Actively Recruiting
The Hyalex First-in-Human Study
Led by Hyalex Orthopaedics, Inc. · Updated on 2025-06-29
15
Participants Needed
2
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Phase 1: Single treatable joint surface lesion, ICRS Grade 3 or 4, on medial or lateral femoral condyle
- Phase 1: Symptomatic single treatable area of 1 to 3.8 cm²
- Phase 1: Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale between 20 and 65
- Phase 1: Stable knee
- Phase 1: No improvement after at least 3 weeks of conservative treatment with NSAIDs and/or physical therapy
- Phase 2: Up to three treatable joint surface lesions, ICRS Grade 3 or 4, on medial or lateral femoral condyles
- Phase 2: Symptomatic total treatable area of 1 to 10 cm²
- Phase 2: KOOS pain subscale between 20 and 65
- Phase 2: Stable knee
- Phase 2: No improvement after at least 3 weeks of conservative treatment with NSAIDs and/or physical therapy
You will not qualify if you...
- Allergy to polyurethanes, bone cement, acrylic, or titanium
- Less than 2 mm of healthy cartilage or vital bone wall around implant site
- Osteochondral defect deeper than 11 mm from adjacent surface
- Bipolar cartilage lesions involving patellar or tibial lesions, ICRS Grade 3 or 4 opposite treatment site
- Insufficient bone stock or density preventing implant press fit
- Kellgren and Lawrence grade 3 or 4 on standing radiographs
- Hip-knee-ankle angle greater than +/- 5 degrees (malalignment)
- Non-functioning contralateral knee limiting activity
- Femoral condyle or tibial plateau insufficiency fracture
- Recent osteochondritis dissecans within 1 year
- Other knee injuries that may interfere with study participation or outcomes
- Systemic cartilage or bone disorders like osteoporosis, chondrodysplasia, or osteogenesis imperfecta
- Symptomatic musculoskeletal conditions affecting lower limbs
- Known tumor in treatment knee
- Prior radiation therapy to the knee joint
- Significant vascular or neurological disorders affecting gait or function
- Untreated ACL/PCL deficiency or complex ligament instability (IKDC Grade C or D)
- Knee surgery within past 6 months except diagnostic arthroscopy, debridement, chondroplasty, or meniscectomy
- Intra-articular injections including hyaluronic acid or steroids within last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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