Knee ArthropathyNCT06337123
Physica TT Tibial Plate Follow up Study
An observational study of Knee Arthropathy, run by Limacorporate S.p.a at 3 sites in Italy.
Trial summary
This clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate in combination with Physica Porous KR or Physica Porous PS up to 2 years after surgery, in order to assess the performance of the devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- Device: Physica TT TIbial Plate and Physica Porous KR and Device: Physica TT TIbial Plate and Physica Porous PS
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 3 sitesItaly
- Study dates
- 15 Apr 2025to Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
- Age ≥ 18 years old.
- Candidate for primary total knee replacement when clinical indications based on physical examination and medical history include one or more of the following conditions:
- Non-inflammatory degenerative joint disease like knee osteoarthritis, post traumatic knee arthritis
- Inflammatory degenerative joint disease like rheumatoid arthritis
- Any other medical reason for which the investigator deems the subject as a possible candidate for total knee replacement.
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- Patient has well-preserved and well-functioning collateral ligaments and one of the following conditions:
- Absent or not-functioning posterior cruciate ligament and severe antero-posterior instability of the knee joint (for Physica Porous PS)
- Undamaged and functional posterior cruciate ligament (for Physica Porous KR)
- 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.
- Patient signed the study-specific informed consent form approved by the ethics committee before study activities
Who cannot join
- 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.
- Any active or suspected infection (local or systemic) or previous history of infection that may affect the prosthetic joint.
- Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy.
- Significant bone loss on femoral or tibial joint side.
- Affected by malignant cancer with life expectancy less than 2 years or where cancer treatment might affect the normal postoperative course.
- Known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials.
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- Septicaemia.
- Persistent acute or chronic osteomyelitis.
- Open epiphyses (immature patient with active bone growth).
- Necrotic bone
- Arterial vascular insufficiency or nerve diseases of the lower limbs severe enough to interfere with the study evaluation.
- Compromised bone stock due to disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis.
- Systemic or metabolic disorders leading to progressive bone deterioration, which may impair fixation and stability of the implant.
- Any concomitant disease and dependency that might affect the performance of the implanted prosthesis.
- Any clinically major pathology based on clinical medical history or any medical intervention or reason that the Investigator feels may affect the study evaluation.
- Neurological or musculoskeletal disorder or disease that may adversely affect gait, functional recovery and evaluation.
- Neuromuscular or neurosensory deficit that would hamper the performance assessment of the device.
- Any psychiatric illness that would prevent comprehension of the details and nature of the study.
- Simultaneously taking part in another surgical intervention study or pain management study that may affect with clinical study outcomes.
- Female patient who is pregnant, nursing, or planning a pregnancy.
- Important osteoporosis, haemophilic disease.
- Internistic problems with high risk for surgery.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
Casa di Cura San Camillo Hopital
Forte dei Marmi, Lucca, 55042
Alessandro Tripodo
Alessandro Tripodo
- Recruiting
Casa di Cura Carmona
Messina, 98100
Marcello La Bruna
Marcello La Bruna
- Recruiting
Istituto Clinico Porta Sole
Perugia, 06100
Stefano Lignini
Stefano Lignini
About this study
Official title: A Post Market Clinical Study Evaluating Clinical and Radiographic Outcomes of Total Knee Arthroplasty With Physica Porous KR or Physica Porous PS in Combination With Physica TT Tibial Plate in Cementless Configuration.
This clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate in combination with Physica Porous KR or Physica Porous PS up to 2 years after surgery, in order to assess the performance of the devices. Furthermore, ithe objective is to collect short-term survivorship of the implant and the incidence of early complications.
- Conditions
- Knee Arthropathy
- Being tested
- Device: Physica TT TIbial Plate and Physica Porous KR, Device: Physica TT TIbial Plate and Physica Porous PS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Physica TT TIbial Plate and Physica Porous KRDevice
Devices: Physica TT Tibial Plate and Physica Porous KR femoral component
Data collection of population that underwent total knee arthroplasty with Physica TT Tibial Plate and Physica Porous KR femoral component
Device: Physica TT TIbial Plate and Physica Porous PSDevice
Devices: Physica TT Tibial Plate and Physica Porous KR femoral component
Data collection of population that underwent total knee arthroplasty with Physica TT Tibial Plate and Physica Porous PS femoral component
| Study group | Role | What they receive |
|---|---|---|
| Physica Porous KR femoral component | Devices: Physica TT Tibial Plate and Physica Porous KR femoral component
Total knee arthroplasty with Physica TT Tibial Plate and Physica Porous KR femoral component Receives: Device: Device: Physica TT TIbial Plate and Physica Porous KR | |
| Physica Porous PS femoral component | Devices: Physica TT Tibial Plate and Physica Porous PS femoral component
Total knee arthroplasty with Physica TT Tibial Plate and physica Porous PS femoral component Receives: Device: Device: Physica TT TIbial Plate and Physica Porous PS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Knee Society Score (KSS) equal or greater than "Good" (score ≥ 70) 2 years after surgery
0-100 scale. Scores rating from 80 to 100 are considered excellent, between 70 and 79 good, between 60 and 69 fair, and less than 60 poor
Measured: 2 years after surgery
Secondary outcomes (7)
Changes in Range of Motion over time up to 2 years after surgery
Measured: From preoperative to 2 years after surgery
Changes in Oxford Knee Score (OKS) over time up to 2 years after surgery.
Overall score from 0 to 48, with 48 being the best outcome
Measured: From preoperative to 2 years after surgery
Changes in Forgotten Joint Score (FJS) over time up to 2 years after surgery.
Overall score from 0 to 100, with 100 being the best outcome
Measured: From preoperative to 2 years after surgery
Changes in Visual Analogue Scale (VAS) Pain over time up to 2 years after surgery.
100 mm line, with 0 mm being best outcome (no pain) and 100 mm worst outcome (very severe pain)
Measured: From preoperative to 2 years after surgery
Radiographic implant evaluation and stability assessment from postoperative (baseline) over time up to 2 years after surgery
The treated knee is analyzed postoperatively based on anteroposterior and lateral x-rays view of the knee. The following parametner are evaluated:
- Presence of radiolucent lines
- Presence of osteolysis
- Presence of loosening
- Presence of heterotopic ossification
- Presence of periprosthetic fractures
Measured: From preoperative to 2 years after surgery
Survival rate (Kaplan-Meier) at 2 years after surgery
Measured: From preoperative to 2 years after surgery
Incidence, type and severity of Adverse Device Effects (ADE) and Serious Adverse Device Effects (SADE) up to 2 years follow up
Measured: From preoperative to 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start15 Apr 2025
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alessandro Tripodo, Principal investigator, Casa di Cura San Camillo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337123
- Sponsor's protocol ID
- K-38
- Status last verified
- Jan 2026
- First submitted
- 15 Mar 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Clinical Study Evaluating Clinical and Radiographic Outcomes of Total Knee Arthroplasty With Physica Porous KR or Physica Porous PS in Combination With Physica TT Tibial Plate in Cementless Configuration.
- ClinicalTrials.gov ID
- NCT06337123
- Acronym / sponsor ID
- K-38
- Conditions
- Knee Arthropathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate in combination with Physica Porous KR or Physica Porous PS up to 2 years after surgery, in order to assess the performance of the devices. Furthermore, ithe objective is to collect short-term survivorship of the implant and the incidence of early complications.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physica Porous KR femoral component | – | Device: Device: Physica TT TIbial Plate and Physica Porous KRDevices: Physica TT Tibial Plate and Physica Porous KR femoral component Total knee arthroplasty with Physica TT Tibial Plate and Physica Porous KR femoral component |
| Physica Porous PS femoral component | – | Device: Device: Physica TT TIbial Plate and Physica Porous PSDevices: Physica TT Tibial Plate and Physica Porous PS femoral component Total knee arthroplasty with Physica TT Tibial Plate and physica Porous PS femoral component |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (11 listed)
- 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.
- Age ≥ 18 years old.
- Candidate for primary total knee replacement when clinical indications based on physical examination and medical history include one or more of the following conditions:
- Patient has well-preserved and well-functioning collateral ligaments and one of the following conditions:
- 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.
Key exclusion criteria (22 listed)
- 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.
- Any active or suspected infection (local or systemic) or previous history of infection that may affect the prosthetic joint.
- Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy.
- Significant bone loss on femoral or tibial joint side.
- Affected by malignant cancer with life expectancy less than 2 years or where cancer treatment might affect the normal postoperative course.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: Physica TT TIbial Plate and Physica Porous KRDevices: Physica TT Tibial Plate and Physica Porous KR femoral component Data collection of population that underwent total knee arthroplasty with Physica TT Tibial Plate and Physica Porous KR femoral component | Device | Physica Porous KR femoral component |
| Device: Physica TT TIbial Plate and Physica Porous PSDevices: Physica TT Tibial Plate and Physica Porous KR femoral component Data collection of population that underwent total knee arthroplasty with Physica TT Tibial Plate and Physica Porous PS femoral component | Device | Physica Porous PS femoral component |
Primary outcome
Percentage of Knee Society Score (KSS) equal or greater than "Good" (score ≥ 70) 2 years after surgery
Time frame: 2 years after surgery
0-100 scale. Scores rating from 80 to 100 are considered excellent, between 70 and 79 good, between 60 and 69 fair, and less than 60 poor
7 secondary outcomes
Changes in Range of Motion over time up to 2 years after surgery
Time frame: From preoperative to 2 years after surgery
Changes in Oxford Knee Score (OKS) over time up to 2 years after surgery.
Time frame: From preoperative to 2 years after surgery
Changes in Forgotten Joint Score (FJS) over time up to 2 years after surgery.
Time frame: From preoperative to 2 years after surgery
Changes in Visual Analogue Scale (VAS) Pain over time up to 2 years after surgery.
Time frame: From preoperative to 2 years after surgery
Radiographic implant evaluation and stability assessment from postoperative (baseline) over time up to 2 years after surgery
Time frame: From preoperative to 2 years after surgery
Survival rate (Kaplan-Meier) at 2 years after surgery
Time frame: From preoperative to 2 years after surgery
Incidence, type and severity of Adverse Device Effects (ADE) and Serious Adverse Device Effects (SADE) up to 2 years follow up
Time frame: From preoperative to 2 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alessandro Tripodo principal investigator
Casa di Cura San Camillo Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthropathy, run by Limacorporate S.p.a at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Domizia Baldassi (+39 3357492586, domizia.baldassi@enovis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Knee Society Score (KSS) equal or greater than "Good" (score ≥ 70) 2 years after surgery (time frame: 2 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.