Knee Arthroplasty
Conditions
Keywords
Osteoarthritis, Joint Disease, Arthritis, Musculoskeletal Disease
Brief summary
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.
Interventions
PROCEDURENon-MAKO® Robot Assisted Total Knee Arthroplasty
Patients undergoing a non-MAKO® robot assisted surgery to replace one or more compartments of the knee.
Patients undergoing a MAKO® robot assisted surgery to replace the medial compartment of the knee.
PROCEDUREMAKO® Robot Assisted Medial and PF Knee Arthroplasty
Patients undergoing a MAKO® robot assisted surgery to replace the medial and patellofemoral (PF) compartments of the knee
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.
The Depuy Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.
The Stryker® Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.
Sponsors
Stryker MAKO Surgical Corp
Northwest Surgical Specialists, Vancouver
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survivorship of Components | 10 years | Survivorship of components is defined as knee implant device(s) remaining in patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Knee Society Knee Score | 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reduced WOMAC | 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 | 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. |
| Knee injury and Osteoarthritis Outcome Score | 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 | 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. |
| EQ-5D | 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 | The EQ-5D is a standardized instrument for use as a measure of health outcome. |
| Forgotten Joint Score | 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 | 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. |
Countries
United States
Outcome results
None listed