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| ID | Type | Description | Link |
|---|---|---|---|
| Borus 2015-005 | Other Identifier | Stryker |
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Changes in funding.
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| Name | Class |
|---|---|
| Stryker MAKO Surgical Corp | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Knee Arthroplasty | 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 . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-MAKO® Robot Assisted Total Knee Arthroplasty | Procedure | Patients undergoing a non-MAKO® robot assisted surgery to replace one or more compartments of the knee. |
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| Measure | Description | Time Frame |
|---|---|---|
| Survivorship of Components | Survivorship of components is defined as knee implant device(s) remaining in patient. | 10 years |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduced WOMAC | The Reduced WOMAC is a truncated version of the Western Ontario and McMaster's University Osteoarthritis Index. The questionnaire is designed to assess pain, disability and joint stiffness in the osteoarthritis patient. | 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 |
Inclusion Criteria:
Exclusion Criteria:
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All male and non-pregnant females undergoing knee replacement
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| Name | Affiliation | Role |
|---|---|---|
| Todd Borus, MD | Northwest Surgical Specialists / Rebound Orthopedics and Neurosurgery | Principal Investigator |
| Donald Roberts, MD | Northwest Surgical Specialists / Rebound Orthopedics and Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rebound Orthopedics and Neurosurgery | Vancouver | Washington | 98686 | United States |
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| MAKO® Robot Assisted Medial Knee Arthroplasty | Procedure | Patients undergoing a MAKO® robot assisted surgery to replace the medial compartment of the knee. |
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| MAKO® Robot Assisted Medial and PF Knee Arthroplasty | Procedure | Patients undergoing a MAKO® robot assisted surgery to replace the medial and patellofemoral (PF) compartments of the knee |
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| RESTORIS Multicompartmental Knee System | Device | 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. |
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| Depuy Knee Replacement System | Device | The Depuy Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement. |
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| Stryker® Knee Replacement System | Device | The Stryker® Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement. |
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| Knee injury and Osteoarthritis Outcome Score | The KOOS or Knee injury and Osteoarthritis Outcome Score are patient completed questionnaires which assess the patient's opinion regarding their knee and its associated osteoarthritis. | 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 |
| EQ-5D | The EQ-5D is a standardized instrument for use as a measure of health outcome. | 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 |
| Forgotten Joint Score | The Forgotten Joint Score is a 12-item questionnaire completed by the patient to determine how aware they are of their joint in their everyday life. | 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 |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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