Prevalence of GermsDISCO-PROPNCT02892617
Evaluation of the Prevalence of Germs Slow Growth in the Intervertebral Disc (IVD) During Spinal Surgery
An observational study of Prevalence of Germs and Spinal Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Low back pain is one of the most frequent reasons for consultation in rheumatology. There is a strong correlation between low back pain, and the presence of a type of Modic 1 signal on MRI. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prevalence of Germs, Spinal Surgery, Anterior Disc Disease
- What is being tested?
- Bacteriological analysis of disc
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Dec 2015
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Disc samples taken during spine surgery during installation of disc prostheses or inter somatic cages made by anterior approach in type discopathies Modic. Fragments disc withdrawn during cures herniated disc surgeries by posterior way. Patients were recruited from the orthopedic service and Neurosurgery at Henri Mondor Hospital in Creteil
Who may be able to join
- Major patients accepted to participate in the study and who signed an informed consent.
- Patients with low back pain lasting for more than 6 months, disabling, with disc disease type 1 Modic eligible for a disc prosthesis or arthrodesis anterior approach.
- Patients underwent surgery for nerve root pain by disc herniation on MRI viewable with a radio-clinical concordance with or without Modic 1 disc disease in the operated disc
Who cannot join
- Lumbar spine surgery history within 12 months and / or presence of osteosynthesis material.
- Immunocompromised patients (HIV, cancer, immunosuppressive treatment, lupus, chronic infection, ...)
- Patients previously treated with antibiotics exceeding 15 days during last 3 months prior enrollment for a period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Prevalence of Germs Slow Growth in the Intervertebral Disc (IVD) During Spinal Surgery: a Single-center Prospective Observational Study
Low back pain is one of the most frequent reasons for consultation in rheumatology. There is a strong correlation between low back pain, and the presence of a type of Modic 1 signal on MRI.
The anomaly Modic 1 results in a hypointense signal T1-weighted images and hyperintense on T2-weighted sequences (including T2 STIR and / or Fat Sat) and contrast enhancement of the endplates after gadolinium injection; it corresponds to a replacement of normal cancellous bone of fibrovascular tissue.
Read more
The origin of this inflammatory process Modic 1 into the vertebra is still unknown.
infectious hypothesis was raised, including contamination by germs called "slow-growth" such as Propionibacterium acnes (PA).
Many studies interesting Bacteriological analysis of disc material found the presence of bacteria (prevalence between 0 and 54%).
A recent clinical trial evaluating the efficacy of antibiotic treatment compared to placebo in low back pain with Modic 1; a show effectiveness of this treatment on the different clinical parameters evaluated.
However skin contamination is not formally excluded, particularly in patients previously infiltrated (including epidural).
Our hypothesis is that the slow-growing bacteria are not involved in Modic 1 type of disc disease, and the possible presence of PA or other slow-growing bacteria in samples obtained discal posterior approach would be related to intraoperative contamination or during preoperative spinal infiltrations The main objective is to assess the prevalence of germs slow growth in the intervertebral disc in the spinal surgery by anterior disc disease in type 1 Modic.
- Conditions
- Prevalence of Germs, Spinal Surgery, Anterior Disc Disease, Modic 1
- Being tested
- Bacteriological analysis of disc
- Keywords
- Modic 1, low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacteriological analysis of discOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with low back pain lasting for more than 6 months, debilitating, with the presence of type 1 Modic disc disease on MRI at the operated disc, eligible for a disc prosthesis or arthrodesis anterior approach Receives: Other: Bacteriological analysis of disc | |
| Group 2 | Patients underwent surgery for nerve root pain by disc herniation on MRI viewable with a radio-clinical concordance with or without Modic 1 disc disease in the operated disc Receives: Other: Bacteriological analysis of disc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or lack of germs slow growth in disc by standard culture and molecular biology technique (16S RNA).
Measured: Visit 2 (surgery day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevalence of GermsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892617
- Sponsor's protocol ID
- 2014-A01831-44
- Acronym
- DISCO-PROP
- Status last verified
- Aug 2016
- First submitted
- 25 Aug 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence of Germs Slow Growth in the Intervertebral Disc (IVD) During Spinal Surgery: a Single-center Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02892617
- Acronym / sponsor ID
- DISCO-PROP / 2014-A01831-44
- Conditions
- Prevalence of Germs, Spinal Surgery, Anterior Disc Disease, Modic 1
- Keywords
- Modic 1, low back pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Sep 2016 (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.
Low back pain is one of the most frequent reasons for consultation in rheumatology. There is a strong correlation between low back pain, and the presence of a type of Modic 1 signal on MRI.
The anomaly Modic 1 results in a hypointense signal T1-weighted images and hyperintense on T2-weighted sequences (including T2 STIR and / or Fat Sat) and contrast enhancement of the endplates after gadolinium injection; it corresponds to a replacement of normal cancellous bone of fibrovascular tissue.
The origin of this inflammatory process Modic 1 into the vertebra is still unknown.
infectious hypothesis was raised, including contamination by germs called "slow-growth" such as Propionibacterium acnes (PA).
Many studies interesting Bacteriological analysis of disc material found the presence of bacteria (prevalence between 0 and 54%).
A recent clinical trial evaluating the efficacy of antibiotic treatment compared to placebo in low back pain with Modic 1; a show effectiveness of this treatment on the different clinical parameters evaluated.
However skin contamination is not formally excluded, particularly in patients previously infiltrated (including epidural).
Our hypothesis is that the slow-growing bacteria are not involved in Modic 1 type of disc disease, and the possible presence of PA or other slow-growing bacteria in samples obtained discal posterior approach would be related to intraoperative contamination or during preoperative spinal infiltrations The main objective is to assess the prevalence of germs slow growth in the intervertebral disc in the spinal surgery by anterior disc disease in type 1 Modic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Bacteriological analysis of discPatients with low back pain lasting for more than 6 months, debilitating, with the presence of type 1 Modic disc disease on MRI at the operated disc, eligible for a disc prosthesis or arthrodesis anterior approach |
| Group 2 | – | Other: Bacteriological analysis of discPatients underwent surgery for nerve root pain by disc herniation on MRI viewable with a radio-clinical concordance with or without Modic 1 disc disease in the operated disc |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Disc samples taken during spine surgery during installation of disc prostheses or inter somatic cages made by anterior approach in type discopathies Modic. Fragments disc withdrawn during cures herniated disc surgeries by posterior way. Patients were recruited from the orthopedic service and Neurosurgery at Henri Mondor Hospital in Creteil
Key inclusion criteria (3 listed)
- Major patients accepted to participate in the study and who signed an informed consent.
- Patients with low back pain lasting for more than 6 months, disabling, with disc disease type 1 Modic eligible for a disc prosthesis or arthrodesis anterior approach.
- Patients underwent surgery for nerve root pain by disc herniation on MRI viewable with a radio-clinical concordance with or without Modic 1 disc disease in the operated disc
Key exclusion criteria (3 listed)
- Lumbar spine surgery history within 12 months and / or presence of osteosynthesis material.
- Immunocompromised patients (HIV, cancer, immunosuppressive treatment, lupus, chronic infection, ...)
- Patients previously treated with antibiotics exceeding 15 days during last 3 months prior enrollment for a period
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 |
|---|---|---|
| Bacteriological analysis of disc | Other | Group 1, Group 2 |
Primary outcome
Presence or lack of germs slow growth in disc by standard culture and molecular biology technique (16S RNA).
Time frame: Visit 2 (surgery day)
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 8 Sep 2016.
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 Prevalence of Germs and Spinal Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 3 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 8 Sep 2016. 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 France. 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?
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?
Presence or lack of germs slow growth in disc by standard culture and molecular biology technique (16S RNA). (time frame: Visit 2 (surgery day)). 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 8 Sep 2016.