The Hyalex First-in-Human Study
ConditionCartilage Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorHyalex Orthopaedics, Inc.
About this trial
The Hyalex First-in-Human Study is a prospective, multicenter, open-label, single-arm, 2-phase, first-in-human 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.
Eligibility criteria
Qualifiers
Phase 1
21-65 years.
Body Mass Index (BMI) ≤ 35.
Singular treatable joint surface lesion, ICRS Grade 3 or 4, located on the medial or lateral femoral condyle.
Disqualifiers
Phase 1 & 2
Known allergy to polyurethanes, bone cement, acrylic, or titanium.
Lack of 2mm of healthy cartilage (ICRS Grade 0 or 1) 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.
Trial design
Treatments tested in this trial
- Surgical (Hyalex Cartilage Knee Implant)
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov