Technology

Clinical Trials

A clinical trial involves research using human volunteers and is intended to collect data that will add to medical knowledge. Below is a list of our product(s) that currently have an ongoing clinical trial.

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HYALOFAST® Trial for Repair of Articular Cartilage in the Knee

Purpose: The purpose of this study is to evaluate the safety and efficacy of the HYALOFAST scaffold with bone marrow aspirate concentrate (BMAC) compared to microfracture in the treatment of symptomatic cartilage defects of the knee.

Eligibility:

  • Age:                18 – 60 years
  • Gender:          Male and Female

Selected Inclusion Criteria:

  • Body Mass Index is < 35 kg/m2
  • Symptomatic lesion of the femoral condyle (medial and/or lateral) or femoral trochlea that is between 1 – 6 cm2
  • The symptomatic lesion is classified as International Cartilage Repair Society (ICRS) grade 3 or 4

Selected Exclusion Criteria:

  • Concomitant cartilage lesion(s) requiring treatment other than debridement
  • Presence of kissing (bipolar) cartilage lesions
  • Diagnosed advanced osteoarthritis as demonstrated by a Kellgren-Lawrence grade of 3 or 4 in the index knee
  • Complex ligamentous instability of the index or contralateral knee

For a complete list of inclusion and exclusion criteria, or more information, including a list of participating sites that are currently enrolling, please click the link below.

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