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 range21 Years ā 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. 21-65 years.
ā. Body Mass Index (BMI) ā¤ 35.
ā. Singular treatable joint surface lesion, ICRS Grade 3 or 4, located on the medial or lateral femoral condyle.
ā. Symptomatic, single treatable area 1 - 3.8cm2.
ā. Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65.
ā. Stable knee.
ā. Non-responsive to a minimum of 3 weeks of conservative treatment, consisting of non-steroidal anti-inflammatory drugs and/or physical therapy.
ā. 21-65 years.
Exclusion criteria
ā. Known allergy to polyurethanes, bone cement, acrylic, or titanium.
ā. Lack of 2mm of healthy cartilage (ICRS Grade 0 or 1) and 2mm of vital bone wall on all sides of the implant site.
ā. Osteochondral defect affecting subchondral bone more than 11mm in depth from adjacent non-defect articular surface.
ā. Bipolar cartilage lesions involving patellar or tibial lesions ICRS Grade 3 - 4 opposite the lesion intended for treatment.
ā. Insufficient bone stock or bone density determined intra-operatively preventing implant press fit.
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.