The purpose of this study is to evaluate the safety and efficacy of Hyalofast® scaffold with
bone marrow aspirate concentrate (BMAC) compared to microfracture in the treatment of
symptomatic cartilage defects of the knee.
Prospective, randomized, active treatment-controlled, evaluator-blinded (radiologist
reviewer and physician evaluator) multicenter study (up to 40 sites in the US and EU).
All subjects that meet preoperative screening eligibility criteria will be randomized to
treatment with Hyalofast® with BMAC or Microfracture.
Hyalofast® is a sterile, biodegradable non-woven pad (2 x 2 cm or 5 x 5 cm) that is
composed of HYAFF-11®, a benzyl ester of hyaluronic acid. Hyalofast® acts as a
biodegradable support for the autologous bone marrow aspirate concentrate. Hyalofast® is
soft and conformable and can easily be cut to fit the lesion size.
Autologous bone marrow is harvested from the subject intraoperatively during the Index
Procedure. Approximately 60 mL of bone marrow will be aspirated from the subject's iliac
crest using the SmartPrep 2 Bone Marrow Processing Pack. The cellular rich portion will
be concentrated via the SmartPrep BMAC 2 Centrifuge System at point-of-care to provide 7
mL of bone marrow aspirate concentrate (BMAC). 1 - 2 mLs will be used for post-procedure
testing of total nucleated cells, cell viability, and sterility.
Hyalofast® with BMAC is implanted during either a standard knee arthroscopy or
min-arthrotomy depending upon surgeon preferences and intra-operative findings. The
lesion to be treated will be debrided to a stable cartilage margin. The defect will be
sized and Hyalofast® will be cut to fit the lesion area. If necessary, more than one
Hyalofast® pad can be overlapped to cover the lesion. 2 mL of BMAC will be loaded per
Hyalofast® scaffold and then implanted to cover the defect. Hyalofast® with BMAC readily
adheres to the site of application, but, if necessary, can be secured to the defect
margins with an FDA-approved fibrin glue.
All subjects will be assessed at intervals post-procedure (1 month, 3 months, 6 months,
12 months, 24 months, and 36 months).
Subjects will be required to follow a strict pre-specified post-surgery rehabilitation
protocol specific to the defect location.
Measures to assess effectiveness will be conducted at follow-ups, with the primary
effectiveness endpoint assessment done at the 24 month timepoint.
Evaluators doing efficacy assessments of the subject and administering subject-reported
outcome instruments will be blinded to the treatment.
Safety will be assessed by the collection of adverse events at all timepoints.
Magnetic Resonance Imaging (MRI) will be conducted at Screening, 1 month, 12 months, 24
months, and 36 months. Evaluation of the MRIs, including the MOCART score, will be done
by blinded radiologist reviewers. The one month MRI will be used as the baseline MRI for
evaluation of treatment effectiveness.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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