Osteoarthritis of KneeNCT06652893
Efficacy and Safety of Sinovial®HL Single Injection in the Knee Osteoarthritis
An observational study of Osteoarthritis of Knee, run by Marcin Domżalski at 1 site in Poland.
Trial summary
The prevalence of knee osteoarthritis (OA) is rising worldwide, leading to disability and a reduced quality of life, particularly in elderly patients. While there are several treatment options, there is little consensus in the scientific community over which methods are most effective. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- Sinovial
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2021to 11 Nov 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic OA of the knee KL II-III with unsucsessful conservative treatment with NSAIDS for 6 weeks. Age 45 -80 without axial deformation of the lower leg more than 10 deg.
The inclusion criteria
- medical indication for viscosupplementation therapy with hybrid HA 2 patients aged between 45 and 80 years 3.diagnosis of gonarthrosis 4. gonarthrosis symptoms for at least 6 months 5. patients who failed to respond to analgesics and/or regular NSAIDs, 6. grade 2 to 3 OA in the Kellgren-Lawrence grading scale 7. pain on walking measured by the Visual Analog Scale (VAS; 0-100 mm) of at least 40 mm on the targeted knee; 8. contralateral knee pain when walking with aVAS of less than 10 mm.
The exclusion criteria were:
- inability to understand the aim of the study
- inability to provide acceptable consent
- pregnancy
- serious psychiatric disorders
- allergy or intolerance to hybrid HA
- secondary gonarthrosis due to systematic and inflammatory disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-world Efficacy and Safety of Sinovial®HL Single Injection in the Treatment of Symptomatic Knee Osteoarthritis: an Observational Study
The prevalence of knee osteoarthritis (OA) is rising worldwide, leading to disability and a reduced quality of life, particularly in elderly patients. While there are several treatment options, there is little consensus in the scientific community over which methods are most effective. Viscosupplementation with hyaluronic acid (HA) has been found to reduce pain in patients with knee OA over a period of up to 6 months, with little to no side effects. The aim of this prospective open-label, uncontrolled, observational, single-site study was to assess the efficacy and safety of a single hybrid HA injection over a period of 6 months in subpopulations of patients with low to severe symptomatic knee OA in everyday clinical practice.
Fifty patients who met the inclusion criteria participated in the study. A single intra-articular ultrasound-guided injection of hybrid HA (Sinovial®) was administered. Patients submitted Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaires at 28-, 42-, 84-, and 168-days post-treatment.
- Conditions
- Osteoarthritis of Knee
- Being tested
- Sinovial
- Keywords
- knee osteoarthritis, hialuronic acid, knee function
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SinovialDrug
A single intra-articular injection of hybrid HA complex, Sinovial® HL (IBSA Pharmaceuticals, Italy, patent number WO/2012/032151 ) in the knee was performed from the lateral approach to the suprapatellar recess using ultrasound. For the ultrasound-guided infiltration method, a sterile linear probe with a 20 G guide was used to visualize the joint suprapatellar recess and avoid intrasynovial infiltration. The patient was positioned supine with the knee in full extension. From the lateral approach to the suprapatellar recess, HA was then injected into the knee joint, verifying intra-articular positioning in real-time via ultrasound imaging (direct visualization of viscous fluid or air bubbles).
Patients did not receive anti-inflammatory or pain-relieving drugs in the week before the first injection . Patients were evaluated at four time points: at baseline and after 28, 42, 84, and 168 days after the intervention. At each evaluation, clinical data relating to the status of the disea
| Study group | Role | What they receive |
|---|---|---|
| Fifty consecutive patients who met the inclusion criteria participated in the study | Consecutive patients with knee osteoarthritis and with a medical indication for viscosupplementation with hybrid hialuronic acid (HA) who fulfilled the inclusion criteria were recruited for the study. The inclusion criteria were: a medical indication for viscosupplementation therapy with hybrid HA; patients aged between 45 and 80 years; diagnosis of femorotibial gonarthrosis associated with femoro-patellar arthrosis or isolated, gonarthrosis symptoms for at least 6 months; patients who failed to respond to analgesics and/or regular NSAIDs, or were proved to be intolerant to the regular use of analgesics, NSAIDS, or weak opioids; grade 2 to 3 OA in the Kellgren-Lawrence grading scale ; pain when walking measured by the Visual Analog Scale of at least 40 mm on the targeted knee; and contralateral knee pain when walking with aVAS of less than 10 mm. The exclusion criteria were: inability to understand the aim of the study, inability to provide acceptable consent, pregnancy, serious ps Receives: Drug: Sinovial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Visual Analog Scale for the assessment of the pain during the study. Scale 0 ( no pain ) to 10 ( extreme pain )
Measured: 6 month
The Western Ontario and McMaster Universities Arthritis Index
The Western Ontario and McMaster Universities Arthritis Index ( WOMAC ) is used to assess the function of the knee in osteoarthritis. Scale 0 ( the worst result ) -100 ( the best result )
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Oct 2021
- Primary completion10 Sep 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Marcin Domżalski
- Sponsor type
- University, hospital or other
- Collaborators
- IBSA Institut Biochimique SA
- Responsible party
- Sponsor-investigator, Marcin Domżalski, Sporto Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652893
- Sponsor's protocol ID
- K.B. 22/2022
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Domzalski ME, Marchewa K. The Efficacy and Safety of Single Injections of Hybrid HA in the Treatment of Symptomatic Knee Osteoarthritis: A Case Series. Rheumatol Ther. 2025 Aug;12(4):695-708. doi: 10.1007/s40744-025-00780-8. Epub 2025 Jul 2.
PubMed 40601162
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Efficacy and Safety of Sinovial®HL Single Injection in the Treatment of Symptomatic Knee Osteoarthritis: an Observational Study
- ClinicalTrials.gov ID
- NCT06652893
- Acronym / sponsor ID
- K.B. 22/2022
- Conditions
- Osteoarthritis of Knee
- Keywords
- knee osteoarthritis, hialuronic acid, knee function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Marcin DomżalskiUniversity, hospital or other
- Collaborators
- IBSA Institut Biochimique SA
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 10 Sep 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of knee osteoarthritis (OA) is rising worldwide, leading to disability and a reduced quality of life, particularly in elderly patients. While there are several treatment options, there is little consensus in the scientific community over which methods are most effective. Viscosupplementation with hyaluronic acid (HA) has been found to reduce pain in patients with knee OA over a period of up to 6 months, with little to no side effects. The aim of this prospective open-label, uncontrolled, observational, single-site study was to assess the efficacy and safety of a single hybrid HA injection over a period of 6 months in subpopulations of patients with low to severe symptomatic knee OA in everyday clinical practice.
Fifty patients who met the inclusion criteria participated in the study. A single intra-articular ultrasound-guided injection of hybrid HA (Sinovial®) was administered. Patients submitted Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaires at 28-, 42-, 84-, and 168-days post-treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fifty consecutive patients who met the inclusion criteria participated in the study | – | Drug: SinovialConsecutive patients with knee osteoarthritis and with a medical indication for viscosupplementation with hybrid hialuronic acid (HA) who fulfilled the inclusion criteria were recruited for the study. The inclusion criteria were: a medical indication for viscosupplementation therapy with hybrid HA; patients aged between 45 and 80 years; diagnosis of femorotibial gonarthrosis associated with femoro-patellar arthrosis or isolated, gonarthrosis symptoms for at least 6 months; patients who failed to respond to analgesics and/or regular NSAIDs, or were proved to be intolerant to the regular use of analgesics, NSAIDS, or weak opioids; grade 2 to 3 OA in the Kellgren-Lawrence grading scale ; pain when walking measured by the Visual Analog Scale of at least 40 mm on the targeted knee; and contralateral knee pain when walking with aVAS of less than 10 mm. The exclusion criteria were: inability to understand the aim of the study, inability to provide acceptable consent, pregnancy, serious ps |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic OA of the knee KL II-III with unsucsessful conservative treatment with NSAIDS for 6 weeks. Age 45 -80 without axial deformation of the lower leg more than 10 deg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SinovialA single intra-articular injection of hybrid HA complex, Sinovial® HL (IBSA Pharmaceuticals, Italy, patent number WO/2012/032151 ) in the knee was performed from the lateral approach to the suprapatellar recess using ultrasound. For the ultrasound-guided infiltration method, a sterile linear probe with a 20 G guide was used to visualize the joint suprapatellar recess and avoid intrasynovial infiltration. The patient was positioned supine with the knee in full extension. From the lateral approach to the suprapatellar recess, HA was then injected into the knee joint, verifying intra-articular positioning in real-time via ultrasound imaging (direct visualization of viscous fluid or air bubbles). Patients did not receive anti-inflammatory or pain-relieving drugs in the week before the first injection . Patients were evaluated at four time points: at baseline and after 28, 42, 84, and 168 days after the intervention. At each evaluation, clinical data relating to the status of the disea | Drug | Fifty consecutive patients who met the inclusion criteria participated in the study |
Primary outcome
Visual Analog Scale
Time frame: 6 month
Visual Analog Scale for the assessment of the pain during the study. Scale 0 ( no pain ) to 10 ( extreme pain )
The Western Ontario and McMaster Universities Arthritis Index
Time frame: 6 months
The Western Ontario and McMaster Universities Arthritis Index ( WOMAC ) is used to assess the function of the knee in osteoarthritis. Scale 0 ( the worst result ) -100 ( the best result )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Derived from this study: PubMed 40601162Domzalski ME, Marchewa K. The Efficacy and Safety of Single Injections of Hybrid HA in the Treatment of Symptomatic Knee Osteoarthritis: A Case Series. Rheumatol Ther. 2025 Aug;12(4):695-708. doi: 10.1007/s40744-025-00780-8. Epub 2025 Jul 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis of Knee, run by Marcin Domżalski at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06652893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.