Actively Recruiting
Interventistic Clinical Investigation on the Use of Medical Device in Subjects With Mild-moderate Osteoarticular Pain
Led by PromoPharma spa · Updated on 2024-05-20
35
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluation of the performance and safety of ArToFILL in subjects with mild to moderate osteoarticular pain
CONDITIONS
Official Title
Interventistic Clinical Investigation on the Use of Medical Device in Subjects With Mild-moderate Osteoarticular Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged between 18 and 84 years (inclusive)
- Patient able to understand the study and provide written informed consent
- Pain of 40 mm or more on the VAS score in the target knee for at least 2 months
- Knee osteoarthritis assessed as grade 1 to 3 by Kellgren-Lawrence scale
- Body mass index (BMI) of 35 or less
- Patient expected to benefit from treatment
- Patient available for the entire study period
- Patient able to cooperate and meet study requirements
You will not qualify if you...
- Knee osteoarthritis assessed as grade 4 by Kellgren-Lawrence scale
- Ongoing inflammation or infection in the joint being studied
- Large amount of fluid inside the joint
- Symptoms of viral or bacterial infections
- Infection or skin disease at the injection site
- Use of disinfectants with quaternary ammonium salts or chlorhexidine
- Allergy or hypersensitivity to any component of the medical device
- Use of thrombolytic or anticoagulant therapy less than 2 weeks before screening
- Intra-articular treatments in the target joint within last 3 months (9 months if containing hyaluronic acid)
- Topical treatments on the target joint within 1 week before screening
- Use of NSAIDs or paracetamol for more than two consecutive days as rescue treatment
- Joint replacement surgery in the target joint
- Physiotherapy or physical therapy on the target joint within 2 weeks before screening or during study
- Participation in another clinical trial within 60 days before screening
- Severe or uncontrolled systemic diseases that limit participation
- Pregnancy or breastfeeding
- Inability to follow study procedures or attend follow-up visits
- Any other medical condition affecting participation or results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
U.O. Recupero e riabilitazione funzionale P.O. "G.Rodolico", Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"
Catania, Italy
Actively Recruiting
Research Team
M
Michele Vecchio
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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