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ACTIVE NOT RECRUITING
NCT07520708
NA

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

Sponsor: Fidia Farmaceutici s.p.a.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

45 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2024-07-12

Completion Date

2026-10

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

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.

Locations (6)

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