DiscitisSPDTISNCT03472131
Unilateral Posterolateral Approach for Spondylodiskitis
A study testing Unilateral Posterolateral Approach and Debridement and Titanium cage insertion supplemented by screw fixation in people with Discitis, run by University Hospital of Patras.
Trial 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. Read more about this study
- Who is it for?
- Ages 44 to 80 years
- Conditions the study is for
- Discitis
- What is being tested?
- Unilateral Posterolateral Approach and Debridement and Titanium cage insertion supplemented by screw fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 44 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- -
About this study
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
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.
Read the 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.
- Conditions
- Discitis
- Being tested
- Unilateral Posterolateral Approach and Debridement, Titanium cage insertion supplemented by screw fixation
- Keywords
- Spondylodiscitis, Titanium Cage, Posterolateral Debridement, Immunosuppressed, Less Invasive, Spine Infection
- Medical subject headings
- Discitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral Posterolateral Approach and DebridementProcedure or surgery
Titanium cage insertion supplemented by screw fixationOther
| Study group | Role | What they receive |
|---|---|---|
| Septic spondylodiscitis | Experimental | A unilateral posterolateral approach and debridement with titanium cage insertion supplemented by screw fixation for severe sick patients suffering from septic spondylodiscitis Receives: Procedure: Unilateral Posterolateral Approach and Debridement; Other: Titanium cage insertion supplemented by screw fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
Survival rate at 2,5 years
Revision surgery or "worst case scenario"
Measured: 2,5 years
Survival rate at 10 years
Revision surgery or "worst case scenario"
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study startJan 2004
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiscitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Collaborators
- St. Andrew's General Hospital, Patras, Greece
- Responsible party
- Principal investigator, Vasileios Syrimpeis, University Hospital of Patras
- Investigators
- Panagiotis Korovessis, PhD, Principal investigator, General Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472131
- Sponsor's protocol ID
- SPONDYLODISKITIS2018
- Acronym
- SPDTIS
- Status last verified
- Mar 2018
- First submitted
- 4 Mar 2018
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 30993521
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03472131
- Acronym / sponsor ID
- SPDTIS / SPONDYLODISKITIS2018
- Conditions
- Discitis
- Keywords
- Spondylodiscitis, Titanium Cage, Posterolateral Debridement, Immunosuppressed, Less Invasive, Spine Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Collaborators
- St. Andrew's General Hospital, Patras, Greece
- Study start
- Jan 2004 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Septic spondylodiscitis | Experimental | Procedure: Unilateral Posterolateral Approach and Debridement, Other: Titanium cage insertion supplemented by screw fixationA unilateral posterolateral approach and debridement with titanium cage insertion supplemented by screw fixation for severe sick patients suffering from septic spondylodiscitis |
Who may qualify
- Ages
- 44 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unilateral Posterolateral Approach and Debridement | Procedure or surgery | Septic spondylodiscitis |
| Titanium cage insertion supplemented by screw fixation | Other | Septic spondylodiscitis |
Primary outcome
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.
2 secondary outcomes
Survival rate at 2,5 years
Time frame: 2,5 years
Survival rate at 10 years
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Derived from this study: PubMed 30993521Korovessis 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Panagiotis Korovessis, PhD principal investigator
General Hospital of Patras
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral Posterolateral Approach and Debridement and Titanium cage insertion supplemented by screw fixation in people with Discitis, run by University Hospital of Patras.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The extent of spinal cord injury (SCI) defined by the American Spinal Injury Association (ASIA) Impairment Scale (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03472131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.