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.

FastTRACK

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.

FastTRACK

 

CINGAL® Trial for Osteoarthritis of the Knee

Purpose: The purpose of this study is to evaluate the safety and efficacy of CINGAL in the treatment of the pain from osteoarthritis of the knee.

Eligibility:

  • Age:                45 – 75 years
  • Gender:          Male and Female

Selected Inclusion Criteria:

  • Body Mass Index is < 40 kg/m2
  • Kellgren-Lawrence (K-L) severity grade I, II or III in the index knee as determined by X-ray

Selected Exclusion Criteria:

  • Received an intra-articular injection of Hyaluronic Acid (HA) and/or steroid in either knee within the past 6 months
  • Had an arthroscopy of either knee within the past 3 months
  • Had an open surgical procedure of either the knee or hip, or any surgery of the spine, within the last 12 months

 

MONOVISC® Trial for Osteoarthritis of the Hip

Purpose: The purpose of this study is to evaluate the safety and efficacy of MONOVISC in the treatment of the pain from osteoarthritis of the hip.

Eligibility:

  • Age:                > 30 years
  • Gender:          Male and Female

Selected Inclusion Criteria:

  • Body Mass Index is < 35 kg/m2
  • Clinical or radiographic diagnosis of hip osteoarthritis in the hip, with a Kellgren-Lawrence (K-L) severity grade of 2 or 3

Selected Exclusion Criteria:

  • Radiographic evidence of osteonecrosis in the target hip
  • Clinically diagnosed osteoarthritis in either knee resulting in walking pain greater than Numerical Rating Scale (NRS) 5
  • Dependence on external stabilization for walking (e.g. cane, crutches, walker, etc.)