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

NCT07580664 | Not Yet Recruiting

• 1 other identifier: 2026-A00343-48
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Degenerative Disc Disease

Keywords

BDyn; Dynamic stabilization; Lumbar stabilization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Reoperation rate at the instrumented segment

  Through study completion, an average of 10 year

• Describe upper adjacent segment integrity

  Through study completion, an average of 10 year

• Describe segmental range of motion (ROM) of the stabilized segment, the upper and lower adjacent segment

  Through study completion, an average of 10 year

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

  Through study completion, an average of 10 year

• Describe sagittal balance

  Through study completion, an average of 10 year

Study Arms (1)

Patients treated with BDyn dynamic stabilization

EXPERIMENTAL

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

Interventions

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.

Also known as: BDyn, BDyn device, BDyn Cousin Biotech, B-Dyn

Patients treated with BDyn dynamic stabilization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cousin Biotech: lead

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 12, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share