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Knee revision success: 3D metal cones show promise in new study

NCT ID NCT06578897

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 118 people who had knee revision surgery using Medacta's 3D metal cones to support the bone. Researchers measured pain, function, and how often patients 'forgot' about their new knee. The goal was to see if the cones help the knee work better and last longer. Since the study is already complete, the results will add to what doctors know about using these cones.

What this could mean

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

Active substance
3D metal tibial and femoral cones (medical device)
What this could lead to
If successful, this could confirm that 3D metal cones help support knee revision surgeries, leading to better long-term outcomes for patients with severe bone loss.
What could go wrong
This is a small, completed retrospective study with no control group. Results may not apply to all patients, and the device is already on the market, so no major breakthrough is expected.

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

118 people

The number who actually took part.

Started

Feb 2024

Finished

Feb 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.

Who is studied

The total expected number of subjects to be included in this study is a minimum number of 50. This number has been estimated according to the number of surgeries that have been performed and is considered in-line with observational studies published in literature.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Subjects underwent revision total knee replacement for any type of etiology (Osteoarthritis, Avascular necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis, Polyarthritis, Primary implantation failure, Infection, Ligamentous Instability) * Subjects must have received a Medacta GMK Revision component using 3D metal tibial and femoral cones * Must be at minimum 1 year (12 months) post-treatment * No age limit criteria Exclusion Criteria: * Subjects with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device * Subjects that were incarcerated at the time of surgery. * History of alcoholism * On chemotherapy or radiation therapy during the time of interest * Habitual use of narcotic pain medications prior to surgery or after surgery for reasons other than knee pain * History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis * History of chronic pain issues for reasons other than knee pain * Progressive local or systemic infection during time of interest * Muscular loss, neuromuscular disease, or vascular deficiency of the affected limb * Obesity or excessive weight of subject

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As listed by the trial registrant

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

Total knee arthroplasty

Contacts and locations

Locations

  • Northwestern

    Chicago, Illinois, 60611, United States

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