NCT06368700

The HYALEX Pivotal Study

The HYALEX Freestyle™ Resurfacing System Pivotal Study: A Multicenter, Single-Arm, Pivotal Study of the HYALEX Freestyle Resurfacing Implant

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Hyalex Orthopaedics, Inc. · Industry
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Damaged Chondral or Osteochondral Area

Interventions

Type	Name	Description
DEVICE	Hyalex Knee Cartilage System	Surgical implantation of the Hyalex Knee Cartilage System

Timeline

• Start date: 2024-04-04
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2024-04-16
• Last updated: 2026-04-16

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study