Survivorship and Outcomes of Robot Assisted Medial Partial Knee Replacement

Survivorship and Outcomes of Robotically Assisted Medial UKA

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.

Study Overview

• Status: Completed
• Conditions: Unicompartmental Knee Arthroplasty
• Intervention / Treatment: 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 Unicompartmental Knee Arthroplasty (UKA) implants at a two, five, and ten year follow up.

• Study Type: Observational
• Enrollment (Actual): 145

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MAKOplasty® medial UKA; Patients knees that have received a MAKOplasty® robotically guided unicompartmental knee arthroplasty (UKA) and received a medial MCK onlay implant.	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.; Other Names: Medial Partial Knee Replacement; Medial Unilateral Knee Arthroplasty; Robot Assisted Partial Knee Replacement

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5 Year Survivorship of Components	Survivorship of components is defined as knee implant device(s) remaining in patient.	5 years after surgery
2 Year Survivorship of Components	Survivorship of components is defined as knee implant device(s) remaining in patient.	2 years after surgery

Collaborators and Investigators

• Sponsor: Northwest Surgical Specialists, Vancouver
• Collaborators: Stryker Corp.
• Investigators: Principal Investigator: Todd Borus, MD, Rebound Orthopedics and Neurosurgery

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: April 29, 2013
• First Submitted That Met QC Criteria: April 30, 2013
• First Posted (Estimated): May 3, 2013

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: MAKO-03; 2016-006 (Other Identifier: Stryker)