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Cervical Arthroplasty Cost Effectiveness Study (CACES)

RecruitingNAAges 18 Years - anyAllValérie Schuermans
NCT04623593 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

To date, no consensus exists on which anterior surgical technique is more cost-effective to treat cervical degenerative disc disease (CDDD). The most commonly used surgical treatment for patients with single- or multilevel symptomatic CDDD is anterior cervical discectomy with fusion (ACDF). However, new complaints of radiculopathy and/or myelopathy commonly develop at adjacent levels, also known as clinical adjacent segment pathology (CASP). It remains unknown to what extent kinematics, surgery-induced fusion and natural history of disease play a role in its development. Anterior cervical discectomy with arthroplasty (ACDA) is thought to reduce the incidence of CASP by preserving motion in the operated segment. ACDA is often discouraged as the implant costs are higher whilst the clinical outcomes are similar to ACDF. However, preventing CASP might be a reason for ACDA to be a more cost-e

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📋 Eligibility rules (as published)
Inclusion Criteria: * Indication for anterior cervical decompression surgery. * Single- or multilevel CDDD between C3 and C7. * Symptoms of myelopathy, radiculopathy, or myeloradiculopathy. * In case of pure radiculopathy: refractory to at least 6 weeks of conservative therapy. * In case of myelopathy: symptomatic myelopathy. * Patients ≥ 18 years of age. Exclusion criteria * Indication for (additional) posterior surgical approach. * Indication for additional stabilization of the pathological segment by a plate. * Previous ventral surgery of the cervical spine. * Traumatic origin of the compression. * Previous radiotherapy of the cervical spine. * Metabolic bone disease. * Inflammatory spinal disease: e.g., Bechterew's disease, Forestier's disease. * Infection of the cervical spine.
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What it tests

  • ACDF
  • ACDA
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Where

1 site
Zuyderland Medical Center
Maastricht, Netherlands
🤝 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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