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Joint Replacement
MOTO Medial® UKA for Knee Arthritis
N/A
Waitlist Available
Research Sponsored by Medacta USA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Awards & highlights
Study Summary
This trial will study the long-term performance of a new type of knee surgery, comparing patient reports, clinical findings, and x-rays.
Who is the study for?
This trial is for adults over 18 with medial knee disease suitable for MOTO Medial® UKA, who can consent and comply with the study. Excluded are those with psychiatric illness, inflammatory arthritis, pregnancy, prior knee arthroplasty or infections, on immunosuppressants or narcotics, undergoing cancer treatments, or have metabolic disorders affecting bones.Check my eligibility
What is being tested?
The performance of MOTO Medial® Unicompartmental Knee Arthroplasty (UKA) is being tested through patient reports, clinical evaluations and X-rays in a prospective study across multiple centers to assess its mid-term effectiveness in treating knee conditions like osteoarthritis.See study design
What are the potential side effects?
While not explicitly listed here, typical side effects from similar procedures may include pain at the surgery site, swelling around the knee joint area post-operation which usually subsides over time. There's also a risk of implant sensitivity or allergic reaction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My knee condition matches the FDA guidelines for MOTO Medial® UKA use.
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I have never had joint replacement surgery on the affected knee.
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My knee condition matches the FDA guidelines for MOTO Medial® UKA use.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in Forgotten Joint Score
Change from baseline in Knee Alignment
Change from baseline in Knee Osteoarthritis Outcome Score
+11 moreSecondary outcome measures
Age of patient
Anesthetic
Complications
+14 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Interventional : MOTO Medial® UKAExperimental Treatment1 Intervention
Interventional : Patients who are planned to undergo a primary medial UKA using the MOTO Medial® will be enrolled.
Find a Location
Who is running the clinical trial?
Medacta USALead Sponsor
16 Previous Clinical Trials
1,811 Total Patients Enrolled
9 Trials studying Osteoarthritis
680 Patients Enrolled for Osteoarthritis
Mukesh Ahuja, MBBS, MS, CPIStudy DirectorMedacta USA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently pregnant.I have had knee replacement surgery on the knee we are discussing.I can follow the study's requirements and attend all visits.I am 18 years old or older.You regularly take strong pain medications (like opioids) before surgery.My knee ligament is unstable.I have had a knee infection in the past.I am currently receiving chemotherapy or radiation for cancer.My knee condition matches the FDA guidelines for MOTO Medial® UKA use.I have never had joint replacement surgery on the affected knee.I can attend follow-up appointments and am mentally capable of participating in the study.You have had an allergic reaction or sensitivity to materials used in orthopedic implants like Titanium and Cobalt-Chrome alloys.I have a metabolic disorder affecting my bones, not including osteoarthritis or osteoporosis.My knee condition matches the FDA guidelines for MOTO Medial® UKA use.I am currently taking medications that suppress my immune system, including steroids.You have a mental health condition.I have inflammatory arthritis.I have long-term pain not related to my knee.You have a history of alcoholism or drug addiction.I have had surgery to realign my knee.
Research Study Groups:
This trial has the following groups:- Group 1: Interventional : MOTO Medial® UKA
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT03211663 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still available in this clinical research study?
"According to clinicaltrials.gov, registration for this medical study has been closed since March 29th of 2022. Nevertheless, there are currently 708 other trials seeking volunteers across the globe."
Answered by AI
What results is this trial intended to yield?
"The primary outcome of this medical trial will be the Forgotten Joint Score, which patients are assessed on at Baseline and 4-8 months post-surgery, 9-15 months, 18-30 and 51-69. Additionally, researchers will gauge Return to Work/Activity questionnaire scores (assessing ability to return to work or other activities), K & L Grading levels (OA Disease Grade in knee compartment) as well as Anesthetic type used during surgery."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
Is this replacement of the meniscus?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I'm looking for something less evasive than total knee replacement.
PatientReceived 2+ prior treatments
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