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

Recruiting

Conditions: Cervical myelopathy and/or radiculopathy
nerve and/or spinal cord compression in the neck
10041543
10009720

Registration Number: NL-OMON55188

Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 198

Inclusion Criteria

- Patients >= 18 and <= 75 years of age.
- Single or 2-level 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.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures