Efficacy and Safety of Anterior Cervical Spine Surgery in Patients With Cervical Degenerative Disc Disease - a Real World Data Collection and Analysis Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cervical Disc Degeneration
- Sponsor
- Beijing Tiantan Hospital
- Enrollment
- 1500
- Locations
- 1
- Primary Endpoint
- Japanese Orthopaedic Association Scale
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This observational study aims to evaluate the efficacy and safety of anterior cervical spine surgery in patients with cervical degenerative disc disease
Detailed Description
This observational study is an ambispective cohort designed. Patients who are diagnosed cervical degenerative disc disease will be selected to join in this study. Visual Analogue Scale, Japanese Orthopaedic Association Scale, Neck Disability Index, SF-36, and device related or procedure related adverse events will be recorded and compared to evaluate the efficacy and safety of anterior cervical spine surgery in patients with cervical degenerative disc disease
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients over 18 years old
- •Clinical symptoms and imaging support cervical degenerative disc disease；
- •Failed a minimum of 3months conservative treatment
- •Have had (retrospective cohort) or the decision has been made to have (prospective cohort) anterior cervical spine surgery
- •Written informed consent given by subject
Exclusion Criteria
- •Patients with non-degenerative (e.g., trauma, tumor, and infection) or neuromuscular diseases (e.g., motor neuron disease) were excluded
- •Patients with cervical spine X-ray film and CT scan contraindications
- •Women who are lactating and pregnant
Outcomes
Primary Outcomes
Japanese Orthopaedic Association Scale
Time Frame: 1st year
Establishing criteria for mild, moderate and severe impairment in patients with degenerative cervical myelopathy. The minimum value is 0, and the maximum value is 17. Higher scores mean a better outcome.
Secondary Outcomes
- Neck Disability Index(1st year)