Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
316 participants
OBSERVATIONAL
2012-10-31
2018-09-19
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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 .
Non-MAKO® Robot Assisted Total Knee Arthroplasty
Patients undergoing a non-MAKO® robot assisted surgery to replace one or more compartments of the knee.
MAKO® Robot Assisted Medial Knee Arthroplasty
Patients undergoing a MAKO® robot assisted surgery to replace the medial compartment of the knee.
MAKO® 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
RESTORIS Multicompartmental Knee System
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.
Depuy Knee Replacement System
The Depuy Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.
Stryker® Knee Replacement System
The Stryker® Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.
Interventions
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Non-MAKO® Robot Assisted Total Knee Arthroplasty
Patients undergoing a non-MAKO® robot assisted surgery to replace one or more compartments of the knee.
MAKO® Robot Assisted Medial Knee Arthroplasty
Patients undergoing a MAKO® robot assisted surgery to replace the medial compartment of the knee.
MAKO® 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
RESTORIS Multicompartmental Knee System
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.
Depuy Knee Replacement System
The Depuy Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.
Stryker® Knee Replacement System
The Stryker® Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* has failed non-operative management of their joint disease
Exclusion Criteria
* pregnant women
21 Years
ALL
No
Sponsors
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Stryker MAKO Surgical Corp
UNKNOWN
Northwest Surgical Specialists, Vancouver
OTHER
Responsible Party
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Principal Investigators
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Todd Borus, MD
Role: PRINCIPAL_INVESTIGATOR
Northwest Surgical Specialists / Rebound Orthopedics and Neurosurgery
Donald Roberts, MD
Role: PRINCIPAL_INVESTIGATOR
Northwest Surgical Specialists / Rebound Orthopedics and Neurosurgery
Locations
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Rebound Orthopedics and Neurosurgery
Vancouver, Washington, United States
Countries
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Other Identifiers
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Borus 2015-005
Identifier Type: OTHER
Identifier Source: secondary_id
MAKO-01
Identifier Type: -
Identifier Source: org_study_id
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