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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEEK-cage | Active Comparator | Patients will receive a PEEK-cage |
|
| PMMA-cage | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of a PEEK-cage | Device | A commercially avaliable cuboid cervical cage will be implantet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome (NDI) | 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). | 12 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome (VAS-neck), Subsidence |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 20, 2014 | |
| Reset | Jun 19, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 20, 2014 | Jun 19, 2014 |
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| PMMA-cage | Device | The in-house produced cervical cage will be implanted |
|
| 12 months postoperative |