New knee implant tested for better mobility and Long-Term relief
NCT ID NCT06337123
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Casa di Cura Carmona
RECRUITINGMessina, 98100, Italy
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Casa di Cura San Camillo Hopital
RECRUITINGForte dei Marmi, Lucca, 55042, Italy
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Istituto Clinico Porta Sole
RECRUITINGPerugia, 06100, Italy
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Other studies related to the condition(s) this trial covers.
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- Can a new knee implant design offer better Long-Term relief?