- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03211663
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
Conditions
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
-
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Florida
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Lady Lake, Florida, United States, 32159
- Unova Health Clinic
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Kentucky
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Louisville, Kentucky, United States, 40223
- Ellis & Badenhausen Orthopaedics PSC
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Montana
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Billings, Montana, United States, 59102
- Ortho Montana
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University
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Pennsylvania
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Meadville, Pennsylvania, United States, 16335
- Whole Health Joint Replacement
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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:
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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
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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
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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
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Assessment of the improvement of joint specific outcomes following knee replacement surgery using the Forgotten Joint Score Questionnaire.
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post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
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Knee Society Score
Time Frame: Baseline
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Assessment of pre-op expectations questionnaire
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Baseline
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Change from baseline in Knee Society Score
Time Frame: post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
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Assessment of the improvement post-op satisfaction following knee replacement surgery using the Knee Society Score questionnaire.
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post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
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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
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Assessment of the improvement of your health using the Veterans Rand 12 score questionnaire.
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Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
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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
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Assessment of the improvement of knee function following knee replacement surgery using the Oxford Knee Score questionnaire.
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Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
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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
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Documentation of osteoarthritis medications
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Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
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Change from baseline in Knee Wound Assessment
Time Frame: post-operative 2-6 weeks, 4-8 months
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Assessment of wound drainage, swelling and infection in surgical knee
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post-operative 2-6 weeks, 4-8 months
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Change from baseline in Visual Analog Scale score
Time Frame: baseline, post-operative 2-6 weeks, 4-8 months
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Assessment of the improvement of patient knee pain following knee replacement surgery using the VAS score questionnaire.
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baseline, post-operative 2-6 weeks, 4-8 months
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Severity of osteoarthritis in the knee compartments
Time Frame: Baseline
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Determine by radiographic analysis for disease progression
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Baseline
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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
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Determine by radiographic analysis Varus or Valgus
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Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
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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
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Determine by radiographic analysis by measuring Radio Lucent lines in millimeters.
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post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
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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
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Determine by radiographic analysis of bone fracture, implant fracture, fixation and wear
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post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
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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
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Reoperations, revisions, removals, and device related adverse events
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post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
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K & L Grading
Time Frame: Baseline
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Assessment of Osteoarthritis Disease Grade of the knee compartment
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Baseline
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Age of patient
Time Frame: Baseline
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Date of birth (age)
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Baseline
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Demographics
Time Frame: Baseline
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Height in inches, weight in pounds to determine BMI
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Baseline
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Number of male or female patients
Time Frame: Baseline
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Gender description male or female
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Baseline
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Occurrence of Knee Treatments prior to surgery
Time Frame: Baseline
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Prior treatments of knee such as bracing, medication, injections, arthroscopy, ligament and cartilage procedures
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Baseline
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Occurrence of prior medical and surgical history
Time Frame: Baseline
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Medical and surgical history of patient prior to knee surgery
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Baseline
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Post-operative pain medications
Time Frame: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
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Medications after knee surgery
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post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
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Return to Work/Activity questionnaire
Time Frame: post-operative 4-8 months, 9-15 months, 18-30 months
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Assessment of ability to return to work or other activities following surgery
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post-operative 4-8 months, 9-15 months, 18-30 months
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Implant demographics
Time Frame: day of surgery
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Implant femoral and tibial size and poly thickness
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day of surgery
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Anesthetic
Time Frame: day of surgery
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type of anesthesia used during surgery
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day of surgery
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Estimated blood loss
Time Frame: day of surgery
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Volume of blood loss during surgery
|
day of surgery
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Length of surgery
Time Frame: day of surgery
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Time in minutes of skin to skin
|
day of surgery
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Length of Hospital Stay
Time Frame: day of surgery
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Length of stay in hours
|
day of surgery
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Frequency of Facility type used for knee surgery
Time Frame: day of surgery
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Type of facility used for knee surgery
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day of surgery
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Tourniquet Time
Time Frame: day of surgery
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Tourniquet time in minutes
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day of surgery
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Complications
Time Frame: day of surgery, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
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Assess adverse events and Serious adverse events
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day of surgery, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
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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
Additional Relevant MeSH Terms
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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