Long-term Assessment of BDyn Dynamic Stabilization Device in Patients With Lumbar Degenerative Disc Disease (MOBIDYN)
5 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
150
Fase
- Non applicabile
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
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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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Reoperation rate at the upper adjacent segment
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Reoperation rate at the instrumented segment
Lasso di tempo: 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
Lasso di tempo: 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
|
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Describe segmental range of motion (ROM) of the stabilized segment, the upper and lower adjacent segment
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
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Describe disc regeneration and degeneration of the stabilized segment, the upper and lower adjacent segment
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 aprile 2026
Completamento primario (Stimato)
1 aprile 2027
Completamento dello studio (Stimato)
1 aprile 2027
Date di iscrizione allo studio
Primo inviato
28 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
5 maggio 2026
Primo Inserito (Effettivo)
12 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
12 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
5 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026-A00343-48
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .