Fixed Bearing Versus Mobile Bearing Patient Satisfaction and Clinical Outcome Study

Study Overview
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Brief Summary
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The purpose of this study is to determine if there is a patient satisfaction preference of Fixed Bearing versus Mobile Bearing Unicompartmental Knee Arthroplasty (UKA) in patients who are at a minimum two years post operative. Patient reported outcomes and expectations will be analyzed along with all retrospective chart data in patient with a Fixed Bearing or a Mobile Bearing UKA in one or both knees.

Official Title
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A Retrospective, Consecutive Series, Single Surgeon Study Comparing Patient Satisfaction and Clinical Outcomes in Patients With Fixed Bearing Versus Mobile Bearing Unicompartmental Knee Arthroplasty

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Fixed Bearing or Mobile Bearing UKA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF) Ability to understand and provide written authorization for use and disclosure of personal health information. Subject who are able and willing to comply with the study protocol and follow-up visit. Must be 18 years or older to participate. Subjects must have a clinically documented Osteoarthritis in a knee, single or multiple compartments, Subjects must have undergone a FB UKA or MB UKA in one and or both knees. MB UKA or FB UKA patients revised to Total Knee Arthroplasty (TKA) are eligible to enroll. Must be a minimum 2 year (24 months) post-surgery on the knee. The UKA operation must have been performed by the Investigator. Subjects must be able to return for the follow-up appointment, and have the mental capacity to cooperate with PRO's, questionnaires, physical exam and imaging studies. Exclusion Criteria: Subjects with Bicompartmental UKA (i.e. medical or lateral UKA combined with Patello Femoral Joint (PFJ) (UKA) Women who are pregnant.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fixed Bearing or Mobile Bearing UKA<br> | Device: Fixed Bearing or Mobile Bearing UKA<br>* Fixed Bearing or Mobile Bearing UKA Patients who have undergone a primary Fixed Bearing or a Mobile Bearing UKA in either knee and are at a minimum 2 years post-op.<br>* Other names: Zimmer Unicompartmental High Flex Knee System or Oxford Mobile Bearing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare patient satisfaction scores of the Unicompartmental Fixed Bearing (FB) UKA vs Unicompartmental Mobile Bearing (MB) UKA | Utilizing Knee Score Society survey sub-score | Minimum of two years post-surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Knee symptoms, pain, function and Qol | Minimum of two years post-surgery. | 
| Forgotten Joint Score (FJS) | Knee Function-patients ability to forget the artificial joint in everyday life | Minimum of two years post-surgery. | 
| Knee Society Score (KSS) subjective measures | patient expectation and satisfaction sub-scores | Minimum of two years post-surgery. | 
| Euro-Qual Health related Quality of Life | General Health Status | Minimum of two years post-surgery. | 
| Return to Work History | Questionnaire for work history prior to surgery and after surgery | Minimum of two years post-surgery. | 
| Radiographic Analysis | Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement. | Minimum of two years post-surgery. | 
| Knee Society Score (KSS) Objective Measures |  | Minimum of two years post-surgery. | 
| Demographics |  | Minimum of two years post-surgery. | 
| Complications | Complications will be recorded | Minimum of two years post-surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unicompartment Knee Replacement