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.
This post-market, multicenter, randomized, controlled, open-label clinical investigation aims to evaluate the performance and safety of three intra-articular (IA) injections of HyalganBio® combined with a Physical Exercise Program (PEP) in patients with symptomatic glenohumeral osteoarthritis. The primary objective is to assess the overall functional clinical improvement at 6 months after the first injection (V1), as measured by the Constant-Murley Score (CMS), comparing HyalganBio® + PEP versus PEP alone. Eligible subjects are screened at Visit 0 (V0) after signing informed consent. If all inclusion and exclusion criteria are met, enrollment occurs and V0 may coincide with the baseline visit (V1). At V1, within 14 days from screening, participants are randomized 1:1. Group 1 receives three weekly IA injections of HyalganBio® (at V1, V2, V3) and is trained to perform a PEP three times per week for 60 days, recording adherence in a patient diary. Group 2 (control) is trained to perform the same PEP schedule and also reports adherence in a diary. Follow-up visits are planned at 2, 4, and 6 months after V1, with telephone contacts at 1 and 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
72
3 weekly intrarticular injections of HyalganBio® in a concentration of HA 2% (20 mg/2 mL) and PEP.
IRCCS Ospedale Galeazzi
Milan, Italy, Italy
Ospedale Cardarelli
Naples, Italy, Italy
Ospedale Concordia
Roma, Italy, Italy
Policlinico Universitario Campus Biomedico
Roma, Italy, Italy
Ospedale Le Molinette
Torino, Italy, Italy
Ospedale Le Molinette
Torino, Italy
Performance of three intra-articular (IA) injections of HyalganBio® plus Physical Exercise Program (PEP), in terms of overall clinical functional assessment on movement.
The primary outcome of the investigation is the change of the total Constant Murley Score (CMS), a 100-point clinical scoring system. Total score evaluates four main components: A- Pain, B- Activities of daily living, C- Range of movement, D- Power each contributing a specific portion of the total score. Pain accounts for 15 points, daily activities for 20, range of motion for 40 and Power for 25.
Time frame: 6 months from baseline.
Clinical functional assessment on movement.
Clinical functional assessment on movement measured by means of the CMS subscores C (range of movement) accounts for 40 points. A higher score reflects better function.
Time frame: 2, 4 and 6 months from baseline.
Clinical functional assessment on movement.
Clinical functional assessment on movement measured by means of the CMS total score. Total Constant Murley Score (CMS), a 100-point clinical scoring system. Total score evaluates four main components: A- Pain, B- Activities of daily living, C- Range of movement, D- Power each contributing a specific portion of the total score. Pain accounts for 15 points, daily activities for 20, range of motion for 40 and Power for 25.
Time frame: 2 and 4 months from baseline.
Pain reduction
Pain reduction in the target shoulder with a 0-100 mm Visual Analogue Scale (VAS), 0 mm=absence of pain; 100 mm = intollerable pain.
Time frame: 2, 4 and 6 months from baseline.
Changes of physical function
Changes of physical function in the target shoulder, evaluated by Disability of the Arm, Shoulder and Hand (DASH). The questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. Each item is scored on a five-points scale (one to five). The overall DASH score, is summed (possible values: 30-150). The higher is the score the greater is the patient's experience of disability/symptoms.
Time frame: 2, 4 and 6 months compared to baseline.
Changes of patient's quality of life.
Changes of patient's quality of life, evaluated by administration of the EuroQol 5-Dimension Questionnaire, (EQ-5D-5L).The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each dimension having 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
Time frame: 2, 4 and 6 months compared to baseline (V1).
Rescue medication consumption
Rescue medication consumption for shoulder pain reported by the patient in a Patient's Diary. The number and percentage of patients who will take at least one dose of rescue medication up to 6 months from baseline (V1) will be analyzed.
Time frame: From baseline to the end of the study at 6 months.
Changes of Clinical Observer Global Assessment (COGA)
Changes of COGA evaluated directly by the Investigator with a 0-100 mm VAS, in the target shoulder. 0= not at all and 100= extremely.
Time frame: 2, 4 and 6 months compared to baseline
Number of Participants with treatment-emergent adverse events.
Safety of HyalganBio® will be evaluated in terms of incidence of treatment-emergent adverse events (TEAEs).
Time frame: From baseline to the end of the study at 6 months.
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