Does size matter? Clinical outcome related to the extent of posterior (cranio)cervical fixations. A prospective international multicenter study.

Recruiting

• Conditions: degenerative disease of the vertebrae; neck pain; 10028377; 10041543; 10009720

• Registration Number: NL-OMON41054
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Male and female patients aged 18 * 80 years planned for posterior (cranio)cervical fixation
Clinical signs and symptoms, i.e. myelopathy or radiculopathy, due to degenerative cervical spine disease
Radiological diagnosis at spinal level in accordance with clinical signs and symptoms
Patient is able and willing to comply with the follow-up schedule and protocol

Exclusion Criteria

Additional anterior surgery required
Cervical spine surgery in the last 6 months
Other cervical spinal disease, e.g. trauma, tumour

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primairy study parameter will be the Neck Disability Index.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary clinical outcome parameters are:<br /><br>- Patient perceived outcome: Likert scale<br /><br>- Pain: VAS for neck pain an VAS for arm pain<br /><br>- Quality of life: SF-36 and EQ-5D<br /><br>- Mental Health: HADS<br /><br>- Neurological status: JOA scale</p><br>