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NCT Number: NCT06506656

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

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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Key information

Conditions

Degenerative Joint Disease Joint Diseases Musculoskeletal Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero-Universitaria Sant'Andrea

Roma, Italy

Location status: Recruiting

Location contact

Maria Chiara Vulpiani

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyadrol®

Device

Sterile single-use Medical Device for intra-articular injections

Primary outcomes

  1. Change of degenerative joint disease symptoms in patients with coxarthrosis:

    Time frame: 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

    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).

  2. Change of degenerative joint disease symptoms in patients with rhizoarthrosis:

    Time frame: 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

    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).

Secondary outcomes

  1. Change of pain symptoms:

    Time frame: 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

    Evaluation of pain intensity assessed by the 11-point Numeric Rating Scale (NRS) scored from 0 to 10, where 0 indicates 'no pain' and 10 corresponds to 'the worst pain ever possible'. The higher the score, the more severe the pain.

  2. Change of patients quality of life:

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

    Quality of Life evaluated by the 12-Item Short Form Health Survey (SF-12). The SF-12 is a self-reported health questionnaire. The score produces two summary measures: a mental (MCS-12) and a physical component score (PCS-12). The PCS-12 score is derived from the subdimensions of general health, physical functioning, role physical, and bodily pain, while the MCS-12 score is derived from the subdimensions of social functioning, role emotional, mental health, and energy. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.

  3. Change of patients self-assessed health status:

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

    The patient's global health status is evaluated through the Likert Patient Global Impression of Change (PGIC) scored in 7 points (from 1, very much improved to 7, very much worse).

  4. Incidence of Adverse Events (Safety and Tolerability):

    Time frame: 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

    Safety of treatment evaluated by monitoring the incidence and severity of adverse events.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Chiara Vulpiani

CONTACT

[email protected]

+39 0633776143

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Collaborators

  • Azienda Ospedaliera "Sant'Andrea"

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2024
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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