Kellgren–Lawrence grade 2–3 knee Osteoarthrosis Musculoskeletal Diseases
Conditions
Interventions
Single-dose (Population A) or repeated-dose (Population B) intra-articular injections of Sinovial® HL 90 (4.5%).
Population A: single injection of Sinovial® HL 90. The follow-up period lasted 6 month
Sponsors
IBSA Farmaceutici (Italy)
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of knee OA (medial, lateral, patellofemoral, bicompartmental, or tricompartmental) 2. Kellgren and Lawrence grade 2 or 3 on radiographic examination (scale 0–4) 3. Age range of 40–80 years 4. Willingness to participate in the study, demonstrated by signing an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Clinically significant abnormal laboratory values indicating disease 2. Confirmed allergy or suspected hypersensitivity to the investigated medical device and/or its excipients 3. A history of anaphylaxis due to drugs, dietary supplements, or any allergic reactions deemed by the investigator to potentially influence the study outcome 4. A significant medical history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, dermatological, hematological, endocrine, or neurological diseases that could interfere with the study's purposes 5. Use of herbal remedies and dietary supplements within 2 weeks prior to the study initiation 6. Prior treatment with corticosteroids, thyroid hormones, antibiotics, or antiepileptics 7. Any clinical condition deemed incompatible with participation by the investigator 8. Alcohol abuse 9. Women who were pregnant or breastfeeding 10. Patients using other intra-articular HA-based medical devices, non-steroidal anti-inflammatory drugs, or corticosteroid painkillers for their knee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional limitation and joint stiffness reduction, measured by the IKDC questionnaire, at 6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Functional limitation and joint stiffness are measured using the International Knee Documentation Committee (IKDC) questionnaire at baseline and 6 months in Population B 2. Pain is measured using a visual analog scale (VAS) at baseline, 3 months, and 6 months in both populations 3. Functional limitation is measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire at baseline, 3 months, and 6 months in both populations 4. Quality of life is measured using the 12-item Short Form Health Survey – Physical Component Summary (SF-12 PCS) score at baseline, 3 months, and 6 months in both populations | — |
Countries
Italy
Contacts
Public ContactAndrea Autelitano
Outcome results
None listed