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

NCT06506656 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2024-07-18

No results posted yet for this study

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

DEVICE

Hyadrol®

Sterile single-use Medical Device for intra-articular injections

Sponsors & Collaborators

  • Azienda Ospedaliera "Sant'Andrea"

    collaborator OTHER

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Maria Chiara Vulpiani · University of Roma La Sapienza

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-16
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06506656 on ClinicalTrials.gov