Knee Arthroplasty, TotalNCT06830603
Physica TT Tibial Plate Prospective Study
An observational study of Knee Arthroplasty, Total and Knee Osteoarthritis, run by Limacorporate S.p.a.
Trial summary
This prospective clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate over 2 years after surgery, in order to assess the performance and safety of the devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroplasty, Total, Knee Osteoarthritis
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Dec 2028
- 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
- Patient requiring a total knee arthroplasty (TKA) and suitable for receiving 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 such as knee osteoarthritis, post traumatic knee arthritis;
- Inflammatory degenerative joint disease such as rheumatoid arthritis;
- Patient has well-preserved and well-functioning collateral ligaments
- Patient is able to understand the conditions of the study, is willing and able to follow all prescribed rehabilitation as well as willing to perform all scheduled follow-up visits;
- Patient has signed the study-specific Informed Consent Form prior to study activities
Who cannot join
- Patient is affected by one or more of the conditions that are stated as Physica contraindications for use, which are:
- Severe instability of the knee joint secondary to the absence of collateral ligament integrity and/or function.
- Any active or suspected infection (local or systemic) or previous history of infection that may affect the prosthetic joint.
- Significant bone loss on femoral or tibial joint side.
- Known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials.
- Septicaemia.
Show all 23Show fewer
- 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.
- Important osteoporosis, haemophilic disease.
- Internistic problems with high risk for surgery.
- Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy.
- Affected by malignant cancer with life expectancy less than 2 years or where cancer treatment might affect the normal postoperative course.
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Francesca Citossi contact
About this study
Official title: A Post Market, Prospective Clinical Study Evaluating Clinical and Radiographic Outcomes of Patients Undergoing Total Knee Arthroplasty with Physica TT Tibial Plate
This prospective clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate over 2 years after surgery, in order to assess the performance and safety of the devices. Short-term survivorship of the implant and the incidence of early complications are evaluated.
- Conditions
- Knee Arthroplasty, Total, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Physica TT Tibial Plate | Total knee arthroplasty with Physica TT Tibial Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Society Score from preoperative to 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: From preoperative to 2 years after surgery
Secondary outcomes (5)
Change in Oxford Knee Score
Overall score from 0 to 48, with 48 being the best outcome
Measured: From preoperative to 2 years after surgery
Change in Range of Motion
Measured: From preoperative to 2 years after surgery
Radiographic implant evaluation and stability assessment
The treated knee is analyzed postoperatively based on knee x-rays. The following parameters 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
Incidence, type and severity of Adverse Device Effects (ADE) and Serious Adverse Device Effects (SADE)
Measured: From preoperative to 2 years after surgery
Implant survival rate
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 posted17 Feb 2025
- Study startMay 2025 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroplasty, TotalStudies 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
- Prospective
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830603
- Sponsor's protocol ID
- K-41
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 17 Feb 2025
- 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 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market, Prospective Clinical Study Evaluating Clinical and Radiographic Outcomes of Patients Undergoing Total Knee Arthroplasty with Physica TT Tibial Plate
- ClinicalTrials.gov ID
- NCT06830603
- Acronym / sponsor ID
- K-41
- Conditions
- Knee Arthroplasty, Total, Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- May 2025 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Feb 2025 (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 prospective clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate over 2 years after surgery, in order to assess the performance and safety of the devices. Short-term survivorship of the implant and the incidence of early complications are evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physica TT Tibial Plate | – | –Total knee arthroplasty with Physica TT Tibial Plate |
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 (8 listed)
- Patient requiring a total knee arthroplasty (TKA) and suitable for receiving 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
- Patient is able to understand the conditions of the study, is willing and able to follow all prescribed rehabilitation as well as willing to perform all scheduled follow-up visits;
Key exclusion criteria (23 listed)
- Patient is affected by one or more of the conditions that are stated as Physica contraindications for use, which are:
- Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy.
- Affected by malignant cancer with life expectancy less than 2 years or where cancer treatment might affect the normal postoperative course.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Knee Society Score from preoperative to 2 years after surgery
Time frame: From preoperative to 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
5 secondary outcomes
Change in Oxford Knee Score
Time frame: From preoperative to 2 years after surgery
Change in Range of Motion
Time frame: From preoperative to 2 years after surgery
Radiographic implant evaluation and stability assessment
Time frame: From preoperative to 2 years after surgery
Incidence, type and severity of Adverse Device Effects (ADE) and Serious Adverse Device Effects (SADE)
Time frame: From preoperative to 2 years after surgery
Implant survival rate
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 17 Feb 2025.
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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.
Francesca Citossi contact
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthroplasty, Total and Knee Osteoarthritis, run by Limacorporate S.p.a.
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 8 inclusion and 23 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: opening soon, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Knee Society Score from preoperative to 2 years after surgery (time frame: From preoperative to 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 17 Feb 2025.