No registrations found.
ID
Source
Brief title
Health condition
Degenerative cervical spine disease in male and female patients aged 18 to 80 years
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical outcome: Neck Disability Index (NDI)
Secondary outcome
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
Background summary
All patients aged between 18 and 80 years with degenerative cervical spine disease requiring posterior (cranio)cervical fixation, with or without decompression, will be asked to participate in this study. Those who meet the inclusion criteria and have given written informed consent will be included in the study. The aim of this study is to prospectively observe and assess the clinical outcome of posterior (cranio)cervical fixations in patients with degenerative cervical spine disease, differentiated for the extent of the procedure.
Study objective
Degenerative disease of the cervical spine is the most common indication for (cranio)cervical fixation, as it is the most common cause of myelopathy and radiculopathy, causing progressive functional disability and impairment. However, consensus has yet to be reached on the extent of the procedure. The extent is, in part, based on the clinical outcome and complications of the procedure. The aim of this study is to prospectively observe and assess the clinical outcome of posterior (cranio)cervical fixations in patients with degenerative cervical spine disease, differentiated for the extent of the procedure
Study design
Follow-up visits are scheduled to be 3 months, 6 months, 1-2- 5 years.
Intervention
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
Leiden University Medical Center <br>
PO Box 9600
C.N. Lie Tjauw
Leiden 2300 RC
The Netherlands
NA
c.n.lie_tjauw@lumc.nl
Leiden University Medical Center <br>
PO Box 9600
C.N. Lie Tjauw
Leiden 2300 RC
The Netherlands
NA
c.n.lie_tjauw@lumc.nl
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
1. Additional anterior fixation required;
2. Cervical spine surgery in the last 6 months;
3. Other cervical spine disease, e.g. trauma, tumor
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4349 |
| NTR-old | NTR4705 |
| CCMO | NL50062.058.14 |
| OMON | NL-OMON41054 |