MOTO Medial® UKA for Knee Arthritis

Not currently recruiting at 4 trial locations

Overseen By Mukesh Ahuja, MBBS, MS, CPI

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medacta USA

Must not be taking: Chemotherapy, Radiation, Immunosuppressants, Steroids

Disqualifiers: Knee instability, Inflammatory arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new knee surgery method called MOTO Medial® UKA (Unicompartmental Knee Arthroplasty) to evaluate its effectiveness for individuals with arthritis in one part of their knee. Researchers aim to assess patient satisfaction, examine knee health, and analyze X-rays after the surgery. It suits individuals with arthritis in the inner part of their knee who have not undergone major knee surgery there before. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant medical advancements.

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.

What prior data suggests that the MOTO Medial® Unicompartmental Knee Arthroplasty is safe for knee arthritis?

Research shows that the MOTO Medial® Unicompartmental Knee Arthroplasty (UKA) has been tested in people with knee arthritis. One study reported a rare complication involving a fracture and dislocation of a part of the knee implant. However, such events are uncommon. Generally, similar knee treatments yield positive results in the medium term, indicating that most patients handle the treatment well. Since this study is not the first to test the device, earlier research provides reassurance about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MOTO Medial® Unicompartmental Knee Arthroplasty (UKA) because it offers a targeted approach to treating knee arthritis. Unlike traditional total knee replacements, which involve replacing the entire knee joint, this treatment focuses only on the damaged compartment of the knee. This means less bone and tissue removal, potentially leading to quicker recovery times and a more natural knee movement. Additionally, the precision of this approach may improve long-term outcomes and reduce recovery complications.

What evidence suggests that the MOTO Medial® UKA is effective for knee arthritis?

Research shows that partial knee replacement, such as the MOTO Medial® UKA, effectively treats knee arthritis. Studies indicate that this procedure relieves pain, reduces swelling, and speeds up recovery. Patients often experience better results compared to other treatments. Over five years, partial knee replacement has demonstrated promising long-term benefits, with improved scores for pain and function. Overall, it is considered a reliable solution for knee arthritis, offering significant improvements in quality of life. ^{1 2 5 6 7}

Who Is on the Research Team?

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.

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.

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?

Group I: Interventional : MOTO Medial® UKA Experimental Treatment 1 Intervention

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised, Double-Blind, Placebo-Controlled Study of Iguratimod in the Treatment of Active Spondyloarthritis. Li, Y., Li, K., Zhao, Z., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03211663

Performance of MOTO Medial® Unicompartmental Knee ... This is a prospective, multi-center study, designed to assess mid-term performance of the MOTO Medial® UKA, with patient report outcomes, clinical findings ...

2. withpower.com withpower.com/trial/phase-osteoarthritis-knee-9-2017-d6bf0

MOTO Medial® UKA for Knee Arthritis · Info for Participants This is a prospective, multi-center study, designed to assess mid-term performance of the MOTO Medial® Unicompartmental Knee Arthroplasty (UKA), with patient ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11371575/

Comparative long-term outcomes of unicompartmental and ... This study aims to evaluate the long-term outcomes over five years, including Knee Society Pain Scores (KSPS), Knee Society Scores (KSS), Knee ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12186333/

Clinical efficacy of unicompartmental knee arthroplasty on ... UKA demonstrates better short-term outcomes in relieving pain, reducing swelling, and promoting functional recovery in patients with knee osteoarthritis.

5. ctv.veeva.com ctv.veeva.com/study/performance-of-moto-medial-r-unicompartmental-knee-arthroplasty

Performance of MOTO Medial® Unicompartmental Knee ... This is a prospective, multi-center study, designed to assess mid-term performance of the MOTO Medial® Unicompartmental Knee Arthroplasty ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10231915/

Midterm Outcomes of Unicompartmental Knee Arthroplasty ... In this study, we report the mid-term outcomes of UKA in a series of patients with medial compartment knee osteoarthritis. Methods: Seventeen patients with ...

7. medacta.com medacta.com/EN/home-moto-platform

MOTO Partial Knee System Medacta has designed a new and optimized partial knee platform that allows the surgeon to always take full advantage of enhanced implant design.