MISHA Knee System for Osteoarthritis

Recruiting at 4 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?

Prospective, multicenter, two-arm, 2:1 randomized controlled trial (RCT) comparing the benefits in subjects with medial knee osteoarthritis who are treated with either the MISHA Knee System or with non-surgical treatment. This is the first randomized head-to-head study comparing outcomes from subjects treated with the MISHA Knee System.

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 does the MISHA Knee System treatment for osteoarthritis differ from other treatments?

The MISHA Knee System is unique because it likely functions as a joint unloading device, similar to the Atlas Knee System, which helps manage knee osteoarthritis by reducing stress on the joint without the need for invasive surgery. This approach is particularly beneficial for younger patients who want to maintain high activity levels and avoid more invasive procedures. ^{1 2 3 4 5}

What data supports the effectiveness of the MISHA Knee System treatment for osteoarthritis?

The research mentions that intra-articular hyaluronic acid (IAHA) knee injections, which are a common treatment for knee osteoarthritis, result in modest improvements in patients. This suggests that treatments involving similar approaches, like the MISHA Knee System, may also offer benefits for managing knee osteoarthritis. ^{6 7 8 9 10}

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

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]

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]

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 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]

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]

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]

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]

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]

Citations

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

Use of viscosupplementation for knee osteoarthritis: an update. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness of an Integrated Multidisciplinary Osteoarthritis Outpatient Program versus Outpatient Clinic as Usual: A Randomized Controlled Trial. [2016]

3. United States 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. [2022]

4. England 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. [2019]

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

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

6. 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]

7. Canada 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. [2020]

8. United States 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). [2020]

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

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

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

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