An observational study in Knee Osteoarthritis, sponsored by Limacorporate S.p.a. Active, not recruiting at 4 sites in 3 countries. Open to participants aged 22 Years to 78 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Limacorporate S.p.a (part of Enovis) · Observational
Type \& Design:
Post-market, international, multicentre Prospective, parallel groups, open-label, baseline controlled
Objectives:
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's enrollment of 157 is above the median of 100 across 486 observational studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Limacorporate S.p.a is the lead sponsor of 31 studies on the registry; 12 are open to participants now.
First submitted before Limacorporate S.p.a became part of Enovis.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any pathology based on clinical history that the Investigator feels may affect the study evaluation including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who have undamaged and functional collateral and posterior cruciate ligaments for the group requiring Physica CR
Device: Physica CR
Patients who have undamaged and functional collateral ligaments for the group requiring Physica PS
Device: Physica PS
Cruciate retaining total knee replacement
Posterior Stabilized total knee replacement
Clinical change in Knee Society Score (KSS)
KSS is divided into two components: the first ("Knee Score", KKSS) assesses the knee clinically through the physical examination, and the second ("Function Score", FKSS) assesses the individual's functionality, while both attain a total of 100 points each. The Clinical KSS (KKSS) evaluates pain (50 points), stability (25 points) and range of motion (25 points). The Functional KSS (FKSS) evaluates the walking distance (50 points), and the act of climbing and descending stairs (50 points). The system for selecting patients is provided through three categories: A- unilateral or bilateral (opposite knee replaced successfully), B- unilateral, other knee symptomatic and C- polyarthritis or clinical disease. Scores rating from 80 to 100 is considered excellent, from 70 to 79 good, from 60 to 69 fair, and less than 60 poor.
Time frame: From preoperative (baseline) to 5 years after surgery
Functional change in Timed up and Go (TUG) test
The Timed-get-up-and-go test (TUG) is a simple test widely used to assess a person's mobility, requiring both static and dynamic balance. Subjects are instructed to walk as quickly as they feel safe and comfortable. Time (seconds) is taken to rise from a chair (seat height, 46 cm), walk 3 meters, turn around, walk back to the chair, then sit down wearing regular footwear. The TUG has excellent inter-rater and intra-rater reliability. Timing starts on the signal to start and terminates once the participant sits back down fully with their back resting on the back of the chair. Regular walking aid is allowed and recorded if required. Two trials are performed and the faster of the 2 trials is recorded to nearest 10th of a second.
Time frame: From preoperative (baseline) to 5 years after surgery
Change in Knee injury and Osteoarthritis Outcome Score (KOOS)
KOOS was developed and is validated for several cohorts of younger and/or more active patients with knee injury and/or knee osteoarthritis. KOOS is a 42-item self-administered self-explanatory questionnaire that covers five patient-relevant dimensions: Pain, Other Disease-Specific Symptoms, Active Daily Living Function, Sport and Recreation Function, and knee-related Quality of Life. The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures.
Time frame: From preoperative (baseline) to 5 years after surgery
Change in Satisfaction Visual Analogue Scale (Satisfaction VAS)
A Satisfaction Visual Analogue Scale (VAS) system was developed to evaluate patient satisfaction with the TKR at follow-up, similar to the system used to measure pain. The scale consists of a 10-cm-long horizontal line ranging from completely satisfied to totally unsatisfied. On top of the scale the question: "Are you satisfied with your knee prosthesis?" is placed. Facial expressions are put above the line to express satisfaction visually. The patient receives this scale and is asked to mark the line at a point that would match his/her satisfaction. With a ruler, the number of millimetres is measured and converted to points. The satisfaction VAS system ranges from 100 (best, completely satisfied) to 0 (worst, totally unsatisfied) points.
Time frame: From 3 months to 5 years after surgery
Change in Forgotten Joint Score (FJS-12)
The Forgotten Joint Scores (FJS-12) comprises measures for the assessment of joint-specific patient-reported outcome and focus on patients' awareness of a specific joint in everyday life. FJS-12 is a 12-item questionnaire that integrates variables such as pain, stiffness, function on activities of daily living, patients' expectations and activity levels and finally psychosocial factors. It consists of 12 questions and is scored using a 5-point Likert response format (never-almost never-seldom-sometimes-mostly) with the raw scores transformed onto a 0-100 point scale. High scores indicate good outcome, that is, a high degree of "forgetting" the joint. FJS-12 evaluation isn't performed preoperatively.
Time frame: From 3 months to 5 years after surgery
Components stability - radiolucent lines evaluation
The radiographical assessment includes a modified evaluation of presence, location and thickness of periprosthetic radiolucent lines. The sums of the width of radiolucent lines for every component are categorised as follows: 4 or less and non progressive is probably not significant; 5-9 should be closely followed for progression; 10 or greater signifies possible or impending failure regardless of symptoms. Signs of a radiographically loose prosthesis include progressively enlarging luciencies, subsidence of the component or a change in alignment from previous films.
Time frame: From discharge to 5 years after surgery
Survival rate of Physica CR and PS
Survival rate of the implant (Kaplan-Meier)
Time frame: At 3 years and 5 years after surgery
Incidence of device-related AE/SAE/DD/ADE/SADE
Incidence of device-related adverse events( AE), serious adverse events (SAE), device deficiency (DD), adverse device effect (ADE), serious adverse device effect (SADE).
Time frame: From intraoperative to 5 years after surgery
Plan to share: No
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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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