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Can a tiny shock absorber in the knee replace the need for joint replacement?

NCT ID NCT03838978

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

81 people

The number who actually took part.

Started

Feb 2019

Finished

Mar 2025

Lead sponsor

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

25 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Mirai Clinic

    Warsaw, Poland

  • SPORTO

    Lodz, Poland

  • UZ Gent

    Ghent, Belgium

  • Zagiel Med Hospital

    Lublin, Poland

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