Degenerative Disc DiseaseMOBIDYNNCT07580664
Long-term Assessment of BDyn Dynamic Stabilization Device in Patients With Lumbar Degenerative Disc Disease
A study testing Dynamic Lumbar Stabilization Device in people with Degenerative Disc Disease, run by Cousin Biotech.
Trial summary
The goal of this clinical trial is to estimate the cumulative reoperation rate at upper adjacent segment level in patients treated with BDyn dynamix stabilization for lumbar degenerative disc diseases over long-term follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Dynamic Lumbar Stabilization Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Apr 2027
- Phase
- Interventional
- 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
Who may be able to join
- Patient, male or female, aged ≥ 18 years old
- Patient treated with BDyn device until end of December 2021, with between one and four fused level(s) maximum for the following indications: Degenerative intervertebral disc disease and/or articular facets confirmed by further examinations, Spinal canal stenosis, Degenerative spondylolisthesis grade 1, Segmental instability
- Patient who signed the informed consent form
- Patient affiliated with a social security scheme
Who cannot join
- Patients who are unable to provide informed consent due to cognitive impairment, language barrier, or any other condition that limits their ability to understand the nature, objectives, or potential risks of the study
- Patient that is pregnant or breastfeeding;
- Patient with protected status under articles L1121-6, LL121-8 and L1122-2 of the French Public Health Code;
- Patient who cannot comply with the protocol requirements based on the investigator's judgment
About this study
The goal of this clinical trial is to estimate the cumulative reoperation rate at upper adjacent segment level in patients treated with BDyn dynamix stabilization for lumbar degenerative disc diseases over long-term follow-up.
Patients will provide baseline socio-demographic and surgical data, complete patient-reported outcome measures (ODI, pain NRS, satisfaction), undergo imaging assessments (dynamic X-rays, EOS, MRI), and participate in safety evaluations including adverse event monitoring throughout follow-up.
- Conditions
- Degenerative Disc Disease
- Being tested
- Dynamic Lumbar Stabilization Device
- Keywords
- BDyn, Dynamic stabilization, Lumbar stabilization
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Lumbar Stabilization DeviceDevice
Also called BDyn, BDyn device, BDyn Cousin Biotech, B-Dyn
BDyn is intended for spine surgery with a posterio approach. The sterile spinal dynamic posterior stabilization devices BDyn is intended to restore the stabilization of the spine segment from T10 to S1 by preserving the anatomical lordosis and the deadening of the intervertebral joint.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with BDyn dynamic stabilization | Experimental | All enrolled patients undergo lumbar dynamic stabilization using the BDyn device. Clinical, radiological, and patient-reported outcomes are collected during long-term follow-up. Receives: Device: Dynamic Lumbar Stabilization Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation rate at the upper adjacent segment
Cumulative reoperation rate at the upper adjacent segment will be defined as the occurrence of reoperation at this level over long-term postoperative follow-up (≥4 years)
Measured: Through study completion, an average of 10 year
Secondary outcomes (12)
Reoperation rate at the instrumented segment
The aim is to estimate the cumulative reoperation rate at the instrumented segment in patients treated with BDyn dynamic stabilization for degenerative disc disease over long-term postoperative follow-up
Measured: Through study completion, an average of 10 year
Describe upper adjacent segment integrity
To evaluate the upper adjacent segment integrity in patients treated with BDyn dynamic stabilization for lumbar degenerative disc disease over long-term postoperative follow-up
Measured: Through study completion, an average of 10 year
Describe segmental range of motion (ROM) of the stabilized segment, the upper and lower adjacent segment
To describe segmental range of motion (ROM) of the stabilized segment, the upper and lower adjacent segment in patients treated with BDyn dynamic stabilization for degenerative disc disease over long-term postoperative follow-up
Measured: Through study completion, an average of 10 year
Describe disc height of the stabilized segment, the upper and lower adjacent segment
Intervertebral disc height measured in millimeters on MRI at the stabilized segment and adjacent segments (upper and lower), assessed at baseline and during long-term postoperative follow-up
Measured: Through study completion, an average of 10 year
Describe sagittal balance
To measure the angle of sagittal balance (the innate neutral standing position with C7 positioned over S1) in patients treated with BDyn dynamic stabilization for degenerative disc disease over long-term postoperative follow-up
Measured: Through study completion, an average of 10 year
Describe disc regeneration and degeneration of the stabilized segment, the upper and lower adjacent segment
Intervertebral disc degeneration assessed using the Pfirrmann grading system (grades I-V) on MRI for the stabilized segment and adjacent segments (upper and lower), evaluated at baseline and during long-term postoperative follow-up
Measured: Through study completion, an average of 10 year
Describe disability
Disability assessed using the Oswestry Disability Index (ODI), reported as a total score ranging from 0 to 100, evaluated at baseline and during long-term postoperative follow-up
Measured: Through study completion, an average of 10 year
Describe back pain
Change from baseline in back pain intensity measured using the Visual Analog Scale (VAS) (0-10), assessed during long-term postoperative follow-up
Measured: Through study completion, an average of 10 year
Describe leg pain
Change from baseline in leg pain intensity measured using the Visual Analog Scale (VAS) (0-10), assessed during long-term postoperative follow-up
Measured: Through study completion, an average of 10 year
Describe satisfaction
Patient satisfaction measured using a patient-reported outcome questionnaire, reported as a total score (range to be specified), assessed during long-term postoperative follow-up
Measured: Through study completion, an average of 10 year
Describe perioperative outcomes
Number of participants with perioperative complications within 30 days after surgery
Measured: Through study completion, an average of 10 year
Describe clinical safety
Number of participants requiring reoperation at the treated or adjacent segments during long-term postoperative follow-up
Measured: Through study completion, an average of 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cousin Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580664
- Sponsor's protocol ID
- 2026-A00343-48
- Acronym
- MOBIDYN
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 12 May 2026
- 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Assessment of BDyn Dynamic Stabilization Device in Patients With Lumbar Degenerative Disc Disease
- ClinicalTrials.gov ID
- NCT07580664
- Acronym / sponsor ID
- MOBIDYN / 2026-A00343-48
- Conditions
- Degenerative Disc Disease
- Keywords
- BDyn, Dynamic stabilization, Lumbar stabilization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cousin BiotechIndustry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 12 May 2026 (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.
The goal of this clinical trial is to estimate the cumulative reoperation rate at upper adjacent segment level in patients treated with BDyn dynamix stabilization for lumbar degenerative disc diseases over long-term follow-up.
Patients will provide baseline socio-demographic and surgical data, complete patient-reported outcome measures (ODI, pain NRS, satisfaction), undergo imaging assessments (dynamic X-rays, EOS, MRI), and participate in safety evaluations including adverse event monitoring throughout follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with BDyn dynamic stabilization | Experimental | Device: Dynamic Lumbar Stabilization DeviceAll enrolled patients undergo lumbar dynamic stabilization using the BDyn device. Clinical, radiological, and patient-reported outcomes are collected during long-term follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient, male or female, aged ≥ 18 years old
- Patient treated with BDyn device until end of December 2021, with between one and four fused level(s) maximum for the following indications: Degenerative intervertebral disc disease and/or articular facets confirmed by further examinations, Spinal canal stenosis, Degenerative spondylolisthesis grade 1, Segmental instability
- Patient who signed the informed consent form
- Patient affiliated with a social security scheme
Key exclusion criteria (4 listed)
- Patients who are unable to provide informed consent due to cognitive impairment, language barrier, or any other condition that limits their ability to understand the nature, objectives, or potential risks of the study
- Patient that is pregnant or breastfeeding;
- Patient with protected status under articles L1121-6, LL121-8 and L1122-2 of the French Public Health Code;
- Patient who cannot comply with the protocol requirements based on the investigator's judgment
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 |
|---|---|---|
| Dynamic Lumbar Stabilization DeviceAlso: BDyn, BDyn device, BDyn Cousin Biotech, B-DynBDyn is intended for spine surgery with a posterio approach. The sterile spinal dynamic posterior stabilization devices BDyn is intended to restore the stabilization of the spine segment from T10 to S1 by preserving the anatomical lordosis and the deadening of the intervertebral joint. | Device | Patients treated with BDyn dynamic stabilization |
Primary outcome
Reoperation rate at the upper adjacent segment
Time frame: Through study completion, an average of 10 year
Cumulative reoperation rate at the upper adjacent segment will be defined as the occurrence of reoperation at this level over long-term postoperative follow-up (≥4 years)
12 secondary outcomes
Reoperation rate at the instrumented segment
Time frame: Through study completion, an average of 10 year
Describe upper adjacent segment integrity
Time frame: Through study completion, an average of 10 year
Describe segmental range of motion (ROM) of the stabilized segment, the upper and lower adjacent segment
Time frame: Through study completion, an average of 10 year
Describe disc height of the stabilized segment, the upper and lower adjacent segment
Time frame: Through study completion, an average of 10 year
Describe sagittal balance
Time frame: Through study completion, an average of 10 year
Describe disc regeneration and degeneration of the stabilized segment, the upper and lower adjacent segment
Time frame: Through study completion, an average of 10 year
Describe disability
Time frame: Through study completion, an average of 10 year
Describe back pain
Time frame: Through study completion, an average of 10 year
Describe leg pain
Time frame: Through study completion, an average of 10 year
Describe satisfaction
Time frame: Through study completion, an average of 10 year
Describe perioperative outcomes
Time frame: Through study completion, an average of 10 year
Describe clinical safety
Time frame: Through study completion, an average of 10 year
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 12 May 2026.
- 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.
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 Dynamic Lumbar Stabilization Device in people with Degenerative Disc Disease, run by Cousin Biotech.
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: opening soon, as of the sponsor's last update on 12 May 2026. 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?
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?
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?
Reoperation rate at the upper adjacent segment (time frame: Through study completion, an average of 10 year). 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 12 May 2026.