nctId: NCT06330454 id: 483/2020/Disp/AOUFe briefTitle: Painful Total Knee Replacement (TKA) and I-one Therapy overallStatus: RECRUITING date: 2020-10-22 date: 2025-10-21 date: 2025-10-21 date: 2024-03-26 date: 2024-03-28 name: University Hospital of Ferrara class: OTHER 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. conditions: Knee Pain Swelling studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 237 type: ESTIMATED name: I-ONE measure: Evaluate pain resolution after treatment with I-ONE® therapy in patients with painful TKA at least 1 month after surgery. measure: reduced NSAID intake measure: improved recovery of joint function sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Ortopedico Rizzoli status: RECRUITING city: Bologna state: BO country: Italy name: Francesco Traina role: CONTACT lat: 44.49381 lon: 11.33875 facility: Poliambulanza Brescia status: RECRUITING city: Brescia state: BS country: Italy name: Francesco Benazzo role: CONTACT lat: 45.53558 lon: 10.21472 facility: Policlinico San Matteo Pavia status: RECRUITING city: Pavia state: PV country: Italy name: Mario Mosconi role: CONTACT lat: 45.19205 lon: 9.15917 facility: Ospedale Mauriziano Torino status: RECRUITING city: Torino state: TO country: Italy name: Roberto Rossi role: CONTACT lat: 45.07049 lon: 7.68682 facility: Ospedale Sacro Cuore Don Calabria Negrar Verona status: RECRUITING city: Negrar state: VR country: Italy name: Claudio Zorzi role: CONTACT lat: 45.52918 lon: 10.93899 facility: Policlinico di Bari status: RECRUITING city: Bari country: Italy name: Biagio Moretti role: CONTACT lat: 41.11148 lon: 16.8554 facility: Ospedale Santo Spirito in Sassia/Ospedale San Filippo Neri Roma status: RECRUITING city: Roma country: Italy name: Francesco Falez role: CONTACT lat: 41.89193 lon: 12.51133 hasResults: False