Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05736601
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Washington University School of Medicine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Knee Osteoarthritis

Additional Details

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

Arms & Interventions

Arms

: UKA MAKO

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

: TKA MAKO

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

Interventions

Device: - focus motion knee brace

knee brace that captures knee motion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Washington University Medical School, Saint Louis, Missouri

Status

Recruiting

Address

Washington University Medical School

Saint Louis, Missouri, 63110

Site Contact

Rondek Salih, MPH

[email protected]

314-747-2495

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