Evaluating the cost-effectiveness of cervical disc surgery techniques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to determine the cost-effectiveness of two surgical techniques for treating cervical degenerative disc disease (CDDD): anterior cervical discectomy with fusion (ACDF) and anterior cervical discectomy with arthroplasty (ACDA). The study will randomly assign patients with symptomatic CDDD to receive either ACDF or ACDA, assessing the long-term outcomes and costs associated with each technique. By comparing the incidence of adjacent segment pathology and overall healthcare costs, the trial seeks to provide clarity on the most economically viable surgical option for patients. The increasing prevalence of CDDD in the aging population underscores the importance of this evaluation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zuyderland Medical Center
  Maastricht, Limburg, Netherlands Recruiting

Study contacts

• Principal investigator: Anouk Smeets, MD, PhD, Professor — Maastricht University Medical Center
• Study coordinator: Valérie Schuermans, MD
• Email: valerie.schuermans@mumc.nl
• Phone: 0031433875001

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.