NCT06506656

Hyaluronic Acid and Adelmidrol (Hyadrol®) in Patients With Degenerative Joint Disease

Effect of an Intra-articular Treatment With a Combination of Hyaluronic Acid and Adelmidrol (Hyadrol®) on Pain, Joint Stiffness and Functional Limitation in Patients With Degenerative Joint Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (estimated)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Degenerative Joint Disease

Interventions

Type	Name	Description
DEVICE	Hyadrol®	Sterile single-use Medical Device for intra-articular injections

Timeline

• Start date: 2024-07-16
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2024-07-17
• Last updated: 2024-07-18

Locations

1 site across 1 country: Italy