Bilateral Total Knee Arthroplasty vs Unicompartment Arthroplasty Retrospective and Clinical Outcome Study

Study Overview
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Brief Summary
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To determine if there is a patient satisfaction preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA) in patients with bilateral knee osteoarthritis who underwent a primary TKA one side and a primary UKA on the opposite side and are at a minimum of two years post-surgery. Patient reported outcomes and data with be analyzed along with all retrospective chart data.

Official Title
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A Retrospective Consecutive Series Patient Preference and Clinical Outcomes Study in Bilateral Knee Osteoarthritis Patients With Both Total Knee Arthroplasty and Unicompartment Knee Arthroplasty Prostheses.

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Total and Unicompartment Knee Replacement


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 both knees, single or multiple compartments Subjects must have undergone a primary TKA and primary UKA in the contralateral knee Must be a minimum 2 year (24 months) post-surgery on each knee One or both TKA/UKA surgeries must have been performed by the Principal 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 radiographs Exclusion Criteria: Subjects who underwent UKA with Patella Femoral Joint (PFJ) replacement on the same side. 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 |
| --- | --- |
| Total and Unicompartment Knee Replacement<br> | Device: Total and Unicompartment Knee Replacement<br>* Patients who have undergone a primary TKA on one side and primary UKA on the opposite side and are at a minimum of two years post-surgery.<br>* Other names: TKA UKA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate patient preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA) | Asking patients which is your better knee overall | Minimum 2 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 2 years post-op | 
| Forgotten Joint Score (FJS) | Knee function-patient's ability to forget the artificial joint in everyday life | Minimum of 2 years post-op | 
| Knee Society Score (KSS) subjective measures | Patient Expectation and Satisfaction Sub-scores | Minimum of 2 years post-op | 
| Euro-Qual Health Related Quality of Life (EQ-5D) | General health status | Minimum of 2 years post-op | 
| Return to work history | Questionnaire for work history prior to surgery and after surgery | Minimum of 2 years post-op | 
| 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. | Pre-operative and minimum of 2 years post-op | 
| Knee Society Score (KSS) Objective measures |  | Minimum of 2 years post-op | 
| Demographics |  | Pre-operative and Minimum of 2 years post-op | 

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