Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty

The Washington University

Status: Active, not recruiting

Conditions: Knee Osteoarthritis

Treatments: Device: focus motion knee brace

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05736601

202203201

Details and patient eligibility

About

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.

Full 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

Enrollment: 95 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

95 participants in 2 patient groups

UKA MAKO

Description:

Prospective group- Patient Reported Outcomes (PROs) will be assessed using the FocusMotion app survey

Treatment:

Device: focus motion knee brace

TKA MAKO

Description:

Control group-Already collected data on patient reported out comes using the FocusMotion app survey

Treatment:

Device: focus motion knee brace