The Hyalex First-in-Human Study (NCT06344481) | Clinical Trial Compass
RecruitingNot Applicable
The Hyalex First-in-Human Study
Poland15 participantsStarted 2024-03-07
Plain-language summary
The Hyalex First-in-Human Study is a prospective, multicenter, open-label, single-arm, 2-phase, first-in-human study to evaluate the safety and technical performance of the HYALEX Knee Cartilage System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment.
Who can participate
Age range
21 Years – 65 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
. 21-65 years.
. Body Mass Index (BMI) ≤ 35.
. Singular treatable joint surface lesion, ICRS Grade 3 or 4, located on the medial or lateral femoral condyle.
. Symptomatic, single treatable area 1 - 3.8cm2.
. Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65.
. Stable knee.
. Non-responsive to a minimum of 3 weeks of conservative treatment, consisting of non-steroidal anti-inflammatory drugs and/or physical therapy.
. 21-65 years.
Exclusion criteria
. Known allergy to polyurethanes, bone cement, acrylic, or titanium.
. Lack of 2mm of healthy cartilage (ICRS Grade 0 or 1) and 2mm of vital bone wall on all sides of the implant site.
. Osteochondral defect affecting subchondral bone more than 11mm in depth from adjacent non-defect articular surface.
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
Freedom from implant rejection and infection.
Timeframe: Through 24 months.
2
Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) from baseline at 12 months.