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
|Condition or disease||Intervention/treatment||Phase|
|Discitis||Procedure: Unilateral Posterolateral Approach and Debridement Other: Titanium cage insertion supplemented by screw fixation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- Survival rate at 2,5 years [ Time Frame: 2,5 years ]Revision surgery or "worst case scenario"
- Survival rate at 10 years [ Time Frame: 10 years ]Revision surgery or "worst case scenario"
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
|Principal Investigator:||Panagiotis Korovessis, PhD||General Hospital of Patras|