The Hyalex Early Feasibility Study (EFS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cartilage Injury; Cartilage Damage
• Intervention / Treatment: Device: Hyalex Knee Cartilage System

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Chris Cain; Phone Number: 408-439-5154; Email: chris.cain@hyalex.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Hospital for Special Surgery
      • Contact: Ava Neijna; Phone Number: 917-260-3677; Email: SGResearch@hss.edu
      • Contact: Morgan Rizy
      • Principal Investigator: Sabrina Strickland, M.D.
      • Sub-Investigator: Andreas Gomoll, M.D.
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
      • Contact: Jessica Ballin; Phone Number: 503-418-9580; Email: ballin@ohsu.edu
      • Principal Investigator: Dennis Crawford, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyalex Knee Cartilage System; Implantation of the Hyalex Knee Cartilage Implant	Device: Hyalex Knee Cartilage System; Surgical implantation of the Hyalex Knee Cartilage System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Hyalex Orthopaedics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CL-00001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes