Evaluating the cost-effectiveness of cervical disc surgery techniques
Economic Evaluation of Anterior Cervical Discectomy With Arthroplasty Versus Anterior Cervical Discectomy With Fusion in the Surgical Treatment of Cervical Degenerative Disc Disease, a Randomized Controlled Trial
This study is testing which of two surgery options for neck pain from disc problems is more cost-effective and beneficial for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 198 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zuyderland Medisch Centrum Academic / other |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT04623593 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with single- or multilevel CDDD between C3 and C7 who exhibit symptoms of myelopathy or radiculopathy.
Not a fit: Patients with a traumatic origin of compression, previous cervical spine surgery, or those requiring additional stabilization are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more cost-effective surgical options for patients suffering from cervical degenerative disc disease.
How similar studies have performed: While there is ongoing debate regarding the cost-effectiveness of these surgical techniques, this study aims to provide new insights, as no consensus currently exists.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Maastricht, Limburg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.