Does size matter? Clinical outcome related to the extent of posterior (cranio)cervical fixations. A prospective international multicenter study
- Conditions
- Degenerative cervical spine disease in male and female patients aged 18 to 80 years
- Registration Number
- NL-OMON21529
- Lead Sponsor
- eiden University Medical Center (LUMC)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 220
Inclusion Criteria
1. Male and female patients aged between 18 and 80 years;
2. Degenerative cervical spine disease requiring posterior (cranio)cervical fixation, with or without decompression;
Exclusion Criteria
1. Additional anterior fixation required;
2. Cervical spine surgery in the last 6 months;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical outcome: Neck Disability Index (NDI)
- Secondary Outcome Measures
Name Time Method eurologic status: Japanese Orthopaedic Association (JOA) score;<br /><br>Surgical outcome: Likert scale;<br /><br>Pain: Visual Analogue Scale (VAS) for arm and neck pain;<br /><br>Quality of life: 36-item Short Form health survey (SF-36), European Quality of life-5 Dimensions (EQ-5D);<br /><br>Mental health: Hospital Anxiety and Depression Scale (HADS);<br /><br>Radiologic data: cervical spine alignment, segmental range of motion (ROM) at the operative levels;<br /><br>Complications, including revision surgery and mortality<br />