Status: Recruiting
The HYALEX Pivotal Study
A multicenter, open-label, single-arm, pivotal study to evaluate the safety and effectiveness of the HYALEX Freestyle Resurfacing System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment, will be enrolled in the study and undergo implantation of the HYALEX Freestyle Resurfacing Implant.
Participants needed: 85
Trial details
Age: 22-70Biological sex: AllType: InterventionalSponsor: Hyalex Orthopaedics, Inc.Updated: Apr 16, 2026Locations: 4
Eligibility criteria
22-70 years. [+6]
Known allergy to polyurethanes, bone cement, acrylic, or titanium. [+16]