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Recruiting Not applicable Interventional

The HYALEX Pivotal Study

ClinicalTrials.gov ID: NCT06368700

Public ClinicalTrials.gov record NCT06368700. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 29, 2026, 8:49 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06368700
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Hyalex Orthopaedics, Inc.
Industry
Enrollment
85 participants

Conditions and interventions

Eligibility (public fields only)

Age range
22 Years to 70 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 4, 2024 (Actual)
Primary completion
Dec 2027 (Estimated)
Completion
Dec 2028 (Estimated)
Last update posted
Oct 7, 2026

2024 – 2028

United States locations

U.S. sites
5
U.S. states
5
U.S. cities
5
Facility City State ZIP Site status
Horizon Clinical Research La Mesa California 91942 Recruiting
Ochsner Sports Medicine Institute New Orleans Louisiana 70121 Recruiting
Hospital for Special Surgery New York New York 10021 Completed
The Ohio State University Wexner Medical Center - Sports Medicine Columbus Ohio 43202 Recruiting
Oregon Health & Science University Portland Oregon 97239 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06368700, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 7, 2026 · Synced Oct 29, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06368700 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →