RECRUITING

The Hyalex Early Feasibility Study (EFS)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-04
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06368700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Known allergy to polyurethanes, bone cement, acrylic, or titanium.
  2. 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. 3. Osteochondral defect affecting subchondral bone more than 11mm in depth from adjacent non-defect articular surface.
  4. 4. Bipolar cartilage lesions involving patellar or tibial lesions ICRS Grade 3 - 4 opposite the lesion intended for treatment.
  5. 5. Insufficient bone stock or bone density determined intra-operatively preventing implant press fit.
  6. 1. Kellgren and Lawrence (KL) grade 3 or 4 on standing radiographs as defined:
  7. 2. Hip-knee-ankle (HKA) angle of greater than +/- 5 degrees (varus or valgus malalignment \> 5 degrees) on standing X-ray.
  8. 3. Lack of normally functioning contralateral knee that restricts activity.
  9. 4. Insufficiency fracture of the femoral condyle or tibial plateau.
  10. 5. Recent Osteochondritis Dissecans within 1 year.
  11. 6. Diagnosis of a concomitant knee injury which the investigator believes may interfere with study participation or confound effectiveness assessment.
  12. 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).
  13. 1. Previous surgical cartilage treatment in the index knee within the last 6 months
  14. 2. Previous intra-articular injections, including HA and steroids, within the last 3 months prior to the date of surgery.
  15. 1. Any known history of inflammatory arthropathy or crystal-deposition arthropathy.
  16. 2. Current cigarette smoker or user of other nicotine products.
  17. 3. Known Type 1 or Type 2 insulin-dependent diabetes mellitus.
  18. 4. Currently undergoing immunosuppressive therapy or long-term steroid use (anabolic or corticosteroid, excluding inhalers) or within 3 months prior to surgery.

Contacts and Locations

Study Contact

Chris Cain
CONTACT
408-439-5154
chris.cain@hyalex.com

Study Locations (Sites)

Horizon Clinical Research
La Mesa, California, 91942
United States
Ochsner Sports Medicine Institute
New Orleans, Louisiana, 70121
United States
Hospital for Special Surgery
New York, New York, 10021
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: Hyalex Orthopaedics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-04
Study Completion Date2026-10

Study Record Updates

Study Start Date2024-04-04
Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

  • Cartilage Injury
  • Cartilage Damage