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

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ClinicalTrials.gov Identifier: NCT01607775
Recruitment Status : Completed
First Posted : May 30, 2012
Last Update Posted : June 5, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Cervical Disc Degeneration Cervical Stenosis Device: Implantation of a PEEK-cage Device: PMMA-cage Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Characterization of In-house Produced PMMA-cages in Patients With Cervical Pathology
Study Start Date : February 2009
Primary Completion Date : February 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: PEEK-cage
Patients will receive a PEEK-cage
Device: Implantation of a PEEK-cage
A commercially avaliable cuboid cervical cage will be implantet
Experimental: PMMA-cage Device: PMMA-cage
The in-house produced cervical cage will be implanted


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. Clinical outcome (VAS-neck), Subsidence [ Time Frame: 12 months postoperative ]
    1. 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).
    2. 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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
More Information

Responsible Party: Martin Barth, MD, M. D., Vice-chairman, University Hospital Mannheim
ClinicalTrials.gov Identifier: NCT01607775     History of Changes
Other Study ID Numbers: 2007-256M-MA
First Posted: May 30, 2012    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases