Glenohumeral OsteoarthritisPhase 4NCT06043544
Hymovis® Intra-articular Injections vs Corticosteroids Intra-articular Injections in Patients Affected by Glenohumeral Osteoarthritis:
A Phase 4 study testing Hyaluronic Acid 24 MG in 3 mL Prefilled Syringe and Corticosteroid injection in people with Glenohumeral Osteoarthritis, run by Concordia Hospital Rome at 1 site in Italy.
Trial summary
This monocentric randomized open-label study aims to assess the efficacy and safety of a treatment with medium molecular weight hyaluronic acid (HA) compared to a treatment with corticosteroids on patients affected by glenohumeral osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Glenohumeral Osteoarthritis
- What is being tested?
- Hyaluronic Acid 24 MG in 3 mL Prefilled Syringe and Corticosteroid injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 2 May 2021to 31 Mar 2022
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient aged ≥40 years
- Patient suffering from glenohumeral osteoarthritis with chronic shoulder pain. Chronic shoulder pain is defined as follows:
- Persistence for a period of at least 6 months, but not more than 5 years;
- Pain perceived by the patient with a frequency of at least 50% of the days in the month preceding the inclusion visit; Kellgren-Lawrence grade of 2 or 3 in the glenohumeral joint confirmed by x-ray exam performed within 3 months prior to the inclusion visit.
- Presence, at baseline, of pain on movement, in the shoulder under study, measured by VAS with a score between 40 and 80 mm Presence at baseline of pain in the contralateral shoulder at least 10mm less than the study shoulder and no more than 40mm as measured by VAS at the inclusion visit
- Presence, at baseline, of limitation of shoulder motion in at least one direction in the following ranges of motion:
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- Fixed scapula abduction ≤ 80°
- Internal rotation in abduction ≤ 55°
- External rotation in abduction ≤ 80° These shoulder limitations are for normal expected excursions. Patient who has not responded adequately to non-pharmacological conservative therapy and to taking simple analgesics Patient willing to sign and able to understand the Informed Consent form Patient who is not pregnant or nursing. Women of childbearing potential (including women who have been less than one year postmenopausal) must agree to use reliable contraception for the duration of the study.
Who cannot join
- Presence, on clinical evaluation, of adhesive capsulitis
- Evidence of rotator cuff injury
- Presence of primary extra-articular shoulder syndromes (eg impingement, bursitis, tendonitis)
- Evidence of clinically significant shoulder deformity
- Signs, evident on X-ray radiography of the shoulder, of recent fractures, severe loss of bone density and/or severe deformity
- Diagnosed with crystal deposition disease of calcium pyrophosphate dihydrate (CPPD) or chondrocalcinosis of the shoulder
Show all 30Show fewer
- Presence of pathology of the cervical vertebrae (able to alter the clinical evaluation) which, in the three months preceding the inclusion visit, was symptomatic and required active treatment
- Presence of any active musculoskeletal disease affecting the diagnosis/evaluation of shoulder pain or presence of pain of any neurological etiology and acute shoulder infection
- Presence of major surgery, arthroplasty or arthroscopy in the shoulder under study in the 6 months prior to inclusion and/or surgery planned during the study
- Patient undergoing local radiotherapy for breast cancer
- Patient with polymyalgia rheumatica
- History of skin cancer (except basal cell carcinoma) treated for less than two years
- History of severe recurrent or immune-mediated allergic reactions
- Presence of infection and/or skin pathologies in the injection area; psoriasis
- Presence of serious gastrointestinal, renal, hepatic, pulmonary, cardiovascular, neurological disorders that could interfere with the study results or patient's inability to comply with the study requirements
- Known allergy or suspected allergic reactions to hyaluronate or corticosteroid preparations
- Taking HA products intra-articularly in the month preceding the inclusion visit
- Taking bisphosphonates and/or pharmaceutical products taken orally and containing glucosamine and/or chondroitin sulphate and/or diacerin (eg Chondrosulf, Structum 500, Dona, Viatril, Fisiodar, Artrodar, etc.) in the month preceding the inclusion visit unless the dosage was stable in the two months prior to the inclusion visit
- Intra-articular corticosteroid injections in the study shoulder in the three months preceding the inclusion visit
- Intra-articular corticosteroid injections in any joint in the month preceding the inclusion
- Taking oral corticosteroids in the month prior to the inclusion visit (only inhaled corticosteroids are permitted)
- Previous use of HA in the study shoulder within 6 months prior to inclusion
- Changed physical therapy in the month prior to inclusion visit or unwillingness to maintain stable regimen
- Patient with history of thyroid insufficiency
- Patient being treated with anticoagulant therapy
- Patient on phenobarbital treatment prior to study inclusion
- Taking analgesic therapies (NSAIDs, opioid analgesics, topical analgesics) for any condition that could interfere with the evaluation of the shoulder under study
- Intake of another experimental product in the month preceding the inclusion visit
- Patient who, in the opinion of the investigator, is unwilling to comply with study procedures or will not cooperate during the course of the study
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hymovis® Intra-articular Injections vs Corticosteroids Intra-articular Injections in Patients Affected by Glenohumeral Osteoarthritis: a Monocentric Randomized Open-label Trial
This monocentric randomized open-label study aims to assess the efficacy and safety of a treatment with medium molecular weight hyaluronic acid (HA) compared to a treatment with corticosteroids on patients affected by glenohumeral osteoarthritis.
Read the detailed description
Glenohumeral osteoarthritis (OA) is a very common joint disease characterized by pain and functional limitation. No standardized protocols of treatment are available in clinical practice and literature data are confusing. This monocentric randomized open-label study aims to assess the efficacy and safety of a treatment with medium molecular weight hyaluronic acid (HA) compared to a treatment with corticosteroids on patients affected by glenohumeral osteoarthritis.
A total of 80 consecutive patients with glenohumeral OA (Kellegren Lawrence degree II or III) were randomized in two different groups, intto Hymovis® (24mg/3ml) (treatment group) or into corticosteroids (control group), with a follow-up after 3 and 6 months. Modifications in terms of pain (VAS), range of motion (ROM) and quality of life (EQ-5D) were observed during the treatment.
- Conditions
- Glenohumeral Osteoarthritis
- Being tested
- Hyaluronic Acid 24 MG in 3 mL Prefilled Syringe, Corticosteroid injection
- Keywords
- Osteoarthritis, Hyaluronic Acid, Corticosteroids
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid 24 MG in 3 mL Prefilled SyringeDevice
Patients in the treatment group received two intra-articular injections with Hymovis® (24mg/3ml) a week apart from each other
Corticosteroid injectionDrug
Patients in control group received two intra-articular injections with corticosteroids a week apart from each other.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | patients shoulder treated with Hymovis® 24mg/3ml. Receives: Device: Hyaluronic Acid 24 MG in 3 mL Prefilled Syringe |
| Control group | Active comparator | patients shoulder treated with Corticosteroid. Receives: Drug: Corticosteroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the pain reduction in the target shoulder compared to control group
Changes of pain on movement in the target shoulder, evaluated with a 0-100 mm Visual Analogue Scale (VAS) values compared to baseline (V1).
Measured: At 6 months
Secondary outcomes (4)
Evaluation of the Quality of Life of the patients
Changes of patient's quality of life, evaluated by administration of the EuroQol 5-Dimension Questionnaire (EQ-5D-5L) compared to baseline (V1)
Measured: At 6 months
Evaluate the amelioration of shoulder functionality
Clinical functional assessment on movement from baseline (V1), measured by Constant Murley (CMS) shoulder test ;
Measured: At 6 months
Evaluate the pain reduction in the target shoulder compared to baseline
Changes of pain on movement in the target shoulder, evaluated with a 0-100 mm Visual Analogue Scale (VAS) values compared to baseline (V1).
Measured: At 6 months
Evaluation of the safety of the treatment
Safety of Hymovis® were evaluated in terms of incidence of treatment-emergent adverse events (TEAEs) over the investigational period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start2 May 2021
- Primary completion10 Nov 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glenohumeral OsteoarthritisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 80 consecutive patients with glenohumeral OA degree II or III were prospectively enrolled in our clinic from May 2021 to March 2022. The study was approved by Concordia Hospital Ethical Committee (02/2021) and performed according to ISO14155:2020 and Declaration of Helsinki.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concordia Hospital Rome
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola de Gasperis, Concordia Hospital Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043544
- Sponsor's protocol ID
- Hymovis 10-04-21
- Status last verified
- Sep 2023
- First submitted
- 29 Aug 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hymovis® Intra-articular Injections vs Corticosteroids Intra-articular Injections in Patients Affected by Glenohumeral Osteoarthritis: a Monocentric Randomized Open-label Trial
- ClinicalTrials.gov ID
- NCT06043544
- Acronym / sponsor ID
- Hymovis 10-04-21
- Conditions
- Glenohumeral Osteoarthritis
- Keywords
- Osteoarthritis, Hyaluronic Acid, Corticosteroids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Concordia Hospital RomeUniversity, hospital or other
- Study start
- 2 May 2021 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 21 Sep 2023 (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.
This monocentric randomized open-label study aims to assess the efficacy and safety of a treatment with medium molecular weight hyaluronic acid (HA) compared to a treatment with corticosteroids on patients affected by glenohumeral osteoarthritis.
Detailed description
Glenohumeral osteoarthritis (OA) is a very common joint disease characterized by pain and functional limitation. No standardized protocols of treatment are available in clinical practice and literature data are confusing. This monocentric randomized open-label study aims to assess the efficacy and safety of a treatment with medium molecular weight hyaluronic acid (HA) compared to a treatment with corticosteroids on patients affected by glenohumeral osteoarthritis.
A total of 80 consecutive patients with glenohumeral OA (Kellegren Lawrence degree II or III) were randomized in two different groups, intto Hymovis® (24mg/3ml) (treatment group) or into corticosteroids (control group), with a follow-up after 3 and 6 months. Modifications in terms of pain (VAS), range of motion (ROM) and quality of life (EQ-5D) were observed during the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 80 consecutive patients with glenohumeral OA degree II or III were prospectively enrolled in our clinic from May 2021 to March 2022. The study was approved by Concordia Hospital Ethical Committee (02/2021) and performed according to ISO14155:2020 and Declaration of Helsinki.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Hyaluronic Acid 24 MG in 3 mL Prefilled Syringepatients shoulder treated with Hymovis® 24mg/3ml. |
| Control group | Active comparator | Drug: Corticosteroid injectionpatients shoulder treated with Corticosteroid. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female patient aged ≥40 years
- Patient suffering from glenohumeral osteoarthritis with chronic shoulder pain. Chronic shoulder pain is defined as follows:
- Persistence for a period of at least 6 months, but not more than 5 years;
- Pain perceived by the patient with a frequency of at least 50% of the days in the month preceding the inclusion visit; Kellgren-Lawrence grade of 2 or 3 in the glenohumeral joint confirmed by x-ray exam performed within 3 months prior to the inclusion visit.
- Presence, at baseline, of pain on movement, in the shoulder under study, measured by VAS with a score between 40 and 80 mm Presence at baseline of pain in the contralateral shoulder at least 10mm less than the study shoulder and no more than 40mm as measured by VAS at the inclusion visit
Key exclusion criteria (30 listed)
- Presence, on clinical evaluation, of adhesive capsulitis
- Evidence of rotator cuff injury
- Presence of primary extra-articular shoulder syndromes (eg impingement, bursitis, tendonitis)
- Evidence of clinically significant shoulder deformity
- Signs, evident on X-ray radiography of the shoulder, of recent fractures, severe loss of bone density and/or severe deformity
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 |
|---|---|---|
| Hyaluronic Acid 24 MG in 3 mL Prefilled SyringePatients in the treatment group received two intra-articular injections with Hymovis® (24mg/3ml) a week apart from each other | Device | Treatment group |
| Corticosteroid injectionPatients in control group received two intra-articular injections with corticosteroids a week apart from each other. | Drug | Control group |
Primary outcome
Evaluate the pain reduction in the target shoulder compared to control group
Time frame: At 6 months
Changes of pain on movement in the target shoulder, evaluated with a 0-100 mm Visual Analogue Scale (VAS) values compared to baseline (V1).
4 secondary outcomes
Evaluation of the Quality of Life of the patients
Time frame: At 6 months
Evaluate the amelioration of shoulder functionality
Time frame: At 6 months
Evaluate the pain reduction in the target shoulder compared to baseline
Time frame: At 6 months
Evaluation of the safety of the treatment
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyaluronic Acid 24 MG in 3 mL Prefilled Syringe and Corticosteroid injection in people with Glenohumeral Osteoarthritis, run by Concordia Hospital Rome 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 9 inclusion and 30 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: finished, as of the sponsor's last update on 21 Sep 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the pain reduction in the target shoulder compared to control group (time frame: At 6 months). 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 21 Sep 2023.