Clinical trial NCT03472131: Unilateral Posterolateral Approach for Spondylodiskitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Discitis
Keywords: Spondylodiscitis
Titanium Cage
Posterolateral Debridement
Immunosuppressed
Less Invasive
Spine Infection
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
Collaborators: name: St. Andrew's General Hospital, Patras, Greece
First posted: 2018-03-21
Enrollment: 20
Sex: ALL
Minimum age (years): 44
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

-

Primary outcomes:
measure: The extent of spinal cord injury (SCI) defined by the American Spinal Injury Association (ASIA) Impairment Scale
timeFrame: 2 years
Secondary outcomes:
measure: Survival rate at 2,5 years
timeFrame: 2,5 years
measure: Survival rate at 10 years
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
affiliation: General Hospital of Patras
name: Panagiotis Korovessis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Korovessis P, Syrimpeis V, Tsekouras V, Baikousis A, Vardakastanis K, Fennema P. A unilateral less invasive posterolateral approach for disc debridement and titanium cage insertion supplemented by contralateral transfascial screw fixation for high-morbidity patients suffering from septic thoracolumbosacral spondylodiscitis. Eur J Orthop Surg Traumatol. 2019 Aug;29(6):1187-1197. doi: 10.1007/s00590-019-02434-2. Epub 2019 Apr 16.