Unilateral Posterolateral Approach for Spondylodiskitis

Not Applicable

Completed

• Conditions: Discitis
• Interventions: Procedure: Unilateral Posterolateral Approach and Debridement; Other: Titanium cage insertion supplemented by screw fixation

• Registration Number: NCT03472131
• Lead Sponsor: University Hospital of Patras

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.

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-03
• Study First Submitted: 2018-03-04
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-21
• Last Update Submitted: 2018-03-24
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Septic spondylodiscitis	Unilateral Posterolateral Approach and Debridement	A unilateral posterolateral approach and debridement with titanium cage insertion supplemented by screw fixation for severe sick patients suffering from septic spondylodiscitis
Septic spondylodiscitis	Titanium cage insertion supplemented by screw fixation	A unilateral posterolateral approach and debridement with titanium cage insertion supplemented by screw fixation for severe sick patients suffering from septic spondylodiscitis

Primary Outcome Measures

Name	Time	Method
The extent of spinal cord injury (SCI) defined by the American Spinal Injury Association (ASIA) Impairment Scale	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 Outcome Measures

Name	Time	Method
Survival rate at 2,5 years	2,5 years	Revision surgery or "worst case scenario"
Survival rate at 10 years	10 years	Revision surgery or "worst case scenario"