HYALEX Freestyle™ Knee Resurfacing System Clinical Studies
Are you suffering from knee pain?
Hyalex Orthopaedics is conducting a prospective, multi-center, single-arm clinical study in the U.S. and Europe to evaluate the HYALEX Freestyle Knee Resurfacing Implant.
Why knee pain happens
Pain and inflammation in the knee joint can result from injury, overuse, or degenerative changes that limit mobility and quality of life.
Today, younger patients are often directed toward biologic therapies that attempt to regenerate tissue, while older patients are typically offered total joint replacement using traditional metal‑based implants.
Hyalex Orthopaedics has developed a new option — one designed to restore the knee’s articulating surface without relying on biologics or requiring a full replacement.
About the HYALEX Freestyle Knee Resurfacing System
The purpose of the Pivotal trial is to evaluate the safety and effectiveness of the HYALEX Freestyle Knee Resurfacing Implant.
All enrolled patients will receive the HYALEX Freestyle Knee Implant, which combines our proprietary HYALEX Hydrosurf™ Material bonded to medical-grade porous titanium. The sterile implant is designed to provide immediate restoration of the knee surface and rapid pain relief in a wide range of patients.
Am I eligible for the HYALEX Freestyle Knee Resurfacing System clinical trial?
This study is designed for symptomatic patients who require surgical treatment due to loss of articular cartilage in the knee femoral condyle. The unique design of the HYALEX Freestyle Knee Resurfacing Implant allows surgeons to treat patients with or without bony involvement. General eligibility criteria include:
- 22 – 70 years old
- Body Mass Index (BMI) ≤ 40
- KOOS pain score between 20 and 65
- Failure of non-operative treatment (e.g., physical therapy) for at least 4 months
For the full list of eligibility criteria, please visit the study sites linked below.
Our clinical sites in the United States are currently enrolling patients.
Our clinical sites in Europe are currently enrolling patients.
