Total Knee Replacement With the Attune vs. the Press Fit Condylar (PFC) Sigma.

Study Overview
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Brief Summary
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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.

Detailed Description
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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-trackprinciples will be applied in both Groups. Patients will be followed for five years.

Official Title
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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)

Conditions
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Osteoarthrosis, Knee

Intervention / Treatment
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* Procedure: Total Knee Replacement (2 different design)


Participation Criteria
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Eligibility Criteria
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Patients with degenerative joint disease of the knee on our waiting list for a total knee replacement will be asked to participate in this study Inclusion Criteria: Medial or lateral primary osteoarthritis (OA) Ahlbäck Grade 2-4 Varus or valgus deformity ≤15 degrees, extension defect ≤15 degrees BMI <35 ASA 1-3. Coming from independent living in own home Written informed consent Exclusion Criteria: Cortisone treatment during the last 6 months before operation Neurological diseases with symptoms, stroke with sequel Endocrine diseases with symptoms OA secondary to trauma, infection, inflammatory disease or congenital and acquired deformities BMI >=35 OA of the hip with symptoms. (Patients operated with total hip arthroplasty are accepted) Ongoing infection Unable or unwilling to participate in the follow-up.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with degenerative knee disease randomely receive one of two types of total knee prostheses
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Total Knee Replacement (2 different design)|Patients will randomely receive either Attune or PFC Sigma TKR|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Knee Score (OKS) | The Oxford Knee Score (OKS) is a 12-item patient-reported outcome measure (PROM) specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is short, reproducible, valid and sensitive to clinically important changes. | Preoperatively to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction is reported on a visual analogue scale (VAS) 1-10 | Patient satisfaction is reported on a visual analogue scale (VAS) 1-10 | Preoperatively to 2 years | 
| Knee Kinematics, (anterior-posterior translations and axial rotations) | Dynamic radiostereometric analysis with detailed recordings of the threedimensional motions of the knee during a step-up | 2 years | 
| Pain (VAS) | Patient pain reported on Visual Analogue Scales(VAS) 1-10 | Preoperatively to 2 years |