

Last Updated: 2015-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Spinal Tuberculosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

no debridement

Intervention Type PROCEDURE

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

Interventions

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no debridement

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Hospital of Anhui Medical University

OTHER

Sponsor Role lead

Responsible Party

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Qian Jun

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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1898

Identifier Type: -

Identifier Source: org_study_id