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

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ClinicalTrials.gov Identifier: NCT02638272
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Sponsor:
Information provided by (Responsible Party):
Qian Jun, The Second Hospital of Anhui Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Tuberculosis Procedure: no debridement Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcomes of Radical Debridement Versus no Debridement Under Different Surgical Procedures for the Treatment of Thoracic and Lumbar Spinal Tuberculosis
Study Start Date : January 2009
Actual Primary Completion Date : February 2014
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. The operative time in minutes [ Time Frame: 5 years ]
  2. blood loss in milliliter [ Time Frame: 5 years ]
  3. erythrocyte sedimentation rate (ESR) in mm/h [ Time Frame: 5 years ]
  4. kyphotic angle in degree [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   14 Years to 67 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Qian Jun, Principal Investigator, The Second Hospital of Anhui Medical University
ClinicalTrials.gov Identifier: NCT02638272    
Other Study ID Numbers: 1898
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Spinal
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Tuberculosis, Osteoarticular
 Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spondylitis
Spinal Diseases