Status:
COMPLETED
A Roentgen Stereophotogrammetric Analysis on Migration of Knee Prostheses.
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aarhus University Hospital
Zimmer Biomet
Conditions:
Osteoarthritis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The purpose of this study is to compare the early migration of two uncemented total knee arthroplasties with different metal coating. Only the tibial prosthesis plateau varies. One is made out of tant...
Detailed Description
Around 4% of total knee arthroplasties (TKA) are revised 15 years after the primary operation, most due to loosening of the implant. The use of uncemented prostheses are expected to extend the fixatio...
Eligibility Criteria
Inclusion
- Patients with one- or double-sided primary knee arthrosis.
- Patients with a sufficient bone quality for implantation of an uncemented prosthesis.
- Informed and written patient consent.
Exclusion
- Patients with neuromuscular or vascular diseases in the affected leg.
- Patients who peroperatively are estimated unsuitable for an uncemented 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 osteoporosis.
- Patients with fracture sequelae.
- Women, who are pregnant or are at risk of getting pregnant.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00138853
Start Date
November 1 2003
End Date
April 1 2010
Last Update
December 19 2022
Active Locations (1)
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1
Orthopaedic Center, Aarhus University Hospital.
Aarhus, Denmark, 8200