Cervical Disc Degeneration
Conditions
Keywords
Cervical Disc Degeneration, cervical anterior discectomy, Spinal alignment
Brief summary
Patients with single-level cervical degenerative disc disease commonly undertook anterior discectomy. To compare the effect of anterior cervical discectomy without fusion (ACD), anterior cervical discectomy with fusion by stand-alone cage (ACDF) or anterior cervical discectomy with arthroplasty (ACDA)， a multiple center randomised controlled trial will be performed in patients with single-level cervical disease. The primary outcome will be cervical alignment by upright cervical spine radiographs estimated by Harrison posterior tangent method.
Detailed description
This study will use a multiple center open-label randomised controlled trial to estimate the effect of ACD, ACDF, ACDA for single-level cervical degenerative disc. Patients with arm pain not responding to conservative treatment take part in this trial. They will be randomised assigned into 3 parallel arms. The participants in the each arm will undertake ACD ACDF or ACDA. The baseline is the day of surgery. The Harrison posterior tangent method was used as an estimate for measuring cervical alignment. The primary outcome will be the cervical sagittal alignment estimated by Harrison posterior tangent method.
Interventions
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients with arm pain not responding to conservative treatment * lasted longer than 10 weeks * single level disc degeneration * mobile spine on dynamic lateral cervical X-rays
Exclusion criteria
* severe cardiopulmonary comorbidity * suspected underlying malignant disease * radicular syndrome * spinal-cord compression syndrome * contraindication for radiography
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of cervical alignment | 1 day postoperatively, 6 weeks, 3 months, 1 year and 2 years | The Harrison posterior tangent method was used as an estimate for curvature |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quality of life | 1 day postoperatively, 6 weeks, 3 months, 1 year and 2 years | Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) |
Contacts
Primary Contactchen guo
Outcome results
None listed