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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Martin Barth, MD, University Hospital Mannheim
ClinicalTrials.gov Identifier:
NCT01607775
First received: May 22, 2012
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Cervical Disc Degeneration
Cervical Stenosis
Device: Implantation of a PEEK-cage
Device: PMMA-cage
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Characterization of In-house Produced PMMA-cages in Patients With Cervical Pathology

Further study details as provided by Universitätsmedizin Mannheim:

Primary Outcome Measures:
  • Clinical outcome (NDI) [ Time Frame: 12 months postoperative ] [ Designated as safety issue: Yes ]
    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:
  • Clinical outcome (VAS-neck), Subsidence [ Time Frame: 12 months postoperative ] [ Designated as safety issue: No ]
    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).


Enrollment: 88
Study Start Date: February 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: May 22, 2012
Last Updated: June 4, 2012
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on September 30, 2014