MISHA Knee System for Osteoarthritis

Recruiting at 2 trial locations

Overseen By Robert Magnussen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Moximed

Disqualifiers: Poor bone quality, Ligamentous instability, Inflammatory joint disease, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 1-2 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test the safety and effectiveness of the MISHA Knee System, a medical device for people with osteoarthritis, specifically targeting those who experience knee pain during activities. Researchers will monitor participants over five years to track any adverse effects and the overall performance of the knee system. The goal is to determine if the device helps avoid further surgeries and maintain good knee function. Ideal participants have tried other non-surgical treatments without success, experience knee pain mainly in the inner part of the knee, and do not have severe bone issues or allergies to metals like nickel. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could improve future osteoarthritis treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the MISHA Knee System is safe for treating osteoarthritis?

Research has shown that the MISHA Knee System is generally well-tolerated. In one study, 95% of patients experienced no major safety issues, and none of the devices broke or failed. This indicates that the device is reliable and does not cause significant problems for most people. The evidence suggests the treatment is safe for many patients, with a high success rate in avoiding complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The MISHA Knee System is unique because it offers a novel approach to treating osteoarthritis by potentially providing a less invasive option compared to traditional treatments like knee replacement surgery. Researchers are excited about this system as it could preserve more of the natural knee structure, potentially leading to quicker recovery times and maintaining more natural joint function. Unlike oral medications or injections that primarily address symptoms, the MISHA Knee System is designed to be an internal support that might slow down the progression of osteoarthritis, offering a new hope for patients seeking alternatives to current surgical options.

What evidence suggests that the MISHA Knee System is effective for osteoarthritis?

Research has shown that the MISHA Knee System, which participants in this trial will receive, may help treat knee osteoarthritis. In studies, 95.8% of patients with the MISHA device reported less pain. This system acts like a cushion inside the knee, reducing pressure with each step and improving knee function. Another study found that the MISHA System succeeded 85.6% of the time, outperforming other treatments. These results suggest that the MISHA Knee System could effectively reduce pain and improve knee function for people with osteoarthritis. ^{2 4 5 6 7}

Who Is on the Research Team?

Dennis Crawford, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for people aged 25-65 with osteoarthritis, experiencing pain mainly in the knee's medial compartment. They must have a BMI of less than 35 and have tried non-surgical treatments without success. It's not for those with poor bone quality, metal allergies, large knee growths that could affect the device, unstable ligaments, recent infections or inflammatory diseases.

Inclusion Criteria

I am between 25 and 65 years old.

Body Mass Index (BMI) of < 35

My knee or hip pain is severe, scoring 40 or more.

Exclusion Criteria

Suspected or documented allergy or hypersensitivity to cobalt, chromium, nickel or other metals

My bones are weak or easily break.

I tend to develop thick scars or internal scar tissue after surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MISHA Knee System implantation and initial assessments

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including adverse events, WOMAC scores, KSS satisfaction, and radiographic evaluations

5 years

Regular visits (in-person) over 5 years

What Are the Treatments Tested in This Trial?

Interventions

• MISHA Knee System

Trial Overview The MISHA Knee System is being tested to see if it's safe and effective for treating knee osteoarthritis. The study will track patients' pain levels, satisfaction, range of motion and activity over five years post-implantation. It aims to determine how many participants remain free from serious side effects related to the device or procedure after five years.

How Is the Trial Designed?

Group I: MISHA Knee System Experimental Treatment 1 Intervention

MISHA Knee System is already approved in United States for the following indications:

Approved in United States as MISHA Knee System for:

• Medial compartment knee osteoarthritis

Who Is Running the Clinical Trial?

Moximed

Lead Sponsor

Trials

8

Recruited

760+

Published Research Related to This Trial

Medications and viscosupplementation provide initial pain relief for knee osteoarthritis, while surgical options like unicompartmental knee arthroplasty and total knee arthroplasty significantly reduce pain scores.

The KineSpring® Knee Implant System shows promising improvements in pain and function over 24 months, but more research is needed to compare its effectiveness directly with other treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conservative treatments, surgical treatments, and the KineSpring® Knee Implant system for knee osteoarthritis: a systematic review. Li, CS., Ayeni, OR., Sprague, S., et al.[2019]

The intra-articular metallic spacer showed significant improvements in knee function and pain relief for patients with isolated medial compartment osteoarthritis, with a 169% improvement in Knee Society knee scores at 1 year and 193% at 2 years based on a study of 71 implants in 67 patients.

Despite some revisions (7% to total knee arthroplasty and 14% to another UniSpacer implant), the early results indicate that this treatment is a promising option for younger patients suffering from knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unicompartmental tibial hemiarthroplasty: early results of the UniSpacer knee. Hallock, RH., Fell, BM.[2016]

The Atlas Knee System, a joint unloading device, showed sustained improvement in pain and function scores over 2 years in 26 young patients with medial knee osteoarthritis, confirming its effectiveness as a treatment option.

Patients also experienced a return to normal range of motion, indicating that the device not only alleviates symptoms but also restores functional mobility in individuals who had previously exhausted conservative treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-Year Results of the PHANTOM High Flex Trial: A Single-Arm Study on the Atlas Unicompartmental Knee System Load Absorber in Patients With Medial Compartment Osteoarthritis of the Knee. Slynarski, K., Walawski, J., Smigielski, R., et al.[2020]

A case report of a 26-year-old ex-professional athlete with knee osteoarthritis showed positive outcomes after treatment with a minimally invasive load-altering implant (Atlas System), improving pain, function, and quality of life at 6 months post-surgery.

This treatment option is particularly relevant for younger patients with early-stage knee OA who are not suitable candidates for traditional surgical interventions, suggesting a potential new pathway for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating Early Knee Osteoarthritis with the Atlas® Unicompartmental Knee System in a 26-Year-Old Ex-Professional Basketball Player: A Case Study. Slynarski, K., Lipinski, L.[2020]

The KineSpring System implant significantly reduces medial compartment loads in knees with osteoarthritis, showing a reduction of 134 ± 53 N during walking, which is clinically relevant for treatment.

Total joint loads also decreased by 91 ± 40 N without affecting lateral compartment loads, indicating that the KineSpring System effectively alleviates stress on the affected knee area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unloading the osteoarthritic knee with a novel implant system. Gabriel, SM., Clifford, AG., Maloney, WJ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12177428/

Medial Implantable Shock Absorber (MISHA) to Treat ... ... knee osteoarthritis, the MISHA group demonstrated favorable outcomes. Specifically, 95.8% of the MISHA group reported pain relief compared ...

2. moximed.com moximed.com/news/first-patients-treated-in-a-new-randomized-controlled-trial-evaluating-the-misha-knee-system-vs-non-surgical-treatment-for-knee-osteoarthritis/

First Patients Treated in a New Randomized Controlled ... The MISHA Knee System is the first implantable shock absorber that reduces weight on the knee joint with every walking step, easing pain, preserving function.

3. moximed.com moximed.com/news/moximeds-misha-knee-system-achieves-superiority-of-primary-endpoint-in-pivotal-study/

Moximed's MISHA™ Knee System Achieves Superiority of ... The MISHA Knee System demonstrated an 85.6% composite success rate compared to that of HTO (65.5%). Moximed's ISA continued to demonstrate ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06843980

Study Details | NCT06843980 | MOTION Clinical Trial This is the first randomized head-to-head study comparing outcomes from subjects treated with the MISHA Knee System. Official Title. Evaluation of the MISHA® ...

5. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm?t_id=384&c_id=7441

522 Postmarket Surveillance Studies Database - FDA Study Objective(s): Prospective evaluation of the safety and effectiveness of the MISHA Knee System. The study will collect data on the procedural and long ...

6. moximed.com moximed.com/news/peer-reviewed-publication-shows-superiority-of-moximeds-misha-knee-system/

Peer-Reviewed Publication Shows Superiority of ... Favorable Safety: 95% of ISA patients were free from an endpoint safety event, and 100% of ISA devices were free from mechanical failure. “The ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06118892

NCT06118892 | MISHA Post-Market Clinical Study Prospective evaluation of the safety and effectiveness of the MISHA Knee System. The study will collect data on the procedural and long-term adverse events.