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In-house Produced PMMA- Versus PEEK-cages

NCT01607775 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2012-06-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Universitätsmedizin Mannheim

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2012-02-29
Completion
2012-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01607775 on ClinicalTrials.gov