Unilateral Posterolateral Approach for Spondylodiskitis (SPDTIS)

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

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.

Study Overview

• Status: Completed
• Conditions: Discitis
• Intervention / Treatment: Procedure: Unilateral Posterolateral Approach and Debridement; Other: Titanium cage insertion supplemented by screw fixation

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 44 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Septic spondylodiscitis; A unilateral posterolateral approach and debridement with titanium cage insertion supplemented by screw fixation for severe sick patients suffering from septic spondylodiscitis	Procedure: Unilateral Posterolateral Approach and Debridement; Other: Titanium cage insertion supplemented by screw fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate at 2,5 years	Revision surgery or "worst case scenario"	2,5 years
Survival rate at 10 years	Revision surgery or "worst case scenario"	10 years

Collaborators and Investigators

• Sponsor: University Hospital of Patras
• Collaborators: St. Andrew's General Hospital, Patras, Greece
• Investigators: Principal Investigator: Panagiotis Korovessis, PhD, General Hospital of Patras

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2004
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: March 4, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 21, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 24, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Spondylodiscitis; Immunosuppressed; Titanium Cage; Posterolateral Debridement; Less Invasive; Spine Infection
• Additional Relevant MeSH Terms: Infections; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylitis; Bone Diseases, Infectious; Discitis
• Other Study ID Numbers: SPONDYLODISKITIS2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No