Actively Recruiting
The HYALEX Pivotal Study
Led by Hyalex Orthopaedics, Inc. · Updated on 2026-04-16
85
Participants Needed
4
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The HYALEX Pivotal Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 22 and 70 years
- Body Mass Index (BMI) of 40 or less
- Up to two treatable joint surface lesions, ICRS Grade 3 or 4, on the medial and/or lateral femoral condyle
- Up to 2 implants allowed, one per condyle, treating up to 2 individual symptomatic lesions with total area up to 4.52 cm2 per condyle
- Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65
- Ligamentously stable knee
- Failure of non-operative treatment (physical therapy, physician-directed exercise, injections, bracing) for at least 4 months prior to study consideration
You will not qualify if you...
- Known allergy to polyurethanes, bone cement, acrylic, or titanium
- Less than 2 mm of cartilage (ICRS Grade 0 to 2) and 2 mm of vital bone wall around implant site
- Osteochondral defect deeper than 11 mm in subchondral bone
- Bipolar cartilage lesions involving patellar or tibial lesions ICRS Grade 3 - 4 opposite the treatment site
- Insufficient bone stock or bone density preventing implant fixation
- Kellgren and Lawrence (KL) grade 3 or 4 on standing radiographs
- Hip-knee-ankle angle greater than plus or minus 8 degrees (varus or valgus malalignment)
- Non-functioning or activity-restricting contralateral knee
- Recent osteochondritis dissecans within 1 year
- Concomitant knee injury interfering with participation or effectiveness assessment
- Untreated ACL and/or PCL deficiency or complex ligament instability graded as abnormal or severely abnormal
- Previous cartilage surgery on the study knee within 6 months
- Previous intra-articular injections including hyaluronic acid or steroids within 3 months prior to surgery
- History of inflammatory or untreated crystal-deposition arthropathy
- Current cigarette smoker or nicotine product user
- Known insulin-dependent diabetes mellitus type 1 or 2
- Current immunosuppressive therapy or long-term steroid use within 3 months prior to surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Horizon Clinical Research
La Mesa, California, United States, 91942
Actively Recruiting
2
Ochsner Sports Medicine Institute
New Orleans, Louisiana, United States, 70121
Actively Recruiting
3
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
4
Oregon Health & Science University
Portland, Oregon, United States, 97239
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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