Evaluation of longterm clinical and radiological results.
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
- Spinal cord and nerve root disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is improvement in the Neck and Disability Index
(NDI) 5 years after surgery.
Secondary outcome
Secondary outcome measure is the longterm evaluation of bony fusion using
dynamic lateral flexion-extension radiographs that
will be quantitatively analysed. Other outcome measures include improvement in
arm pain and neck pain (VAS), EuroQol-5D and patients' perceived recovery 5
years after surgery.
Background summary
Based on the previous EFFECT trial, patients treated with 3D printed porous
titanium cages have similar fusion rates at 1 year after surgery compared to
PEEK although the fusion speed of titanium is faster. Since longterm results of
porous titanium is lacking, all patients who participated in the EFFECT trial
will be approached 5 years after surgery.
Study objective
Evaluation of longterm clinical and radiological results.
Study design
The EFFECT extension study is designed as a prospective consecutive cohort of
the original EFFECT trial with a total follow-up period of 5 years.
Study burden and risks
Patients will be controlled in the outpatient clinic once and have to fill out
several questionnaires in addition to one radiograph of the cervical spine.
Lijnbaan 32
Den Haag 2512 VA
NL
Lijnbaan 32
Den Haag 2512 VA
NL
Listed location countries
Age
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
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76079.058.20 |