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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00175162
• Date of registration: 10/09/2005
• Primary sponsor: University of Aarhus
• Public title: A Comparison of Fixation Method in Total Knee Arthroplasty - Low Viscosity Versus High Viscosity Bone Cement
• Scientific title: 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.
• Date of first enrolment: June 2007
• Target sample size: 50
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT00175162
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Countries of recruitment

Denmark

Contacts

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

Key inclusion & exclusion criteria

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.



Age minimum: 70 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Osteoarthritis

Intervention(s)

Device: Osteopal G vs. Refobacin-Palacos R bone cement

Primary Outcome(s)

Tibial prosthesis part migration evaluated by RSA. [Time Frame: 2011]

Secondary Outcome(s)

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

Secondary ID(s)

20030249

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Aarhus University Hospital

Biomet, Inc.