The HYALEX Pivotal Study
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
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
Treatments tested in this trial
- Hyalex Knee Cartilage System
Treatment groups
85 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov