Economic evaluation of the surgical treatment of cervical myelopathy, radiculopathy, or myeloradiculopathy: anterior cervical discectomy with arthroplasty versus anterior cervical discectomy with fusion.

Economic evaluation of the surgical treatment of cervical myelopathy, radiculopathy, or myeloradiculopathy: anterior cervical discectomy with arthroplasty versus anterior cervical discectomy with fusion. - Cervical Arthroplasty Cost Effectiveness Study (CACES)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55188

Enrollment

198

Registered

2020-04-28

Start date

2020-10-01

Completion date

Unknown

Last updated

2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical myelopathy and/or radiculopathy nerve and/or spinal cord compression in the neck

Interventions

The intervention group receives ACDA (n=89) and the control group receives ACDF (n=89).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients >= 18 and

Exclusion criteria

Exclusion criteria: - Kellgren-Lawrence score of 4 at the target level(s). - Indication for (additional) posterior surgical approach. - Indication for surgery on three or more levels. - Previous ventral surgery of the cervical spine. - Traumatic origin of the compression. - Previous radiotherapy to the cervical spine. - Metabolic bone disease. - Inflammatory spinal disease: e.g. Ankylosing spondylitis, Forestier*s disease. - Infection of the cervical spine. - Unable to fill out Dutch questionnaires. - Informed consent not possible.

Design outcomes

Primary

Measure	Time frame
This study consists of three parts: clinical effectiveness, economic evaluation and process evaluation. For clinical effectiveness we investigate whether the rate of symptomatic ASD and re-operation is lower after ACDA in comparison with ACDF. Moreover, we evaluate whether ACDA is non-inferior to ACDF in terms the Neck Disability Index, the Visual Analogue Scale score for neck and arm pain, the Hospital Anxiety Depression Scale, Generic Quality of Life, and the Modified Japanese Orthopedic Association score for myelopathy patients. For the economic evaluation, we analyse the cost-effectiveness and the cost-utility of ACDA in comparison with ACDF from a societal perspective. For the process evaluation interviews will be held with patients, informal care givers and professionals. We compare outcomes between groups at baseline and every 6 months till 4 years postoperatively.	—

Measure

Time frame

This study consists of three parts: clinical effectiveness, economic evaluation and process evaluation. For clinical effectiveness we investigate whether the rate of symptomatic ASD and re-operation is lower after ACDA in comparison with ACDF. Moreover, we evaluate whether ACDA is non-inferior to ACDF in terms the Neck Disability Index, the Visual Analogue Scale score for neck and arm pain, the Hospital Anxiety Depression Scale, Generic Quality of Life, and the Modified Japanese Orthopedic Association score for myelopathy patients. For the economic evaluation, we analyse the cost-effectiveness and the cost-utility of ACDA in comparison with ACDF from a societal perspective. For the process evaluation interviews will be held with patients, informal care givers and professionals. We compare outcomes between groups at baseline and every 6 months till 4 years postoperatively.

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Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)