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Hymovis® Intra-articular Injections vs Corticosteroids Intra-articular Injections in Patients Affected by Glenohumeral Osteoarthritis: | Clinical Trials | Clareo Health

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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

NCT06043544•Concordia Hospital Rome

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patient aged ≥40 years
•Patient suffering from glenohumeral osteoarthritis with chronic shoulder pain. Chronic shoulder pain is defined as follows:
•Persistence for a period of at least 6 months, but not more than 5 years;
•Pain perceived by the patient with a frequency of at least 50% of the days in the month preceding the inclusion visit; Kellgren-Lawrence grade of 2 or 3 in the glenohumeral joint confirmed by x-ray exam performed within 3 months prior to the inclusion visit.
•Presence, at baseline, of pain on movement, in the shoulder under study, measured by VAS with a score between 40 and 80 mm Presence at baseline of pain in the contralateral shoulder at least 10mm less than the study shoulder and no more than 40mm as measured by VAS at the inclusion visit
•Presence, at baseline, of limitation of shoulder motion in at least one direction in the following ranges of motion:
•Fixed scapula abduction ≤ 80°
•Internal rotation in abduction ≤ 55°
•External rotation in abduction ≤ 80° These shoulder limitations are for normal expected excursions. Patient who has not responded adequately to non-pharmacological conservative therapy and to taking simple analgesics Patient willing to sign and able to understand the Informed Consent form Patient who is not pregnant or nursing. Women of childbearing potential (including women who have been less than one year postmenopausal) must agree to use reliable contraception for the duration of the study.

Exclusion Criteria

•Presence, on clinical evaluation, of adhesive capsulitis
•Evidence of rotator cuff injury
•Presence of primary extra-articular shoulder syndromes (eg impingement, bursitis, tendonitis)
•Evidence of clinically significant shoulder deformity
•Signs, evident on X-ray radiography of the shoulder, of recent fractures, severe loss of bone density and/or severe deformity
•Diagnosed with crystal deposition disease of calcium pyrophosphate dihydrate (CPPD) or chondrocalcinosis of the shoulder
•Presence of pathology of the cervical vertebrae (able to alter the clinical evaluation) which, in the three months preceding the inclusion visit, was symptomatic and required active treatment
•Presence of any active musculoskeletal disease affecting the diagnosis/evaluation of shoulder pain or presence of pain of any neurological etiology and acute shoulder infection
•Presence of major surgery, arthroplasty or arthroscopy in the shoulder under study in the 6 months prior to inclusion and/or surgery planned during the study
•Patient undergoing local radiotherapy for breast cancer
+20 more criteria

Locations (1)

Concordia Hospital

Rome, Italy

Key Dates

Start Date

May 2, 2021

Primary Completion Date

November 10, 2021

Completion Date

March 31, 2022

Last Updated

September 21, 2023

Enrollment

ACTUAL participants

Conditions

Glenohumeral Osteoarthritis

Interventions

Hyaluronic Acid 24 MG in 3 mL Prefilled Syringe

DEVICE

Corticosteroid injection

DRUG

ZILRETTA in Subjects With Shoulder Osteoarthritis

NCT06269705

Glenohumeral Osteoarthritis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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