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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON21529

Enrollment

220

Registered

2014-07-30

Start date

2015-05-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative cervical spine disease in male and female patients aged 18 to 80 years

Interventions

Posterior (cranio)cervical fixations stratified into the following five groups: 1. C0 to C2/3

2. C0 to C4/5/6

3. C0 to T2/3

4. Cervical fixation > 2 levels

5. Cervicothoracic fixation

Eligibility

Inclusion criteria

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; 3. Radiological findings in accordance with clinical signs and symptoms; 4. Patient is able and willing to comply with the follow-up schedule and protocol; 5. Patient is able to provide informed written consent

Exclusion criteria

Exclusion criteria: 1. Additional anterior fixation required; 2. Cervical spine surgery in the last 6 months; 3. Other cervical spine disease, e.g. trauma, tumor

Design outcomes

Primary

Measure	Time frame
Clinical outcome: Neck Disability Index (NDI)	—

Secondary

Measure	Time frame
Neurologic status: Japanese Orthopaedic Association (JOA) score; Surgical outcome: Likert scale; Pain: Visual Analogue Scale (VAS) for arm and neck pain; Quality of life: 36-item Short Form health survey (SF-36), European Quality of life-5 Dimensions (EQ-5D); Mental health: Hospital Anxiety and Depression Scale (HADS); Radiologic data: cervical spine alignment, segmental range of motion (ROM) at the operative levels; Complications, including revision surgery and mortality	—

Measure

Time frame

Neurologic status: Japanese Orthopaedic Association (JOA) score; Surgical outcome: Likert scale; Pain: Visual Analogue Scale (VAS) for arm and neck pain; Quality of life: 36-item Short Form health survey (SF-36), European Quality of life-5 Dimensions (EQ-5D); Mental health: Hospital Anxiety and Depression Scale (HADS); Radiologic data: cervical spine alignment, segmental range of motion (ROM) at the operative levels; Complications, including revision surgery and mortality

—

Contacts

Public ContactC.N. Lie Tjauw

Department of Neurosurgery Leiden University Medical Center PO Box 9600

c.n.lie_tjauw@lumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)