Trial record 2 of 260 for:    Open Studies | knee replacement

Clinical Outcomes of Knee Replacement

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Northwest Surgical Specialists, Vancouver
Sponsor:
Collaborator:
MAKO Surgical Corp.
Information provided by (Responsible Party):
Northwest Surgical Specialists, Vancouver
ClinicalTrials.gov Identifier:
NCT01705366
First received: October 9, 2012
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

The objective of this study is to document the demographic and clinical characteristics and the long-term clinical outcomes of patients who require a total knee arthroplasty (TKA).

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.


Condition Intervention
Knee Arthroplasty
Procedure: Non-MAKO® Robot Assisted Total Knee Arthroplasty
Procedure: MAKO® Robot Assisted Medial Knee Arthroplasty
Procedure: MAKO® Robot Assisted Medial and PF Knee Arthroplasty
Device: RESTORIS Multicompartmental Knee System
Device: Depuy Knee Replacement System
Device: Stryker® Knee Replacement System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcomes of Joint Arthroplasty

Resource links provided by NLM:


Further study details as provided by Northwest Surgical Specialists, Vancouver:

Primary Outcome Measures:
  • Survivorship of Components [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Survivorship of components is defined as knee implant device(s) remaining in patient.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    The EQ-5D is a standardized instrument for use as a measure of health outcome.

  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 300
Study Start Date: October 2012
Estimated Study Completion Date: October 2025
Estimated Primary Completion Date: October 2025 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 .

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:
  • TKA
  • Total Knee Replacement
  • 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 Name: 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 Name: Bi-compartmental Knee Arthroplasty
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All male and non-pregnant females undergoing knee replacement

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705366

Contacts
Contact: Pam Fairchild 360-449-8728 pfairchild@reboundmd.com
Contact: Mike Baer, MSPT 360-449-8700 mbaer@reboundmd.com

Locations
United States, Washington
Rebound Orthopedics and Neurosurgery Recruiting
Vancouver, Washington, United States, 98686
Contact: Pam Fairchild    360-449-8728    pfairchild@reboundmd.com   
Contact: Mike Baer, MSPT    360-449-8700    mbaer@reboundmd.com   
Principal Investigator: Todd Borus, MD         
Principal Investigator: Donald Roberts, MD         
Sponsors and Collaborators
Northwest Surgical Specialists, Vancouver
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
  More Information

No publications provided

Responsible Party: Northwest Surgical Specialists, Vancouver
ClinicalTrials.gov Identifier: NCT01705366     History of Changes
Other Study ID Numbers: MAKO-01
Study First Received: October 9, 2012
Last Updated: April 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwest Surgical Specialists, Vancouver:
Osteoarthritis
Joint Disease
Arthritis
Musculoskeletal Disease

ClinicalTrials.gov processed this record on August 18, 2014