The Hyalex Early Feasibility Study (EFS)

Not Applicable

Recruiting

• Conditions: Cartilage Injury; Cartilage Damage
• Interventions: Device: Hyalex Knee Cartilage System

• Registration Number: NCT06368700
• Lead Sponsor: Hyalex Orthopaedics, Inc.

Brief Summary

The Hyalex Early Feasibility Study is a prospective, multicenter, open-label, single-arm, 2-phase early feasibility 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, will be enrolled in the study and undergo implantation of the HYALEX Knee Implant.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-04
• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

HYALEX Implant, Surgical Technique, and Lesion Site Exclusions:

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyalex Knee Cartilage System	Hyalex Knee Cartilage System	Implantation of the Hyalex Knee Cartilage Implant

Primary Outcome Measures

Name	Time	Method
Freedom from implant rejection and infection.	12 months	To assess the safety (implant rejection, implant dislocation or disassociation (delamination), infection) and tolerability of the Hyalex Knee Cartilage Implant.
Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) at 12 months.	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.

Trial Locations

Locations (4)

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