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 1.5 – 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 Study

 

Cingal Pilot Trial

Study of Cingal® and Triamcinolone Hexacetonide for the Relief of Knee Osteoarthritis Pain

Purpose: The purpose of this trial is to determine the pain relief provided by Cingal, compared to a steroid or placebo when used to improve pain and function for patients with knee osteoarthritis.

Eligibility:

Selected Inclusion Criteria:

  • Age 40-75 years old
  • BMI ≤ 40 kg/m2
  • Subject has Kellgren-Lawrence (K-L) severity grade II or III in the Index knee as determined by X-Ray.  Contralateral knee: K-L severity grade 0, I or II.
  • Two signs and symptoms of knee osteoarthritis:
    • Signs: crepitus, restricted movement and bony enlargement
    • Symptoms: persistent knee pain, limited morning stiffness and reduced function
  • Subject must be willing to abstain from other IA treatments of the knee for the duration of the study.

Selected Exclusion Criteria:

  • Subject received an intra-articular knee injection in previous 6 months.
  • Subject had an arthroscopy of either knee within 3 months
  • Medical history of inflammatory conditions including septic arthritis; inflammatory joint disease; gout.
  • Subject had an open surgical procedure of either knee or hip or any surgery of the spine within 12 months
  • Receiving or in litigation for worker’s compensation.

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.

Cingal Study