Study Stopped
Changes in funding.
Clinical Outcomes of Knee Replacement
Clinical Outcomes of Joint Arthroplasty
2 other identifiers
observational
316
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 9, 2012
CompletedFirst Posted
Study publicly available on registry
October 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2018
CompletedSeptember 26, 2018
September 1, 2018
6 years
October 9, 2012
September 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survivorship of Components
Survivorship of components is defined as knee implant device(s) remaining in patient.
10 years
Secondary Outcomes (1)
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
Other Outcomes (4)
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
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
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
- +1 more other outcomes
Study Arms (1)
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 .
Interventions
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.
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.
Eligibility Criteria
All male and non-pregnant females undergoing knee replacement
You may qualify if:
- 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
You may not qualify if:
- cognitively unable to complete study health-related quality of life forms
- pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rebound Orthopedics and Neurosurgery
Vancouver, Washington, 98686, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Todd Borus, MD
Northwest Surgical Specialists / Rebound Orthopedics and Neurosurgery
- PRINCIPAL INVESTIGATOR
Donald Roberts, MD
Northwest Surgical Specialists / Rebound Orthopedics and Neurosurgery
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2012
First Posted
October 12, 2012
Study Start
October 1, 2012
Primary Completion
September 19, 2018
Study Completion
September 19, 2018
Last Updated
September 26, 2018
Record last verified: 2018-09