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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Surgical (Hyalex Cartilage Knee Implant)
DeviceImplantation of Hyalex Cartilage Knee Implant.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Hyalex Cartilage SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Freedom from implant rejection and infection.
Assess the safety (implant rejection, infection) and tolerability of the Hyalex Cartilage Implant.
Time frame
Through 24 months.2
Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) from baseline 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
Through 12 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov