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

RecruitingNAAges 18 Years - anyAllKing Saud University
NCT07142174 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 t

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age \> 18 * Signed Informed Consent * Patients undergoing posterior cervical Spine surgery for CDD (for radiculopathy or myelopathy) Exclusion Criteria: * Non-degenerative cervical spine pathologies, including infection, tumor, or trauma.
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What it tests

  • cervical facet implant will be introduced into the cervical levels that were mobile on flexion-extension x-ray and exhibited foramen stenosis or spondylolisthesis
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Where

1 site
King Saud University Medical City
Riyadh, Saudi Arabia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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