2. HYMOVIS on Knee Study title A multi-centre, open label, long term follow up study to evaluate the benefits of a new viscoelastic hydrogel (hymovis) in the treatment of knee osteoarthritis Prot n. R29-10-01
3. Coordinating investigator: Francesco Benazzo, MD, Professor of Orth & Traum, Chairman, Clinica Ortopedica e Traumatologica dell’ Università di Pavia Fondazione IRCCS Policlinico San Matteo A new site will be opened in the next few weeks Clinical sites
4. Objectives and variables Primary Efficacy Objective and Variable : To evaluate the long term benefits of Hymovis on pain due to knee OA measured by WOMAC pain (A) subscore over 52 weeks.
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17. The study… at the moment Patient ’s status Planned patients to recruit 50 Patients recruited up to now 21 Drop-out patients 2 First patient in Sept 2010 Ethic Committee approval May 2010 V0 V1 V2 V3 V4 V5 V6 V7 pts 21 20 20 12 10 9 9 3
19. Baseline knee OA characteristics Affected knee Left Right Bilateral 5 (55.6%) 4 (44.4%) 0 (0.0%) Kellgren-Lawrence 2 3 5 (55.6%) 4 (44.4%) Morning Stiffness 30 minutes Yes No 5 (55.6%) 4 (44.4%) Crepitus on motion Yes No 6 (66.7%) 3 (33.3%) Joint tenderness Yes No 2 (22.2%) 7 (77.8%) Swelling Yes No 0 (0.0%) 9 (100.0%) Redness/Inflammation Yes No 0 (0.00%) 9 (100.0%) Presence of Effusion Yes No 0 (0.0%) 9 (100.0%) Pain perceived by the patient walking on a flat surface Moderate Severe 8 (88.9%) 1 (11.1%)
20. Let ’s take a look to the results Preliminary analysis conducted on 9 patients WOMAC normalised scores at study visits
21. Preliminary analysis conducted on 9 patients Intensity of Pain perceived by the patient walking on a flat surface (WOMAC question A1) at each study visit: Let ’s take a look to the results
22. Preliminary analysis conducted on 9 patients PTGA and COGA at study visits PTGA(Patient's Global Assessment): The patient is asked to indicate on a VAS how the treated knee affects the patient's status in his/her opinion (0-100 mm) COGA(Investigator's Global Assessment): The investigator is asked to indicate on a VAS how the treated knee affects the patient's status in his opinion (0-100 mm) Let ’s take a look to the results
