UKA Manual Versus UKA MAKO Robotic

May 7, 2024 updated by: Washington University School of Medicine

Post-Market Study of Robotic-Arm Assisted Unicompartmental Knee Arthroplasty in Comparison to Traditional UKA (Fixed and Mobile Bearings)

The purposes of this investigation is to 1) To determine if Robotic-arm assisted UKA (RA-UKA) allows for more accurate component placement than manual UKA (MI-UKA)and 2) prospectively assess the learning curve, radiographic, and clinical outcomes of use of the RIO system as it is incorporated into our clinical practice and compare it to historical data on manual UKAs and TKAs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Total knee arthroplasty (TKA) is known to have excellent long-term survivorship and clinical success in the management of degenerative joint disease, and remains the primary treatment for patients with bi- or tri-compartmental osteoarthritis. However, the patient population seeking knee arthroplasty is evolving, with patients being younger and more demanding on their prostheses (1). Recent investigations have highlighted that there remains a high incidence of residual symptoms including grinding/popping/clicking, swelling, and difficulties getting in and out of a car and chair, and 16% of patients remain "unsatisfied" following TKA (1).

Medial unicompartmental knee arthroplasty (UKA) remains a viable alternative to total knee arthroplasty in patients presenting with isolated, medial compartment osteoarthritis of the knee. Its use has increased in popularity in the United States, as the number of UKA performed over the last decade has increased by 30%(1). Proposed benefits of UKA include a smaller incision, less blood loss as well as shorter recovery time to functional level. Other benefits of UKAs include improved knee range of motion and better restoration of the knee kinematics (2, 5). These benefits are attributed to the less invasive nature of the procedure with preservation of the anterior and posterior cruciate ligaments, and minimal bony resections.

Unfortunately, historically the survival rate of UKA has been poor, with several reports demonstrating a survival rate of only 65-70% at 7-10 year follow-up (8, 9). These historically poor results have been attributed to instrumentation that was difficult to use, poor indications for the surgical procedure, and inadequate implant designs. More recent reports have shown 10-year survival rates ranging from 91% to 98% using both mobile-bearing and fixed-bearing UKA designs (7, 10-12). Mobile bearing UKA have a 92% survival rate at 20 years (5). However, the vast majority of these studies were performed at high-volume centers, and national joint registries have continued to demonstrate an increased rate of early failure and decreased survivorship of UKA versus TKA(13).

Recently, robotic-assisted UKA has been introduced to improve the accuracy of implant positioning (4). As implant positioning including alignment and translation in the coronal and sagittal planes and implant sizing are critical for success after UKA, the addition of robotic-assistance theoretically can improve radiographic alignment and clinical outcomes.

Currently, the most common robotic guidance system used in UKA is the Robotic Arm Interactive Orthopedic System (RIO; MAKO Surgical; Ft. Lauderdale, FLA). The purposes of this investigation is to 1) retrospectively review the radiographic and clinical outcomes of medial UKA using conventional techniques performed at our institution and 2) prospectively assess the learning curve, radiographic, and clinical outcomes of use of the RIO system as it is incorporated into our clinical practice.

Study Type

Observational

Enrollment (Actual)

486

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes Jewish Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Unilateral arthroplasty knee patients and total Knee arthroplasty patients

Description

Inclusion Criteria:

  • All patients who receive a robotic arm assisted UKA using the RIO navigation system will be prospectively included. All patients who have received a medial fixed or mobile UKA performed by surgeons in the Joint Preservation, Resurfacing, and Replacement Service at Washington University will be retrospectively reviewed. Also, all TKAs from a pervious study (IRB 201308057) performed by surgeons in the Joint Preservation, Resurfacing, and Replacement Service at Washington University will be retrospectively reviewed as well.

    • Patient is willing and able to comply with postoperative follow-up requirements and self-evaluations
    • Patient is willing to sign an IRB approved informed consent
    • Patient is at least 18 years of age

Exclusion Criteria:

  • • Patient has a BMI < 40

    • Patient is skeletally immature
    • Patient has an active infection or suspected infection in or about the joint
    • Bone stock that is inadequate to support fixation of the prosthesis
    • Neuromuscular disorders, muscular atrophy or vascular deficiency in the affected limb rendering the procedure unjustified.
    • Patients with mental or neurological conditions which may be incapable of following instructions.
    • Blood supply limitations
    • Collateral ligament insufficiency.
    • Patients with prior HTOs or Unis.
    • Patients requiring bilateral knee arthroplasty.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prospective Group- Robotic UKA Arm
Robotic UKA with the MAKO machine.
Device: MAKO Robotic UKA
Prospective UKA patient receiving unilateral knee arthroplasty using the MAKO robotic machine
Control- Fixed and Mobile UKA Arm
Patients who have received fixed or mobile bearing UKA
Control-Total Knee Arthroplasty
Patients who have had cemented or cementless total knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Op EOS measurements for alignment
Time Frame: 1 day- post op
To determine if Robotic-arm assisted UKA (RA-UKA) allows for more accurate component placement than manual UKA (MI-UKA). units of measurement will be inches.
1 day- post op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2019

Primary Completion (Actual)

December 12, 2020

Study Completion (Actual)

April 7, 2024

Study Registration Dates

First Submitted

December 11, 2017

First Submitted That Met QC Criteria

February 21, 2018

First Posted (Actual)

February 27, 2018

Study Record Updates

Last Update Posted (Estimated)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201708096

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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