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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 9, 2015
First Posted Date  ICMJE December 23, 2015
Last Update Posted Date December 23, 2015
Study Start Date  ICMJE January 2009
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2015)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Outcomes of Radical Debridement Versus no Debridement Under Different Surgical Procedures
Official Title  ICMJE Outcomes of Radical Debridement Versus no Debridement Under Different Surgical Procedures for the Treatment of Thoracic and Lumbar Spinal Tuberculosis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Tuberculosis
Intervention  ICMJE Procedure: no debridement
It is a spinal surgery performed with isolated posterior instrumentation without debridement.
Study Arms  ICMJE 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.
Intervention: Procedure: no debridement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2015)
74
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 67 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02638272
Other Study ID Numbers  ICMJE 1898
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Qian Jun, The Second Hospital of Anhui Medical University
Study Sponsor  ICMJE The Second Hospital of Anhui Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Second Hospital of Anhui Medical University
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP