Performance of MOTO Medial® Unicompartmental Knee Arthroplasty

NCT03211663 | Active Not Recruiting FDA Device

• 1 other identifier: MUSA-K-MTM-001
• Study Type: observational
• Target: 269
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Knee Osteoarthritis; Knee Arthritis; Knee Pain Chronic

Outcome Measures

Primary Outcomes (14)

• Change from baseline in Knee Society Score Objective

  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

  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

  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

  Assessment of pre-op expectations questionnaire

  Baseline

• Change from baseline in Knee Society Score

  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

  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

  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

  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

  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

  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

  Determine by radiographic analysis for disease progression

  Baseline

• Change from baseline in Knee Alignment

  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

  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

  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 Outcomes (17)

• Number of knee Implant faliures

  post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months

• K & L Grading

  Baseline

• Age of patient

  Baseline

• Demographics

  Baseline

• Number of male or female patients

  Baseline

Study Arms (1)

Interventional : MOTO Medial® UKA

Interventional : Patients who are planned to undergo a primary medial UKA using the MOTO Medial® will be enrolled.

Device: MOTO Medial® UKA

Interventions

MOTO Medial® UKA DEVICE

Knee replacement surgery with the MOTO Medial® UKA

Also known as: Medial Unicondylar Knee Replacement

Interventional : MOTO Medial® UKA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery as part of routine care.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medacta USA: lead

Study Sites (5)

Unova Health Clinic

Lady Lake, Florida, 32159, United States

Location

Ellis & Badenhausen Orthopaedics PSC

Louisville, Kentucky, 40223, United States

Location

Ortho Montana

Billings, Montana, 59102, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Whole Health Joint Replacement

Meadville, Pennsylvania, 16335, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 7, 2017
• Study Start: October 9, 2017
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)