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NCT Number: NCT07580664

Long-term Assessment of BDyn Dynamic Stabilization Device in Patients With Lumbar Degenerative Disc Disease

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.

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Dynamic Lumbar Stabilization Device

Device

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.

Other names: BDyn, BDyn device, BDyn Cousin Biotech, B-Dyn

Primary outcomes

  1. 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)

Secondary outcomes

  1. Reoperation rate at the instrumented segment

    Time frame: Through study completion, an average of 10 year

    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

  2. Describe upper adjacent segment integrity

    Time frame: Through study completion, an average of 10 year

    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

  3. 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

    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

  4. Describe disc height of the stabilized segment, the upper and lower adjacent segment

    Time frame: Through study completion, an average of 10 year

    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

  5. Describe sagittal balance

    Time frame: Through study completion, an average of 10 year

    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

  6. 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

    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

  7. Describe disability

    Time frame: Through study completion, an average of 10 year

    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

  8. Describe back pain

    Time frame: Through study completion, an average of 10 year

    Change from baseline in back pain intensity measured using the Visual Analog Scale (VAS) (0-10), assessed during long-term postoperative follow-up

  9. Describe leg pain

    Time frame: Through study completion, an average of 10 year

    Change from baseline in leg pain intensity measured using the Visual Analog Scale (VAS) (0-10), assessed during long-term postoperative follow-up

  10. Describe satisfaction

    Time frame: Through study completion, an average of 10 year

    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

  11. Describe perioperative outcomes

    Time frame: Through study completion, an average of 10 year

    Number of participants with perioperative complications within 30 days after surgery

  12. Describe clinical safety

    Time frame: Through study completion, an average of 10 year

    Number of participants requiring reoperation at the treated or adjacent segments during long-term postoperative follow-up

Sponsors and collaborators

Lead sponsor

Cousin Biotech

Industry

Registry information

Acronym: MOBIDYN

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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