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Procedure

Hyalex System for Cartilage Damage

Phase 1
Recruiting
Research Sponsored by Hyalex Orthopaedics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

This trial aims to test a new knee cartilage system for patients with knee joint problems. It will assess the safety and performance of the system in patients who need surgical treatment for knee cartilage and bone

Who is the study for?
This trial is for individuals with knee cartilage injuries or damage who need surgery. Specific details about who can join are not provided, but typically participants would have symptoms that require surgical intervention and meet certain health standards.
What is being tested?
The Hyalex Early Feasibility Study is testing the safety and how well the HYALEX Knee Cartilage System works. This system is designed to replace damaged knee cartilage and bone in patients' femoral condyles (part of the thigh bone that makes up the knee joint).
What are the potential side effects?
Since this study focuses on a device implant rather than a drug, side effects may include typical surgical risks such as infection, pain at the implant site, swelling, and potential issues with how well the implant works or stays in place.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) at 12 months.
Freedom from implant rejection and infection.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hyalex Knee Cartilage SystemExperimental Treatment1 Intervention
Implantation of the Hyalex Knee Cartilage Implant

Find a Location

Who is running the clinical trial?

Hyalex Orthopaedics, Inc.Lead Sponsor
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Cartilage Injury
15 Patients Enrolled for Cartilage Injury
~13 spots leftby Oct 2025
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