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Custom knee implant tested for Long-Term relief

NCT ID NCT03755388

Disease control Sponsor: Universitaire Ziekenhuizen KU Leuven 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing a custom-made metal knee implant called Episealer for people with cartilage damage in the knee. The implant is designed based on each patient's MRI scan. Researchers are following a small group of patients for up to 10 years to see if the implant stays in place and helps with pain and function.

What this could mean

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

Active substance
Episealer device (custom metal implant for knee cartilage)
What this could lead to
If successful, this could offer a long-lasting option for people with knee cartilage damage who haven't been helped by other surgeries.
What could go wrong
This is a very small, early-stage trial with only 4 participants, so results may not apply to everyone. The implant could fail or require removal over time.

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

4 people

The number who actually took part.

Started

Sep 2018

Expected to finish

Dec 2034

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Subjects with a focal cartilage lesion of the distal femur in which biological surgical methods have failed or are not eligible * Minimal age 18 years (Preferred age group \>40 years) * Suitable for implant, to be determined by analysis of MRI imaging. Suitability is set by the size and location of the lesion. * Informed consent Exclusion Criteria: * Under age (\<18yrs) * Active or recent (\<1 yr) septic arthritis of the involved knee * Associated symptomatic untreated ligamentary or meniscal pathology in the involved knee * (Severe) osteoarthritis in the involved or other compartments of the involved knee * Severe osteoporosis * MRI not possible (eg. due to pacemaker) * Marked valgus- or varus alignment (\>6 degrees)

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Conditions

The condition(s) this trial relates to.

Knee Injuries

As listed by the trial registrant

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

Cartilage damage Knee injuries

Contacts and locations

Locations

  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.