Clinical Outcomes of Knee Replacement

Study Overview
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Brief Summary
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The objective of this study is to document the demographic and clinical characteristics and the long-term clinical outcomes of patients who require a robot assisted knee arthroplasty. The hypothesis is that MAKO® robot assisted surgery replacing one or two compartments of the knee joint has 10 year implant survival and clinical outcomes that are equivalent to other knee replacement systems.

Official Title
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Clinical Outcomes of Joint Arthroplasty

Conditions
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Knee Arthroplasty

Intervention / Treatment
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* Procedure: Non-MAKO® Robot Assisted Total Knee Arthroplasty
* Procedure: MAKO® Robot Assisted Medial Knee Arthroplasty
* Procedure: MAKO® Robot Assisted Medial and PF Knee Arthroplasty
* Device: RESTORIS Multicompartmental Knee System
* Device: Depuy Knee Replacement System
* Device: Stryker® Knee Replacement System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: requires either primary or revision knee replacement surgery because of pain and joint stiffness that interferes with performance of normal daily activities has failed non-operative management of their joint disease Exclusion Criteria: cognitively unable to complete study health-related quality of life forms pregnant women

Ages Eligible for Study
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Minimum Age: 21 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Knee Arthroplasty<br>Patients undergoing total knee arthroplasty. This may be Non-MAKO® Robot Assisted Total Knee Arthroplasty or MAKO® Robot Assisted Medial Knee Arthroplasty or MAKO® Robot Assisted Medial and PF Knee Arthroplasty The Non-MAKO® Robot Assisted Total Knee Arthroplasty uses the Depuy Knee Replacement System or the Stryker® Knee Replacement System. The MAKO® Robot Assisted Arthroplasty uses the RESTORIS Multicompartmental Knee System . | Procedure: Non-MAKO® Robot Assisted Total Knee Arthroplasty<br>* Patients undergoing a non-MAKO® robot assisted surgery to replace one or more compartments of the knee.<br>* Other names: Revision Knee Arthroplasty;Procedure: MAKO® Robot Assisted Medial Knee Arthroplasty<br>* Patients undergoing a MAKO® robot assisted surgery to replace the medial compartment of the knee.<br>* Other names: Unicompartmental Knee Arthroplasty (UKA);Procedure: MAKO® Robot Assisted Medial and PF Knee Arthroplasty<br>* Patients undergoing a MAKO® robot assisted surgery to replace the medial and patellofemoral (PF) compartments of the knee<br>* Other names: Bi-compartmental Knee Arthroplasty;Device: RESTORIS Multicompartmental Knee System<br>* The RESTORIS Multicompartmental Knee (MCK) System components are intended for single or multicompartmental knee replacement used in conjunction with the MAKO® Robotic Arm Interactive Orthopedic System (RIO®). The components can be used for medial compartment, lateral compartment, patellofemoral compartment, or bicompartmental (medial and patellofemoral compartments) knee replacement. The device is intended to be used with bone cement.<br>* Other names: FDA 501K number K090763;Device: Depuy Knee Replacement System<br>* The Depuy Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.<br>Device: Stryker® Knee Replacement System<br>* The Stryker® Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship of Components | Survivorship of components is defined as knee implant device(s) remaining in patient. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Knee Society Knee Score | The American Knee Society Score is an assessment and questionnaire that provides a rating of the pain, function, range of motion, and knee joint stability. It is subdivided into a knee score that rates only the knee joint itself and a functional score that rates the patient's ability to walk and climb stairs. | 1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year, 2 years, 5 years, and 10 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Joint Disease, Arthritis, Musculoskeletal Disease