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