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Procedure

Hyalex Knee Cartilage System for Cartilage Injury

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

Study 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.Check my eligibility

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).See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Do I qualify?Apply below to find out

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are considered more suitable candidates for participation in this medical study?

"Candidates interested in participating in this research study must have sustained cartilage damage and fall within the age range of 21 to 65. The trial aims to enroll approximately 20 individuals."

Answered by AI

Has the Hyalex Knee Cartilage System received approval from the FDA?

"Given the preliminary nature of this study, our team at Power has rated the safety of the Hyalex Knee Cartilage System as a 1 on a scale from 1 to 3. This Phase 1 trial indicates that there is only minimal supporting data for both safety and effectiveness."

Answered by AI

Are there still opportunities for individuals to participate in this ongoing medical research study?

"As per the data available on clinicaltrials.gov, this trial is currently in need of volunteers. It was originally shared on April 4th, 2024 and last revised on April 11th, 2024."

Answered by AI

Is this medical study open to individuals who are 75 years of age or older?

"Applicants eligible for this study must be aged between 21 and 65. Notably, there are separate trials available for individuals under 18 years old as well as those over the age of 65."

Answered by AI

What is the cumulative enrollment count for participants in this clinical investigation?

"Affirmative, the information on clinicaltrials.gov indicates that this investigation is currently seeking suitable candidates. The trial was first uploaded on April 4th, 2024 and underwent its last revision on April 11th, 2024. Seeking a total of 20 participants spread across two distinct locales."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Hyalex Early Feasibility Study (EFS)

2024. "The Hyalex Early Feasibility Study (EFS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06368700.

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