Clinical Outcomes of Knee Replacement

NCT ID: NCT01705366

Last Updated: 2018-09-26

Study Results

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

316 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2018-09-19

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.

Detailed Description

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Conditions

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Knee Arthroplasty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type PROCEDURE

Patients undergoing a non-MAKO® robot assisted surgery to replace one or more compartments of the knee.

MAKO® Robot Assisted Medial Knee Arthroplasty

Intervention Type PROCEDURE

Patients undergoing a MAKO® robot assisted surgery to replace the medial compartment of the knee.

MAKO® Robot Assisted Medial and PF Knee Arthroplasty

Intervention Type PROCEDURE

Patients undergoing a MAKO® robot assisted surgery to replace the medial and patellofemoral (PF) compartments of the knee

RESTORIS Multicompartmental Knee System

Intervention Type 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.

Depuy Knee Replacement System

Intervention Type DEVICE

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

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

MAKO® Robot Assisted Medial Knee Arthroplasty

Patients undergoing a MAKO® robot assisted surgery to replace the medial compartment of the knee.

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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TKA Total Knee Replacement Revision Knee Arthroplasty Unicompartmental Knee Arthroplasty (UKA) Bi-compartmental Knee Arthroplasty RESTORIS® MCK MultiCompartmental Knee System FDA 501K number K090763

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stryker MAKO Surgical Corp

UNKNOWN

Sponsor Role collaborator

Northwest Surgical Specialists, Vancouver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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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