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Survivorship and Outcomes of Robot Assisted Medial Partial Knee Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01845597
Recruitment Status : Active, not recruiting
First Posted : May 3, 2013
Last Update Posted : September 29, 2021
Sponsor:
Collaborator:
Stryker Corp.
Information provided by (Responsible Party):
Northwest Surgical Specialists, Vancouver

Study Description
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Brief Summary:
The purpose of this study is to determine the survivorship rate of robotic assisted medial partial knee replacement at a two, five, and ten years.

Condition or disease Intervention/treatment
Unicompartmental Knee Arthroplasty Procedure: MAKOplasty® medial UKA

Detailed Description:
The purpose of this study is to determine the survivorship rate of robotically guided MultiCompartmental Knee system (MCK) medial onlay Unilateral Knee Arthroplasty (UKA) implants at a two, five, and ten year follow up.
Study Design
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Study Type : Observational
Actual Enrollment : 134 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Survivorship and Outcomes of Robotically Assisted Medial UKA
Study Start Date : April 2013
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Groups and Cohorts
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Group/Cohort Intervention/treatment
MAKOplasty® medial UKA
Patients who have received a MAKOplasty® robotically guided unilateral knee arthroplasty (UKA) and received a medial MCK onlay implant.
 Procedure: MAKOplasty® medial UKA
A robot guided medical Unicompartmental knee arthroplasty (UKA) is a procedure to replace only the medial tibiofemoral compartment of the knee.
Other Names:
  • Medial Partial Knee Replacement
  • Medial Unilateral Knee Arthroplasty
  • Robot Assisted Partial Knee Replacement


Outcome Measures
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Primary Outcome Measures :
  1. 10 Year Survivorship of Components [ Time Frame: 10 years after surgery ]
    Survivorship of components is defined as knee implant device(s) remaining in patient.


Secondary Outcome Measures :
  1. 5 Year Survivorship of Components [ Time Frame: 5 years after surgery ]
    Survivorship of components is defined as knee implant device(s) remaining in patient.

  2. 2 year Survivorship of Components [ Time Frame: 2 years after surgery ]
    Survivorship of components is defined as knee implant device(s) remaining in patient.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent a MAKOplasty procedure by the investigating surgeon and received a medial MCK onlay implant.
Criteria

Inclusion Criteria:

  • over 21 years of age
  • underwent primary robotically guided UKA and received a medial MCK onlay implant by the investigating surgeon
  • at least 24 months post-operative

Exclusion Criteria:

  • Patients will be excluded from participation in the study if they are cognitively unable to answer study questions
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845597


Locations
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United States, Washington
Rebound Orthopedics and Neurosurgery
Vancouver, Washington, United States, 98686
Sponsors and Collaborators
Northwest Surgical Specialists, Vancouver
Stryker Corp.
Investigators
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Principal Investigator: Todd Borus, MD Rebound Orthopedics and Neurosurgery
More Information
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Responsible Party: Northwest Surgical Specialists, Vancouver
ClinicalTrials.gov Identifier: NCT01845597    
Other Study ID Numbers: MAKO-03
2016-006 ( Other Identifier: Stryker )
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021