Active — Not RecruitingNot Applicable

Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty

United States95 participantsStarted 2022-12-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Patient reported Questionnaires for weekly VAS pain scores up weekly

Timeframe: 1 year

Trial details

NCT IDNCT05736601

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Knee Osteoarthritis trials