Cervical Disc Degeneration, Cervical Stenosis
Conditions
Brief summary
Subsidence of cervical cages is a common problem. For the study, a new polyacrylmethacrylate cage was designed and prospectively implanted in patients with a mono- or bilevel cervical pathology. As control, a commercially available PEEK-cage was used, patients were randomized using minimization randomization, controlling for age and bone mineral densitiy. The investigators hypothesize that the newly developed cage has similar clinical and radiological qualities compared to the PEEK-cage, but at a much more favourable cost-performance ratio.
Interventions
DEVICEImplantation of a PEEK-cage
A commercially avaliable cuboid cervical cage will be implantet
DEVICEPMMA-cage
The in-house produced cervical cage will be implanted
Sponsors
Universitätsmedizin Mannheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* virgin spines * no emergency operation * age above 18 * sufficient knowledge of the German language * indication for anterior cervical discectomy and fusion * absence of concomitant spinal disease
Exclusion criteria
* prior cervical surgery * indications other than ACDF * concomitant neoplastic, metabolic, severe general or infectious disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome (NDI) | 12 months postoperative | NDI (Neck disability index) will be measured prior to surgery and 12 months after surgery. A difference of 20% between both groups is considered to be clinically significant, which is proposed for the experimental implant (PMMA-cage). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome (VAS-neck), Subsidence | 12 months postoperative | 1. VAS-neck will be measured prior to surgery and 12 months after surgery. A difference of 20% between both groups is considered to be clinically significant, which is proposed for the experimental implant (PMMA-cage). 2. Cage Subsidence will be measured using lateral radiographs prior to surgery and 12 months after surgery. Due to an improved cage design, significantly less subsidence is proposed for the experimental implant (PMMA-cage). |
Outcome results
None listed