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OpenTrials
Active, Not Recruiting

NCT Number: NCT05736601

Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University Medical School

St Louis, Missouri, 63110, United States

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

focus motion knee brace

Device

knee brace that captures knee motion

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Stryker Nordic

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Feb 21, 2023
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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