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Smart knee surgery: new navigation tool aims for perfect fit

NCT ID NCT04844879

Knowledge-focused Sponsor: Medacta International SA Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a surgical navigation system called NextAR TKA that helps surgeons balance soft tissues during knee replacement. Forty adults scheduled for knee replacement with a specific implant were enrolled. The goal was to see if the system improves patient-reported outcomes like pain and function. The study is complete, and results will show whether this technology offers benefits over standard surgery.

What this could mean

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

Active substance
NextAR TKA system (surgical guidance device)
What this could lead to
If successful, this could lead to more personalized and potentially better outcomes for knee replacement surgery.
What could go wrong
This is a small, early-stage study with only 40 participants, so results may not apply to everyone. The device is already approved, but its added benefit over standard surgery is not yet proven.

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

40 people

The number who actually took part.

Started

May 2021

Finished

Jun 2024

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

18 years and older

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. Males and females aged over 18 years at time of surgery. 2. Patients who are scheduled to receive Medacta GMK® Sphere system for primary TKA (class III, CE-marked). 3. Patients with functional contralateral knee (i.e. without the need to use walking aids). 4. Patients willing and able to provide written informed consent for participation. 5. Patients willing to comply with the pre and post-operative evaluation schedule. Exclusion Criteria: 1. Patients with one or more medical conditions identified as a contraindication defined by the labelling on any Medacta implants used in this study: * Patients presenting with progressive local or systemic infection * Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable. * Severe instability secondary to advanced destruction of condralar structures or loss of integrity of the medial or lateral ligament 2. Patients whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems. 3. Patients affected by concomitant spine, hip, ankle or contralateral knee pathologies that can affect walking capacity. 4. Patients unable to understand and take action. 5. Patients with known allergy to the materials used. 6. Patients in which Medacta GMK® Sphere system is used in emergency interventions.

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Conditions

The condition(s) this trial relates to.

musculoskeletal system disorder osteoarthritis, knee

As listed by the trial registrant

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

Musculoskeletal diseases

Contacts and locations

Locations

  • Kantonsspital Winterthur

    Winterthur, 8401, Switzerland

  • Privatklinik Belair

    Schaffhausen, 8200, Switzerland

  • Privatklinik Lindberg

    Winterthur, 8400, Switzerland

  • Uniklinik Balgrist

    Zurich, 8008, Switzerland

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