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Knee replacement system under the microscope: 5-Year safety check

NCT ID NCT07491575

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 1 time

Summary

This study will follow 100 adults who receive the 5C® MEDic Knee System during knee replacement surgery. Researchers want to see how long the implant lasts without needing another operation and track any complications over 5 years. Participants will also fill out health questionnaires to measure how well the knee works in daily life. The goal is to make sure the device is safe and performs as 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.

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

About 100 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Apr 2035

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: 1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures 2. At least 18 years of age at the time of signing the Informed Consent Form (ICF) 3. The patient will be operated at the Leuven University Hospital (primary or revision surgery). 4. The patient will receive the 5C® MEDic Knee System (manufactured by implantcast GmbH). 5. The implantation will be performed according to the medical indications listed in the product specific Instruction for Use (IFU): 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2. Post-traumatic osteoarthritis 3. Treatment of fractures that are unmanageable using other surgical techniques 4. Rheumatoid arthritis 5. Revision arthroplasty (revision prosthesis) 6. The patient is willing and able to follow all study specific procedures and to attend the follow-up visits at the study site 7. The patient agrees to be contacted by telephone or by mail. Exclusion Criteria: 1. The patient is \<18 years of age, or unable to understand and sign a written informed consent form or legally incompetent or limited in his legal capacity. 2. Patient has history of malignancy within the past 5 years before screening. 3. Patients with Adipositas permagna (BMI ≥40 kg/m²). 4. Has a current infection as well as infections close (in the opinion of the investigator) to the knee joint within the last 3 years. 5. Known allergy to any of the implant materials. 6. Female who is pregnant or intends to become pregnant during screening and at the moment of operation 7. Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, as assessed by the Investigator. 8. Current alcohol and/or drug abuse or other addictions that might impair the patient's capacity to estimate the nature and the scope of the study. 9. Bilateral Total Knee Arthroplasty in a period of \< 3 months. 10. Physiological or anatomical conditions, which preclude or are not expected to maintain adequate bony support of the implant or do not allow the implantation of a sufficiently large prosthesis, in the opinion of the investigator. 11. Bone tumors in the implant fixation area. 12. Has an untreated vascular diseases which limit blood supply to the affected limb, in the opinion of the investigator 13. Has a metabolic disorders that may impair bone formation. 14. In case of insufficient quantity and quality of bone stock, an alternative prosthetic treatment allowing for sufficient bony fixation should be considered. 15. Has severe axis deviation in treated knee under study and/or non-treated knee. 16. Ligament instability in treated knee under study. 17. Participation in an interventional trial with an investigational medicinal product (IMP) or device within the last four weeks before Screening. 18. Any other clinical history finding that, in the judgment of the investigator, would pose a potential hazard for performing a knee surgery

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  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

  • Universitaire Ziekenhuizen KU Leuven

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

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