Unilateral Posterolateral Approach for Spondylodiskitis

Discitis Clinical Trial

— SPDTIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03472131
• Other study ID #: SPONDYLODISKITIS2018
• Status: Completed
• Phase: N/A
• First received: March 4, 2018
• Last updated: March 24, 2018
• Start date: January 2004
• Est. completion date: December 2016

Study information

• Verified date: March 2018
• Source: University Hospital of Patras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 44 Years to 80 Years

Eligibility

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:

Related Conditions & MeSH terms

• Discitis

Intervention

Procedure:
• Unilateral Posterolateral Approach and Debridement

Other:
• Titanium cage insertion supplemented by screw fixation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of Patras	St. Andrew's General Hospital, Patras, Greece

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The extent of spinal cord injury (SCI) defined by the American Spinal Injury Association (ASIA) Impairment Scale	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.	2 years
Secondary	Survival rate at 2,5 years	Revision surgery or "worst case scenario"	2,5 years
Secondary	Survival rate at 10 years	Revision surgery or "worst case scenario"	10 years