Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Knee implant materials put to the test in human cells

NCT ID NCT07671521

Knowledge-focused Sponsor: Stefano Zaffagnini 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This study will test whether common orthopedic materials, like titanium alloy and polylactic acid (PLA), are safe for use in knee surgery. Researchers will expose human tissue samples from 50 knee replacement patients to these materials in the lab. They will check for cell damage, inflammation, and other signs of toxicity to ensure the materials are safe before moving to animal or human trials.

What this could mean

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

Active substance
titanium alloy and polylactic acid (PLA) materials, with platelet-rich plasma (PRP)
What this could lead to
If successful, this study could confirm that these materials are safe and help improve how well knee grafts heal, leading to better surgical outcomes.
What could go wrong
This is a very early lab study using cells in a dish, not in people. Results may not predict what happens inside the body, and further testing is needed.

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 50 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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.

Who is studied

Subjects will be recruited among patients admitted to the IRCCS Istituto Ortopedico Rizzoli and scheduled for total knee arthroplasty for the treatment of chondral defects and/or undergoing regenerative infiltrative therapies with BMC and PRP. For the study, biological material obtained during the surgical removal of femoral condyles, tibial plateaus and synovial membranes, as well as during implantation of the prosthetic components, will be used. For BMC and PRP, only waste material not required for the surgical procedures will be collected. The recovery of such material will be performed during routine clinical practice by the medical staff of the Orthopaedic and Trauma Clinic II.

Ages

18 to 80 years

Sex

Anyone

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.

Femoral condyle, tibial plateau and synovial membrane samples Patients undergoing primary total knee arthroplasty at the Orthopaedic and Trauma Clinic II of the IRCCS Istituto Ortopedico Rizzoli (Bologna, Italy), in whom collection of tibial plateau, femoral condyles and/or synovial tissue is planned. Inclusion criteria: Age 18-80 years, male or female Primary tricompartmental osteoarthritis Body Mass Index (BMI) \< 35 Kellgren-Lawrence grade III-IV osteoarthritis Written informed consent Exclusion criteria: Previous partial knee arthroplasty or cartilage repair/regenerative procedures Rheumatoid arthritis or chronic corticosteroid/immunosuppressive therapy Positive testing for HIV, HBV or HCV infection Concentrated bone marrow (BMC) samples Patients of both sexes providing written informed consent and presenting with the following characteristics: Inclusion criteria: Age 18-70 years Medial compartment knee osteoarthritis (Kellgren-Lawrence grade II-III for \>4 months) Failure of ≥6 months of conservative treatment (NSAIDs/analgesics, hyaluronic acid, corticosteroid or PRP injections) Written informed consent Exclusion criteria: Inability to provide informed consent Knee trauma within the previous 6 months Malignancy, rheumatic disease, uncontrolled diabetes, uncontrolled thyroid disorders Alcohol or drug abuse BMI \> 35 Intra-articular injections within the previous 6 months Knee surgery within the previous 12 months HIV, HBV or HCV positivity Platelet-rich plasma (PRP) samples Patients of both sexes with degenerative cartilage disease of the knee. Inclusion criteria: Age 18-65 years Clinical signs and symptoms of knee cartilage degeneration Radiographic or MRI evidence of degeneration (Kellgren-Lawrence grade II-IV) Hemoglobin \> 11 g/dL Platelet count \> 150,000/mm³ No clinically relevant ECG abnormalities Written informed consent Exclusion criteria: Rheumatoid arthritis or chronic corticosteroid/immunosuppressive therapy Uncontrolled diabetes Hematological disorders or anticoagulant/antiplatelet therapy Thyroid metabolic disorders Alcohol, drug or medication abuse NSAID use within 3 days prior to blood draw Cardiovascular disease contraindicating a 150 mL blood draw HIV, HBV or HCV positivity

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cytotoxicity are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

osteoarthritis osteoarthritis, knee

As listed by the trial registrant

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

Cytotoxicity

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

  • IRCCS Rizzoli Orthopedic Institute

    Bologna, Bologna, 40136, Italy

More trials for these conditions

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