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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):
Martin Barth, MD, Universitätsmedizin Mannheim

May 22, 2012
May 30, 2012
June 5, 2012
February 2009
February 2012   (Final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01607775 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
In-house Produced PMMA- Versus PEEK-cages
Clinical Characterization of In-house Produced PMMA-cages in Patients With Cervical Pathology
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Cervical Disc Degeneration
  • Cervical Stenosis
  • 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
  • Active Comparator: PEEK-cage
    Patients will receive a PEEK-cage
    Intervention: Device: Implantation of a PEEK-cage
  • Experimental: PMMA-cage
    Intervention: Device: PMMA-cage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
Same as current
February 2012
February 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01607775
2007-256M-MA
No
Not Provided
Not Provided
Martin Barth, MD, Universitätsmedizin Mannheim
Universitätsmedizin Mannheim
Not Provided
Not Provided
Universitätsmedizin Mannheim
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP