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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
University Hospital of Patras
About
Eligibility
Locations
Arms
Outcomes
Full info

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

44 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 4, 2018
    Last Updated
    March 24, 2018
    Sponsor
    University Hospital of Patras
    Collaborators
    St. Andrew's General Hospital, Patras, Greece
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    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

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    Unilateral Posterolateral Approach for Spondylodiskitis

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