MISHA Knee System for Osteoarthritis

Recruiting at 7 trial locations

Overseen By Joy Biggers

Age: Any Age

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)

Compensation: Varies

Number of Visits: 6

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new knee implant, the MISHA Knee System, for individuals with osteoarthritis in the inner knee. It compares this implant with non-surgical treatments like physical therapy, medications, and injections to determine which provides more relief. The trial suits those with knee pain worsened by activity who haven't found relief with non-surgical options. The researchers aim to discover if the MISHA Knee System can better reduce knee pain and improve movement compared to other methods. As an unphased trial, it offers patients the chance to explore innovative treatment options that might provide better relief than current non-surgical methods.

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 medial knee osteoarthritis?

Research has shown that the MISHA Knee System is generally safe for people. Studies have found that this implant, which reduces pressure on the knee joint, has received FDA approval for sale, indicating it meets safety standards for treating knee osteoarthritis. Additionally, a previous study reported a high success rate with no device-specific problems. These findings suggest that most patients tolerate the MISHA Knee System well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The MISHA Knee System is unique because it offers a non-invasive, mechanical approach to managing osteoarthritis in the knee, unlike standard treatments like medications, physical therapy, or surgical procedures. This system uses an extra-capsular implant with an absorber that reduces the load on the medial knee, allowing for natural knee motion and potentially delaying or avoiding the need for knee replacement surgery. Researchers are excited about this treatment because it directly addresses the mechanical stress in the knee joint, which is a root cause of osteoarthritis symptoms, offering a promising new way to relieve pain and improve mobility.

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

Studies have shown that the MISHA Knee System, one of the treatments in this trial, acts like a cushion inside the knee and can significantly help people with knee osteoarthritis, a condition affecting the knee joint. For those with mild-to-moderate knee osteoarthritis, this system has an 85% chance of working well for at least five years. One study found it to be successful 86% of the time compared to a common surgery called high tibial osteotomy, which realigns the knee. The system reduces pressure on the knee with each step, relieving pain and helping maintain knee function. This new approach offers a promising alternative to traditional surgeries. Participants in this trial may receive the MISHA Knee System or be part of the non-surgical treatment arm, which includes assistive devices, physical conditioning, medications, and other therapies. ^{1 6 7 8 9}

Who Is on the Research Team?

Rose S Weinstein

Principal Investigator

Moximed

Are You a Good Fit for This Trial?

This trial is for individuals with medial knee osteoarthritis. Specific eligibility details are not provided, but typically participants should meet certain health standards and may be excluded based on factors that could interfere with the study or their safety.

Inclusion Criteria

WOMAC pain ≥ 40

My knee pain worsens with activity and is focused on the inner side.

Non-surgical treatments have not eased my condition.

Exclusion Criteria

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

History of keloid, hypertrophic or contracture scarring

My bones are weak or easily damaged.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated with either the MISHA Knee System or non-surgical treatment options

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up visit at 6 months

What Are the Treatments Tested in This Trial?

Interventions

• MISHA Knee System

Trial Overview

The MISHA Randomized Study is testing the effectiveness of the MISHA Knee System compared to non-surgical treatment in managing knee osteoarthritis. It's a prospective, multicenter trial where subjects are randomly assigned in a 2:1 ratio to either intervention.

How Is the Trial Designed?

Group I: MISHA Knee System Experimental Treatment 1 Intervention

The MISHA Knee System is an extra-capsular knee implant intended to reduce loads on the medial knee. The implant consists of an absorber located between bases fixed with locking screws to the medial cortices of the distal femur and proximal tibia. The implant shares the load with the medial knee joint and articulating ball-and-sockets allow the device to accommodate the natural motions of the knee.

Group II: Non-Surgical Treatment Active Control 1 Intervention

The non-surgical arm includes assist devices, physical conditioning, prescription or nonprescription medications, creams, vitamins, or supplements, intra-articular Injections, physical therapy and weight loss.

Who Is Running the Clinical Trial?

Moximed

Lead Sponsor

Trials

8

Recruited

760+

Published Research Related to This Trial

The study aims to evaluate the effectiveness of a smartphone app combined with a wearable activity monitor in improving mobility for patients with knee osteoarthritis (OA), focusing on real-time tracking and encouragement of physical activity.

This mHealth approach is expected to provide personalized feedback and support for self-management, potentially enhancing patient adherence to exercise regimens and improving overall treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating Novel Mobile Health Technologies Into Management of Knee Osteoarthritis in Patients Treated With Intra-Articular Hyaluronic Acid: Rationale and Protocol of a Randomized Controlled Trial. Jones, D., Skrepnik, N., Toselli, RM., 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 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]

Intra-articular hyaluronic acid (IAHA) knee injections provide modest improvements in pain and function for patients with knee osteoarthritis, based on multiple systematic reviews and meta-analyses.

The editorial discusses key considerations for IAHA treatment, including identifying ideal candidates, understanding the varying effects at different disease stages, determining optimal dosing, and exploring alternative delivery methods beyond injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of viscosupplementation for knee osteoarthritis: an update. Divine, JG., Shaffer, MD.[2022]

An international working group developed a Standard Set of outcome measures for patients with hip or knee osteoarthritis, focusing on key factors like joint pain, physical functioning, and overall treatment satisfaction, based on consensus from experts across 10 countries.

The recommended annual measurement of these outcomes aims to improve the monitoring and comparison of care, ultimately supporting value-based healthcare improvements for osteoarthritis treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining an International Standard Set of Outcome Measures for Patients With Hip or Knee Osteoarthritis: Consensus of the International Consortium for Health Outcomes Measurement Hip and Knee Osteoarthritis Working Group. Rolfson, O., Wissig, S., van Maasakkers, L., et al.[2022]

The German version of the Forgotten Joint Score (FJS) was validated in a cohort of patients after surgical treatment for tibial plateau fractures, showing excellent internal consistency (Cronbach's alpha of .96) and high test-retest reliability (ICC of .91).

The FJS effectively differentiates between patients with varying degrees of osteoarthritis (OA), indicating that symptomatic patients report significantly lower scores than asymptomatic ones, thus confirming its relevance in assessing patient-reported outcomes in knee OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Joint awareness in posttraumatic osteoarthritis of the knee: validation of the forgotten joint score in long term condition after tibial plateau fracture. Baumann, F., Weber, J., Mahr, D., et al.[2019]

In a study of 26 young patients with medial knee osteoarthritis, the Atlas Knee System showed significant improvements in knee function and pain scores after 12 months, indicating its potential as a non-invasive treatment option.

Approximately 96.2% of patients reported a 20% or greater improvement in pain levels, suggesting that this joint unloading device could effectively manage symptoms and enhance quality of life for young patients who wish to avoid surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of the Atlas Unicompartmental Knee System Load Absorber in Improving Pain Relief and Function in Patients Needing Unloading of the Medial Compartment of the Knee: 1-Year Follow-Up of a Prospective, Multicenter, Single-Arm Pilot Study (PHANTOM High Flex Trial). Slynarski, K., Walawski, J., Smigielski, R., et al.[2020]

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]

Patients with osteoarthritis who participated in a new integrated multidisciplinary outpatient program reported significantly higher satisfaction with their healthcare compared to those receiving usual care, with a mean difference of -1.05 on a satisfaction scale after 4 months.

While the multidisciplinary program improved self-efficacy regarding symptoms, it did not lead to clinically relevant improvements in health outcomes, and some pain and fatigue scores worsened at 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an Integrated Multidisciplinary Osteoarthritis Outpatient Program versus Outpatient Clinic as Usual: A Randomized Controlled Trial. Moe, RH., Grotle, M., Kjeken, I., et al.[2016]

In a randomized controlled trial involving 60 patients with advanced knee osteoarthritis, Periosteal Stimulation Therapy (PST) combined with home exercises significantly reduced pain and improved function compared to Transcutaneous Electrical Nerve Stimulation (TENS) after 10 weeks and 6 months.

The PST group showed statistically significant improvements in pain levels and functional scores, indicating that this treatment approach may be more effective for managing chronic pain and functional impairments in older adults with knee OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Periosteal Stimulation Therapy and Home Exercise Program in the Rehabilitation of Patients With Advanced Knee Osteoarthritis. Elbadawy, MA.[2018]

Citations

1.

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.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36951981/

An implantable shock absorber yields an 85% survival- ...

In younger patients with mild-to-moderate symptomatic medial compartment knee OA, implantation of the ISA device resulted in a 5-year survival rate of 85%.

3.

health.osu.edu

health.osu.edu/discovery-and-innovation/treatment-advances/minimally-invasive-knee-replacement

Minimally invasive knee replacement | Ohio State Health ...

MISHA's effectiveness. The shock absorber had a success rate of 86% compared to the most common procedure, high tibial osteotomy, which has a ...

4.

moximed.com

moximed.com/news/favorable-five-year-survivorship-of-implantable-shock-absorber-and-reduction-of-arthroplasty-risk-in-high-risk-patients-reported-in-peer-reviewed-publications/

Favorable Five-Year Survivorship of Implantable Shock ...

An implantable shock absorber yields an 85% survival-from-arthroplasty rate through 5 years in working-age patients with medial compartment knee osteoarthritis.

5.

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.

6.

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 ...

7.

moximed.com

moximed.com/news/fda-authorizes-marketing-of-misha-knee-system-for-people-suffering-from-knee-osteoarthritis/

FDA Authorizes Marketing of MISHA™ Knee System ...

The MISHA Knee System is indicated to treat people with medial knee OA who failed to find relief from non-surgical or surgical treatment.

8.

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%).

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4521683/

Safety and Feasibility of a KineSpring Knee System for ...

Experimentation demonstrated no complications that could be attributed to the device specifically and that it replicated healthy joint behavior.