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Cervical Arthroplasty Cost Effectiveness Study (CACES)

Launched by VALÉRIE SCHUERMANS · Nov 9, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Cost Effectivity Economic Evaluation Health Utility Randomised Controlled Trial Rct Acda Acdf Anterior Cervical Discectomy And Fusion Anterior Cervical Discectomy With Arthroplasty Degenerative Cervical Myelopathy Degenerative Cervical Radiculopathy Asd Adjacent Segment Disease Adjacent Level Disease

ClinConnect Summary

The Cervical Arthroplasty Cost Effectiveness Study (CACES) is examining which surgical method is more cost-effective for treating certain neck conditions caused by degenerative disc disease. Patients with symptoms like pain, weakness, or numbness in their arms due to issues in the cervical spine (the neck region) will be randomly assigned to receive one of two types of surgery: anterior cervical discectomy with fusion (ACDF), which involves removing the damaged disc and fusing the vertebrae together, or anterior cervical discectomy with arthroplasty (ACDA), which replaces the disc with an artificial one while preserving movement. The study aims to determine not only the costs associated with these procedures but also their effectiveness over time.

To be eligible for this trial, participants must be adults aged 18 or older with specific symptoms related to cervical disc disease that have not improved with conservative treatments for at least six weeks. They should not have had previous surgeries on their cervical spine or certain other medical conditions that could complicate the surgery. Participants can expect to be monitored for clinical and radiological outcomes at the start of the study and every six months for up to four years after their surgery. This study is particularly important as it addresses the rising healthcare costs and aims to provide valuable information on the best surgical options for patients dealing with these common neck issues.

Gender

ALL

Eligibility criteria

  • 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.

About Valérie Schuermans

Valérie Schuermans is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and innovation. With a focus on enhancing patient outcomes, she leads initiatives that prioritize ethical standards and regulatory compliance in clinical studies. Valérie's extensive experience in project management and collaboration with multidisciplinary teams ensures the efficient design and execution of trials, fostering partnerships with healthcare professionals and stakeholders. Her strategic vision drives the exploration of new therapeutic options, contributing to the development of safe and effective treatments that address unmet medical needs.

Locations

Maastricht, Limburg, Netherlands

Patients applied

0 patients applied

Trial Officials

Anouk Smeets, MD, PhD, Professor

Principal Investigator

Maastricht University Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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