Lumbar Disc HerniationNCT05277818
Post-marketing Clinical Follow-up of the Medical Device DIVA®
An observational study of Lumbar Disc Herniation, run by SC Medica at 1 site in France.
Trial summary
Observational, ambispective, longitudinal, comparative, open, multicentric study. The main objective is to compare the performance of care in patients operated with and without DIVA®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Surgery lumbar disc herniation
- Type of treatment
- Surgery or procedure
- How many people
- 822 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2022to 15 Mar 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: All patients with the DIVA® device operated in the study centers for at least 12 months (with the exception of the first 30 operated by practitioner, to take into account the learning curve), as well as all patients operated on over a period similar before the installation of DIVA® in the establishment, will receive the information note of the study. if the patient agrees to participate to the study, patient's data will be collected on a case report form.
Who may be able to join
- Adult patient, having undergone surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated with or without a DIVA® implant;
- Patient operated for at least 12 months;
- Patient able to understand the information related to the study;
- Patient having indicated his/her non-opposition to the collection of his/her personal data.
Who cannot join
- History of pathologies, malformations or surgical interventions on the spine;
- Patient belonging to the first 30 operated by the surgeon with the DIVA® implant;
- Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
- Patient not benefiting from a social security scheme.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Civils de Colmar
Colmar
Robin SROUR, MD, robin.srour@ch-colmar.fr
About this study
Official title: Clinical Follow-up of the DIVA® Device in Lumbar Disc Herniation Surgery
Observational, ambispective, longitudinal, comparative, open, multicentric study.
The main objective is to compare the performance of care in patients operated with and without DIVA®.
Read the detailed description
The primary endpoint is the reoperation for any cause (excluding trauma) on the lumbar spine.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Surgery lumbar disc herniation
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery lumbar disc herniationProcedure or surgery
Surgery for a degenerative or traumatic mono-segmental lumbar disc herniation
| Study group | Role | What they receive |
|---|---|---|
| Patient with medical device DIVA® | Adult patient, operated for at least 12 months, having had surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated with DIVA® implant Receives: Procedure: Surgery lumbar disc herniation | |
| Patient without medical device DIVA® | Adult patient, operated for at least 12 months, having had surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated without DIVA® implant Receives: Procedure: Surgery lumbar disc herniation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of patients requiring reoperation for any cause (excluding trauma) on the lumbar spine 5 years postoperatively.
The main analysis will compare the rates of patients requiring reoperation due to any cause (excluding trauma) on the lumbar spine 5 years after surgery between the group with DIVA® and the group without DIVA®, using a Chi-square test.
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 posted14 Mar 2022
- Study start7 Sep 2022
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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
- Cross-sectional
- Enrolment
- 822 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- SC Medica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277818
- Sponsor's protocol ID
- 2021-A02667-34
- Status last verified
- Oct 2022
- First submitted
- 3 Mar 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Follow-up of the DIVA® Device in Lumbar Disc Herniation Surgery
- ClinicalTrials.gov ID
- NCT05277818
- Acronym / sponsor ID
- 2021-A02667-34
- Conditions
- Lumbar Disc Herniation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 822 participants (estimated)
- Lead sponsor
- SC MedicaIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 14 Mar 2022 (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.
Observational, ambispective, longitudinal, comparative, open, multicentric study.
The main objective is to compare the performance of care in patients operated with and without DIVA®.
Detailed description
The primary endpoint is the reoperation for any cause (excluding trauma) on the lumbar spine.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with medical device DIVA® | – | Procedure: Surgery lumbar disc herniationAdult patient, operated for at least 12 months, having had surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated with DIVA® implant |
| Patient without medical device DIVA® | – | Procedure: Surgery lumbar disc herniationAdult patient, operated for at least 12 months, having had surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated without DIVA® implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with the DIVA® device operated in the study centers for at least 12 months (with the exception of the first 30 operated by practitioner, to take into account the learning curve), as well as all patients operated on over a period similar before the installation of DIVA® in the establishment, will receive the information note of the study. if the patient agrees to participate to the study, patient's data will be collected on a case report form.
Key inclusion criteria (4 listed)
- Adult patient, having undergone surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated with or without a DIVA® implant;
- Patient operated for at least 12 months;
- Patient able to understand the information related to the study;
- Patient having indicated his/her non-opposition to the collection of his/her personal data.
Key exclusion criteria (4 listed)
- History of pathologies, malformations or surgical interventions on the spine;
- Patient belonging to the first 30 operated by the surgeon with the DIVA® implant;
- Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
- Patient not benefiting from a social security scheme.
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 |
|---|---|---|
| Surgery lumbar disc herniationSurgery for a degenerative or traumatic mono-segmental lumbar disc herniation | Procedure or surgery | Patient with medical device DIVA®, Patient without medical device DIVA® |
Primary outcome
Rates of patients requiring reoperation for any cause (excluding trauma) on the lumbar spine 5 years postoperatively.
Time frame: 5 years
The main analysis will compare the rates of patients requiring reoperation due to any cause (excluding trauma) on the lumbar spine 5 years after surgery between the group with DIVA® and the group without DIVA®, using a Chi-square test.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Individual participant dataSharing planned: No
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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.
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 Lumbar Disc Herniation, run by SC Medica 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 31 Oct 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurélie MULLER (+33 3 88 23 71 04, dpo@sc-medica.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of patients requiring reoperation for any cause (excluding trauma) on the lumbar spine 5 years postoperatively. (time frame: 5 years). 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 31 Oct 2022.