Performance of MOTO Medial® Unicompartmental Knee Arthroplasty

February 5, 2024 updated by: Medacta USA

A Prospective, Multi-Center Study To Assess Performance of MOTO Medial® in Unicompartmental Knee Arthroplasty (UKA).

This is a prospective, multi-center study, designed to assess mid-term performance of the MOTO Medial® Unicompartmental Knee Arthroplasty (UKA), with patient report outcomes, clinical findings and radiographic analysis.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Detailed Description

This is a prospective, multi-center study, designed to assess mid-term performance of the MOTO Medial® UKA, with patient report outcomes, clinical findings and radiographic analysis. Additionally, several perioperative factors, medical and surgical history will be evaluated. Implant survival and complications will be detailed throughout the study. Data from pre-operative evaluation, day of surgery, and post-operatively at 4 weeks, 6 months, and years 1, 2 & 5, will be collected.

Study Type

Observational

Enrollment (Estimated)

269

Phase

  • Not Applicable

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

    • Florida
      • Lady Lake, Florida, United States, 32159
        • Unova Health Clinic
    • Kentucky
      • Louisville, Kentucky, United States, 40223
        • Ellis & Badenhausen Orthopaedics PSC
    • Montana
      • Billings, Montana, United States, 59102
        • Ortho Montana
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Pennsylvania
      • Meadville, Pennsylvania, United States, 16335
        • Whole Health Joint Replacement

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing surgery as part of routine care.

Description

Inclusion Criteria:

  • Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF).

    • Ability to understand and provide written authorization for use and disclosure of personal health information.
    • Subject who are able and willing to comply with the study protocol and follow-up visits.
    • Must be 18 years or older to participate.
    • Subjects must have medial knee disease in the affected knee compliant with the FDA-approved indications for use of MOTO Medial® UKA.
    • Must have had no prior arthroplasty to the medial compartment of the study knee.
    • Subjects must be able to return for the follow-up appointments, and have the mental capacity to cooperate and complete Patient Reported Outcome questionnaires, physical exam and radiographs.

Exclusion Criteria:

  • Knee ligament instability (deficiency of cruciate or collateral ligaments)

    • Inflammatory Arthritis
    • History of prior knee infection
    • History of Alcoholism or Drug Abuse
    • Currently on chemotherapy or radiation therapy for neoplastic disease. Medacta MOTO Medial® Version 1 Confidential Page 9 of 36 June 5, 2017
    • Currently on immunosuppressive medications including steroids
    • History of known sensitivity or allergy to materials used in orthopedic implants, specifically Titanium and Cobalt-Chrome alloys
    • Habitual use of narcotic pain medications prior to surgery (more than 3 doses or pills per week)
    • History of metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis (e.g., Osteomalacia, Ricketts)
    • History of chronic pain issues for reasons other than knee pain.
    • Women who are pregnant.
    • Psychiatric illness
    • Any patient, in the opinion of the investigator, is unable to fully comply with the surgical, rehabilitation, or follow-up aspects of this procedure.
    • Prior joint arthroplasty on the target knee, including prior medial UKA (revision), lateral UKA, or Patellofemoral Joint
    • Prior high tibial osteotomy (HTO).

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Interventional : MOTO Medial® UKA
Interventional : Patients who are planned to undergo a primary medial UKA using the MOTO Medial® will be enrolled.
Knee replacement surgery with the MOTO Medial® UKA
Other Names:
  • Medial Unicondylar Knee Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Knee Society Score Objective
Time Frame: Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Assessment of improvement of clinical outcomes following knee replacement surgery using the Knee Society Score Questionnaire
Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Change from baseline in Knee Osteoarthritis Outcome Score
Time Frame: Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Assessment of improvement of activity levels following knee replacement surgery using the Knee Osteoarthritis Score Questionnaire
Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Change from baseline in Forgotten Joint Score
Time Frame: post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Assessment of the improvement of joint specific outcomes following knee replacement surgery using the Forgotten Joint Score Questionnaire.
post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Knee Society Score
Time Frame: Baseline
Assessment of pre-op expectations questionnaire
Baseline
Change from baseline in Knee Society Score
Time Frame: post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Assessment of the improvement post-op satisfaction following knee replacement surgery using the Knee Society Score questionnaire.
post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Change from baseline in Veterans Rand 12 Score
Time Frame: Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Assessment of the improvement of your health using the Veterans Rand 12 score questionnaire.
Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Change from baseline in Oxford Knee Score
Time Frame: Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Assessment of the improvement of knee function following knee replacement surgery using the Oxford Knee Score questionnaire.
Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Change from baseline in Medication for Osteoarthritis
Time Frame: Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Documentation of osteoarthritis medications
Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Change from baseline in Knee Wound Assessment
Time Frame: post-operative 2-6 weeks, 4-8 months
Assessment of wound drainage, swelling and infection in surgical knee
post-operative 2-6 weeks, 4-8 months
Change from baseline in Visual Analog Scale score
Time Frame: baseline, post-operative 2-6 weeks, 4-8 months
Assessment of the improvement of patient knee pain following knee replacement surgery using the VAS score questionnaire.
baseline, post-operative 2-6 weeks, 4-8 months
Severity of osteoarthritis in the knee compartments
Time Frame: Baseline
Determine by radiographic analysis for disease progression
Baseline
Change from baseline in Knee Alignment
Time Frame: Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Determine by radiographic analysis Varus or Valgus
Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Change from baseline of Implant position fixation
Time Frame: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Determine by radiographic analysis by measuring Radio Lucent lines in millimeters.
post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Change from baseline of implant survivorship
Time Frame: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Determine by radiographic analysis of bone fracture, implant fracture, fixation and wear
post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of knee Implant faliures
Time Frame: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Reoperations, revisions, removals, and device related adverse events
post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
K & L Grading
Time Frame: Baseline
Assessment of Osteoarthritis Disease Grade of the knee compartment
Baseline
Age of patient
Time Frame: Baseline
Date of birth (age)
Baseline
Demographics
Time Frame: Baseline
Height in inches, weight in pounds to determine BMI
Baseline
Number of male or female patients
Time Frame: Baseline
Gender description male or female
Baseline
Occurrence of Knee Treatments prior to surgery
Time Frame: Baseline
Prior treatments of knee such as bracing, medication, injections, arthroscopy, ligament and cartilage procedures
Baseline
Occurrence of prior medical and surgical history
Time Frame: Baseline
Medical and surgical history of patient prior to knee surgery
Baseline
Post-operative pain medications
Time Frame: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Medications after knee surgery
post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Return to Work/Activity questionnaire
Time Frame: post-operative 4-8 months, 9-15 months, 18-30 months
Assessment of ability to return to work or other activities following surgery
post-operative 4-8 months, 9-15 months, 18-30 months
Implant demographics
Time Frame: day of surgery
Implant femoral and tibial size and poly thickness
day of surgery
Anesthetic
Time Frame: day of surgery
type of anesthesia used during surgery
day of surgery
Estimated blood loss
Time Frame: day of surgery
Volume of blood loss during surgery
day of surgery
Length of surgery
Time Frame: day of surgery
Time in minutes of skin to skin
day of surgery
Length of Hospital Stay
Time Frame: day of surgery
Length of stay in hours
day of surgery
Frequency of Facility type used for knee surgery
Time Frame: day of surgery
Type of facility used for knee surgery
day of surgery
Tourniquet Time
Time Frame: day of surgery
Tourniquet time in minutes
day of surgery
Complications
Time Frame: day of surgery, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Assess adverse events and Serious adverse events
day of surgery, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months

Collaborators and Investigators

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

Sponsor

Investigators

  • Study Director: Mukesh Ahuja, MBBS, MS, CPI, Medacta USA

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)

October 9, 2017

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 28, 2017

First Submitted That Met QC Criteria

July 5, 2017

First Posted (Actual)

July 7, 2017

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • MUSA-K-MTM-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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