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Clinical Trials/NCT03472131
NCT03472131
Completed
Not Applicable

Unilateral Posterolateral Approach for Disc Debridement and Titanium Cage Insertion Supplemented by Contralateral Transfascial Screw Fixation for Sick Patients Suffering From Septic Thoracolumbosacral Spondylodiscitis

University Hospital of Patras0 sites20 target enrollmentJanuary 2004
ConditionsDiscitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Discitis
Sponsor
University Hospital of Patras
Enrollment
20
Primary Endpoint
The extent of spinal cord injury (SCI) defined by the American Spinal Injury Association (ASIA) Impairment Scale
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This retrospective study assess the efficacy and safety of a posterolateral unilateral approach for debridement and titanium cage insertion supplemented by contralateral transfascial screw fixation for sick patients suffering from septic thoracolumbosacral spondylodiskitis. Hematogenous pyogenic spondylodiskitis requires surgical intervention in cases of development of neurological signs, spinal instability, progressive spinal deformity and abscess. When operative treatment is indicated, an anterior approach by open thoracotomy or by a thoraco-abdominal approach or combined anterior and posterior approaches are recommended. In cases of severe sick patients anterior approach is associated with high morbidity and mortality.

Detailed Description

Twenty consecutive sick (ASA\>III) patients, 14 men and 6 women, aged 64±14 years, suffering from single level septic thoracolumbosacral spondylodiskitis underwent an one-stage less invasively unilateral posterolateral decompression, insertion of titanium cage\& pedicle screw fixation plus contralateral transfascial pedicle screw fixation.

Registry
clinicaltrials.gov
Start Date
January 2004
End Date
December 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital of Patras
Responsible Party
Principal Investigator
Principal Investigator

Vasileios Syrimpeis

Orthopaedic Surgeon

University Hospital of Patras

Eligibility Criteria

Inclusion Criteria

  • Single-level thoracic, thoracolumbar, lumbar or lumbosacral spondylodiskitis
  • Medical comorbidities were present in all 20 patients. These included diabetes mellitus, chronic renal insufficiency, advanced heart insufficiency, hypertension, cortisone abuse, drug abuse and/or advanced age (\>65y).

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The extent of spinal cord injury (SCI) defined by the American Spinal Injury Association (ASIA) Impairment Scale

Time Frame: 2 years

Grade A Complete lack of motor and sensory function below the level of injury (including the anal area) Grade B Some sensation below the level of the injury (including anal sensation) Grade C Some muscle movement is spared below the level of injury, but 50 percent of the muscles below the level of injury cannot move against gravity. Grade D Most (more than 50 percent) of the muscles that are spared below the level of injury are strong enough to move against gravity. Grade E All neurologic function has returned.

Secondary Outcomes

  • Survival rate at 2,5 years(2,5 years)
  • Survival rate at 10 years(10 years)

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