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

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Reoperation rate at the upper adjacent segment [Срок оценки: Through study completion, an average of 10 year]

Вторичные конечные точки (12)

• Reoperation rate at the instrumented segment [Срок оценки: Through study completion, an average of 10 year]
• Describe upper adjacent segment integrity [Срок оценки: Through study completion, an average of 10 year]
• Describe segmental range of motion (ROM) of the stabilized segment, the upper and lower adjacent segment [Срок оценки: Through study completion, an average of 10 year]
• Describe disc height of the stabilized segment, the upper and lower adjacent segment [Срок оценки: Through study completion, an average of 10 year]
• Describe sagittal balance [Срок оценки: Through study completion, an average of 10 year]
• Describe disc regeneration and degeneration of the stabilized segment, the upper and lower adjacent segment [Срок оценки: Through study completion, an average of 10 year]
• Describe disability [Срок оценки: Through study completion, an average of 10 year]
• Describe back pain [Срок оценки: Through study completion, an average of 10 year]
• Describe leg pain [Срок оценки: Through study completion, an average of 10 year]
• Describe satisfaction [Срок оценки: Through study completion, an average of 10 year]
• Describe perioperative outcomes [Срок оценки: Through study completion, an average of 10 year]
• Describe clinical safety [Срок оценки: Through study completion, an average of 10 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07580664 · 2026-A00343-48

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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