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

June 4, 2012 updated by: Martin Barth, MD, Universitätsmedizin Mannheim

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsmedizin Mannheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

May 22, 2012

First Submitted That Met QC Criteria

May 24, 2012

First Posted (ESTIMATE)

May 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 5, 2012

Last Update Submitted That Met QC Criteria

June 4, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-256M-MA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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