Calypso Knee System for Osteoarthritis

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

81 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and effectiveness of the Calypso Knee System, a device for knee pain relief, in adults aged 25-65 with medial knee osteoarthritis. The device supports the damaged area of the knee to reduce pain and improve function.

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.

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

The Calypso Knee System is unique because it is an implantable device designed to reduce the load on the knee joint, specifically targeting the medial compartment, which is often affected in osteoarthritis. Unlike traditional treatments that may involve medication or more invasive surgery, this system offers a less invasive option that aims to alleviate pain and improve function by unloading the joint, potentially bridging the gap between conservative treatments and total knee replacement. ^{1 2 3 4 5}

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

The KineSpring Knee System, a similar treatment, showed improvements in pain and function for patients with knee osteoarthritis over five years, suggesting that the Calypso Knee System might also be effective. ^{1 2 6 7 8}

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

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

I am between 25 and 65 years old.

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

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

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 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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

What interventions can improve quality of life or psychosocial factors of individuals with knee osteoarthritis? A systematic review with meta-analysis of primary outcomes from randomised controlled trials. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Relationship between scores from the Knee Outcome Survey and a single assessment numerical rating in patients with patellofemoral pain. [2022]

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

Safety and Feasibility of a KineSpring Knee System for the Treatment of Osteoarthritis: A Case Series. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Cross-cultural adaptation and validation of the Portuguese version of the Knee injury and Osteoarthritis Outcome Score (KOOS). [2022]

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

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

7. New Zealand pubmed.ncbi.nlm.nih.gov

The KineSpring(®) Knee Implant System: an implantable joint-unloading prosthesis for treatment of medial knee osteoarthritis. [2022]

8. Italy pubmed.ncbi.nlm.nih.gov

Can UKA after KineSpring system failure be a viable option? A case report. [2020]