269 Participants Needed

MOTO Medial® UKA for Knee Arthritis

Recruiting at 4 trial locations
MA
Overseen ByMukesh Ahuja, MBBS, MS, CPI
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on chemotherapy, radiation therapy, or immunosuppressive medications like steroids, you cannot participate in the trial.

Is MOTO Medial® UKA safe for humans?

A case report mentions a rare complication involving a fracture and dislocation of a component in a similar knee treatment, but it was resolved with surgery. This suggests that while complications can occur, they can be managed.12345

How is the MOTO Medial® Unicompartmental Knee Arthroplasty treatment different from other treatments for knee arthritis?

The MOTO Medial® Unicompartmental Knee Arthroplasty (UKA) is unique because it focuses on replacing only the damaged part of the knee, which allows for a minimally invasive surgery and often results in quicker recovery and better knee function compared to total knee replacement. This approach is particularly beneficial for younger patients with isolated medial knee arthritis, offering high patient satisfaction and long-term success.678910

What data supports the effectiveness of the treatment MOTO Medial® Unicompartmental Knee Arthroplasty for knee arthritis?

Research shows that unicompartmental knee arthroplasty (UKA) is effective for treating medial knee osteoarthritis, with high patient satisfaction and good knee function, especially in younger patients. Long-term studies report high success rates, with 94% to 97% of UKA procedures still functioning well after 10 years.6791112

Who Is on the Research Team?

MA

Mukesh Ahuja, MBBS, MS, CPI

Principal Investigator

Medacta USA

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can follow the study's requirements and attend all visits.
My knee condition matches the FDA guidelines for MOTO Medial® UKA use.
I have never had joint replacement surgery on the affected knee.
See 4 more

Exclusion Criteria

I am currently pregnant.
I have had knee replacement surgery on the knee we are discussing.
You regularly take strong pain medications (like opioids) before surgery.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Evaluation

Collection of baseline data including medical and surgical history, demographics, and osteoarthritis severity

1 day
1 visit (in-person)

Surgery

Participants undergo the MOTO Medial® Unicompartmental Knee Arthroplasty

1 day
1 visit (in-person)

Post-operative Monitoring

Participants are monitored for safety, effectiveness, and complications with follow-up assessments at various intervals

69 months
Multiple visits (in-person and virtual) at 4 weeks, 6 months, 1, 2, and 5 years

Follow-up

Participants are monitored for long-term outcomes and implant survivorship

51-69 months

What Are the Treatments Tested in This Trial?

Interventions

  • MOTO Medial® Unicompartmental Knee Arthroplasty
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Interventional : MOTO Medial® UKAExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medacta USA

Lead Sponsor

Trials
17
Recruited
2,100+

Published Research Related to This Trial

In a study involving 73 participants with active spondyloarthritis (SpA), Iguratimod significantly improved symptoms, with 80% of patients responding positively compared to 44% in the placebo group after 24 weeks.
The treatment was well-tolerated, with similar rates of gastrointestinal discomfort and liver enzyme elevation between the Iguratimod and placebo groups, indicating good safety and tolerance for patients.
Randomised, Double-Blind, Placebo-Controlled Study of Iguratimod in the Treatment of Active Spondyloarthritis.Li, Y., Li, K., Zhao, Z., et al.[2021]

Citations

Unicompartmental knee arthroplasty: a review of literature. [2021]
Unicompartmental knee arthroplasty for spontaneous osteonecrosis. [2018]
[Experience with medial unicompartmental prostheses with a mobile plateau]. [2021]
15-Year Follow-Up of Mobile Bearing Medial Unicompartmental Knee Arthroplasty. [2023]
Ten- to 15-year results of the Oxford Phase III mobile unicompartmental knee arthroplasty: a prospective study from a non-designer group. [2022]
Fracture and Posterior Dislocation of Meniscal Bearing Insert in Mobile Bearing Unicompartmental Knee Arthroplasty: A Case Report. [2020]
Long-term safety study of iguratimod in patients with rheumatoid arthritis. [2016]
Randomised, Double-Blind, Placebo-Controlled Study of Iguratimod in the Treatment of Active Spondyloarthritis. [2021]
9.United Arab Emiratespubmed.ncbi.nlm.nih.gov
The Oral Administration Effect of Drug Mannuronic Acid (M2000) on Gene Expression of Matrix and Tissue Inhibitor of Metalloproteinases in Rheumatoid Arthritis Patients. [2021]
Suspected drug-induced liver injury associated with iguratimod: a case report and review of the literature. [2018]
Balancing in Unicompartmental Knee Arthroplasty: Balancing in Flexion or in Extension? [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Outcomes of a Fixed-Bearing, Medial, Cemented Unicondylar Knee Arthroplasty Design: Survival Analysis and Functional Score of 460 Cases. [2019]
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