Interbody fusion in the treatment of cervicobrachial syndrome; a prospective 5-year follow up extension study of porous titanium cervical cages
Recruiting
- Conditions
- cervical herniated disc100283771004154310009720
- Registration Number
- NL-OMON50926
- Lead Sponsor
- neurochirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 49
Inclusion Criteria
• Subject must have completed participation in the EFFECT trial
• Ability and willingness to comply with study requirements
• Written informed consent given by the subject or the subject's legally
authorized representati
Exclusion Criteria
• Severe mental or psychiatric disorder
• Inadequate Dutch language
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure is improvement in the Neck and Disability Index<br /><br>(NDI) 5 years after surgery.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measure is the longterm evaluation of bony fusion using<br /><br>dynamic lateral flexion-extension radiographs that<br /><br>will be quantitatively analysed. Other outcome measures include improvement in<br /><br>arm pain and neck pain (VAS), EuroQol-5D and patients' perceived recovery 5<br /><br>years after surgery.</p><br>