Compare Different Cervical Anterior Discectomy Procedures for Cervical Degenerative Disc Disease by After Procedure Sagittal Alignment on Radiograph :a Multiple Center Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cervical Disc Degeneration
- Sponsor
- Peking University People's Hospital
- Enrollment
- 150
- Primary Endpoint
- change of cervical alignment
- Last Updated
- 8 years ago
Overview
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.
Investigators
Zhu Zhenqi
department of spinal surgery
Peking University People's Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
change of cervical alignment
Time Frame: 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 Outcomes
- quality of life(1 day postoperatively, 6 weeks, 3 months, 1 year and 2 years)