Open-label study to evaluate the efficacy and safety of a high-concentration hybrid hyaluronic acid (Sinovial HL 4.5% in 2 ml), in single administration and in a secondary population, in repeated administration, in patients with gonarthrosis.
Project objectivesNational clinical study with a medical device, prospective, single-centre, open-label, to evaluate the clinical efficacy and safety of single intra-articular administration of a vial (treatment A) of high concentration hybrid hyaluronic acid Sinovial HL 4.5% in 2 ml vs the baseline in a main population of patients suffering from knee osteoarthritis, and to evaluate the clinical efficacy and safety of the repeated intra-articular administration (treatment B)* of a vial of high concentration hyaluronic acid Sinovial HL 4.5% in 2 ml vs baseline in a secondary population of patients with gonarthrosis. *treatment B will consist of 2 or 3 repeated intra-articular administrations of Sinovial HL 4.5% in 2 ml (over the entire duration of the study), in a secondary population of patients who, according to the investigator's judgment, will be able to benefit of this dosage schedule. The second and possible third administration of Sinovial HL 4.5% in 2 ml intra-articularly will be carried out within three months of the first. Primary goal - Evaluation of the effectiveness of the single intra-articular administration of a vial of high concentration hybrid hyaluronic acid Sinovial HL 4.5% in 2 ml (treatment A) on joint mobility (IKDC), in the main population of patients with gonarthrosis, vs the baseline. 8.3 Secondary objectives - Evaluation of the efficacy of repeated intra-articular administration of a vial of high concentration hybrid hyaluronic acid Sinovial HL 4.5% in 2 ml (treatment B) on joint mobility (IKDC), in the secondary population of patients with gonarthrosis, vs baseline . - Evaluation of treatment A (in the main population) and treatment B (in the secondary population) on the improvement of secondary outcomes, through rating scales (VAS, KOOS) and questionnaires used in the study, vs the baseline. - Evaluation of treatment A (in the main population) and treatment B (in the secondary population) on quality of life, through the SF-12 questionnaire used in the study, vs baseline. - Evaluation of treatment A (in the main population) and treatment B (in the secondary population) on pain intensity (using the NRS scale), vs baseline. - Evaluation of treatment A (in the main population) and treatment B (in the secondary population) on the reduction of cytokines, vs baseline. - Evaluation of treatment A (in the main population) and treatment B (in the secondary population) on the incidence of adverse events and incidents during the study. |
Start and end date |
| Ongoing |
Project Manager |
| Prof. Rocco Papalia – Director of Orthopedics and Traumatology |
Coordinating institution of the project |
| Department of Orthopedics and Trauma Surgery /Università Campus Bio-Medico di Roma - Via Alvaro del Portillo 200, 00128 Rome. |
Other Institutions involved |
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Funding source(s). |
| • IBSA Farmaceutici Italia Srl - Via Martiri di Cefalonia, 2 - 26900 Lodi (Italy) |