NCT06043544

Hymovis® Intra-articular Injections vs Corticosteroids Intra-articular Injections in Patients Affected by Glenohumeral Osteoarthritis:

Hymovis® Intra-articular Injections vs Corticosteroids Intra-articular Injections in Patients Affected by Glenohumeral Osteoarthritis: a Monocentric Randomized Open-label Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Concordia Hospital Rome · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Hyaluronic Acid 24 MG in 3 mL Prefilled Syringe	Patients in the treatment group received two intra-articular injections with Hymovis® (24mg/3ml) a week apart from each other
DRUG	Corticosteroid injection	Patients in control group received two intra-articular injections with corticosteroids a week apart from each other.

Timeline

• Start date: 2021-05-02
• Primary completion: 2021-11-10
• Completion: 2022-03-31
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

1 site across 1 country: Italy