NCT01607775

In-house Produced PMMA- Versus PEEK-cages

Clinical Characterization of In-house Produced PMMA-cages in Patients With Cervical Pathology

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Universitätsmedizin Mannheim · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Disc Degeneration
• Cervical Stenosis

Interventions

Type	Name	Description
DEVICE	Implantation of a PEEK-cage	A commercially avaliable cuboid cervical cage will be implantet
DEVICE	PMMA-cage	The in-house produced cervical cage will be implanted

Timeline

• Start date: 2009-02-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2012-05-30
• Last updated: 2012-06-05