Treatment for degenerative joint disease using Hyaluronic Acid and Adelmidrol
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
This study is testing a new treatment combining Hyaluronic Acid and Adelmidrol to see if it can help people with arthritis in their hips and hands feel less pain and improve their joint function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 59 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of Roma La Sapienza Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06506656 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to evaluate the safety and efficacy of a treatment combining Hyaluronic Acid and Adelmidrol (Hyadrol®) for patients suffering from degenerative joint diseases, specifically arthritis of the hip and trapezium-metacarpal joints. The study focuses on addressing chronic neuroinflammation caused by mast cell overactivation and the reduction of viscoelastic properties in synovial fluid. Eligible participants will be those diagnosed with stage II-III coxarthrosis or rhizoarthrosis, experiencing significant pain. The treatment is designed to potentially restore joint function and alleviate pain.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 and older with stage II-III coxarthrosis or rhizoarthrosis and a pain intensity of 5 or higher on the NRS.
Not a fit: Patients under 40 years old or those with inflammatory systemic diseases like rheumatoid arthritis may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pain and improve joint function for patients with degenerative joint disease.
How similar studies have performed: While the specific combination of Hyaluronic Acid and Adelmidrol is novel, similar approaches targeting neuroinflammation in joint diseases have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Roma
- Azienda Ospedaliero-Universitaria Sant'Andrea — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Maria Chiara Vulpiani — University of Roma La Sapienza
- Study coordinator: Maria Chiara Vulpiani
- Email: mariachiara.vulpiani@uniroma1.it
- Phone: +39 0633776143
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.