Collagen-PVP vs Hylan G-F 20 in the Treatment of Knee Osteoarthritis (NCT04019782) | Clinical Trial Compass
UnknownPhase 3
Collagen-PVP vs Hylan G-F 20 in the Treatment of Knee Osteoarthritis
Mexico120 participantsStarted 2019-08-01
Plain-language summary
Articular cartilage degradation is the main characteristic of osteoarthritis (OA), involving enzymatic and inflammatory mechanisms that change it into a chronic disease. Since articular cartilage shows limited regenerative ability, several intra-articular drugs have been developed in order to decrease inflammation and provide a better clinical outcome to the patient.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged between 40 and 80 years old
* Osteoarthritis in the knee rated II or III (Kellgren-Lawrence Grading Scale).
* Pain intensity (MOS Pain Severity Scale) greater than 40.
* Subject able to understand, co-operative and reliable.
* Written informed consent.
Exclusion Criteria:
* Acute arthritis in the knee.
* Ongoing anticoagulant therapy.
* Skin infection at the injection site.
* Systemic or intraarticular (target knee) corticosteroids in the past 3 months.
* Viscosupplementation (target knee) in the past year
* Arthroscopy/osteotomy/surgery in the past 5 months (target knee).
* Any surgery scheduled in the next 6 months
* Concomitant rheumatic disease (rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus, fibromyalgia).
* Severe varus/valgus deformity (\>15°).
* Frontal deformity greater than 20 degrees
* History of allergy or hypersensitivity to hyaluronic acid or avian proteins
* History/present evidence of: metabolic joint diseases; crystal arthropaties; ochronosis; acromegaly; haemochromatosis; Wilson's disease; primary osteochondromatosis; heritable disorders.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
International Knee Documentation Committee (IKDC).
Timeframe: Evaluation will be conducted at Baseline and 6 months after first infiltration
Trial details
NCT IDNCT04019782
SponsorCoordinación de Investigación en Salud, Mexico