New knee implant aims to make patients forget they have a replacement

NCT ID NCT05459948

Symptom relief Sponsor: Medacta International SA Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new knee implant called the GMK SpheriKA, placed using a special alignment technique. The goal is to see if patients can forget they have an artificial joint in everyday life. Researchers will follow 281 adults aged 18 to 80 who need a first-time total knee replacement. They will measure how natural the knee feels and how well it works over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: GMK SpheriKA knee prosthesis
What this could lead to: If it works, this could mean a more natural-feeling knee replacement that patients barely notice in daily life.
What could go wrong: This is an observational post-market study, not a randomized trial. Results may not apply to all patients, and some may still feel the implant or have complications.

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.

Participants

About 281 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

May 2035

An estimate. End dates often move.

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.

Who is studied

281 participants are planned for the entire project (all sites combined). Patients requiring "GMK® SpheriKA" implanted via the kinematic alignment technique will be informed and enrolled during the preoperative visit. The study is conducted as standard of care treatment and participants will receive the same treatment and undergo the same postoperative assessments as non-participants.

Ages: 18 to 80 years
Sex: Anyone

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: * Patients willing to sign the informed consent. * Patients able to comply with follow-up requirements, including postoperative weight-bearing restrictions and self-evaluations. * Patients 18 - 80 years of age at the time of surgery. * Patients requiring a primary total knee replacement (on label use). * Patients with intact collateral ligaments. Exclusion Criteria: * Patients with inflammatory arthritis. * Morbidly obese patients, with a body mass index (BMI) \> 40. * Patients with a history of total or unicompartmental reconstruction of the affected joint. * Patients that have had a high tibial osteotomy or femoral osteotomy. * Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. * Patients with a systemic or metabolic disorder leading to progressive bone deterioration. * Patients that are immunologically compromised or receiving chronic steroids (\> 30 days). * Patients whose bone stock is compromised due to disease or infection, unable to provide adequate support and/or fixation to the prosthesis. * Patients with an active or suspected latent infection in or surrounding the knee joint. * Pregnant or breastfeeding women.

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Conditions

The condition(s) this trial relates to.

arthropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arthropathy Knee replacement

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

4 sites in 3 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

New knee implant aims to make patients forget they have a replacement

What the study statuses mean