Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05736601

Enrollment

Registered

2023-02-21

Start date

2022-12-27

Completion date

2028-12-31

Last updated

2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Brief summary

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.

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

Interventions

DEVICEfocus motion knee brace

knee brace that captures knee motion

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026