Degenerative Joint DiseaseNCT06506656
Hyaluronic Acid and Adelmidrol (Hyadrol®) in Patients With Degenerative Joint Disease
A study testing Hyadrol® in people with Degenerative Joint Disease, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Degenerative Joint Disease
- What is being tested?
- Hyadrol®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jul 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria Sant'Andrea
Roma
Maria Chiara Vulpiani, mariachiara.vulpiani@uniroma1.it
About this study
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
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
- Being tested
- Hyadrol®
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyadrol®Device
Sterile single-use Medical Device for intra-articular injections
| Study group | Role | What they receive |
|---|---|---|
| Patients with coxarthrosis | Experimental | Three intra-articular infiltrations (1/week) with 2 ml Hyaluronic Acid and Adelmidrol Receives: Device: Hyadrol® |
| Patients with rhizoarthrosis | Experimental | Three intra-articular infiltrations (1/week) with 1 ml Hyaluronic Acid and Adelmidrol Receives: Device: Hyadrol® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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:
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.
Measured: 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:
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.
Measured: Follow up (T3): one week after the last infiltration; Follow up (T4): four weeks after T3
Change of patients self-assessed health status:
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).
Measured: Follow up (T3): one week after the last infiltration; Follow up (T4): four weeks after T3
Incidence of Adverse Events (Safety and Tolerability):
Safety of treatment evaluated by monitoring the incidence and severity of adverse events.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start16 Jul 2024
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Joint DiseaseStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera "Sant'Andrea"
- Responsible party
- Principal investigator, Maria Chiara Vulpiani, University of Roma La Sapienza
- Investigators
- Maria Chiara Vulpiani, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506656
- Sponsor's protocol ID
- Hy-ad2
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06506656
- Acronym / sponsor ID
- Hy-ad2
- Conditions
- Degenerative Joint Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera "Sant'Andrea"
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with coxarthrosis | Experimental | Device: Hyadrol®Three intra-articular infiltrations (1/week) with 2 ml Hyaluronic Acid and Adelmidrol |
| Patients with rhizoarthrosis | Experimental | Device: Hyadrol®Three intra-articular infiltrations (1/week) with 1 ml Hyaluronic Acid and Adelmidrol |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyadrol®Sterile single-use Medical Device for intra-articular injections | Device | Patients with coxarthrosis, Patients with rhizoarthrosis |
Primary outcome
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).
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).
4 secondary outcomes
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
Change of patients quality of life:
Time frame: Follow up (T3): one week after the last infiltration; Follow up (T4): four weeks after T3
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Guida F et al.,Targeting Neuroinflammation in Osteoarthritis with Intra-Articular Adelmidrol. Biomolecules. 2022; 11;12(10):1453Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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 2024Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Chiara Vulpiani principal investigator
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyadrol® in people with Degenerative Joint Disease, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Chiara Vulpiani (+39 0633776143, mariachiara.vulpiani@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.