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 |
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.
We found this trial at
6
sites
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Northwestern University Northwestern is recognized both nationally and internationally for the quality of its educational...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Nashville, Tennessee 37232
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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