Cervical Vertebrae, Degenerative Disease, Single
Conditions
Keywords
Cervical vertebrae, single, degenerative disease, Fusion, Sagittal angle
Brief summary
The use of plate in addition to autologous bone is better then stand alone cage fusion regarding fusion rate and segmental lordosis.
Detailed description
cage: MC+® cage plate: atlantis® plate
Interventions
PROCEDURECage fusion
Randomized selection of surgery type
PROCEDUREPlate fusion
Randomized selection of surgery type
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
ACDF with plate and autologous bone
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Single level degenerative cervical spine disease * aged 30 - 70 * no improvement of symptom for 8 weeks of non-surgical treatment. * degeneration in other levels without stenosis, accepted
Exclusion criteria
* osteoporosis * disease with poor bone quality * Cancer * Previous cervical spine surgery * Multiple levels disease * Ossification of posterior longitudinal ligament * Kyphosis at the index level * Developmental stenosis (diameter of C7 spinal canal \< 10mm)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fusion rate | 2 years | The rate of interbody fusion at 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Segmental angle | 2 years | the segmental angle at the fused level |
| cervical lordosis | 2 years | The cervical lordosis at 2 years |
| pain change | 2 years | Visual analogue pain score |
| functional status change. | 2 years | Neck disability index |
Countries
South Korea
Outcome results
None listed