The Hyalex Early Feasibility Study (EFS)

Cartilage Injury Clinical Trial

Official title:

The Hyalex EFS: A Prospective, Multicenter, Single-Arm, 2-Phase Early Feasibility Study (EFS) of the HYALEX® Knee Cartilage System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06368700
• Other study ID #: CL-00001
• Status: Recruiting
• Phase: Phase 1
• Start date: April 4, 2024
• Est. completion date: October 2026

Study information

• Verified date: April 2024
• Source: Hyalex Orthopaedics, Inc.
• Contact: Chris Cain
• Phone: 408-439-5154
• Email: chris.cain[@]hyalex.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria (Phase 1):

1. 21-65 years.

2. Body Mass Index (BMI) = 35.

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.

Inclusion Criteria (Phase 2):

1. 21-65 years.

2. Body Mass Index (BMI) = 35.

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:

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 or 1) 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 as defined:

2. Hip-knee-ankle (HKA) angle of greater than +/- 5 degrees (varus or valgus malalignment > 5 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 (anabolic or corticosteroid, excluding inhalers) or within 3 months prior to surgery.

Related Conditions & MeSH terms

• Cartilage Damage
• Cartilage Injury

Intervention

Device:
• Hyalex Knee Cartilage System
Surgical implantation of the Hyalex Knee Cartilage System

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Hyalex Orthopaedics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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