Prospective, Multi-Center Clinical Outcomes Study Evaluating the chronOS Strip Combined With Bone Marrow Aspirate



Status:Archived
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:July 2009
End Date:July 2012

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Prospective, Multi-Center Clinical Outcomes Study Evaluating the chronOS Strip Combined With Bone Marrow Aspirate Plus Local Bone for Posterolateral Lumbar Interbody Fusion or Lumbosacral Interbody Fusion


The chronOS Strip is a synthetic bone void filler manufactured from chronOS beta-tricalcium
phosphate (β-TCP) granules and a resorbable polymer [poly(lactide-co-ε-caprolactone)]. The
result is a porous, osteoconductive, three-dimensional composite that is flexible, with
excellent memory characteristics. The chronOS Strip conforms to the implant site, allowing
site-specific placement.

The use of the chronOS Strip eliminates the need for autologous bone graft harvesting from a
secondary surgical site, thus reducing donor site morbidity. The chronOS Strip, combined
with autogenous blood and/or bone marrow aspirate, or autograft such as may be obtained from
the posterior spinal elements, is intended to be used in the spine for posterolateral
fusion. Following placement into the bony void, chronOS Strip resorbs and is replaced with
bone during the healing process.


The use of the chronOS Strip eliminates the need for autologous bone graft harvesting from a
secondary surgical site, thus reducing donor site morbidity. The chronOS Strip, combined
with autogenous blood and/or bone marrow aspirate, or autograft such as may be obtained from
the posterior spinal elements, is intended to be used in the spine for posterolateral
fusion. Following placement into the bony void, chronOS Strip resorbs and is replaced with
bone during the healing process. The chronOS Strip has several handling advantages over
existing ceramic bone void fillers traditionally utilized in spine fusion surgery. It is
easily shaped to precisely fill the skeletal void and stays localized once placed. Further,
the implant can be rolled, folded, cut or sutured intra-operatively, and then conformed to
each patient's anatomy.

The chronOS Strip is available in various sizes and thicknesses. It is provided in a
sterile perfusion pack which, when connected to a standard syringe, can be used to perfuse
the chronOS Strip with the patient's blood and/or bone marrow aspirate.


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3400 Spruce St
Philadelphia, Pennsylvania 19104
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Decatur, Georgia 30033
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Pittsburgh, Pennsylvania 15213
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