Osteoarthrosis, Knee Clinical Trial
Official title:
Total Knee Replacement With the Attune vs. the Press Fit Condylar (PFC) Sigma. Randomised Study of 50 Attune and 50 PFC Sigma Total Knee Replacements (TKRs)
100 knees with primary osteoarthritis and scheduled for a total knee replacement (TKR) will be recruited from our waiting list. The patients will be randomized to become operated with the Attune or PFC total knee arthroplasty. Randomisation will be done using envelopes. Patients can only participate with one knee.
The Attune total knee replacement is a recently developed implant with the intention to
improve the outcome after this procedure. One of the primary aims is to improve the
kinematics of the knee in order to more closely mimic the normal knee. Thereby the patients
are expected to experience improved function, better stability and less pain during
activity. So far there are no randomized studies which have demonstrated this potential
superior performance when compared to its predecessor, the PFC Sigma TKR. This study aims to
evaluate the clinical outcome and the knee kinematics of the Attune knee using recognized
clinical outcome parameters and dynamic radiostereometry. The PFC sigma knee will be used as
control.
100 knees with primary osteoarthritis and scheduled for a total knee replacement (TKR) will
be recruited from our waiting list. The patients will be randomized to become operated with
the Attune or PFC total knee arthroplasty. Randomization will be done using envelopes.
Patients can only participate with one knee.
Surgical procedure: The operations will be done according to our routines without use of
bloodless field. Local analgesia will be infiltrated periarticulary during the operation.
Cemented fixation will be used in all cases. So-called "fast-track"principles will be
applied in both Groups.
Patients will be followed for five years.
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