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

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 Overview

• Status: Not yet recruiting
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: Dynamic Lumbar Stabilization Device

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other Names: BDyn; BDyn device; BDyn Cousin Biotech; B-Dyn

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Through study completion, an average of 10 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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	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	Through study completion, an average of 10 year
Describe perioperative outcomes	Number of participants with perioperative complications within 30 days after surgery	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	Through study completion, an average of 10 year

Collaborators and Investigators

• Sponsor: Cousin Biotech

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Lumbar stabilization; BDyn; Dynamic stabilization
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: 2026-A00343-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No