Defect of Articular Cartilage Clinical Trial
Official title:
Comparison of BioCartilage Versus Marrow Stimulating Procedure for Cartilage Defects of the Knee
Subjects will be selected among the investigators' patient population who are already
scheduled to receive a marrow stimulating procedure (MSP), with or without the addition of
BioCartilage.
During the surgical operation for MSP, a portion of the patient's blood is taken out and used
to form a patch to cover a cartilage defect of the knee. Currently it is considered standard
of care to either form the patch using only a portion of the patient's blood, or form the
patch using a portion of the patient's blood combined with an FDA-approved augmentation such
as BioCartilage.
This study will collect outcomes data and MRI for patients that are undergoing MSP with and
without BioCartilage augmentation, then compare the data between those who received
BioCartilage and those who did not.
The primary endpoint is to determine whether subjects receiving a marrow stimulating
procedure (MSP) augmented with BioCartilage have improved outcomes (measured using quality of
life indicators, functional outcomes, and MRI) compared to subjects who receive MSP without
the use of BioCartilage.
Recent developments in the treatment of articular cartilage defects have resulted in several
techniques that involve the stimulation of native cellular components for the purpose of
differentiation and proliferation in the cartilage defect. Techniques of interest for this
study are the use of microfracture combined with platelet rich plasma (PRP), and a recently
developed augmentation of the microfracture procedure-BioCartilage.
The microfracture procedure is performed with PowerPick. During the procedure, a patient with
focal cartilage defect undergoes arthroscopic debridement of the defect before microfracture
is used to create holes in the subchondral plate in order to provide access to mesenchymal
stem cells (MSCs). To complete this marrow stimulating procedure (MSP), the microfractured
region is filled with PRP harvested intraoperatively from the patient. A fibrin glue is then
used to cover the defect and hold the PRP repair in place.
This basic MSP has been shown to regenerate cartilage tissue and improve joint function.
Microfracture treatments using PRP are "shown to have good to excellent short-term outcomes
in appropriately indicated patients" (Abrams, Mall, Fortier, Roller, & Cole, 2013), however
successful long-term outcomes have not been demonstrated in the literature.
BioCartilage, a novel therapy developed by Arthrex Inc, is implemented as an augmentation of
the basic approach of using microfracture and PRP. All aspects of the procedure, as well as
indications for the procedure, are the same as the basic MSP described above, except the PRP
is combined with BioCartilage powder, which acts as a scaffolding for cellular growth.
BioCartilage is an FDA approved augmentation of microfracture treatment with PRP, and the
powder itself contains no living cells.
Animal models using BioCartilage have provided data that supports the assertion that the
BioCartilage augmentation may improve outcomes for patients who receive it; however there is
currently no published human clinical outcomes data available for using BioCartilage (Abrams
et al., 2013).
;
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