The Hyalex First-in-Human Study

Not Applicable

Recruiting

• Conditions: Cartilage Injury

• Registration Number: NCT06344481
• Lead Sponsor: Hyalex Orthopaedics, Inc.

Brief Summary

The Hyalex First-in-Human Study is a prospective, multicenter, open-label, single-arm, 2-phase, first-in-human study to evaluate the safety and technical performance of the HYALEX Knee Cartilage System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-07
• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-27
• Study First Posted: 2024-04-03
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-06-29
• Primary Completion: 2026-09
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Freedom from implant rejection and infection.	Through 24 months.	Assess the safety (implant rejection, infection) and tolerability of the Hyalex Cartilage Implant.
Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) from baseline at 12 months.	Through 12 months.	The KOOS assesses patient pain, other symptoms, function in daily living, function in sport and recreation, and knee related quality of life. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.

Trial Locations

Locations (2)

LIFE Medical Center; 🇵🇱 Warsaw, Poland

SPORTO; 🇵🇱 Łódź, Poland