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New knee implant tested for better mobility and Long-Term relief

NCT ID NCT06337123

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study is testing a new type of knee implant that doesn't require bone cement, in 130 people needing total knee replacement. The goal is to see if the implant improves knee function, reduces pain, and helps patients feel more natural after surgery. Researchers will track outcomes like knee scores and movement for up to 2 years.

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 130 people

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

Started

Apr 2025

Expected to finish

Apr 2029

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

General population of subjects requiring a primary TKR with a diagnosis of painful primary or secondary osteoartrithis not responding to other conservative treatments, after the review of medical history and the radiographic evaluation of the affected knee.

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. Male or female of any race requiring a total knee replacement (TKR) and suitable for receiving Physica Porous KR or Physica Porous PS femoral component in combination with Physica TT Tibial Plate. 2. Age ≥ 18 years old. 3. Candidate for primary total knee replacement when clinical indications based on physical examination and medical history include one or more of the following conditions: 1. Non-inflammatory degenerative joint disease like knee osteoarthritis, post traumatic knee arthritis 2. Inflammatory degenerative joint disease like rheumatoid arthritis 3. Any other medical reason for which the investigator deems the subject as a possible candidate for total knee replacement. 4. Patient has well-preserved and well-functioning collateral ligaments and one of the following conditions: 1. Absent or not-functioning posterior cruciate ligament and severe antero-posterior instability of the knee joint (for Physica Porous PS) 2. Undamaged and functional posterior cruciate ligament (for Physica Porous KR) 5. Patient is able to understand the conditions of the study, to comply with the prescribed rehabilitation as well as willing to perform all scheduled follow-up visits. 6. Patient signed the study-specific informed consent form approved by the ethics committee before study activities Exclusion Criteria: 1. Severe instability of the knee joint secondary to the absence of collateral ligament integrity and/or function. Only for Physica Porous KR: important joint instability and deficiency of posterior cruciate ligament. 2. Any active or suspected infection (local or systemic) or previous history of infection that may affect the prosthetic joint. 3. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy. 4. Significant bone loss on femoral or tibial joint side. 5. Affected by malignant cancer with life expectancy less than 2 years or where cancer treatment might affect the normal postoperative course. 6. Known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials. 7. Septicaemia. 8. Persistent acute or chronic osteomyelitis. 9. Open epiphyses (immature patient with active bone growth). 10. Necrotic bone 11. Arterial vascular insufficiency or nerve diseases of the lower limbs severe enough to interfere with the study evaluation. 12. Compromised bone stock due to disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis. 13. Systemic or metabolic disorders leading to progressive bone deterioration, which may impair fixation and stability of the implant. 14. Any concomitant disease and dependency that might affect the performance of the implanted prosthesis. 15. Any clinically major pathology based on clinical medical history or any medical intervention or reason that the Investigator feels may affect the study evaluation. 16. Neurological or musculoskeletal disorder or disease that may adversely affect gait, functional recovery and evaluation. 17. Neuromuscular or neurosensory deficit that would hamper the performance assessment of the device. 18. Any psychiatric illness that would prevent comprehension of the details and nature of the study. 19. Simultaneously taking part in another surgical intervention study or pain management study that may affect with clinical study outcomes. 20. Female patient who is pregnant, nursing, or planning a pregnancy. 21. Important osteoporosis, haemophilic disease. 22. Internistic problems with high risk for 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

    3 sites. 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

  • Casa di Cura Carmona

    RECRUITING

    Messina, 98100, Italy

  • Casa di Cura San Camillo Hopital

    RECRUITING

    Forte dei Marmi, Lucca, 55042, Italy

  • Istituto Clinico Porta Sole

    RECRUITING

    Perugia, 06100, Italy

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