Improving Cervical Spine Alignment and Intervertebral Foramen Expansion Using a Novel Distally Expanding Cervical Facet Implant for Cervical Degenerative Disease

Официальное название

Improving Cervical Spine Alignment and Intervertebral Foramen Expansion Using a Novel Distally Expanding Cervical Facet Implant (CeLFI) for Cervical Degenerative Disease

Обзор

Cervical degenerative disease (CDD) resulting in myelopathy represents the commonest disease affecting the spinal cord in adults. Cervical radiculopathy can be associated with myelopathy or occurs alone. The treatment frequently requires surgical intervention; which could be done through anterior or posterior cervical spine approach, or a combination. In this study, we aim to evaluate the value of the innovative device (CeLFI; Cervical expanding facet implant), inserted from posterior approach, in widening the neural intervertebral foramina by providing an anterior distraction of the cervical facet joint space (FJS). Therefore, achieving indirect nerve decompression while maintaining cervical alignment and stability. A prospective clinical study of a biomechanically and cadaver-validated device, following the pathway of similarly approved devices. Informed consent will be taken before the participation of every patient. 20 adult patients undergoing posterior surgery for CDD (for radiculopathy or myelopathy); from C2-6, will be included. Clinical evaluation will include pre- and post-operative standard outcome measures including visual analogue score (VAS), Neck disability index (NDI), and Modified Japanese Orthopedic Association score (mJOA). Standard radiologic evaluation will be performed before and after surgery including X-ray, computer tomography scan (CT), and Magnetic resonance imaging (MRI). Interim detailed safety analysis will be conducted after the first 5 cases are performed.

Вмешательства

• Устройство cervical facet implant will be introduced into the cervical levels that were mobile on flexion-extension x-ray and exhibited foramen stenosis or spondylolisthesis
  The patients will be managed according to the current practice for posterior cervical spine surgical approaches regarding patient positioning, surgical exposure, and neural decompression. The patients will be positioned prone with the head in a Mayfield headrest, All patients will be monitored using intraoperative motor evoked potentials (MEP) and somatosensory evoked potentials (SSEP). Intra-operative X-rays (antero-posterior and lateral) will be used to identify the index cervical level and to

Первичные конечные точки

• • Primary outcome (Radiological Evaluation): o Reduction of spondylolisthesis segment on X-rays (both intra-operative and post-operative within 1 week from surgery). This is defined here as a reduction of prior cervical vertebral mal-alignment to less t [Срок оценки: 1, 3, and 6 months after surgery]

Критерии участия

Критерии включения

• Age > 18
• Signed Informed Consent
• Patients undergoing posterior cervical Spine surgery for CDD (for radiculopathy or myelopathy)

Критерии исключения

• Non-degenerative cervical spine pathologies, including infection, tumor, or trauma.

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

Саудовская Аравия · 1 центр

• King Saud University Medical City — Riyadh

Идентификаторы

NCT: NCT07142174 · E-21-6224 · 2329

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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