Spinal TuberculosisNCT02638272
Early Outcomes of Radical Debridement Versus no Debridement Under Different Surgical Procedures
A study testing no debridement in people with Spinal Tuberculosis, run by The Second Hospital of Anhui Medical University.
Trial summary
Whether radical debridement is necessary for the treatment of thoracic and lumbar tuberculosis is still questionable. The objective of this prospective randomized study was to compare the outcomes of radical debridement versus no debridement under different surgical procedures for the treatment of thoracic and lumbar… Read more about this study
- Who is it for?
- Ages 14 to 67 years
- Conditions the study is for
- Spinal Tuberculosis
- What is being tested?
- no debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Sep 2015
- 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 14 to 67 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Frankel grading was grade D and E
- Severe back pain
- Abscess combined with high pressure symptoms
- Larger sequestrum formation or sinus
- Significant spinal instability.
Who cannot join
- Frankel grading was grade A,B and C
- Conservative treatment
About this study
Official title: Outcomes of Radical Debridement Versus no Debridement Under Different Surgical Procedures for the Treatment of Thoracic and Lumbar Spinal Tuberculosis
Whether radical debridement is necessary for the treatment of thoracic and lumbar tuberculosis is still questionable. The objective of this prospective randomized study was to compare the outcomes of radical debridement versus no debridement under different surgical procedures for the treatment of thoracic and lumbar tuberculosis.
Read the detailed description
Seventy-four thoracic and lumbar tuberculosis patients with a neurological function of grade D and E underwent surgeries from January 2009 to January 2014. All patients were divided into group A and group B by taking the drawing of lots. In group A, radical debridement, bone graft and instrumentation were performed. In group B, isolated posterior instrumentation without debridement were performed in all cases and drainage of iliopsoas abscess via laparoscopy in 2 cases. The operative time, blood loss, visual analogue score (VAS), erythrocyte sedimentation rate (ESR), kyphotic angle, Frankel grading, fusion rate and complications were evaluated.
- Conditions
- Spinal Tuberculosis
- Being tested
- no debridement
- Medical subject headings
- Tuberculosis, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no debridementProcedure or surgery
It is a spinal surgery performed with isolated posterior instrumentation without debridement.
| Study group | Role | What they receive |
|---|---|---|
| spine surgery | Other | The objective was to compare the outcomes of radical debridement versus no debridement under different surgical procedures for the treatment of thoracic and lumbar tuberculosis. Receives: Procedure: no debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The operative time in minutes
Measured: 5 years
blood loss in milliliter
Measured: 5 years
erythrocyte sedimentation rate (ESR) in mm/h
Measured: 5 years
kyphotic angle in degree
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startJan 2009
- Primary completionFeb 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal TuberculosisStudies 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Jun, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638272
- Sponsor's protocol ID
- 1898
- Status last verified
- Dec 2015
- First submitted
- 9 Dec 2015
- Last updated
- 23 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Radical Debridement Versus no Debridement Under Different Surgical Procedures for the Treatment of Thoracic and Lumbar Spinal Tuberculosis
- ClinicalTrials.gov ID
- NCT02638272
- Acronym / sponsor ID
- 1898
- Conditions
- Spinal Tuberculosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 23 Dec 2015 (estimated)
- 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.
Whether radical debridement is necessary for the treatment of thoracic and lumbar tuberculosis is still questionable. The objective of this prospective randomized study was to compare the outcomes of radical debridement versus no debridement under different surgical procedures for the treatment of thoracic and lumbar tuberculosis.
Detailed description
Seventy-four thoracic and lumbar tuberculosis patients with a neurological function of grade D and E underwent surgeries from January 2009 to January 2014. All patients were divided into group A and group B by taking the drawing of lots. In group A, radical debridement, bone graft and instrumentation were performed. In group B, isolated posterior instrumentation without debridement were performed in all cases and drainage of iliopsoas abscess via laparoscopy in 2 cases. The operative time, blood loss, visual analogue score (VAS), erythrocyte sedimentation rate (ESR), kyphotic angle, Frankel grading, fusion rate and complications were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spine surgery | Other | Procedure: no debridementThe objective was to compare the outcomes of radical debridement versus no debridement under different surgical procedures for the treatment of thoracic and lumbar tuberculosis. |
Who may qualify
- Ages
- 14 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Frankel grading was grade D and E
- Severe back pain
- Abscess combined with high pressure symptoms
- Larger sequestrum formation or sinus
- Significant spinal instability.
Key exclusion criteria (2 listed)
- Frankel grading was grade A,B and C
- Conservative treatment
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 |
|---|---|---|
| no debridementIt is a spinal surgery performed with isolated posterior instrumentation without debridement. | Procedure or surgery | spine surgery |
Primary outcome
The operative time in minutes
Time frame: 5 years
blood loss in milliliter
Time frame: 5 years
erythrocyte sedimentation rate (ESR) in mm/h
Time frame: 5 years
kyphotic angle in degree
Time frame: 5 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 23 Dec 2015.
Related trials for Spinal Tuberculosis
Not yet recruitingPhase 2
Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis
Mild Spinal Tuberculosis
RecruitingObservational study
Gene Expression Profiles in Spinal Tuberculosis.
Tuberculosis, Spinal, Tuberculosis, Osteoarticular
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing no debridement in people with Spinal Tuberculosis, run by The Second Hospital of Anhui Medical University.
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 5 inclusion and 2 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 23 Dec 2015. 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 operative time in minutes (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2015.