Knee Pain Swelling Clinical Trial
Official title:
Multicenter Prospective Observational Study in Patients With Painful Total Knee Replacement and I-one Therapy
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.
Status | Recruiting |
Enrollment | 237 |
Est. completion date | October 21, 2025 |
Est. primary completion date | October 21, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - informed consent - painful total knee replacement at least 30 ± 3 days post-op up to a maximum of 180 ± 3 days post-op - VAS = 5 - absence of infection Exclusion Criteria: - pain caused by mechanical problems (misalignment, mobilisation, etc.), - the presence of hip prostheses, - previous knee infections, - rheumatoid arthritis - autoimmune diseases - systemic diseases - tumours - major axial deviations - obesity (BMI > 30 kg/m2). |
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico di Bari | Bari | |
Italy | IRCCS Istituto Ortopedico Rizzoli | Bologna | BO |
Italy | Poliambulanza Brescia | Brescia | BS |
Italy | Ospedale Sacro Cuore Don Calabria Negrar Verona | Negrar | VR |
Italy | Policlinico San Matteo Pavia | Pavia | PV |
Italy | Ospedale Santo Spirito in Sassia/Ospedale San Filippo Neri Roma | Roma | |
Italy | Ospedale Mauriziano Torino | Torino | TO |
Lead Sponsor | Collaborator |
---|---|
University Hospital of Ferrara |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate pain resolution after treatment with I-ONE® therapy in patients with painful TKA at least 1 month after surgery. | Visual analogue scales (VAS, 0 is the minimum and 10 is maximum values) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid classification of symptom severity and disease control. | baseline, 30 days, 60 days, 180 days, 1 year, 2 years | |
Secondary | reduced NSAID intake | NSAID usage registration | baseline, 30 days, 60 days, 180 days, 1 year, 2 years | |
Secondary | improved recovery of joint function | The SF-12 (12-Item Short Form Surveyis range from 0 to 100) a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. | baseline, 30 days, 60 days, 180 days, 1 year, 2 years |
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