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
The Second Hospital of Anhui Medical University
Information provided by (Responsible Party):
Qian Jun, The Second Hospital of Anhui Medical University
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|
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 (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
Primary Outcome Measures :
- 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 ]
No Contacts or Locations Provided