Long-term Assessment of BDyn Dynamic Stabilization Device in Patients With Lumbar Degenerative Disc Disease (MOBIDYN)
5 mei 2026 bijgewerkt door: Cousin Biotech
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
150
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Patients treated with BDyn dynamic stabilization
All enrolled patients undergo lumbar dynamic stabilization using the BDyn device.
Clinical, radiological, and patient-reported outcomes are collected during long-term follow-up.
|
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.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Reoperation rate at the upper adjacent segment
Tijdsspanne: 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)
|
Through study completion, an average of 10 year
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Reoperation rate at the instrumented segment
Tijdsspanne: 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
|
Through study completion, an average of 10 year
|
|
Describe upper adjacent segment integrity
Tijdsspanne: 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
|
Through study completion, an average of 10 year
|
|
Describe segmental range of motion (ROM) of the stabilized segment, the upper and lower adjacent segment
Tijdsspanne: 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
|
Through study completion, an average of 10 year
|
|
Describe disc height of the stabilized segment, the upper and lower adjacent segment
Tijdsspanne: 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
|
Through study completion, an average of 10 year
|
|
Describe sagittal balance
Tijdsspanne: 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
|
Through study completion, an average of 10 year
|
|
Describe disc regeneration and degeneration of the stabilized segment, the upper and lower adjacent segment
Tijdsspanne: 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
|
Through study completion, an average of 10 year
|
|
Describe disability
Tijdsspanne: 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
|
Through study completion, an average of 10 year
|
|
Describe back pain
Tijdsspanne: 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
|
Through study completion, an average of 10 year
|
|
Describe leg pain
Tijdsspanne: 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
|
Through study completion, an average of 10 year
|
|
Describe satisfaction
Tijdsspanne: 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
|
Through study completion, an average of 10 year
|
|
Describe perioperative outcomes
Tijdsspanne: Through study completion, an average of 10 year
|
Number of participants with perioperative complications within 30 days after surgery
|
Through study completion, an average of 10 year
|
|
Describe clinical safety
Tijdsspanne: 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
|
Through study completion, an average of 10 year
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 april 2026
Primaire voltooiing (Geschat)
1 april 2027
Studie voltooiing (Geschat)
1 april 2027
Studieregistratiedata
Eerst ingediend
28 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
5 mei 2026
Eerst geplaatst (Werkelijk)
12 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
12 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
5 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2026-A00343-48
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .