Knee OsteoarthristisACTANCT07465601
Daily Activity and Clinical Outcome Measurement of Arthrosamid® Administration in Symptomatic Knee Osteoarthritis.
A study testing Arthrosamid in people with Knee Osteoarthristis, run by Medisch Centrum Latem at 1 site in Belgium.
Trial summary
This study is a prospective, monocentric, interventional post-market study evaluating the effects of a single intra-articular injection of Arthrosamid in patients with symptomatic knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- Arthrosamid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Jul 2024to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects > 18 years of age at the time of injection
- Advanced osteoarthritis, involving one or multiple of the following phenotypes: tricompartmental osteoarthritis, isolated or severe patella-femoral osteoarthritis, and/or a Kellgren and Lawrence grade II or III classification:
- Patellofemoral osteoarthritis referring to symptoms, including pain, that are principally of patellofemoral origin (Patellar syndrome).
- Radiological Kellgren and Lawrence grade II to III from a standing knee radiograph taken less than 6 months previously.
- Subjects with a normal BMI ≥ 18.5 kg/m² and < 30 kg/m²
- Symptomatic osteoarthritis diagnosed via radiographic assessment and according to the clinical and radiological criteria of the American College of Rheumatology
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- Fully ambulatory patient for functional evaluation.
- Able to understand and follow the instructions of the study.
- Having signed a written informed consent
Who cannot join
- Meeting one of the following contraindications as stated in the instructions for use (IFU) of Arthrosamid®:
- If an active skin disease or infection is present at or near the injection site
- If the joint is infected or severely inflamed
- If a degradable intra-articular injectable such as hyaluronic acid is present, it must be expected to be absorbed according to the manufacturer's information for the specific product, before injection with Arthrosamid®
- Other medical conditions contributing to the rehabilitation process of the injection according to the surgeon
- Important medical conditions such as, Parkinson's Disease, dementia, multiple sclerosis and cerebral vascular accident, which can disturb the patient's rehabilitation after injection according to the surgeon
- Patient is participating in another clinical trial or has participated in a clinical trial in the last three months
- Patients who did not met all the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Daily Activity and Clinical Outcomes After a Single, Intra-articular, Injection of Arthrosamid® in Patients With Symptomatic Knee Osteoarthritis: a Monocentric Trial With a 12-month Follow-up Period
This study is a prospective, monocentric, interventional post-market study evaluating the effects of a single intra-articular injection of Arthrosamid in patients with symptomatic knee osteoarthritis. Arthrosamid is a polyacrylamide hydrogel consisting of 97.5% sterile water and 2.5% cross-linked polyacrylamide that integrates into the synovial tissue and is used for the symptomatic treatment of knee osteoarthritis.
The study will include 30 eligible patients receiving a single Arthrosamid injection and will be followed for up to 12 months. The primary objective is to evaluate the performance of Arthrosamid in terms of daily activities and clinical outcomes in patients with symptomatic knee osteoarthritis. The primary endpoint assesses the percentage change from baseline in daily activity levels at 6 months after injection, measured using an activity tracker combined with a digital rehabilitation tool. Additional assessments include patient-reported outcome measures and clinical follow-up visits conducted as part of standard care.
- Conditions
- Knee Osteoarthristis
- Being tested
- Arthrosamid
- Keywords
- Knee Osteoarthritis, Arthrosamid, Polyacrylamide Hydrogel, Activity Monitoring, Intra-Articular Injection
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthrosamidDevice
Single intra-articular injection of Arthrosamid, a polyacrylamide hydrogel consisting of 97.5% sterile water and 2.5% cross-linked polyacrylamide, administered for the symptomatic treatment of knee osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| Arthrosamid Injection | Experimental | Patients with symptomatic knee osteoarthritis receiving a single intra-articular injection of Arthrosamid and followed for clinical outcomes and activity levels for up to 12 months. Receives: Device: Arthrosamid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline in Daily Activity Levels
Percentage change from baseline in daily activity levels at 6 months after a single intra-articular Arthrosamid injection, measured using an activity tracker coupled with a digital rehabilitation tool.
Measured: 6 months follow-up
Secondary outcomes (2)
Percentage Change From Baseline in Daily Activity Levels
Percentage change from baseline in daily activity levels at 12 months after a single intra-articular Arthrosamid injection, measured using an activity tracker coupled with a digital rehabilitation tool.
Measured: 12 months follow-up
Change From Baseline in Patient-Reported Outcome Measures
Absolute and percentage change from baseline in patient-reported outcome measures (PROMs), including KOOS (total and subscales), Oxford Knee Score, Forgotten Joint Score (FJS), EQ-5D, UCLA Activity Score, and the moveUP index score, in patients with symptomatic knee osteoarthritis treated with Arthrosamid.
Measured: 7 to 14 days before injection, Day 0 (baseline), 2 weeks, 6 weeks, 3 months, 6 months, and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start25 Jul 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medisch Centrum Latem
- Sponsor type
- University, hospital or other
- Collaborators
- Contura
- Responsible party
- Principal investigator, Philippe Van Overschelde, Medisch Centrum Latem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465601
- Sponsor's protocol ID
- BUN3002024000098
- Other IDs
- 6568
- Acronym
- ACTA
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Daily Activity and Clinical Outcomes After a Single, Intra-articular, Injection of Arthrosamid® in Patients With Symptomatic Knee Osteoarthritis: a Monocentric Trial With a 12-month Follow-up Period
- ClinicalTrials.gov ID
- NCT07465601
- Acronym / sponsor ID
- ACTA / BUN3002024000098
- Conditions
- Knee Osteoarthristis
- Keywords
- Knee Osteoarthritis, Arthrosamid, Polyacrylamide Hydrogel, Activity Monitoring, Intra-Articular Injection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Medisch Centrum LatemUniversity, hospital or other
- Collaborators
- Contura
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 12 Mar 2026 (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.
This study is a prospective, monocentric, interventional post-market study evaluating the effects of a single intra-articular injection of Arthrosamid in patients with symptomatic knee osteoarthritis. Arthrosamid is a polyacrylamide hydrogel consisting of 97.5% sterile water and 2.5% cross-linked polyacrylamide that integrates into the synovial tissue and is used for the symptomatic treatment of knee osteoarthritis.
The study will include 30 eligible patients receiving a single Arthrosamid injection and will be followed for up to 12 months. The primary objective is to evaluate the performance of Arthrosamid in terms of daily activities and clinical outcomes in patients with symptomatic knee osteoarthritis. The primary endpoint assesses the percentage change from baseline in daily activity levels at 6 months after injection, measured using an activity tracker combined with a digital rehabilitation tool. Additional assessments include patient-reported outcome measures and clinical follow-up visits conducted as part of standard care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthrosamid Injection | Experimental | Device: ArthrosamidPatients with symptomatic knee osteoarthritis receiving a single intra-articular injection of Arthrosamid and followed for clinical outcomes and activity levels for up to 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects > 18 years of age at the time of injection
- Advanced osteoarthritis, involving one or multiple of the following phenotypes: tricompartmental osteoarthritis, isolated or severe patella-femoral osteoarthritis, and/or a Kellgren and Lawrence grade II or III classification:
- Subjects with a normal BMI ≥ 18.5 kg/m² and < 30 kg/m²
- Symptomatic osteoarthritis diagnosed via radiographic assessment and according to the clinical and radiological criteria of the American College of Rheumatology
- Fully ambulatory patient for functional evaluation.
Key exclusion criteria (8 listed)
- Meeting one of the following contraindications as stated in the instructions for use (IFU) of Arthrosamid®:
- Other medical conditions contributing to the rehabilitation process of the injection according to the surgeon
- Important medical conditions such as, Parkinson's Disease, dementia, multiple sclerosis and cerebral vascular accident, which can disturb the patient's rehabilitation after injection according to the surgeon
- Patient is participating in another clinical trial or has participated in a clinical trial in the last three months
- Patients who did not met all the inclusion criteria
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 |
|---|---|---|
| ArthrosamidSingle intra-articular injection of Arthrosamid, a polyacrylamide hydrogel consisting of 97.5% sterile water and 2.5% cross-linked polyacrylamide, administered for the symptomatic treatment of knee osteoarthritis. | Device | Arthrosamid Injection |
Primary outcome
Percentage Change From Baseline in Daily Activity Levels
Time frame: 6 months follow-up
Percentage change from baseline in daily activity levels at 6 months after a single intra-articular Arthrosamid injection, measured using an activity tracker coupled with a digital rehabilitation tool.
2 secondary outcomes
Percentage Change From Baseline in Daily Activity Levels
Time frame: 12 months follow-up
Change From Baseline in Patient-Reported Outcome Measures
Time frame: 7 to 14 days before injection, Day 0 (baseline), 2 weeks, 6 weeks, 3 months, 6 months, and 12 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Arthrosamid in people with Knee Osteoarthristis, run by Medisch Centrum Latem at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2026. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage Change From Baseline in Daily Activity Levels (time frame: 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2026.