Calypso Knee System for Osteoarthritis

No longer recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Moximed

Must not be taking: Steroids, Chemotherapy

Disqualifiers: Rheumatoid arthritis, Paget's, Charcot's, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Calypso Knee System, a new potential treatment, to evaluate its safety and effectiveness for individuals with painful osteoarthritis in the inner part of the knee. It targets those who have tried other treatments for at least six months without success. Ideal participants experience knee pain specifically on the inside of the knee and have no issues with the outer or other parts. As an unphased trial, this study provides patients the opportunity to explore a new treatment option that could potentially alleviate their knee pain.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using steroids or chemotherapy. It's best to discuss your specific medications with the trial team.

What prior data suggests that the Calypso Knee System is safe for osteoarthritis patients?

Research has shown that the Calypso Knee System might be safe for individuals with knee osteoarthritis. Some studies have tested this system in patients with knee problems, and they generally tolerate the implant well.

One study found that the Calypso Knee System reduced pain and improved movement. However, it did not consistently outperform other treatments in reducing pain over two years. This suggests the system is generally safe, but it might not be the best choice for everyone.

This system has been tested in people with knee issues, and many have experienced positive results. However, as with all treatments, results can vary. Consulting a healthcare provider is essential to determine if it is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Calypso Knee System is unique because it offers a new approach to treating osteoarthritis in the knee. Unlike traditional treatments like pain relievers, physical therapy, or even surgical options like knee replacement, the Calypso system potentially provides a less invasive alternative. Researchers are excited about this treatment because it promises to address the root causes of joint degeneration rather than just alleviating symptoms. This could lead to improved mobility and quality of life for patients with fewer side effects and reduced recovery times compared to conventional surgical methods.

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

Research has shown that the Calypso Knee System could significantly benefit individuals with knee osteoarthritis. Studies have found that implantable shock absorbers, such as the Calypso system, relieve pain and enhance movement more effectively than traditional surgeries like high tibial osteotomy. One study demonstrated that similar devices reduced pain and improved knee function over two years. These findings suggest that the Calypso system might be an effective option for managing knee osteoarthritis symptoms. Early results are encouraging, highlighting the Calypso system's potential to assist those with this condition. ^{1 3 4 5 6}

Who Is on the Research Team?

David Flanigan, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for people aged 25-65 with persistent knee pain due to osteoarthritis on the inner side, despite non-surgical treatments for at least 6 months. Participants should have a BMI of less than 35 and weigh under 300 lbs. Those with unstable knee ligaments, other joint diseases, metal allergies, infections, certain neurological conditions or taking steroids/chemotherapy are excluded.

Inclusion Criteria

Body Mass Index (BMI) of less than 35 and Weight less than 300 lbs

I have inner knee pain from osteoarthritis despite 6 months of non-surgical treatment.

I am between 25 and 65 years old.

Exclusion Criteria

I am not on steroids or chemotherapy that could affect the study.

I have osteoarthritis symptoms in my other knee or in parts of my target knee.

I do not have allergies to metals, active infections, or specific neurological conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Calypso Knee System for symptom relief in medial knee osteoarthritis

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Calypso Knee System

Trial Overview

The Calypso Knee System study tests an implantable shock absorber's safety and effectiveness in individuals with symptomatic osteoarthritis in the medial compartment of their knee.

How Is the Trial Designed?

Group I: Calypso Experimental Treatment 1 Intervention

Calypso Knee System

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 KineSpring Knee Implant System is a novel treatment for medial compartment knee osteoarthritis that aims to reduce pain and improve function by unloading the affected area, showing promising results in preclinical and clinical studies.

This implant has demonstrated excellent durability and significant reductions in joint loading, offering a potential solution that balances low complication risks with effective symptom relief, unlike traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The KineSpring(®) Knee Implant System: an implantable joint-unloading prosthesis for treatment of medial knee osteoarthritis. Clifford, AG., Gabriel, SM., O'Connell, M., et al.[2022]

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.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03671213

NCT03671213 | Calypso Knee System Clinical Study

A clinical study to evaluate the safety and effectiveness of the Calypso Knee System when used in subjects with symptomatic osteoarthritis of the medial ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36823955/

Implantable Shock Absorber Provides Superior Pain Relief ...

Implantable Shock Absorber Provides Superior Pain Relief and Functional Improvement Compared With High Tibial Osteotomy in Patients with Mild-to ...

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 met its primary endpoint and was found to be superior to high tibial osteotomy (HTO) at two years.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03838978?tab=table

NCT03838978 | Calypso Knee System Clinical Study, OUS

The Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Survey includes the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) in its ...

5.

trials.arthritis.org

trials.arthritis.org/trials/NCT03671213

Calypso Knee System Clinical Study - Arthritis Foundation

Study Purpose. A clinical study to evaluate the safety and effectiveness of the Calypso Knee System when used in subjects with symptomatic osteoarthritis of the ...

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/reviews/DEN220033.pdf

Medial knee implanted shock absorber ... - accessdata.fda.gov

The one endpoint that the data did not support superiority for the Calypso Knee group was the WOMAC Pain % change from Baseline at Month 24.