UKA Manual Versus UKA MAKO Robotic

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
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 - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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.

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.

NCT03447626
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
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Arthritis
Additional Details

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.

Arms & Interventions

Arms

: Prospective Group- Robotic UKA Arm

Robotic UKA with the MAKO 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

Interventions

Device: - MAKO Robotic UKA

Prospective UKA patient receiving unilateral knee arthroplasty using the MAKO robotic machine

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.

Barnes Jewish Hospital, Saint Louis, Missouri

Status

Recruiting

Address

Barnes Jewish Hospital

Saint Louis, Missouri, 63110

Site Contact

Rondek Salih, MPH

[email protected]

314-747-2495