Performance of MOTO Medial® Unicompartmental Knee Arthroplasty
United States269 participantsStarted 2017-10-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
* Histo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in Knee Society Score Objective