To compare functional recovery of the patient and the fusion status of ceramic cages versus PEEK cages on the short and long term.
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
Neck Disability Index (NDI)
Secondary outcome
Neckpain, armpain, patient's perceived recovery, fusion, EuroQol, re-operations
and complications.
Background summary
Anterior discectomy with intercorporal fusion with PEEK cages is the golden
standard in the treatment of patients with cervicobrachialgia due to a
herniated disc and/or osteophyte. The hydrophobic characteristics of PEEK
however, result in bone growth around the cage with possible risk of
subsidence. The newly developed cancellous structured ceramic (CSC) cages have
hydrophylic properties which facilitate bone adherence and incorporation into
the cage. Moreover, ceramics have desirable imaging properties. A randomised
controlled trial on ceramic cages versus PEEK cages has never been performed.
Study objective
To compare functional recovery of the patient and the fusion status of ceramic
cages versus PEEK cages on the short and long term.
Study design
Prospective randomised controlled blinded trial with a follow-up of 2 years.
Intervention
Anterior discectomy with ceramic cages versus anterior discectomy with PEEK
cages.
Study burden and risks
Besides the known complications of an anterior cervical approach, there are
implant related risks like displacement, subsidence, or breakage. The
outpatient control will be more frequently than usual and patients are asked to
fill out several questionnaires.
West 2100 South 1885
Salt Lake City UT 84119
US
West 2100 South 1885
Salt Lake City UT 84119
US
Listed location countries
Age
Inclusion criteria
* Age between 18 - 75 years.
* Radicular signs and symptoms in one or both arms (i.e., pain, paraesthesiae or paresis in a specific nerve root distribution) or symptoms and signs of acute or chronic myelopathy.
* At least 8 weeks prior conservative treatment (i.e., physical therapy, pain medication).
* Radiographic diagnosis of cervical disc herniation and/or osteophyte at 1 level (C3-C4 to C7-T1) in accordance with clinical signs and symptoms.
* Written informed consent .
Exclusion criteria
* Previous cervical surgery (either anterior or posterior).
* Increased motion on dynamic studies (> 3 mm).
* Severe segmental kyphosis of the involved disc level (> 7 degrees).
* Patient cannot be imaged with MRI.
* Neck pain only (without radicular or medullary symptoms).
* Infection.
* Metabolic and bone diseases (osteoporosis, severe osteopenia).
* Neoplasma or trauma of the cervical spine.
* Spinal anomaly (Klippel Feil, Bechterew, OPLL).
* Severe mental or psychiatric disorder.
* Inadequate Dutch language.
* Planned (e)migration abroad in the year after inclusion.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL36103.098.11 |