Can a tiny shock absorber in the knee replace the need for joint replacement?
NCT ID NCT03838978
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This study tests whether an implantable device called the Calypso Knee System can relieve pain and improve function in people with knee osteoarthritis that has not responded to at least six months of non-operative treatment. The device acts as a shock absorber to offload the inner part of the knee. Researchers will measure pain, function, and safety over 24 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an implantable shock absorber called the Calypso Knee System
- What this could lead to
- If it works, this could offer a new treatment option for knee osteoarthritis that fills the gap between conservative care and more invasive surgery.
- What could go wrong
- This is an early study with 81 participants, so results may not apply to everyone. Risks include device-related infections, nerve or ligament damage, and the need for additional surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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81 people
The number who actually took part.
- Started
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Feb 2019
- Finished
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Mar 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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25 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participants age - 25 to 65 years 2. Body Mass Index (BMI) of \< 35, Weight \< 300 lbs (136 kg) 3. Knee osteoarthritis pain on the inner side of knee that has continued after at least 6 months of non-operative treatment Exclusion Criteria: 1. Symptoms of osteoarthritis in the other knee or in lateral (outer) or patellofemoral compartments of the target knee 2. Knee ligament or meniscal instability 3. Other bone or joint conditions such as Rheumatoid arthritis, Paget's disease, Charcot's disease or general conditions such as allergy or hypersensitivity to certain metals, active infection, certain neurological conditions, use of medication such as steroids or chemotherapy that could impact study participation or results
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Carolina Medical Center
Warsaw, Poland
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Mirai Clinic
Warsaw, Poland
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SPORTO
Lodz, Poland
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UZ Gent
Ghent, Belgium
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Zagiel Med Hospital
Lublin, Poland
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