In-house Produced PMMA- Versus PEEK-cages

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-02-29

Brief Summary

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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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Detailed Description

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Conditions

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Cervical Disc Degeneration Cervical Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PEEK-cage

Patients will receive a PEEK-cage

Group Type ACTIVE_COMPARATOR

Implantation of a PEEK-cage

Intervention Type DEVICE

A commercially avaliable cuboid cervical cage will be implantet

PMMA-cage

Group Type EXPERIMENTAL

PMMA-cage

Intervention Type DEVICE

The in-house produced cervical cage will be implanted

Interventions

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Implantation of a PEEK-cage

A commercially avaliable cuboid cervical cage will be implantet

Intervention Type DEVICE

PMMA-cage

The in-house produced cervical cage will be implanted

Intervention Type DEVICE

Eligibility Criteria

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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