Unilateral Posterolateral Approach for Spondylodiskitis (SPDTIS)
Primary Purpose
Discitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Unilateral Posterolateral Approach and Debridement
Titanium cage insertion supplemented by screw fixation
Sponsored by
About this trial
This is an interventional treatment trial for Discitis focused on measuring Spondylodiscitis, Titanium Cage, Posterolateral Debridement, Immunosuppressed, Less Invasive, Spine Infection
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:
-
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Septic spondylodiscitis
Arm Description
A unilateral posterolateral approach and debridement with titanium cage insertion supplemented by screw fixation for severe sick patients suffering from septic spondylodiscitis
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Survival rate at 2,5 years
Revision surgery or "worst case scenario"
Survival rate at 10 years
Revision surgery or "worst case scenario"
Full Information
NCT ID
NCT03472131
First Posted
March 4, 2018
Last Updated
March 24, 2018
Sponsor
University Hospital of Patras
Collaborators
St. Andrew's General Hospital, Patras, Greece
1. Study Identification
Unique Protocol Identification Number
NCT03472131
Brief Title
Unilateral Posterolateral Approach for Spondylodiskitis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2004 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Patras
Collaborators
St. Andrew's General Hospital, Patras, Greece
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discitis
Keywords
Spondylodiscitis, Titanium Cage, Posterolateral Debridement, Immunosuppressed, Less Invasive, Spine Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Septic spondylodiscitis
Arm Type
Experimental
Arm Description
A unilateral posterolateral approach and debridement with titanium cage insertion supplemented by screw fixation for severe sick patients suffering from septic spondylodiscitis
Intervention Type
Procedure
Intervention Name(s)
Unilateral Posterolateral Approach and Debridement
Intervention Type
Other
Intervention Name(s)
Titanium cage insertion supplemented by screw fixation
Primary Outcome Measure Information:
Title
The extent of spinal cord injury (SCI) defined by the American Spinal Injury Association (ASIA) Impairment Scale
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Survival rate at 2,5 years
Description
Revision surgery or "worst case scenario"
Time Frame
2,5 years
Title
Survival rate at 10 years
Description
Revision surgery or "worst case scenario"
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
44 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panagiotis Korovessis, PhD
Organizational Affiliation
General Hospital of Patras
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30993521
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.
Results Reference
derived
Learn more about this trial
Unilateral Posterolateral Approach for Spondylodiskitis
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