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Unilateral Posterolateral Approach for Spondylodiskitis (SPDTIS)

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ClinicalTrials.gov Identifier: NCT03472131
Recruitment Status : Completed
First Posted : March 21, 2018
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
St. Andrew's General Hospital, Patras, Greece
Information provided by (Responsible Party):
Vasileios Syrimpeis, University Hospital of Patras

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.

Condition or disease Intervention/treatment Phase
Discitis Procedure: Unilateral Posterolateral Approach and Debridement Other: Titanium cage insertion supplemented by screw fixation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2004
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

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



Primary Outcome Measures :
  1. The extent of spinal cord injury (SCI) defined by the American Spinal Injury Association (ASIA) Impairment Scale [ Time Frame: 2 years ]

    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 :
  1. Survival rate at 2,5 years [ Time Frame: 2,5 years ]
    Revision surgery or "worst case scenario"

  2. Survival rate at 10 years [ Time Frame: 10 years ]
    Revision surgery or "worst case scenario"



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Ages Eligible for Study:   44 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472131


Sponsors and Collaborators
University Hospital of Patras
St. Andrew's General Hospital, Patras, Greece
Investigators
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Principal Investigator: Panagiotis Korovessis, PhD General Hospital of Patras
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vasileios Syrimpeis, Orthopaedic Surgeon, University Hospital of Patras
ClinicalTrials.gov Identifier: NCT03472131    
Other Study ID Numbers: SPONDYLODISKITIS2018
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vasileios Syrimpeis, University Hospital of Patras:
Spondylodiscitis
Titanium Cage
Posterolateral Debridement
Immunosuppressed
Less Invasive
Spine Infection
Additional relevant MeSH terms:
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Discitis
Spondylitis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases