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Can a meniscus implant keep knees working years later?

NCT ID NCT07800923

Disease control Sponsor: Orteq Sports Medicine 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This study looks back at people who received an Actifit meniscal scaffold, a small implant that replaces damaged meniscus tissue in the knee after a tear or partial removal. Researchers will contact about 120 past patients to see if the implant is still in place and how their knee is doing 4 to 6 years after surgery. They will collect information on pain, function, and quality of life, and may take new X-rays or MRIs if patients agree. The goal is to understand how well the scaffold holds up over time and whether it helps people avoid more serious knee surgery.

What this could mean

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

Active substance
Actifit meniscal scaffold, a medical implant designed to replace damaged meniscus tissue in the knee
What this could lead to
If the scaffold holds up well over several years, it could offer a lasting option for people with meniscus tears who want to avoid or delay knee replacement.
What could go wrong
This is a follow-up study, not a new treatment test, so it won't prove the scaffold works better than other options. Some patients may have had the scaffold removed or needed further surgery, which could limit the findings.

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 120 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

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

Patients implanted with an Actifit scaffold more than 4 years ago with the implant still intact and a baseline IKDC score.

Ages

18 to 50 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: At time of operation, with respect to the involved knee: * Patients with irreparable, painful and/or dysfunctional meniscal tissue loss having undergone partial meniscectomy. * Sufficient rim over the entire circumference of the meniscus to ensure stable fixation. * Well aligned knee joint (varus/valgus \<5o) or willing to correct alignment at implant surgery * Stable knee joint or ACL deficiencies corrected within 12 weeks after implantation of Actifit. * ICRS classification ≤ 3. * No more than 3 prior meniscal surgeries on the involved knee. * Skeletally mature men or women, aged 16 to 50 years at time of Actifit procedure. * Actifit implantation at a minimum of 4 years ago * Willing to participate in this long-term follow-up study. Exclusion: At time of operation: * PCL insufficiency of the involved knee. * Significant uncorrected malformations, axial malalignment in the ipsilateral leg. * Documented allergy to any of the product components. * Systemic or local infection at the time of the operation. * Overweight at the time of operation (defined as BMI greater than 35kg/m²) * Systemic administration of any type of corticosteroid, antineoplastics, immune-stimulating or immunosuppressive agent within 30 days before or after implantation of Actifit. * Evidence of osteonecrosis in the involved knee at the time of the operation. * Medical history at time of operation that is positive, for, but not restricted to, the following diseases: Rheumatoid arthritis Relapsing polychondritis Severe degenerative osteoarthrosis Inflammatory arthritis

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As listed by the trial registrant

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

Meniscus lesion Meniscus tear

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • University Hospital Gent

    Ghent, Oost-Vlaanderen, 9000, Belgium

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