NCT07520708

Performance and Safety of HyalganBio® Intra-Articular Injections as Add-On to Physical Exercise for Symptomatic Glenohumeral Osteoarthritis

A Post-market, Randomized, Controlled, Clinical Investigation to Assess the Performance and Safety of HyalganBio® Intra-articular Injections, as add-on Physical Exercise Program, in the Symptomatic Relief of Glenohumeral Osteoarthritis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Fidia Farmaceutici s.p.a. · Industry
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Glenohumeral Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Hyaluronic acid plus Physical Exercise Program (PEP)	3 weekly intrarticular injections of HyalganBio® in a concentration of HA 2% (20 mg/2 mL) and PEP.

Timeline

• Start date: 2024-07-12
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2026-04-09
• Last updated: 2026-04-16

Locations

6 sites across 1 country: Italy