Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-04-04
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Hyalex Knee Cartilage System
Implantation of the Hyalex Knee Cartilage Implant
Hyalex Knee Cartilage System
Surgical implantation of the Hyalex Knee Cartilage System
Interventions
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Hyalex Knee Cartilage System
Surgical implantation of the Hyalex Knee Cartilage System
Eligibility Criteria
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Inclusion Criteria
2. Body Mass Index (BMI) ≤ 38.
3. Singular treatable joint surface lesion, ICRS Grade 3 or 4, located on the medial or lateral femoral condyle.
4. One implant to treat a single symptomatic lesion with up to 3.8cm2 total lesion area.
5. Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65.
6. Stable knee.
7. Failure of non-operative treatment (e.g., physical therapy, physician-directed at home exercise program, intra-articular injections, bracing) for at least 4 weeks prior to consideration for participation in the study.
1. 21-70 years.
2. Body Mass Index (BMI) ≤ 38.
3. Up to three treatable joint surface lesion(s), ICRS Grade 3 or 4, located on the medial or lateral femoral condyle(s).
4. Up to 3 implants to treat up to 3 individual symptomatic lesions with a total summative area up to 10cm2.
5. Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65.
6. Stable knee.
7. Failure of non-operative treatment (e.g., physical therapy, physician-directed at home exercise program, intra-articular injections, bracing) for at least 4 weeks prior to consideration for participation in the study.
Exclusion Criteria
1. Known allergy to polyurethanes, bone cement, acrylic, or titanium.
2. Lack of 2mm of healthy cartilage (ICRS Grade 0 to 2) and 2mm of vital bone wall on all sides of the implant site.
3. Osteochondral defect affecting subchondral bone more than 11mm in depth from adjacent non-defect articular surface.
4. Bipolar cartilage lesions involving patellar or tibial lesions ICRS Grade 3 - 4 opposite the lesion intended for treatment.
5. Insufficient bone stock or bone density determined intra-operatively preventing implant press fit.
Patient Orthopaedic Health Exclusions:
1. Kellgren and Lawrence (KL) grade 3 or 4 on standing radiographs.
2. Hip-knee-ankle (HKA) angle of greater than +/- 8 degrees (varus or valgus malalignment \> 8 degrees) on standing X-ray.
3. Lack of normally functioning contralateral knee that restricts activity.
4. Insufficiency fracture of the femoral condyle or tibial plateau.
5. Recent Osteochondritis Dissecans within 1 year.
6. Diagnosis of a concomitant knee injury which the investigator believes may interfere with study participation or confound effectiveness assessment.
7. Untreated ACL and/or PCL deficiency or complex ligamentous instability of the study knee according to IKDC Grade C (abnormal) or D (severely abnormal).
Previous Surgery and Intervention Exclusions:
1. Previous surgical cartilage treatment in the index knee within the last 6 months
2. Previous intra-articular injections, including HA and steroids, within the last 3 months prior to the date of surgery.
Patient Overall Health and Health History Exclusions:
1. Any known history of inflammatory arthropathy or crystal-deposition arthropathy.
2. Current cigarette smoker or user of other nicotine products.
3. Known Type 1 or Type 2 insulin-dependent diabetes mellitus.
4. Currently undergoing immunosuppressive therapy or long-term steroid use (corticosteroid, excluding inhalers) or within 3 months prior to surgery.
21 Years
70 Years
ALL
No
Sponsors
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Hyalex Orthopaedics, Inc.
INDUSTRY
Responsible Party
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Locations
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Horizon Clinical Research
La Mesa, California, United States
Ochsner Sports Medicine Institute
New Orleans, Louisiana, United States
Hospital for Special Surgery
New York, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Scott Hacker, M.D.
Role: backup
Deryk Jones, M.D.
Role: backup
Sabrina Strickland, M.D.
Role: backup
Andreas Gomoll, M.D.
Role: backup
Dennis Crawford, M.D.
Role: backup
Other Identifiers
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CL-00001
Identifier Type: -
Identifier Source: org_study_id
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