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

Primary Purpose

Spinal Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
no debridement
Sponsored by
The Second Hospital of Anhui Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Tuberculosis

Eligibility Criteria

14 Years - 67 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    spine surgery

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    The operative time in minutes
    blood loss in milliliter
    erythrocyte sedimentation rate (ESR) in mm/h
    kyphotic angle in degree

    Secondary Outcome Measures

    Full Information

    First Posted
    December 9, 2015
    Last Updated
    December 18, 2015
    Sponsor
    The Second Hospital of Anhui Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02638272
    Brief Title
    Early Outcomes of Radical Debridement Versus no Debridement Under Different Surgical Procedures
    Official Title
    Outcomes of Radical Debridement Versus no Debridement Under Different Surgical Procedures for the Treatment of Thoracic and Lumbar Spinal Tuberculosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    February 2014 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Second Hospital of Anhui Medical University

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Tuberculosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    74 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    spine surgery
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    no debridement
    Intervention Description
    It is a spinal surgery performed with isolated posterior instrumentation without debridement.
    Primary Outcome Measure Information:
    Title
    The operative time in minutes
    Time Frame
    5 years
    Title
    blood loss in milliliter
    Time Frame
    5 years
    Title
    erythrocyte sedimentation rate (ESR) in mm/h
    Time Frame
    5 years
    Title
    kyphotic angle in degree
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    67 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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