MedTrace Logo

A Migration and Bone Density Study Comparing 2 Types of Bone Cement in the OptiPac Bone Cement Mixing System

NCT00678236 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2013-08-20

No results posted yet for this study

Summary

The goal of this scientific study is to determine whether there are differences in early migration and prosthesis-near bone density when a standard knee prosthesis is fixed with Refobacin Bone Cement R or with Refobacin Plus Bone Cement. Migration will be evaluated with RSA and bone density around the prosthesis with DEXA. The study will be successful if the prosthesis is fixed and remains in place throughout the entire period of the study, that is, that there is no increasing migration as measured by RSA. The cement type that ensures the largest number of solidly fixed prostheses during the two-year evaluation period will be "the best".

Conditions

Interventions

OTHER

Refobacin Bone Cement R

Insertion of a knee prosthesis fixed by Refobacin Bone Cement R

OTHER

Refobacin Plus Bone Cement

Insertion of a knee prosthesis fixed by Refobacin Plus Bone Cement

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Zimmer Biomet

    collaborator INDUSTRY

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Kjeld Soballe, MD, Prof. · Orthopaedic Center, Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Århus C, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00678236 on ClinicalTrials.gov