Clinical trial NCT06506656: Hyaluronic Acid and Adelmidrol (Hyadrol®) in Patients With Degenerative Joint Disease
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Degenerative Joint Disease
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera "Sant'Andrea"
First posted: 2024-07-17
Enrollment: 59
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Change of degenerative joint disease symptoms in patients with coxarthrosis:
timeFrame: 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
measure: Change of degenerative joint disease symptoms in patients with rhizoarthrosis:
timeFrame: 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:
measure: Change of pain symptoms:
timeFrame: 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
measure: Change of patients quality of life:
timeFrame: Follow up (T3): one week after the last infiltration; Follow up (T4): four weeks after T3
measure: Change of patients self-assessed health status:
timeFrame: Follow up (T3): one week after the last infiltration; Follow up (T4): four weeks after T3
measure: Incidence of Adverse Events (Safety and Tolerability):
timeFrame: 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
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Azienda Ospedaliero-Universitaria Sant'Andrea
Study officials:
affiliation: University of Roma La Sapienza
name: Maria Chiara Vulpiani
role: PRINCIPAL_INVESTIGATOR
References: