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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01705366
Other study ID # MAKO-01
Secondary ID Borus 2015-005
Status Terminated
Phase
First received
Last updated
Start date October 2012
Est. completion date September 19, 2018

Study information

Verified date September 2018
Source Northwest Surgical Specialists, Vancouver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 316
Est. completion date September 19, 2018
Est. primary completion date September 19, 2018
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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
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.
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.

Locations

Country Name City State
United States Rebound Orthopedics and Neurosurgery Vancouver Washington

Sponsors (2)

Lead Sponsor Collaborator
Northwest Surgical Specialists, Vancouver Stryker MAKO Surgical Corp

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Reduced WOMAC 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
Other Knee injury and Osteoarthritis Outcome Score 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
Other EQ-5D 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
Other Forgotten Joint Score 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
Primary Survivorship of Components Survivorship of components is defined as knee implant device(s) remaining in patient. 10 years
Secondary American Knee Society Knee Score 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
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