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

NCT06043544 | Completed Phase 4

• 1 other identifier: Hymovis 10-04-21
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glenohumeral Osteoarthritis

Keywords

Osteoarthritis; Hyaluronic Acid; Corticosteroids

Outcome Measures

Primary Outcomes (1)

• Evaluate the pain reduction in the target shoulder compared to control group

  Changes of pain on movement in the target shoulder, evaluated with a 0-100 mm Visual Analogue Scale (VAS) values compared to baseline (V1).

  At 6 months

Secondary Outcomes (4)

• Evaluation of the Quality of Life of the patients

  At 6 months

• Evaluate the amelioration of shoulder functionality

  At 6 months

• Evaluate the pain reduction in the target shoulder compared to baseline

  At 6 months

• Evaluation of the safety of the treatment

  12 months

Study Arms (2)

Treatment group

EXPERIMENTAL

patients shoulder treated with Hymovis® 24mg/3ml.

Device: Hyaluronic Acid 24 MG in 3 mL Prefilled Syringe

Control group

ACTIVE COMPARATOR

patients shoulder treated with Corticosteroid.

Drug: Corticosteroid injection

Interventions

Hyaluronic Acid 24 MG in 3 mL Prefilled Syringe DEVICE

Patients in the treatment group received two intra-articular injections with Hymovis® (24mg/3ml) a week apart from each other

Treatment group

Corticosteroid injection DRUG

Patients in control group received two intra-articular injections with corticosteroids a week apart from each other.

Control group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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 any active musculoskeletal disease affecting the diagnosis/evaluation of shoulder pain or presence of pain of any neurological etiology and acute shoulder infection
• Patient undergoing local radiotherapy for breast cancer
• Patient with polymyalgia rheumatica
• History of skin cancer (except basal cell carcinoma) treated for less than two years
• History of severe recurrent or immune-mediated allergic reactions
• Presence of infection and/or skin pathologies in the injection area; psoriasis
• Presence of serious gastrointestinal, renal, hepatic, pulmonary, cardiovascular, neurological disorders that could interfere with the study results or patient's inability to comply with the study requirements
• Known allergy or suspected allergic reactions to hyaluronate or corticosteroid preparations
• Patient with history of thyroid insufficiency

Sponsors & Collaborators

• Concordia Hospital Rome: lead

Study Sites (1)

Concordia Hospital

Rome, 00145, Italy

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 80 consecutive patients with glenohumeral OA degree II or III were prospectively enrolled in our clinic from May 2021 to March 2022. The study was approved by Concordia Hospital Ethical Committee (02/2021) and performed according to ISO14155:2020 and Declaration of Helsinki.

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 21, 2023
• Study Start: May 2, 2021
• Primary Completion: November 10, 2021
• Study Completion: March 31, 2022
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

IT (1)