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NCT06368700 · ClinicalTrials.gov registry record · NA
The Hyalex Early Feasibility Study (EFS)
A NA study of Cartilage Injury and Cartilage Damage, sponsored by Hyalex Orthopaedics.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 4
- Study locations
NCT06368700: Recruiting NA study of Cartilage Injury and Cartilage Damage, sponsored by Hyalex Orthopaedics.
NCT06368700 is a NA study of Cartilage Injury and Cartilage Damage that is actively recruiting participants, run by Hyalex Orthopaedics. The registered enrollment target is 20 participants, below the 432-participant average among 4 other Cartilage Injury trials with a reported enrollment target (95% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06368700, a NA study of Cartilage Injury and Cartilage Damage, is actively recruiting participants, sponsored by Hyalex Orthopaedics.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 4
- Study locations
Study Summary
The Hyalex Early Feasibility Study is a prospective, multicenter, open-label, single-arm, 2-phase early feasibility 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, will be enrolled in the study and undergo implantation of the HYALEX Knee Implant.
Primary Outcome
* A clinically significant improvement in KOOS Pain score; * A clinically significant improvement in KOOS ADL score; * Lack of treatment-related SAEs; and * Absence of secondary surgical intervention defined as HYALEX Freestyle Resurfacing Implant removal or revision due to a treatment-related finding.
Conditions Studied
Interventions
- DEVICE Hyalex Knee Cartilage System
Study Locations (4)
California
- Horizon Clinical Research - La Mesa
Louisiana
- Ochsner Sports Medicine Institute - New Orleans
New York
- Hospital for Special Surgery - New York
Oregon
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-04-04 |
| Est. Completion | 2026-10 |
| Phase | NA |
What NCT06368700 shows while recruiting
NCT06368700 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 432-participant average among 4 other Cartilage Injury trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Cartilage Injury appearing as the primary indexed condition, and to 1 intervention - of which Hyalex Knee Cartilage System is the first listed.
NCT06368700 reports a single indexed study location in California, Louisiana, New York.
Frequently Asked Questions
What is clinical trial NCT06368700 about?
NCT06368700 is a clinical study titled "The Hyalex Early Feasibility Study (EFS)". The Hyalex Early Feasibility Study is a prospective, multicenter, open-label, single-arm, 2-phase early feasibility 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 sympt...
What is the current status of trial NCT06368700?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2024-04-04. Estimated completion is 2026-10.
What conditions does trial NCT06368700 study?
This clinical trial studies the following conditions: Cartilage Injury, Cartilage Damage.
What interventions are being tested in trial NCT06368700?
The interventions under investigation include: Hyalex Knee Cartilage System (DEVICE).
Who is sponsoring clinical trial NCT06368700?
This trial is sponsored by Hyalex Orthopaedics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06368700 being conducted?
This trial has 4 study locations across California, Louisiana, New York, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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