Status:
WITHDRAWN
A Comparison of Fixation Method in Total Knee Arthroplasty - Low Viscosity Versus High Viscosity Bone Cement
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aarhus University Hospital
Zimmer Biomet
Conditions:
Osteoarthritis
Eligibility:
All Genders
70+ years
Phase:
NA
Brief Summary
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.
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 result...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00175162
End Date
December 1 2010
Last Update
December 19 2022
Active Locations (1)
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1
Orthopaedic Center, Aarhus University Hospital
Aarhus, Denmark, 8200