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?

This trial is testing a new knee implant called the MISHA Knee System. It aims to help people who need knee implants by improving their knee function and reducing pain. The study will follow patients over several years to see how well the implant works and if it is safe.

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.

How is the MISHA Knee System treatment different from other treatments for knee osteoarthritis?

The MISHA Knee System is unique because it is an implant designed to reduce the load on the knee joint, specifically targeting the medial compartment, which is often affected in osteoarthritis. Unlike traditional treatments like insoles or braces, this system offers a minimally invasive option that can provide significant load reduction and improve knee function without the need for more invasive surgeries. ^{1 2 3 4 5}

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

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Unloading the osteoarthritic knee with a novel implant system. [2022]

2. United States 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. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Conservative treatments, surgical treatments, and the KineSpring® Knee Implant system for knee osteoarthritis: a systematic review. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Unicompartmental tibial hemiarthroplasty: early results of the UniSpacer knee. [2016]

5. United States 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. [2020]