Performance and Safety of HyalganBio® Intra-Articular Injections as Add-On to Physical Exercise f… (NCT07520708) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Performance and Safety of HyalganBio® Intra-Articular Injections as Add-On to Physical Exercise for Symptomatic Glenohumeral Osteoarthritis
Italy72 participantsStarted 2024-07-12
Plain-language summary
This investigation evaluates performance and safety of three intra-articular injections of HyalganBio®, combined with a Physical Exercise Program (PEP) in subjects with glenohumeral osteoarthritis. The main goal is to see whether patients improve shoulder function six months after the first injection, compared with patients who only follow the exercise program. Improvement is measured using the Constant-Murley Score (CMS).
Participants first attend a screening visit and, if they meet all criteria, they are enrolled. Within 14 days, they are randomly assigned to one of two groups: group 1 receives three weekly HyalganBio® injections and performs the PEP three times a week for 60 days, recording adherence in a diary; group 2: performs the same PEP schedule and also records adherence in a diary.
Follow-up visits take place at 2, 4, and 6 months after the first injection, with additional telephone check-ins at 1 and 3 months.
Who can participate
Age range
45 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female subjects aged ≥ 45 years and ≤ 85 years.
. Samilson Prieto Grade 1 to 3 of glenohumeral joint confirmed by a X-ray performed in the 6 months before the screening visit (or at the screening if not available in the past 6 months).
. Patient suffering from glenohumeral arthrosis with chronic shoulder pain. Chronic shoulder pain is defined as follows:
. Presence of pain on movement, in the target shoulder, measured by VAS with a score \> 40 mm.
. VAS for pain in the contralateral shoulder of at least 10 mm less than the target joint.
. Willingness to discontinue oral and topical analgesics including NSAIDs if taken before study inclusion except for assumption of rescue medication (paracetamol) at a maximum dose of 6 tablets of 500 mg a day.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Performance of three intra-articular (IA) injections of HyalganBio® plus Physical Exercise Program (PEP), in terms of overall clinical functional assessment on movement.
. Patient willing to sign and able to understand the Informed Consent form.
. If female of childbearing potential, must have a negative pregnancy test at screening and agree to use a reliable method of contraception throughout the investigation\*.
Exclusion criteria
. Presence, at clinical evaluation, of adhesive capsulitis.
. Presence of rotator cuff injury (Massive Rotator Cuff Tears).
. Signs, evident on X-ray of the shoulder, of recent fractures, intense loss of bone density and/or severe deformity.
. Diagnosis of major calcium pyrophosphate dihydrate crystal deposition (CPPD) or shoulder chondrocalcinosis disease.
. Presence of pathology of the cervical vertebrae (capable of altering the clinical evaluation) which, in the three months preceding the screening visit, was symptomatic and required active treatment.
. Presence of any active musculoskeletal disease capable of altering the diagnosis/assessment of the shoulder with pain or presence of pain of any neurological aetiology and acute shoulder infection.
. Presence of major surgery in arthroscopy in the shoulder under investigation in the 6 months prior to the screening and/or need to plan it.
. Patient undergoing local radiotherapy for breast cancer.