Status:
RECRUITING
Cervical Arthroplasty Cost Effectiveness Study (CACES)
Lead Sponsor:
Valérie Schuermans
Conditions:
Radiculopathy, Cervical
Myelopathy Cervical
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Cervical degenerative disc disease (CDDD) is the degeneration of a cervical intervertebral disc and/or the adjoining vertebral bodies, resulting in clinical symptoms of cervical radiculopathy, myelopa...
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.
Key Trial Info
Start Date :
January 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT04623593
Start Date
January 17 2022
End Date
June 1 2028
Last Update
January 25 2024
Active Locations (1)
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1
Zuyderland Medical Center
Maastricht, Limburg, Netherlands, 6419 PC