protocolSection identificationModule nctId: NCT06337123, orgStudyIdInfo id: K-38, briefTitle: Physica TT Tibial Plate Follow up Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Limacorporate S.p.a, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Knee Arthropathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Device: Physica TT TIbial Plate and Physica Porous KR, interventions name: Device: Physica TT TIbial Plate and Physica Porous PS, outcomesModule primaryOutcomes measure: Percentage of Knee Society Score (KSS) equal or greater than "Good" (score ≥ 70) 2 years after surgery, secondaryOutcomes measure: Changes in Range of Motion over time up to 2 years after surgery, secondaryOutcomes measure: Changes in Oxford Knee Score (OKS) over time up to 2 years after surgery., secondaryOutcomes measure: Changes in Forgotten Joint Score (FJS) over time up to 2 years after surgery., secondaryOutcomes measure: Changes in Visual Analogue Scale (VAS) Pain over time up to 2 years after surgery., secondaryOutcomes measure: Radiographic implant evaluation and stability assessment from postoperative (baseline) over time up to 2 years after surgery, secondaryOutcomes measure: Survival rate (Kaplan-Meier) at 2 years after surgery, secondaryOutcomes measure: Incidence, type and severity of Adverse Device Effects (ADE) and Serious Adverse Device Effects (SADE) up to 2 years follow up, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Casa di Cura San Camillo Hopital, city: Forte Dei Marmi, state: Lucca, zip: 55042, country: Italy, contacts name: Alessandro Tripodo, role: CONTACT, contacts name: Alessandro Tripodo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.96388, lon: 10.17478, locations facility: Ospedale Privato Accreditato Sol et Salus, city: Torre Pedrera, state: Rimini, zip: 47922, country: Italy, contacts name: Marco Fravisini, role: CONTACT, contacts name: Marco Fravisini, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.10694, lon: 12.51274, locations facility: Casa di Cura Carmona, city: Messina, zip: 98100, country: Italy, contacts name: Marcello La Bruna, role: CONTACT, contacts name: Marcello La Bruna, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.19394, lon: 15.55256, locations facility: Istituto Clinico Porta Sole, city: Perugia, zip: 06100, country: Italy, geoPoint lat: 43.1122, lon: 12.38878, hasResults: False