Date Posted: 28 September 2007
DASCORT disc nucleus replacement pilot clinical study (Sponsored pilot clinical study listing).
A prospective, multicenter pilot study of the Disc Dynamics DASCORT Disc Arthroplasty System in the treatment of degenerative disc disease.
Study objectives for the DASCORT Disc Arthroplasty System pilot clinical study.
This pilot clinical study is designed to evaluate the initial safety and effectiveness of the DASCORT Disc Arthroplasty device in subjects with single-level degenerative disc disease (DDD) of the lumbar spine from L2 to the sacrum and to provide data for use in hypothesis and endpoint determination for the pivotal study.
Design of the DASCORT pilot study
This study is a multicenter, prospective, pilot study in which 20 qualified subjects will be enrolled at up to five investigational sites. Study subjects will undergo surgery to implant the DASCORT Disc Arthroplasty device and will be followed postoperatively at predetermined intervals to evaluate safety and effectiveness.
Description of the DASCORT Disc Arthroplasty device
The DASCORT Disc Arthroplasty device is an in-situ, curable polymer that is designed to replace the degenerated nucleus and restore the disc function in subjects with single-level DDD of the lumbar spine from L2 to the sacrum.
The DASCORT is a disc nucleus replacement device
The DASCORT Disc Arthroplasty System replaces an abnormal disc nucleus with an artificial device that conforms to the disc nucleus space and is designed to perform like a natural healthy nucleus. The DASCORT device is different from an entire artificial disc replacement, where the entire spinal disc - not just the nucleus (the inner portion of the disc) - is replaced. Unlike total disc replacement, the DASCORT procedure is minimally invasive and preserves the anatomy of the spine.