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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-16

Study Completion Date

2025-07-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Degenerative Joint Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with coxarthrosis

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

Group Type EXPERIMENTAL

Hyadrol®

Intervention Type DEVICE

Sterile single-use Medical Device for intra-articular injections

Patients with rhizoarthrosis

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

Group Type EXPERIMENTAL

Hyadrol®

Intervention Type DEVICE

Sterile single-use Medical Device for intra-articular injections

Interventions

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Hyadrol®

Sterile single-use Medical Device for intra-articular injections

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No