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
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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;

• wash-out for at least two weeks from anti-inflammatory drugs before enrollment;

• compliant patients;

• signed informed consent.

Locations
Other Locations
Italy
Azienda Ospedaliero-Universitaria Sant'Andrea
RECRUITING
Roma
Contact Information
Primary
Maria Chiara Vulpiani
mariachiara.vulpiani@uniroma1.it
+39 0633776143
Time Frame
Start Date: 2024-07-16
Estimated Completion Date: 2025-07
Participants
Target number of participants: 59
Treatments
Experimental: Patients with coxarthrosis
Three intra-articular infiltrations (1/week) with 2 ml Hyaluronic Acid and Adelmidrol
Experimental: Patients with rhizoarthrosis
Three intra-articular infiltrations (1/week) with 1 ml Hyaluronic Acid and Adelmidrol
Related Therapeutic Areas
Sponsors
Collaborators: Azienda Ospedaliera Sant'Andrea
Leads: University of Roma La Sapienza

This content was sourced from clinicaltrials.gov