A Comparison of Fixation Method in Total Knee Arthroplasty - Low Viscosity Versus High Viscosity Bone Cement

December 14, 2022 updated by: University of Aarhus

A Comparison of Fixation Method in Total Knee Arthroplasty - Low Viscosity Versus High Viscosity Bone Cement. A Prospective Randomized Migration- and Bone Density Study on Primary Cemented Knee Implants.

The purpose of this study is to compare the early migration and periprosthetic bone changes of two total knee arthroplasties fixated with two different type bone cement.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Around 4% of total knee arthroplasties (TKA) are revised 15 years after the primary operation, most due to loosening of the implant. About 70 % TKA are fixed with bone cement and in general the results after total knee arthroplasty are excellent and with the existing technique about 95% well functioning prostheses can be expected 10 years post surgery. The most serious late complication to surgery is aseptic loosening of the implants; and this remains one of the main courses of failure of both uncemented and cemented total knee implants.

Implant design, method of fixation, the quality of bone cement, surgerytechnique and the bone mass density are some of the factors that have a large influence on implant stability. Fixation of the tibia baseplates in total knee arthroplasty can be obtained by different type bone cement.

In this project we are using a modular tibia component with a central wedge-shaped stem. Upon randomization at surgery the implant is consolidated in the bone with either low-viscosity or high-viscosity bone cement.

The purpose of this study is to compare the early migration of a total knee implant fixated with two different bone cements using RSA (radio stereophotogrammetric analysis) for evaluation. Furthermore, we will make research into the periprosthetic bone and its changes post surgery using DEXA. Finally, the extend of the expected micromovements between the polyethylen liner and the metal backing of the titanium plateau will be compared and taken into account with the results.

Several factors can influence the long-term survival of cemented TKA. Bone-sclerosing at the tibia condyles may induce a problem with cement penetration into the cancellous bone. Furthermore, blood-contamination in the cancellous bone may reduce the shear-strength at the bone-cement site by 50%. A solid cement-implant interface limits the amount of debris in the interface bringing down the risk of radiolucent lines and osteolysis. The tibial implant used in this study is designed with a rim under the plateau to support the cement layer on the tibial condyles at the time of fixation. The implant has a stem making it more resistant to shearing forces. In this study we primarily consider the bone cement viscosity on the outcome. Both types are used in hip-arthroplasties with good results.

To evaluate both the implant-bone micromotions and the polyethylen-implant micromovements metal markers have been placed on the tibial implants pre-operatively. They will also be inserted into the tibial bone and into the tibial polyethylen intra-operatively allowing us to evaluate stereo x-rays by a photogrammetric computer analyses called RSA at the Orthopaedic Center, Aarhus University Hospital. Follow-up stereo x-rays will be scheduled for 1 week, 3 months, 6 month, 1 years and 2 years post-surgery. Periprostetic bone density will be evaluated at 1 week, 1 year and 2 years upon inclusion at the Orthopaedic Center, Aarhus University Hospital.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Orthopaedic Center, Aarhus University Hospital

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

66 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with one- or double-sided primary knee arthrosis.
  • Patients with a sufficient bone quality for implantation of knee prosthesis.
  • Informed and written patient consent.

Exclusion Criteria:

  • Patients with neuromuscular or vascular diseases in the affected leg.
  • Patients who peroperatively are estimated unsuitable for knee arthroplasty e.g. due to bone cysts or dilution of the bone mass.
  • Patients who use non-steroid anti-inflammatory drugs (NSAID) and cannot refrain from taking them postoperatively (this includes COX-2-inhibitors).
  • Patients with osteoporosis estimated from the preoperative x-ray or former diagnosis of osteoporo-sis.
  • Patients with knee arthrosis following fracture sequelae.
  • Women, who are pregnant or are at risk of getting pregnant throughout the 2 year follow-up.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Osteopal G bone cement
Device: Osteopal G vs. Refobacin-Palacos R bone cement
Bone cement
Other Names:
  • Osteopal G bone cement
  • refobacin-palacos R bone cement
Active Comparator: Refobacin-Palacos R bone cement
Device: Osteopal G vs. Refobacin-Palacos R bone cement
Bone cement
Other Names:
  • Osteopal G bone cement
  • refobacin-palacos R bone cement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tibial prosthesis part migration evaluated by RSA.
Time Frame: 2011
2011

Secondary Outcome Measures

Outcome Measure
Time Frame
Micromotion of the modular polyethylen liner in both type prostheses evaluated by RSA estimating the role of wear.
Time Frame: 2011
2011

Collaborators and Investigators

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

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital
Zimmer Biomet

Investigators

  • Principal Investigator: Kjeld Søballe, MD, Prof., Orthopaedic Center, Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Aarhus C, Denmark.

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 Completion

December 1, 2010

Study Registration Dates

First Submitted

September 10, 2005

First Submitted That Met QC Criteria

September 10, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

December 19, 2022

Last Update Submitted That Met QC Criteria

December 14, 2022

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20030249

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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