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The OsteoCure™ Plug is a cylindrical implant ideal for
filling circular drill holes in bone. The implant is a resorbable, porous
scaffold, which allows the in-growth of new healing tissue. The implant
is sized for cylindrical defects with a minimum depth of 5 mm and a maximum
depth of 12mm.
OsteoCure implants use the PolyGraft® technology and are
porous, resorbable scaffolds composed of polylactide-co-glycolide (PLG)
copolymer for providing structure and calcium sulfate for enhancing bone
growth. The copolymer is amorphous (noncrystalline) and resorbs in six
to nine months. In addition, polyglycolide (PGA) fibers are incorporated
for strength, and surfactant is added to allow fluids to be easily absorbed
into the scaffolds. The implants are structurally sound to effectively
fill defects left by surgery, trauma or disease, and due to their porous
nature, provide conduits for tissue ingrowth. The various sizes of plugs
allow the implants to be press fit into defects and maintain space.
The hydrophilic properties and interconnected porosity of the PolyGraft material
enable absorption of blood, bone marrow cells, and proteins to nourish
healing.
The safety and effectiveness of this device for use in osteochondral defects have not been established.
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OsteoCure™ Plug Implant Kit
OsteoCure™ Plus Site Preparation Kit
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PolyGraft Material Technology is a Template for Healing...
The hydrophilic properties and interconnected porosity of the PolyGraft material
enables absorption of blood, bone marrow cells and proteins in as little
as 2.5 minutes.
Staged Resorbtion... OsteoCure Biologic
Scaffolds at Work
1 The scaffold is press fit into
the defect site. Note the close apposition with the adjacent
tissue to encourage migration of tissue into the scaffold. Using
a tamp, the scaffold can be formed to match the surface geometry.
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2 Immediately post implantation,
the hydrophilic properties of the scaffold allow blood, marrow
and progenitor cells to be wicked into the pores. The scaffold
provides a porous and mechanically protected environment for
healing, tissue in-growth and cellular development.
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3 Between six weeks and six months,
the calcium sulfate has dissolved. Progenitor cells have infiltrated
the scaffold and have differentiated. New tissue has formed within
the pores. The scaffold has maintained the defect walls to protect
the integrity of the "zone of influence."
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4 Between six months and twelve
months, the polymer undergoes resorbtion and is gradually replaced
with tissue. Loading is progressively transferred to condition
the new tissue.
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5 After twelve months, the polymer
is predominantly resorbed and the defect now contains new tissue.
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Supporting Documentation
Indications
The OsteoCure Plug implants are to be used to fill bony voids
or gaps of the skeletal sysytem (i.e. the extremeties) caused by trauma
or surgery that are not intrinsic to the stability of the bony structure.
PolyGraft® is a trademark of OsteoBiologics, Inc.
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