About this trial
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).
Eligibility criteria
Qualifiers
age ≥ 40 years;
both genders;
diagnosis of stage II-III coxarthrosis or rhizoarthrosis according to radiological classification (Kellgren and Lawrence or modified Eaton-Littler criteria respectively)
pain intensity ≥ 5 on NRS;
Disqualifiers
age < 40 years;
presence of concomitant inflammatory systemic pathologies (e.g.: rheumatoid arthritis, etc.);
severe and progressive clinical conditions,
NSAIDs therapy in the 2 weeks prior to enrollment;
Trial design
Treatments tested in this trial
- Hyadrol®
Treatment groups
Sponsors and collaborators
University of Roma La Sapienza
Lead sponsor
Azienda Ospedaliera "Sant'Andrea"
Collaborator