Comparative Study of Two Hyaluronic Acid Formulation in the Management of Knee Osteoarthritis
NCT Number: NCT06528600
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoarthritis, Knee
Interventions: DEVICE: Hymovis ONE|DEVICE: Monovisc
Sponsor: Fidia Farmaceutici s.p.a.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-09-16
Completion Date: 2024-06-15
Locations: Fondazione Poliambulanza , Istituto Ospedaliero UO di Ortopedia e Traumatologia, Brescia, BS, 25124, Italy|ASST Valcamonica U.O.C. Ortopedia, Esine, BS, 25040, Italy|A.O.R.N. S. Anna e S. Sebastiano U.O.C. Ortopedia e Traumatologia, Caserta, CE, 81100, Italy|U.O. Ortopedia e Traumatologia Casa di Cura, Maddaloni, CE, 81024, Italy|A.O. Ospedale Santa Croce e Carle S.C. Ortopedia e Traumatologia, Cuneo, CN, 12100, Italy|Ospedale S. Maria Borgo Val di Taro - AUSL Parma U.O. Ortopedia e Traumatologia, Borgo Val Di Taro, PR, 43043, Italy|Azienda Ospedaliero-Universitaria di Parma U.O. Clinica Ortopedica, Parma, PR, 43126, Italy|Fondazione IRCCS Policlinico San Matteo Pavia U.O.C. Ortopedia e Traumatologia, Pavia, PV, 27100, Italy|Policlinico universitario Campus Biomedico, Roma, RO, 00128, Italy|Ospedale San Giovanni Calibita Fatebenefratelli - Isola Tiberina U.O.C. di Ortopedia e Traumatologia, Roma, RO, 00186, Italy|Ospedale Santo Spirito in Sassia - ASL Roma 1 Ortopedia e Traumatologia, Roma, RO, 00193, Italy|A.O. Città della Salute e della Scienza - Presidio CTO (Centro Traumatologico Ortopedico) S.C. Ortopedia e Traumatologia 1 U, Torino, TO, 10126, Italy|AOU Città della Salute e della Scienza di Torino -Ospedale Molinette S.C. Medicina Fisica e Riabilitazione U Dip. Ortopedia Traumatologia e Riabilitazione, Torino, TO, 10126, Italy|Presidio Sanitario Ospedale Cottolengo Ortopedia, Torino, TO, 10126, Italy|Azienda ULSS 2 Marca Trevigiana - Ospedale di Conegliano U.O.C. Ortopedia e Traumatologia, Conegliano, TV, 31015, Italy|A.O. Ospedale Cardarelli I Ortopedia, Napoli, 80131, Italy|AOU Federico II Napoli UOC Ortopedia e Traumatologia, Napoli, 80131, Italy|P.O. Ospedale del Mare ASL 1 Napoli U.O.C. Ortopedia, Napoli, 80131, Italy|A.O.U. " Maggiore della Carità" S.C. di Ortopedia e Traumatologia, Novara, 28100, Italy

Summary:
The objective of this randomized, double-blind, active-controlled, non-inferiority study is to compare the effectiveness and safety of a single injection of Hymovis ONE®, a sodium hyaluronate formulation, to Monovisc™, another sodium hyaluronate formulation, for the treatment of pain from osteoarthritis (OA) of the knee in patients who have not responded to non-pharmacological therapies or analgesic regimens. This study consists of a 2-week period for screening, one baseline treatment visit, and a 26- week evaluation phase. Subjects will be randomized to receive a single intra-articular (IA) injection of either Hymovis ONE® or Monovisc™ into the knee using an 18-20 gauge needle.

Primary Outcome Measures: Pain relief compared to baseline, Change From Baseline (CFB) in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK3.1 A1 Pain subscale (walking on a flat surface) score, week 12
Secondary Outcome Measures: Patient respons to treatment, "Patient Success" is defined by OMERACT-OARSI criteria:

(1) improvement in pain or physical function ≥50% and an absolute change ≥20; or (2) improvement of ≥20% with an absolute change of≥ 10 in at least two of the following three categories: pain, physical function, and patient's global assessment, Week 12 and 26|Pain relief compared to baseline, Change from Baseline (CFB) in the Pain subscale in WOMAC LK3.1, Week 26|Joint Stiffness compared to baseline, Change from Baseline (CFB) in the WOMAC LK3.1 Stiffness, Week 26|Joint Function compared to baseline, Change from Baseline (CFB) in the WOMAC LK3.1 Function, Week 26|Patient quality of life, Evaluation through SF-12 questionnaire, Weeks 4,12 and 26|Patient Global Assessment (PGA), Evaluation of disease severity measured by patient using a 0-100 Visual Analogue Scale (VAS) as a Change From Baseline, Weeks 4,12 and 26|Clinical Observer Global Assessment (COGA), Evaluation of disease severity measured by clinician using a 0-100 Visual Analogue Scale (VAS) as a Change From Baseline, Weeks 4,12 and 26|Rescue paracetamol use, evaluation of paracetamol consumption during the study duration through a patient diary, up to 26 weeks|Safety of the treatment. Number of patient with treatment related adverse events, Safety evaluation by tracking the number of adverse events correlated to treatment at each visit, up to 26 weeks