Spine InfectionNCT05013203
NGS for Spine Surgery Patients
An observational study of Spine Infection, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
During revision spinal surgery for aseptic indications, there remains a concern that the failure may have resulted from undetectable subclinical infection. In the common revision indications of hardware loosening and adjacent segment disease it is possible that bacterial colonization and low-grade infection… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Infection
- What is being tested?
- Tissue culture and Next Generation Sequencing
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2021to 28 Feb 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who are having spine surgery who are >18 years old for degenerative disease, infection, and malignancy.
Who may be able to join
- All patients >18 years of age undergoing spinal surgery
Who cannot join
- All patients <18 years of age undergoing spinal surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Next Generation Sequencing for the Detection of Clinical and Subclinical Infection in Patient Undergoing Spine Surgery
During revision spinal surgery for aseptic indications, there remains a concern that the failure may have resulted from undetectable subclinical infection. In the common revision indications of hardware loosening and adjacent segment disease it is possible that bacterial colonization and low-grade infection precipitated the failure event. There is also significant controversy on the role infectious processes have in the development of degenerative disc disease (modic changes). In particular, this study will investigate whether discogenic colonization with Propionibacterium acnes (P. acnes) can be associated with modic changes. Whereas, in surgery for known spinal infection, epidural abscess and septic revisions, it is possible that standard culture techniques fail to detect polymicrobial flora or accurate speciation. This may lead to inappropriate antibiotic management that is not addressing the range of pathology present. There remains an incomplete understanding of the role that subclinical infection plays in aseptic spinal revision surgery and degenerative disc disease
- Conditions
- Spine Infection
- Being tested
- Tissue culture, Next Generation Sequencing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue cultureDiagnostic test
Discarded tissue collected during surgery will be sent to the hospital microbiological lab for aerobic and anaerobic
Next Generation SequencingDiagnostic test
Discarded tissue collected during surgery will be sent to an outside lab for testing using next generation sequencing (NGS)
| Study group | Role | What they receive |
|---|---|---|
| Aseptic (uninfected) Revision Spine Surgery | Aseptic revision for indications including but not limited to hardware failure, adjacent segment pathology, radiculopathy, instability, cord compression. Receives: Diagnostic Test: Tissue culture; Diagnostic Test: Next Generation Sequencing | |
| Spine Surgery for Degenerative Disease | Primary degenerative pathology surgery where a disc sample is extracted to enable spinal decompression or fusion. The potential primary surgeries include but are not limited to microdiscectomy, laminectomy, and lumbar and cervical fusion Receives: Diagnostic Test: Tissue culture; Diagnostic Test: Next Generation Sequencing | |
| Septic (infected) Revision Spine Surgery | Spine surgery for known infection specifically: epidural abscess or septic revision. Epidural abscess must be managed surgically for inclusion. Septic revision cases include any surgery to address infected hardware from a previous spinal surgery. Receives: Diagnostic Test: Tissue culture; Diagnostic Test: Next Generation Sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
complications that patients experience after surgery will be noted from the patient chart after they have been evaluated by their surgeon
Measured: 1 year
Patient Satisfaction
will be measured using the Short Form 12 Physical and Mental Score (SF-12)
Measured: 1 year
Patient pain
will be measured using the Visual Analog Scale Neck and Arm Pain Score (VAS)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start18 Feb 2021
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013203
- Sponsor's protocol ID
- CKEP21d.121
- Status last verified
- Aug 2021
- First submitted
- 13 Aug 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next Generation Sequencing for the Detection of Clinical and Subclinical Infection in Patient Undergoing Spine Surgery
- ClinicalTrials.gov ID
- NCT05013203
- Acronym / sponsor ID
- CKEP21d.121
- Conditions
- Spine Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 19 Aug 2021 (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.
During revision spinal surgery for aseptic indications, there remains a concern that the failure may have resulted from undetectable subclinical infection. In the common revision indications of hardware loosening and adjacent segment disease it is possible that bacterial colonization and low-grade infection precipitated the failure event. There is also significant controversy on the role infectious processes have in the development of degenerative disc disease (modic changes). In particular, this study will investigate whether discogenic colonization with Propionibacterium acnes (P. acnes) can be associated with modic changes. Whereas, in surgery for known spinal infection, epidural abscess and septic revisions, it is possible that standard culture techniques fail to detect polymicrobial flora or accurate speciation. This may lead to inappropriate antibiotic management that is not addressing the range of pathology present. There remains an incomplete understanding of the role that subclinical infection plays in aseptic spinal revision surgery and degenerative disc disease
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aseptic (uninfected) Revision Spine Surgery | – | Diagnostic Test: Tissue culture, Diagnostic Test: Next Generation SequencingAseptic revision for indications including but not limited to hardware failure, adjacent segment pathology, radiculopathy, instability, cord compression. |
| Spine Surgery for Degenerative Disease | – | Diagnostic Test: Tissue culture, Diagnostic Test: Next Generation SequencingPrimary degenerative pathology surgery where a disc sample is extracted to enable spinal decompression or fusion. The potential primary surgeries include but are not limited to microdiscectomy, laminectomy, and lumbar and cervical fusion |
| Septic (infected) Revision Spine Surgery | – | Diagnostic Test: Tissue culture, Diagnostic Test: Next Generation SequencingSpine surgery for known infection specifically: epidural abscess or septic revision. Epidural abscess must be managed surgically for inclusion. Septic revision cases include any surgery to address infected hardware from a previous spinal surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who are having spine surgery who are >18 years old for degenerative disease, infection, and malignancy.
Key inclusion criteria (1 listed)
- All patients >18 years of age undergoing spinal surgery
Key exclusion criteria (1 listed)
- All patients <18 years of age undergoing spinal surgery
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 |
|---|---|---|
| Tissue cultureDiscarded tissue collected during surgery will be sent to the hospital microbiological lab for aerobic and anaerobic | Diagnostic test | Aseptic (uninfected) Revision Spine Surgery, Septic (infected) Revision Spine Surgery, Spine Surgery for Degenerative Disease |
| Next Generation SequencingDiscarded tissue collected during surgery will be sent to an outside lab for testing using next generation sequencing (NGS) | Diagnostic test | Aseptic (uninfected) Revision Spine Surgery, Septic (infected) Revision Spine Surgery, Spine Surgery for Degenerative Disease |
Primary outcome
Postoperative complications
Time frame: 1 year
complications that patients experience after surgery will be noted from the patient chart after they have been evaluated by their surgeon
Patient Satisfaction
Time frame: 1 year
will be measured using the Short Form 12 Physical and Mental Score (SF-12)
Patient pain
Time frame: 1 year
will be measured using the Visual Analog Scale Neck and Arm Pain Score (VAS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Infection, run by Rothman Institute Orthopaedics at 1 site in United States.
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 1 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: status not confirmed, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Postoperative complications (time frame: 1 year). The study lists 3 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 19 Aug 2021.