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

5. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

150

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: Dynamic Lumbar Stabilization 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.
Andre navne:
  • BDyn
  • BDyn device
  • BDyn Cousin Biotech
  • B-Dyn

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reoperation rate at the upper adjacent segment
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reoperation rate at the instrumented segment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cousin Biotech

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. april 2026

Primær færdiggørelse (Anslået)

1. april 2027

Studieafslutning (Anslået)

1. april 2027

Datoer for studieregistrering

Først indsendt

28. april 2026

Først indsendt, der opfyldte QC-kriterier

5. maj 2026

Først opslået (Faktiske)

12. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-A00343-48

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Degenerativ diskussygdom

Kliniske forsøg med Dynamic Lumbar Stabilization Device

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