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NCT05736601 | RECRUITING | Knee Osteoarthritis

Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty
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.

Condition or disease

Knee Osteoarthritis

Intervention/treatment

focus motion knee brace

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 Type : OBSERVATIONAL
Estimated Enrollment : 95 participants
Official Title : Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty
Actual Study Start Date : 2022-12-27
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
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
Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty

Location Details

NCT05736601

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Locations

RECRUITING

United States, Missouri

Washington University Medical School

St. Louis, Missouri, United States, 63110