Osteoarthritis, KneeNCT06422169
Interventistic Clinical Investigation on the Use of Medical Device in Subjects With Mild-moderate Osteoarticular Pain
A study testing ArToFILL in people with Osteoarthritis, Knee, run by PromoPharma spa at 1 site in Italy.
Trial summary
Evaluation of the performance and safety of ArToFILL in subjects with mild to moderate osteoarticular pain Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- ArToFILL
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 8 May 2024to 8 May 2025
- Phase
- Interventional
- 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 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient (males and females) aged between 18 and 84 years (limits included);
- Patient able to understand the nature and purpose of the study, including possible risks and side effects;
- Patient able to provide written Informed Consent, in accordance with good clinical practice and current legislation;
- Pain ≥ 40 mm on the VAS score in the target knee for at least 2 months;
- Patient with knee osteoarthritis assessed radiographically, grade 1 to 3 according to the Kellgren-Lawrence scale (K-L);
- Body Mass Index (BMI) ≤ 35;
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- Patient who will benefit from this treatment;
- Patient available for the entire study period;
- Patient able to cooperate and meet the requirements of the clinical investigation plan.
Who cannot join
- Patient with knee osteoarthritis, assessed radiographically, grade 4 by the K-L scale;
- Patient presenting ongoing inflammation/infection at the level of the joint being investigated;
- Patient with abundant intra-articular effusion;
- Patient with symptoms of viral or bacterial infections or similar;
- Patient with insertion point of the joint infected or in the presence of a skin disease;
- Simultaneous treatment with disinfectants containing quaternary ammonium salts or chlorhexidine;
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- Patient with known or potential allergy or hypersensitivity and/or history of allergic reactions to one of the components of the medical device;
- Concomitant treatments with thrombolytic or anticoagulant therapies, for less than 2 weeks prior to the screening visit;
- Intra-articular treatments carried out in the last 3 months (9 months if with products containing hyaluronic acid) of the target joint;
- Topical treatments of the target joint in progress or performed within 1 week of the screening visit;
- Taking NSAIDs and/or paracetamol as rescue treatment for more than two consecutive days;
- Surgical interventions of prosthetic replacement in the target joint;
- Physiotherapy and instrumental physical therapy treatments for the target joint performed in the last 2 weeks prior to the screening visit, and during the study period;
- Participation in another clinical trial within 60 days prior to the screening visit;
- Evidence of severe or uncontrolled systemic disease or any other significant disorder (e.g. haemophilia, bleeding disorders etc.); which do not allow participation in the study or could compromise the results.
- Patients who are pregnant or breastfeeding;
- Subject unable to follow clinical investigation procedures and follow-up visits;
- Any other medical condition which could influence participation in the clinical investigation or compromise its results.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
U.O. Recupero e riabilitazione funzionale P.O. "G.Rodolico", Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"
Catania
Michele Vecchio, +39 0953782702, michele.vecchio@unict.it
Michele Vecchio
About this study
Official title: Interventistic Monocentric Pre-market Clinical Investigation on the Use of Medical Device "ArToFILL" in Subjects With Mild-moderate Osteoarticular Pain
Evaluation of the performance and safety of ArToFILL in subjects with mild to moderate osteoarticular pain
Read the detailed description
Monocenter, prospective, open label, interventional clinical investigation evaluating the performance and safety of 3 intra-articular injections of ArToFILL for the treatment of mild-moderate osteoarticular pain.
- Conditions
- Osteoarthritis, Knee
- Being tested
- ArToFILL
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArToFILLDevice
ArToFILL is an injectable medical device (class III) intended for use as a temporary filler in joints. It is a sterile, non-pyrogenic, colorless and transparent hyaluronic acid gel of non-animal origin. ArToFILL is a hydrogel consisting of a mixture of two different molecular weights of hyaluronic acid, for a total HA concentration of 2.7 %.
| Study group | Role | What they receive |
|---|---|---|
| Artofill | Experimental | One vial for intra-articular infiltration every 7 days, for three consecutive weeks. After the injection it is necessary to keep the infiltrated joint at rest for at least 24 hours. In addition, as with all invasive joint treatments, the patient is advised to avoid any physical activity 2-3 days after the injection. Do not repeat the treatment before 7 days from the previous one. Receives: Device: ArToFILL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction ≥ of 15 points on VAS scale, at the Study Termination Visit compared to baseline
Assessment of pain reduction using the visual analogue scale (VAS) ranging from 0 to 100 mm (where 0 = absent and 100 = strongest pain)
Measured: Up to 180 days
Secondary outcomes (2)
Clinical improvement assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. The total score is the result of the sum of 3 groups of questions with 5 possible answers (between 0 and 4, where 0=none and 4=extreme) for the self-assessment of:
- pain:five questions (score from 0 to 20);
- joint stiffness: two questions (score from 0 to 8);
- functional limitations: 17 questions (score from 0 to 68).
Measured: Up to 180 days
Improved range of motion (ROM) of the knee joint
The variation of the ROM joint excursion used for the analysis of the joint excursion (flexion-extension), will be calculated as the difference between maximum width and minimum width of the angular profile on the basis of the following formula: ROMα = max (α) - min (α) (flexion-extension)
Measured: Up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start8 May 2024
- Primary completion8 Mar 2025 (estimated)
- Study completion8 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PromoPharma spa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michele Vecchio, Principal investigator, Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco", P.O. "G. Rodolico"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422169
- Sponsor's protocol ID
- ARTO/09/2023
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 20 May 2024
- Results posted
- 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 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventistic Monocentric Pre-market Clinical Investigation on the Use of Medical Device "ArToFILL" in Subjects With Mild-moderate Osteoarticular Pain
- ClinicalTrials.gov ID
- NCT06422169
- Acronym / sponsor ID
- ARTO/09/2023
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- PromoPharma spaIndustry (pharma, biotech, devices)
- Study start
- 8 May 2024 (actual)
- Primary completion
- 8 Mar 2025 (estimated)
- Study completion
- 8 May 2025 (estimated)
- First posted
- 20 May 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.
Evaluation of the performance and safety of ArToFILL in subjects with mild to moderate osteoarticular pain
Detailed description
Monocenter, prospective, open label, interventional clinical investigation evaluating the performance and safety of 3 intra-articular injections of ArToFILL for the treatment of mild-moderate osteoarticular pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Artofill | Experimental | Device: ArToFILLOne vial for intra-articular infiltration every 7 days, for three consecutive weeks. After the injection it is necessary to keep the infiltrated joint at rest for at least 24 hours. In addition, as with all invasive joint treatments, the patient is advised to avoid any physical activity 2-3 days after the injection. Do not repeat the treatment before 7 days from the previous one. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient (males and females) aged between 18 and 84 years (limits included);
- Patient able to understand the nature and purpose of the study, including possible risks and side effects;
- Patient able to provide written Informed Consent, in accordance with good clinical practice and current legislation;
- Pain ≥ 40 mm on the VAS score in the target knee for at least 2 months;
- Patient with knee osteoarthritis assessed radiographically, grade 1 to 3 according to the Kellgren-Lawrence scale (K-L);
Key exclusion criteria (18 listed)
- Patient with knee osteoarthritis, assessed radiographically, grade 4 by the K-L scale;
- Patient presenting ongoing inflammation/infection at the level of the joint being investigated;
- Patient with abundant intra-articular effusion;
- Patient with symptoms of viral or bacterial infections or similar;
- Patient with insertion point of the joint infected or in the presence of a skin disease;
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 |
|---|---|---|
| ArToFILLArToFILL is an injectable medical device (class III) intended for use as a temporary filler in joints. It is a sterile, non-pyrogenic, colorless and transparent hyaluronic acid gel of non-animal origin. ArToFILL is a hydrogel consisting of a mixture of two different molecular weights of hyaluronic acid, for a total HA concentration of 2.7 %. | Device | Artofill |
Primary outcome
Reduction ≥ of 15 points on VAS scale, at the Study Termination Visit compared to baseline
Time frame: Up to 180 days
Assessment of pain reduction using the visual analogue scale (VAS) ranging from 0 to 100 mm (where 0 = absent and 100 = strongest pain)
2 secondary outcomes
Clinical improvement assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Up to 180 days
Improved range of motion (ROM) of the knee joint
Time frame: Up to 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- 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.
Michele Vecchio principal investigator
Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco", P.O. "G. Rodolico"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ArToFILL in people with Osteoarthritis, Knee, run by PromoPharma spa at 1 site in Italy.
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 18 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: status not confirmed, as of the sponsor's last update on 20 May 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michele Vecchio (+39 0953782702, michele.vecchio@unict.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction ≥ of 15 points on VAS scale, at the Study Termination Visit compared to baseline (time frame: Up to 180 days). 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 20 May 2024.