In-house Produced PMMA- Versus PEEK-cages (Palcage)
|ClinicalTrials.gov Identifier: NCT01607775|
Recruitment Status : Completed
First Posted : May 30, 2012
Last Update Posted : June 5, 2012
Information provided by (Responsible Party):
Martin Barth, MD, Universitätsmedizin Mannheim
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Disc Degeneration Cervical Stenosis||Device: Implantation of a PEEK-cage Device: PMMA-cage||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Characterization of In-house Produced PMMA-cages in Patients With Cervical Pathology|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Active Comparator: PEEK-cage
Patients will receive a PEEK-cage
Device: Implantation of a PEEK-cage
A commercially avaliable cuboid cervical cage will be implantet
The in-house produced cervical cage will be implanted
Primary Outcome Measures :
- Clinical outcome (NDI) [ Time Frame: 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 Outcome Measures :
- Clinical outcome (VAS-neck), Subsidence [ Time Frame: 12 months postoperative ]
- 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).
- 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).
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