Clinical Outcomes of Knee Replacement

September 24, 2018 updated by: Northwest Surgical Specialists, Vancouver

Clinical Outcomes of Joint Arthroplasty

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

316

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Vancouver, Washington, United States, 98686
        • Rebound Orthopedics and Neurosurgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All male and non-pregnant females undergoing knee replacement

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 .
Device: 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.
Other Names:
  • RESTORIS® MCK MultiCompartmental Knee System
  • FDA 501K number K090763
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.
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.
Procedure: Non-MAKO® Robot Assisted Total Knee Arthroplasty
Patients undergoing a non-MAKO® robot assisted surgery to replace one or more compartments of the knee.
Other Names:
  • Total Knee Replacement
  • TKA
  • Revision Knee Arthroplasty
Procedure: MAKO® Robot Assisted Medial Knee Arthroplasty
Patients undergoing a MAKO® robot assisted surgery to replace the medial compartment of the knee.
Other Names:
  • Unicompartmental Knee Arthroplasty (UKA)
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
Other Names:
  • Bi-compartmental Knee Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survivorship of Components
Time Frame: 10 years
Survivorship of components is defined as knee implant device(s) remaining in patient.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Knee Society Knee Score
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduced WOMAC
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwest Surgical Specialists, Vancouver

Collaborators

Stryker MAKO Surgical Corp

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

September 19, 2018

Study Completion (Actual)

September 19, 2018

Study Registration Dates

First Submitted

October 9, 2012

First Submitted That Met QC Criteria

October 9, 2012

First Posted (Estimate)

October 12, 2012

Study Record Updates

Last Update Posted (Actual)

September 26, 2018

Last Update Submitted That Met QC Criteria

September 24, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MAKO-01
  • Borus 2015-005 (Other Identifier: Stryker)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Arthroplasty

Clinical Trials on RESTORIS Multicompartmental Knee System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe