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

University of Roma La Sapienza

Status: Enrolling

Conditions: Degenerative Joint Disease

Treatments: Device: Hyadrol®

Study type: Interventional

Funder types: Other

Identifiers

NCT06506656

Hy-ad2

Details and patient eligibility

About

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).

Enrollment: 59 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• corticosteroid therapy in the 3 months prior to enrollment;
• chondroprotectors intake in the 6 months prior to enrollment;
• arthroscopic procedures or intra-articular visco-supplementation in the 6 months prior to enrollment;
• presence of cognitive impairment;
• ongoing rehabilitation and/or physiotherapy;
• allergy or hypersensitivity to the study treatment;
• pregnant and/or lactating female subjects;
• not compliant patients;
• denied informed consent.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Patients with coxarthrosis

Experimental group

Description:

Three intra-articular infiltrations (1/week) with 2 ml Hyaluronic Acid and Adelmidrol

Treatment:

Device: Hyadrol®

Patients with rhizoarthrosis

Experimental group

Description:

Three intra-articular infiltrations (1/week) with 1 ml Hyaluronic Acid and Adelmidrol

Treatment:

Device: Hyadrol®