Functional Results With Attune Fixed Bearing Posterior Stabilized Knee Arthroplasty (A-16)

Study Overview
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Brief Summary
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Functional results with Attune Fixed Bearing Posterior Stabilized total knee arthroplasty evaluated with KOOS. A prospective longitudinal cohort study with repetitive measurements 6 weeks, 3, 6, 12 and 24 months postoperative.

Detailed Description
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Total knee arthroplasty is a well documented and efficient treatment method for degenerative knee arthritis. Nevertheless it is reported that 15-20% of patients are not satisfied with the result. Some of the complaints are anterior knee pain, mid flexion instability and range of motion. Attune Fixed Bearing Posterior Stabilized knee have been developed to address the common complaints after knee arthroplasty surgery . The investigators like to use the Attune Fixed Bearing Posterior Stabilized knee with patella resurfacing on 65 of Our departments eligible patients to evaluate the functional results. Our primary outcome measure is change in Knee Osteoarthritis Outcome Score.

Official Title
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Functional Results With Attune Fixed Bearing Posterior Stabilized Knee Arthroplasty

Conditions
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Knee Arthroplasty

Intervention / Treatment
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* Device: Attune FB PS knee arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 50-80 years eligible for total knee arthroplasty at our hospital Exclusion Criteria: Patients unable to cooperate Larger deformity that not suitable for a Posterior Stabilized total knee prostheses. Revision operation Diagnosed with inflammatory arthritis Previously septic arthritis in the current knee joint Local malignancy/general bone metastases Serious Medical conditions that inflict on the walking ability Active infections, latent infections og increased risk og infection Previously arthrodeses or not well functioned arthroplasties in hips, knees or ankles. Neurologic illness with symptoms from the current limb

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Attune FB PS<br>Attune FB PS knee arthroplasty | Device: Attune FB PS knee arthroplasty<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee injury and Osteoarthritis Outcome Score - (KOOS) | Knee injury and Osteoarthritis Outcome Score | 2 years postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forgotten Joint Score (FJS-12) | Forgotten Joint Score -12. Translated Norwegian version | 2 years postoperative | 
| Quality of Life (EQ-5D) | Quality of life questionnaire | 2 years postoperative | 
| University of California Los Angeles-Activity score | Record change in Activity level | 2 years postoperative | 
| Range of Movement (ROM) | Range of movement pre- and postoperative | 2 years postoperative | 
| Stair climbing test functional test | Time spend on walking up and down 9 stairs | 2 years postoperative | 
| 30 seconds stand up functional test | Number of stand ups from a chair in 30 seconds | 2 years postoperative | 
| 40 meters walking functional test | Time spend on walking 40 meters | 2 years postoperative | 
| Visual Analogue Scale Satisfaction (VAS-satisfaction) | Scale for assesment of the satisfaction with the arthroplasty | 2 years postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attune