The aim of the proposed study is to examine whether ACDA compared to ACDF is preferable in terms of costs, effectiveness and utility from a hospital and a societal perspective.
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Not applicable.
Background summary
The standard surgical procedure for treating patients with single or multilevel
cervical degenerative disc disease (CDDD) and symptoms of radiculopathy and/or
myelopathy is anterior cervical discectomy, either with fusion (ACDF) or
without. Adjacent segment disease (ASD) occurs in approximately 25% of patients
during 10 years follow-up. More than 2/3 of these patients need additional
surgery. Anterior cervical discectomy with arthroplasty (ACDA) was developed in
an effort to reduce the incidence of ASD by preserving physiological motion in
the operated segment.
Study objective
The aim of the proposed study is to examine whether ACDA compared to ACDF is
preferable in terms of costs, effectiveness and utility from a hospital and a
societal perspective.
Study design
The study design will be a prospective randomised controlled trial.
Intervention
The intervention group receives ACDA (n=89) and the control group receives ACDF
(n=89).
Study burden and risks
The burden for patients in this study is low. The surgical procedures of the
intervention and control group are comparable and the complication risks are
similar. Patients are only asked to fill in questionnaires during 4 years
postoperatively. This study can lead to important new insights and might change
the standard surgical for patients with CDD in the Netherlands.
Henri Dunantstraat 5
Heerlen 6419PC
NL
Henri Dunantstraat 5
Heerlen 6419PC
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04623593 |
| CCMO | NL72534.096.20 |