Actively Recruiting
A Prospective, Multicenter, Single-Arm, 2-Phase First-in-Human Feasibility Study of the HYALEX Cartilage System
Led by Hyalex Orthopaedics, Inc. · Updated on 2025-06-29
15
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and technical performance of the HYALEX Knee Cartilage System in patients with cartilage injury of the knee femoral condyles who need surgical treatment. This first-in-human, prospective, multicenter, open-label study aims to assess the implant in symptomatic patients aged 21 to 65 years, focusing on areas with specific cartilage damage. The study is divided into two phases to test feasibility and outcomes in different lesion severities and sizes. Participants will receive the Hyalex Cartilage Knee Implant surgically, targeting cartilage and bone loss at the medial or lateral femoral condyles. Phase 1 involves patients with a single lesion, while phase 2 includes those with up to three treatable lesions. The study evaluates implant safety over 24 months and changes in knee function and pain scores over 12 months after implantation. Throughout the study, patients will be monitored for implant rejection, infection, and improvements in knee pain using the Knee Injury & Osteoarthritis Outcome Score (KOOS). Assessments include clinical evaluations and imaging as needed. The trial spans up to two years post-implantation, with regular follow-ups to track safety and technical performance of the device.
CONDITIONS
Brief Title
The Hyalex First-in-Human Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 21 and 65 years
- Body Mass Index (BMI) of 35 or less
- For Phase 1: Single treatable joint surface lesion, ICRS Grade 3 or 4, on medial or lateral femoral condyle
- For Phase 2: Up to three treatable joint surface lesions, ICRS Grade 3 or 4, on medial or lateral femoral condyles
- Symptomatic treatable area size between 1 and 3.8 cm2 (Phase 1) or 1 to 10 cm2 (Phase 2)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65
- Stable knee
- Not improved after at least 3 weeks of conservative treatment including non-steroidal anti-inflammatory drugs and/or physical therapy
You will not qualify if you...
- Known allergy to polyurethane, bone cement, acrylic, or titanium
- Less than 2 mm of healthy cartilage and 2 mm of vital bone wall around the implant site
- Osteochondral defect deeper than 11 mm from adjacent articular surface
- Bipolar cartilage lesions involving patellar or tibial lesions opposite the treatment site
- Insufficient bone stock or bone density preventing implant fit
- Kellgren and Lawrence grade 3 or 4 on standing X-rays
- Hip-knee-ankle angle malalignment greater than ±5 degrees
- Non-functioning opposite knee limiting activity
- Femoral condyle or tibial plateau insufficiency fracture
- Recent osteochondritis dissecans within 1 year
- Other knee injuries interfering with participation or assessment
- Systemic bone or cartilage disorders like osteoporosis or osteogenesis imperfecta
- Symptomatic musculoskeletal conditions in lower limbs affecting assessments
- Tumors in the treatment knee
- Prior radiation therapy to the knee joint
- Significant vascular or neurological disorders of lower limbs affecting function
- Untreated ligament deficiencies or severe ligament instability in study knee
- Knee surgery within past 6 months except diagnostic arthroscopy, debridement, or meniscectomy
- Intra-articular injections (hyaluronic acid or steroids) within 3 months before surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to several days to weeks as clinically indicated
Participants undergo implantation of the Hyalex Cartilage Knee Implant and receive immediate post-operative care.
1 surgical visit (in-person) and approximately 6 post-operative visits
Duration - Up to 24 months
Participants are monitored for implant rejection, infection, and recovery, including assessments of knee function and pain.
Regular visits through 24 months, including assessments at 12 months
Trial Site Locations
Total: 2 locations
1
SPORTO
Lodz, Poland, 09-038
Actively Recruiting
2
LIFE Medical Center
Warsaw, Poland, 00-855
Actively Recruiting
Research Team
C
Chris Cain
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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