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

Primary Purpose

Cervical Disc Degeneration, Cervical Stenosis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Implantation of a PEEK-cage
PMMA-cage
Sponsored by
Universitätsmedizin Mannheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Disc Degeneration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    PEEK-cage

    PMMA-cage

    Arm Description

    Patients will receive a PEEK-cage

    Outcomes

    Primary Outcome Measures

    Clinical outcome (NDI)
    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
    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).

    Full Information

    First Posted
    May 22, 2012
    Last Updated
    June 4, 2012
    Sponsor
    Universitätsmedizin Mannheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01607775
    Brief Title
    In-house Produced PMMA- Versus PEEK-cages
    Acronym
    Palcage
    Official Title
    Clinical Characterization of In-house Produced PMMA-cages in Patients With Cervical Pathology
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2009 (undefined)
    Primary Completion Date
    February 2012 (Actual)
    Study Completion Date
    February 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitätsmedizin Mannheim

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Disc Degeneration, Cervical Stenosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    88 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PEEK-cage
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive a PEEK-cage
    Arm Title
    PMMA-cage
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Implantation of a PEEK-cage
    Intervention Description
    A commercially avaliable cuboid cervical cage will be implantet
    Intervention Type
    Device
    Intervention Name(s)
    PMMA-cage
    Intervention Description
    The in-house produced cervical cage will be implanted
    Primary Outcome Measure Information:
    Title
    Clinical outcome (NDI)
    Description
    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).
    Time Frame
    12 months postoperative
    Secondary Outcome Measure Information:
    Title
    Clinical outcome (VAS-neck), Subsidence
    Description
    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).
    Time Frame
    12 months postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

    In-house Produced PMMA- Versus PEEK-cages

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