What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, particularly those focusing on structural support and alignment for the knee joint, include the use of knee braces and orthotics. Side effects of knee bracing can include minor complications such as slipping, poor fit, and discomfort, with compliance rates varying between 45 to 58 percent. For broader osteoarthritis treatments, nonsteroidal anti-inflammatory drugs (NSAIDs) are frequently used and can cause gastrointestinal issues, cardiovascular risks, and other major adverse effects. Intraarticular glucocorticoid injections, while providing short-term relief, are associated with potential joint damage and are less effective compared to physical therapy.

What prior FDA approvals exist?

The FDA has approved various treatments for osteoarthritis, primarily focusing on pain relief and functional improvement. These include nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen, and intraarticular glucocorticoid injections for short-term pain relief. While the Calypso Knee System focuses on structural support and alignment, similar FDA-approved treatments include knee braces and orthotic devices designed to offload stress from the affected knee compartment. Surgical options such as total knee arthroplasty (knee replacement) are also approved for severe cases where other treatments have failed.

What other types of research exist?

Promising alternatives to the Calypso Knee System for osteoarthritis patients include: 1) Generation II (G II) knee brace, which has shown clinical efficacy in severe medial compartment osteoarthritis. 2) Valgus unloading braces like the Bledsoe Thruster and SofTec OA braces, which have demonstrated positive short-term clinical and radiographic outcomes. 3) Masai Barefoot Technology shoes, which have been shown to reduce knee joint moments in osteoarthritis patients. 4) Atlas Unicompartmental Knee System, which has shown favorable clinical outcomes in a two-year study for medial compartment osteoarthritis.

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Not Applicable

Calypso Knee System for Osteoarthritis

N/A

Waitlist Available

Led By David Flanigan, MD

Research Sponsored by Moximed

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants age 25 to 65 years

Be older than 18 years old

Must not have

Symptoms of osteoarthritis in the other knee or in lateral (outer) or patellofemoral compartments of the target knee

Other bone or joint conditions such as Rheumatoid arthritis, Paget's disease, Charcot's disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 24 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include discomfort at the implant site, potential allergic reactions to materials used in the device, infection risk post-surgery and possible impact on mobility if complications arise.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 25 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have a condition like Rheumatoid arthritis, Paget's disease, or Charcot's disease.

Select...

My knee is unstable due to a ligament or meniscal issue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite Clinical Success (CCS)

Secondary study objectives

Time to Full Weight Bearing (Days)

WOMAC Function Percent Change to Month 24

WOMAC Function Percent Change to Month 3

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CalypsoExperimental Treatment1 Intervention

Calypso Knee System

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for osteoarthritis (OA) include nonsteroidal anti-inflammatory drugs (NSAIDs), which reduce inflammation and pain by inhibiting cyclooxygenase enzymes; duloxetine, an antidepressant that helps manage chronic pain by modulating neurotransmitters; and intraarticular glucocorticoid injections, which provide short-term pain relief by reducing local inflammation. Structural support and alignment systems, such as the Calypso Knee System, aim to alleviate symptoms by redistributing load and improving joint alignment, thereby reducing stress on the affected areas. This is particularly important for OA patients as it can help preserve joint function, delay the progression of the disease, and improve overall quality of life.

Knee osteoarthritis: pathophysiology and current treatment modalities.