The Hyalex First-in-Human Study

NCT06344481 | Recruiting DMC FDA Device

• 1 other identifier: CL-00003
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

The Hyalex First-in-Human Study is a prospective, multicenter, open-label, single-arm, 2-phase, first-in-human 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.

Conditions

Cartilage Injury

Keywords

Knee; Cartilage; Lesion

Outcome Measures

Primary Outcomes (2)

• Freedom from implant rejection and infection.

  Assess the safety (implant rejection, infection) and tolerability of the Hyalex Cartilage Implant.

  Through 24 months.

• Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) from baseline 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.

  Through 12 months.

Study Arms (1)

Hyalex Cartilage System

EXPERIMENTAL

Implantation of Hyalex Cartilage Knee Implant

Device: Surgical (Hyalex Cartilage Knee Implant)

Interventions

Surgical (Hyalex Cartilage Knee Implant) DEVICE

Implantation of Hyalex Cartilage Knee Implant.

Hyalex Cartilage System

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years.
• Body Mass Index (BMI) ≤ 35.
• Singular treatable joint surface lesion, ICRS Grade 3 or 4, located on the medial or lateral femoral condyle.
• Symptomatic, single treatable area 1 - 3.8cm2.
• Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65.
• Stable knee.
• Non-responsive to a minimum of 3 weeks of conservative treatment, consisting of non-steroidal anti-inflammatory drugs and/or physical therapy.
• years.
• Body Mass Index (BMI) ≤ 35.
• Up to three treatable joint surface lesion(s), ICRS Grade 3 or 4, located on the medial or lateral femoral condyle(s).
• Symptomatic total treatable area 1 - 10cm2.
• Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65.
• Stable knee.
• Non-responsive to a minimum of 3 weeks of conservative treatment, consisting of non-steroidal anti-inflammatory drugs and/or physical therapy.

You may not qualify if:

• Known allergy to polyurethanes, bone cement, acrylic, or titanium.
• Lack of 2mm of healthy cartilage (ICRS Grade 0 or 1) and 2mm of vital bone wall on all sides of the implant site.
• Osteochondral defect affecting subchondral bone more than 11mm in depth from adjacent non-defect articular surface.
• Bipolar cartilage lesions involving patellar or tibial lesions ICRS Grade 3 - 4 opposite the lesion intended for treatment.
• Insufficient bone stock or bone density determined intra-operatively preventing implant press fit.
• Kellgren and Lawrence (KL) grade 3 or 4 on standing radiographs as defined:
• Hip-knee-ankle (HKA) angle of greater than +/- 5 degrees (varus or valgus malalignment \> 5 degrees) on standing X-ray.
• Lack of normally functioning contralateral knee that restricts activity.
• Insufficiency fracture of the femoral condyle or tibial plateau.
• Recent Osteochondritis Dissecans within 1 year.
• Diagnosis of a concomitant knee injury which the investigator believes may interfere with study participation or confound effectiveness assessment.
• Any known systemic cartilage and/or bone disorder, such as but not limited to osteoporosis, chondrodysplasia or osteogenesis imperfecta.
• A symptomatic musculoskeletal condition in the lower limbs that could impede effectiveness measurements in the target knee.
• Any known tumor of the treatment knee.
• Prior radiation therapy to the knee joint.

Sponsors & Collaborators

• Hyalex Orthopaedics, Inc.: lead

Study Sites (2)

SPORTO

Lodz, 09-038, Poland

RECRUITING

LIFE Medical Center

Warsaw, 00-855, Poland

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Marcin Domzalski, MD

  SPORTO, Łódź, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Cain

CONTACT

408-439-5154; chris.cain@hyalex.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 3, 2024
• Study Start: March 7, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

PL (2)