No phaseRecruiting
The HYALEX Pivotal Study
The HYALEX Freestyle™ Resurfacing System Pivotal Study: A Multicenter, Single-Arm, Pivotal Study of the HYALEX Freestyle Resurfacing Implant
- Sponsor
- Hyalex Orthopaedics, Inc. (Industry)
- Enrolment
- 85 planned
- Conditions
- Damaged Chondral or Osteochondral Area
- Interventions
- Hyalex Knee Cartilage System
- Ages
- adults, older adults
- Registry
- NCT06368700
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Composite Primary Endpoint
- Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) at 12 months.
History
Study completion expected
Primary completion expected
Last registry update
Registered
Started