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

NCT06506656 | Recruiting

• 1 other identifier: Hy-ad2
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change of degenerative joint disease symptoms in patients with coxarthrosis:

  Evaluation of degenerative joint disease symptoms assessed by Western Ontario and McMaster Universities (WOMAC) scale for patients with coxarthrosis. WOMAC is a self-report questionnaire consisting of 24 questions divided into 3 groups: pain (5 items), joint stiffness (2 items) and functional limitations (17 items). Each question has 5 possible answers, evaluate in a Likert scale, from 0 (none) to 4 (extreme): * pain: score from 0 to 20; * joint stiffness: score from 0 to 8; * functional limitations: score from 0 to 68. The sum of the individual scores results in an overall score from 0 to 96 (96 indicates severe disability).

  Baseline (T0): first intra-articular infiltration; Treatment (T1): second intra-articular infiltration; Treatment (T2): third intra-articular infiltration; Follow up (T3): 1 week after T2; Follow up (T4): 4 weeks after T3

• Change of degenerative joint disease symptoms in patients with rhizoarthrosis:

  Evaluation of degenerative joint disease symptoms assessed by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaires for patients with rhizoarthrosis.The questionnaire is divided into 3 modules: symptom/disability module consisting of 30 questions investigating aspects of daily life; occupational module and sports/recreational activities module (optional) consisting of 8 questions in total. Optional items are used for workers and individuals whose occupation or sports or recreational activity requires a high level of physical performance. Each question has 5 possible answers, from 1 (no difficulty) to 5 (unable to perform a specific activity). The sum of the individual scores results in an overall score, which is converted into a scale from 0 to 100 (100 indicates severe disability).

  Baseline (T0): first intra-articular infiltration; Treatment (T1): second intra-articular infiltration; Treatment (T2): third intra-articular infiltration; Follow up (T3): 1 week after T2; Follow up (T4): 4 weeks after T3

Secondary Outcomes (4)

• Change of pain symptoms:

  Baseline (T0): first intra-articular infiltration; Treatment (T1): second intra-articular infiltration; Treatment (T2): third intra-articular infiltration; Follow up (T3): 1 week after T2; Follow up (T4): 4 weeks after T3

• Change of patients quality of life:

  Follow up (T3): one week after the last infiltration; Follow up (T4): four weeks after T3

• Change of patients self-assessed health status:

  Follow up (T3): one week after the last infiltration; Follow up (T4): four weeks after T3

• Incidence of Adverse Events (Safety and Tolerability):

  Baseline (T0): first intra-articular infiltration; Treatment (T1): second intra-articular infiltration; Treatment (T2): third intra-articular infiltration; Follow up (T3): 1 week after T2; Follow up (T4): 4 weeks after T3

Study Arms (2)

Patients with coxarthrosis

EXPERIMENTAL

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

Device: Hyadrol®

Patients with rhizoarthrosis

EXPERIMENTAL

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

Device: Hyadrol®

Interventions

Hyadrol® DEVICE

Sterile single-use Medical Device for intra-articular injections

Patients with coxarthrosis; Patients with rhizoarthrosis

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Azienda Ospedaliera "Sant'Andrea": collaborator

Study Sites (1)

Azienda Ospedaliero-Universitaria Sant'Andrea

Roma, Italy

RECRUITING

Related Links

• Guida F et al.,Targeting Neuroinflammation in Osteoarthritis with Intra-Articular Adelmidrol. Biomolecules. 2022; 11;12(10):1453
• Vulpiani MC et al.,Hyaluronic acid alone versus hyaluronic acid associated with adelmidrol for Intra-articular treatment of knee osteoarthritis: A long-term follow -up. Int J Physiother Res 2023;11(1):4453-4460.
• Cavallaro C et al.,Adelmidrol Protects Hyaluronic Acid against Oxidative Degradation and Improves the Outcome in Patients with Adhesive Capsulitis of the Shoulder Managed by Physical Therapy. J Orthop Res Ther 2024

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

• Maria Chiara Vulpiani

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Chiara Vulpiani

CONTACT

+39 0633776143; mariachiara.vulpiani@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 17, 2024
• Study Start: July 16, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 18, 2024

Record last verified: 2024-07

Locations

IT (1)