Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty

Active, not recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Device: focus motion knee brace

• Registration Number: NCT05736601
• Lead Sponsor: Washington University School of Medicine

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

Study Timeline

• Study Start: 2022-12-27
• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-02-18
• Study First Posted: 2023-02-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 95

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Washington University Medical School; 🇺🇸 Saint Louis, Missouri, United States