Survivorship and Outcomes of Robot Assisted Medial Partial Knee Replacement

Unicompartmental Knee Arthroplasty Clinical Trial

Official title:

Survivorship and Outcomes of Robotically Assisted Medial UKA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845597
• Other study ID #: MAKO-03
• Secondary ID: 2016-006
• Status: Completed
• Start date: April 2013
• Est. completion date: February 28, 2022

Study information

• Verified date: August 2022
• Source: Northwest Surgical Specialists, Vancouver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The purpose of this study is to determine the survivorship rate of robotically guided MultiCompartmental Knee system (MCK) medial onlay Unicompartmental Knee Arthroplasty (UKA) implants at a two, five, and ten year follow up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Unicompartmental Knee Arthroplasty

Intervention

Procedure:
• MAKOplasty® medial UKA
A robot guided medial Unicompartmental knee arthroplasty (UKA) is a procedure to replace only the medial tibiofemoral compartment of the knee.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Northwest Surgical Specialists, Vancouver	Stryker Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	10 Year Survivorship of Components	Survivorship of components is defined as knee implant device(s) remaining in patient.	10 years after surgery
Secondary	5 Year Survivorship of Components	Survivorship of components is defined as knee implant device(s) remaining in patient.	5 years after surgery
Secondary	2 Year Survivorship of Components	Survivorship of components is defined as knee implant device(s) remaining in patient.	2 years after surgery