Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty

N/AActive Not RecruitingNCT05736601

Washington University School of Medicine95 enrolled

Overview

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.

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

Conditions

Knee Osteoarthritis

Interventions

focus motion knee braceDEVICE

knee brace that captures knee motion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Washington University Medical School

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Patient reported Questionnaires for weekly VAS pain scores up weekly

Patients will assess their weekly pain scores by filling out patient reported outcomes.

Time frame: 1 year

Secondary Outcomes

Patient will track their Opioid Consumption use by filling out a chart weekly

Patients will report their weekly use by Opioid Consumption filling out a patient diary.

Time frame: 3 months

Data from ClinicalTrials.gov

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