Hyaluronic Acid and Adelmidrol (Hyadrol®) in Patients With Degenerative Joint Disease
NCT Number: NCT06506656
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Degenerative Joint Disease
Interventions: DEVICE: Hyadrol®
Sponsor: University of Roma La Sapienza
Collaborators: Azienda Ospedaliera "Sant'Andrea"
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 59
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-16
Completion Date: 2025-07
Locations: Azienda Ospedaliero-Universitaria Sant'Andrea, Roma, Italy

Summary:
Osteoarthritis is a major cause of chronic musculoskeletal pain. Behind this disorder there is a process of chronic neuroinflammation due to the overactivation of mast cells at the tissue level. The mast cells present in the synovial membranes act as first sensors in pathological situations, degranulating in an uncontrolled manner.

Furthermore, in degenerative joint pathologies, there is a marked reduction in the viscoelastic capacity of the synovial fluid associated with a reduction in both the concentration and the average molecular weight of endogenous hyaluronic acid. The association of hyaluronic acid and Adelmidrol (Hyadrol®) could represent an effective treatment for controlling the neuroinflammation process that supports degenerative joint diseases.

The objective of the present clinical investigation is to evaluate its safety and efficacy in patients with arthritis of the hip (coxarthrosis) and trapezium-metacarpal joints (rhizoarthrosis).

Primary Outcome Measures: Change of degenerative joint disease symptoms in patients with coxarthrosis:, Evaluation of degenerative joint disease symptoms assessed by Western Ontario and McMaster Universities (WOMAC) scale for patients with coxarthrosis. WOMAC is a self-report questionnaire consisting of 24 questions divided into 3 groups: pain (5 items), joint stiffness (2 items) and functional limitations (17 items). Each question has 5 possible answers, evaluate in a Likert scale, from 0 (none) to 4 (extreme):

* pain: score from 0 to 20;
* joint stiffness: score from 0 to 8;
* functional limitations: score from 0 to 68.

The sum of the individual scores results in an overall score from 0 to 96 (96 indicates severe disability)., Baseline (T0): first intra-articular infiltration; Treatment (T1): second intra-articular infiltration; Treatment (T2): third intra-articular infiltration; Follow up (T3): 1 week after T2; Follow up (T4): 4 weeks after T3|Change of degenerative joint disease symptoms in patients with rhizoarthrosis:, Evaluation of degenerative joint disease symptoms assessed by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaires for patients with rhizoarthrosis.The questionnaire is divided into 3 modules: symptom/disability module consisting of 30 questions investigating aspects of daily life; occupational module and sports/recreational activities module (optional) consisting of 8 questions in total. Optional items are used for workers and individuals whose occupation or sports or recreational activity requires a high level of physical performance. Each question has 5 possible answers, from 1 (no difficulty) to 5 (unable to perform a specific activity). The sum of the individual scores results in an overall score, which is converted into a scale from 0 to 100 (100 indicates severe disability)., Baseline (T0): first intra-articular infiltration; Treatment (T1): second intra-articular infiltration; Treatment (T2): third intra-articular infiltration; Follow up (T3): 1 week after T2; Follow up (T4): 4 weeks after T3
Secondary Outcome Measures: Change of pain symptoms:, Evaluation of pain intensity assessed by the 11-point Numeric Rating Scale (NRS) scored from 0 to 10, where 0 indicates 'no pain' and 10 corresponds to 'the worst pain ever possible'. The higher the score, the more severe the pain., Baseline (T0): first intra-articular infiltration; Treatment (T1): second intra-articular infiltration; Treatment (T2): third intra-articular infiltration; Follow up (T3): 1 week after T2; Follow up (T4): 4 weeks after T3|Change of patients quality of life:, Quality of Life evaluated by the 12-Item Short Form Health Survey (SF-12). The SF-12 is a self-reported health questionnaire. The score produces two summary measures: a mental (MCS-12) and a physical component score (PCS-12). The PCS-12 score is derived from the subdimensions of general health, physical functioning, role physical, and bodily pain, while the MCS-12 score is derived from the subdimensions of social functioning, role emotional, mental health, and energy. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning., Follow up (T3): one week after the last infiltration; Follow up (T4): four weeks after T3|Change of patients self-assessed health status:, The patient's global health status is evaluated through the Likert Patient Global Impression of Change (PGIC) scored in 7 points (from 1, very much improved to 7, very much worse)., Follow up (T3): one week after the last infiltration; Follow up (T4): four weeks after T3|Incidence of Adverse Events (Safety and Tolerability):, Safety of treatment evaluated by monitoring the incidence and severity of adverse events., Baseline (T0): first intra-articular infiltration; Treatment (T1): second intra-articular infiltration; Treatment (T2): third intra-articular infiltration; Follow up (T3): 1 week after T2; Follow up (T4): 4 weeks after T3