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…
ID
Bron
Verkorte titel
Aandoening
Degenerative cervical spine disease in male and female patients aged 18 to 80 years
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Clinical outcome: Neck Disability Index (NDI)
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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
Onderzoeksopzet
Follow-up visits are scheduled to be 3 months, 6 months, 1-2- 5 years.
Onderzoeksproduct en/of interventie
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
Algemeen / deelnemers
Leiden University Medical Center <br>
PO Box 9600
C.N. Lie Tjauw
Leiden 2300 RC
The Netherlands
NA
c.n.lie_tjauw@lumc.nl
Wetenschappers
Leiden University Medical Center <br>
PO Box 9600
C.N. Lie Tjauw
Leiden 2300 RC
The Netherlands
NA
c.n.lie_tjauw@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Additional anterior fixation required;
2. Cervical spine surgery in the last 6 months;
3. Other cervical spine disease, e.g. trauma, tumor
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4349 |
| NTR-old | NTR4705 |
| CCMO | NL50062.058.14 |
| OMON | NL-OMON41054 |