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Completed

NCT Number: NCT01607775

In-house Produced PMMA- Versus PEEK-cages

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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Key information

Conditions

Cervical Disc Degeneration Cervical Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantation of a PEEK-cage

Device

A commercially avaliable cuboid cervical cage will be implantet

PMMA-cage

Device

The in-house produced cervical cage will be implanted

Primary outcomes

  1. 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 outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Universitätsmedizin Mannheim

Other

Registry information

Official study title

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

Acronym: Palcage

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 30, 2012
Registry last updated
Jun 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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