The efficacy and safety of a high- concentration hybrid hyaluronic acid in patients with knee osteoarthritis: an open-label study
| ISRCTN | ISRCTN12974924 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12974924 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | SINO90/01-20 |
| Sponsor | IBSA Farmaceutici (Italy) |
| Funder | IBSA Farmaceutici Italia |
- Submission date
- 03/10/2025
- Registration date
- 20/01/2026
- Last edited
- 20/01/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Osteoarthritis is a common condition that causes joints to become painful and stiff, often due to the breakdown of cartilage and a reduction in natural joint lubricants like hyaluronic acid. This study is testing a treatment called Sinovial® HL 90, a type of hyaluronic acid that is injected directly into the knee joint. The aim is to see whether it helps improve joint movement, reduce pain, and delay the need for surgery in people with knee osteoarthritis.
Who can participate?
Adults diagnosed with moderate knee osteoarthritis (Kellgren–Lawrence grade 2–3) were eligible to take part in the study.
What does the study involve?
Participants received either one or two injections of Sinovial® HL 90 into their knee joint over a three-month period. The number of injections was decided based on each person’s clinical assessment. Researchers then monitored changes in pain, movement, and overall quality of life over time.
What are the possible benefits and risks of participating?
The treatment may help reduce pain, improve joint function, and enhance quality of life. It could also help delay the need for surgery. As with any injection, there may be minor risks such as temporary discomfort, swelling, or infection at the injection site.
Where is the study run from?
The study was carried out at the Orthopaedic and Trauma Surgery Unit at Fondazione Policlinico Universitario Campus Bio-Medico in Rome, Italy.
When is the study starting and how long is it expected to run for?
November 2021 to November 2023
Who is funding the study?
IBSA Farmaceutici Italia.
Who is the main contact?
Dr Fabrizio Russo, fabrizio.russo@policlinicocampus.it
Contact information
Principal investigator
Via Alvaro del Portillo 200
Roma
00128
Italy
| Phone | +39 3334985912 |
|---|---|
| b.zampogna@policlinicocampus.it |
Scientific
Via Alvaro del Portillo 200
roma
00128
Italy
 ORCID ID |
0000-0002-8566-8952 |
|---|---|
| Phone | +39 3493601908 |
| fabrizio.russo@policlinicocampus.it |
Public
Via della Filanda 30
lodi
26900
Italy
| Phone | +39 3450908561 |
|---|---|
| andrea.autelitano@ibsa.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective single-center open-label clinical study |
| Secondary study design | Non randomised study |
| Scientific title | An open-label study to evaluate the efficacy and safety of a high-concentration hybrid hyaluronic acid, administered as a single dose and, in a secondary population, with repeated administration, in patients with knee osteoarthritis |
| Study acronym | SINO90/01-20 |
| Study objectives | Intra-articular injections of hybrid HA formulation, analysis of functional and quality of life outocome thug IKDC, KOOS, and SF-12 PCS questionnaires, pain assessment using VAS. Adverse event monitoring including classification by causality (unrelated, possibly, probably related), classification by severity (mild, moderate, severe), incident classification (serious, non-serious) |
| Ethics approval(s) |
Approved 15/12/2020, Comitato Etico dell’Università Campus Bio-Medico di Roma (Via Alvaro del Portillo 5, Roma, 00128, Italy; +39 0622548812; comitato.etico@unicampus.it), ref: 92/20 PAR ComEt CBM |
| Health condition(s) or problem(s) studied | Kellgren–Lawrence grade 2–3 knee Osteoarthrosis |
| Intervention | 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 months. Population B: two or three intra-articular injections of Sinovial® HL 90 (4.5%) over the study duration. This group included patients with very low International Knee Documentation Committee (IKDC) scores who, based on the investigator's judgment, were expected to benefit from this dosage schedule. The follow-up period lasted 6 months |
| Intervention type | Device |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Sinovial® HL 90 |
| Primary outcome measure(s) |
Functional limitation and joint stiffness reduction, measured by the IKDC questionnaire, at 6 month |
| Key secondary outcome measure(s) |
1. Functional limitation and joint stiffness are measured using the International Knee Documentation Committee (IKDC) questionnaire at baseline and 6 months in Population B |
| Completion date | 29/11/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 40 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 32 |
| Total final enrolment | 45 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/12/2021 |
| Date of final enrolment | 24/04/2023 |
Locations
Countries of recruitment
- Italy
Study participating centre
Roma
00128
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and analysed during the current study will be available upon request from: Fabrizio Russo fabrizio.russo@policlinicocampus.it |
Editorial Notes
03/10/2025: Trial's existence confirmed by Comitato Etico dell’Università Campus Bio-Medico di Roma.
