In-house Produced PMMA- Versus PEEK-cages (Palcage)

Universitätsmedizin Mannheim

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cervical Disc Degeneration; Cervical Stenosis

Treatments: Device: PMMA-cage; Device: Implantation of a PEEK-cage

Study type: Interventional

Funder types: Other

Identifiers

NCT01607775

2007-256M-MA

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• prior cervical surgery
• indications other than ACDF
• concomitant neoplastic, metabolic, severe general or infectious disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

PEEK-cage

Active Comparator group

Description:

Patients will receive a PEEK-cage

Treatment:

Device: Implantation of a PEEK-cage

PMMA-cage

Experimental group

Treatment:

Device: PMMA-cage