Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty

March 12, 2026 updated by: Washington University School of Medicine
To determine if robotically-assisted UKA results in more consistent and improved component positioning and better patient reported outcome scores compared to manual TKA and MAKO TKA.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine the early clinical and radiographic outcomes of robotically-assisted medial unicompartmental knee arthroplasty (mUKA) with the MAKO surgical robot using the Restoris MCK Partial Implant System. The primary end point will be the mean weekly VAS pain score during the first four weeks postoperatively. The results of this study may be compared to those of previously studied cohorts of patients from this institution who underwent manual total knee arthroplasty (TKA) with the Triathlon Knee System as well as robotically-assisted total knee arthroplasty with the MAKO surgical robot using the Triathlon Knee System

Study Type

Observational

Enrollment (Estimated)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Participants 18 years and older who have chosen to partial knee surgery using the mako robotic system.

Description

Inclusion Criteria:

A. Unilateral primary medial unicompartmental knee arthroplasty

B. Age 18 years of age or older

C. Willing to sign informed consent

D. Willing to return for all follow-up visits

E. Smartphone or tablet device capable of running the FocusMotion platform

Exclusion Criteria:

A. BMI > 40

B. Personal history of DVT or PE

C. Inflammatory arthritis

D. Peripheral vascular disease

E. Opioid use greater than 5 days per week

F. Nonsteroidal anti-inflammatory allergy

G. Walking aid for musculoskeletal or neurologic issue other than operative joint

H. Bilateral medial unicompartmental knee arthroplasty

I. Patient with an active infection or suspected infection in the operative joint

J. The absolute and relative contraindications stated in the FDA cleared labeling for the device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
UKA MAKO
Prospective group- Patient Reported Outcomes (PROs) will be assessed using the FocusMotion app survey
Device: focus motion knee brace
knee brace that captures knee motion
TKA MAKO
Control group-Already collected data on patient reported out comes using the FocusMotion app survey
Device: focus motion knee brace
knee brace that captures knee motion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported Questionnaires for weekly VAS pain scores up weekly
Time Frame: 1 year
Patients will assess their weekly pain scores by filling out patient reported outcomes.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient will track their Opioid Consumption use by filling out a chart weekly
Time Frame: 3 months
Patients will report their weekly use by Opioid Consumption filling out a patient diary.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Stryker Nordic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

February 18, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202203201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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