The HYALEX Pivotal Study

ConditionDamaged Chondral or Osteochondral Area

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age22-70

SponsorHyalex Orthopaedics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

22-70 years.

Body Mass Index (BMI) ≤ 40.

Up to two treatable joint surface lesion, ICRS Grade 3 or 4, located on the medial and/or lateral femoral condyle.

Up to 2 implants (one implant per condyle) to treat up to 2 individual symptomatic lesions with a total summative area up to 4.52cm2 / condyle.

Disqualifiers

Known allergy to polyurethanes, bone cement, acrylic, or titanium.

Lack of 2mm of cartilage (ICRS Grade 0 to 2) and 2mm of vital bone wall on all sides of the implant site.

Osteochondral defect affecting subchondral bone more than 11mm in depth from adjacent non-defect articular surface.

Bipolar cartilage lesions involving patellar or tibial lesions ICRS Grade 3 - 4 opposite the lesion intended for treatment.

Trial design

Design model

Single group

Treatments tested in this trial

Hyalex Knee Cartilage System
Device
Surgical implantation of the Hyalex Knee Cartilage System

Treatment groups

85 Participants

are divided into 1 treatment group

Group A: HYALEX Freestyle Resurfacing SystemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Composite Primary Endpoint

* 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.

Time frame

12 months

Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) at 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.

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hyalex Orthopaedics, Inc.

Lead sponsor

Source ClinicalTrials.gov

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