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Recruiting NCT06344481

The Hyalex First-in-Human Study

No phase Interventional Cartilage Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surgical (Hyalex Cartilage Knee Implant).
Who it may be relevant to
Registry conditions: Cartilage Injury. Basic parameters: 21 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Multicenter, Single-Arm, 2-Phase First-in-Human Feasibility Study of the HYALEX® Cartilage System

Overview

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.

Interventions

  • Device Surgical (Hyalex Cartilage Knee Implant)
    Implantation of Hyalex Cartilage Knee Implant.

Primary outcome measures

  • Freedom from implant rejection and infection. [Time frame: Through 24 months.]
  • Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) from baseline at 12 months. [Time frame: Through 12 months.]

Eligibility criteria

Inclusion Criteria - Phase 1

  • 21-65 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.

Inclusion Criteria - Phase 2

  • 21-65 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.

Exclusion Criteria - Phase 1 \& 2

HYALEX Implant, Surgical Technique, and Lesion Site Exclusions:

  • 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.

Patient Orthopaedic Health Exclusions:

  • 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.
  • Clinically significant or symptomatic vascular or neurological disorder of the lower extremities affecting gait or function.
  • 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:

  • Previous surgery in the past 6 months on the index knee except for:
  • Diagnostic knee arthroscopy and/or debridement / chondroplasty, and
  • Meniscectomy
  • Previous intra-articular injections, including HA and steroids, within the last 3 months prior to the date of surgery.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Poland · 2 centers
  • SPORTO — Lodz
  • LIFE Medical Center — Warsaw

Identifiers

NCT: NCT06344481 · CL-00003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗