Combination of PRP and XLHA Prepared With RegenMatrix Medical Device To Treat Moderate to Severe … (NCT05727371) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Combination of PRP and XLHA Prepared With RegenMatrix Medical Device To Treat Moderate to Severe Knee Osteoarthritis
France280 participantsStarted 2023-08-21
Plain-language summary
In this clinical trial the investigator assess the safety and efficacy of a single injection of a combination of cross-linked hyaluronic acid (HA) with autologous platelet-rich plasma (PRP) obtained with the RegenMatrix medical device to improve symptoms of moderate to severe knee osteoarthitis (grade III-IV Kellgren-Lawrence).
Who can participate
Age range
40 Years – 90 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:
* Tibiofemoral knee osteoarthrosis according to ACR criteria
* Tibiofemoral knee osteoarthrosis grade 3-4 according to the Kellgren \& Lawrence grading scale, as defined on knee radiographs (less than 3 months old: face view, schuss view, profile and patellar axial view at 30°)
* Symptomatic knee osteoarthrosis as evidenced by pain on walking (WOMAC A1 assessed in the last 24 hours on a scale of 0 to 100 mm: 50 ≤ DM 90 or reduced joint function (WOMAC C total score assessed or within the previous 24 hours based on a scale of 0-100-mm: 50 ≤ WOMAC C ≤ 90)
* Patient able to understand the requirements of the trial and who has signed a free and informed consent prior to study entry
* Patient able to read and understand the written instructions
* Patient able to complete the self-assessment questionnaires
Exclusion Criteria:
* Tibiofemoral knee osteoarthrosis grade I or II according to the Kellgren and Lawrence grading scale
* Knee surgery planned in the next 6 months
* Patient affected by autoimmune disease (rheumatoid arthritis, lupus, Hashimoto's disease and Bechterew's syndrome)
* Chronic inflammatory rheumatism other than arthritis (polyarthrosis, etc.)
* Patient affected by a knee infection in the past 6 months
* Clinical signs of local knee inflammation (redness or warmth of the knee joint)
* Last PRP or PRP/HA injection received in the last year
* Last viscosupplementation received in the past 6 months
* Last corticosteroid injection received in the …
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.