protocolSection identificationModule nctId: NCT06330454, orgStudyIdInfo id: 483/2020/Disp/AOUFe, briefTitle: Painful Total Knee Replacement (TKA) and I-one Therapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-10-22, primaryCompletionDateStruct date: 2025-10-21, completionDateStruct date: 2025-10-21, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University Hospital of Ferrara, class: OTHER, descriptionModule briefSummary: Arthroplasty operations are very frequent and their number is constantly increasing. The success of prosthetic surgery is linked to surgical factors (prosthesis type, prosthesis design, prosthesis material, surgical hand) and 'biological' factors (inflammation, pain, oedema, impingement). It is well known that important functional limitations may result mainly from an overreaction involving the peri-articular tissues. This is particularly true after total knee arthroplasty (TKA) surgery, during which a large part of the bone tissue and part of the peri-articular tissues (joint capsule, ligaments, synovium) are dislodged or removed. In the days following arthroplasty operations, the presence of a strong local inflammatory component is associated with pain and functional limitation, which usually resolves within a few months; however, it can sometimes take longer, and sometimes result in a chronic, albeit modest, inflammatory condition that lasts for years. There is still a percentage of 11-25% of patients who remain not completely satisfied with the result achieved with prosthetic surgery . Baker et al. state that 19.8% of patients experience pain one year after arthroplasty . Beswick et al. report that many patients (10-34%) continue to experience significant pain and functional limitation after arthroplasty even years later., conditionsModule conditions: Knee Pain Swelling, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 237, type: ESTIMATED, armsInterventionsModule interventions name: I-ONE, outcomesModule primaryOutcomes measure: Evaluate pain resolution after treatment with I-ONE® therapy in patients with painful TKA at least 1 month after surgery., secondaryOutcomes measure: reduced NSAID intake, secondaryOutcomes measure: improved recovery of joint function, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Ortopedico Rizzoli, status: RECRUITING, city: Bologna, state: BO, country: Italy, contacts name: Francesco Traina, role: CONTACT, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Poliambulanza Brescia, status: RECRUITING, city: Brescia, state: BS, country: Italy, contacts name: Francesco Benazzo, role: CONTACT, geoPoint lat: 45.53558, lon: 10.21472, locations facility: Policlinico San Matteo Pavia, status: RECRUITING, city: Pavia, state: PV, country: Italy, contacts name: Mario Mosconi, role: CONTACT, geoPoint lat: 45.19205, lon: 9.15917, locations facility: Ospedale Mauriziano Torino, status: RECRUITING, city: Torino, state: TO, country: Italy, contacts name: Roberto Rossi, role: CONTACT, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Ospedale Sacro Cuore Don Calabria Negrar Verona, status: RECRUITING, city: Negrar, state: VR, country: Italy, contacts name: Claudio Zorzi, role: CONTACT, geoPoint lat: 45.52918, lon: 10.93899, locations facility: Policlinico di Bari, status: RECRUITING, city: Bari, country: Italy, contacts name: Biagio Moretti, role: CONTACT, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Ospedale Santo Spirito in Sassia/Ospedale San Filippo Neri Roma, status: RECRUITING, city: Roma, country: Italy, contacts name: Francesco Falez, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False