Clinical Trial

The HYALEX Pivotal Study

Recruiting
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Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-04-11; most recent amendment 2026-04-13.
Trial Details
NCT Number NCT06368700
Lead Sponsor Hyalex Orthopaedics, Inc.
Conditions Damaged Chondral or Osteochondral Area
Enrollment 85 participants
Start Date 2024-04-04
Primary Completion 2027-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-16