DASCOR™ disc nucleus replacement study

Note: This trial has now been completed.

Desert Institute for Spine Care has been selected to participate in the DASCOR™ disc nucleus replacement pilot clinical study.

Study objectives for the DASCOR™ Disc Arthroplasty System pilot clinical study

This pilot clinical study is designed to evaluate the initial safety and effectiveness of the DASCOR™ 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 DASCOR™ 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 DASCOR™ Disc Arthroplasty device and will be followed postoperatively at predetermined intervals to evaluate safety and effectiveness.

Description of the DASCOR™ Disc Arthroplasty device

The DASCOR™ 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 DASCOR™ is a disc nucleus replacement device

The DASCOR™ 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 DASCOR™ 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 DASCOR™ procedure is minimally invasive and preserves the anatomy of the spine.

The following images depict how the DASCOR™ Disc Arthroplasty System works:

STEP 1: The surgeon accesses the spine creating a small entry site into the annulus or outer portion of the disc.

STEP 2: The surgeon uses a series of instruments to perform a Total Nucleus Removal (TNR).

STEP 3: After total nucleus removal, a sizing/diagnostic balloon is inserted into the disc space.

STEP 4: The balloon is filled with contrast solution that allows it to be seen on fluoroscopy. Then images of the balloon are taken to ensure proper positioning and sizing of the final implant. The contrast material and catheter are then removed.

STEP 5: Another catheter with a balloon is inserted into the disc space.

STEP 6: The mixed polymer passes through the catheter, as a liquid, filling the balloon and the disc space. The implant cures to form a firm but pliable implant that conforms to the individual’s anatomy. The polymer forms a single implant that remains in place.

STEP 7: The catheter is then cut off at the edge of the implant and removed. The remaining implant is designed to restore the original disc function and now replaces the diseased nucleus.

To view an animation of the DASCOR™ Disc Arthroplasty System procedure, please visit www.discdyn.com and click on the image of the spine in the center of the page.

Study sponsor: Disc Dynamics, Inc.

Who can participate in the DASCOR™ pilot study?

Subjects must meet all of the following inclusion criteria and none of the exclusion criteria. A highlight of the criteria are listed below:

Inclusion Criteria

• Subject has single-level degenerative disc disease (DDD). For this study, DDD is defined as degeneration of the disc as confirmed by subject history, physical examination, and radiographic studies with one or both of the following factors (as measured radiographically, by Computed Tomography (CT), Magnetic Resonance Imaging (MRI), plain film, myelography, CT discography, etc.):
  • Decreased disc height of > 2 mm (subject must have at least 5.5 mm of disc height at the affected level), and/or
  • Scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule
• Condition involves only one lumbar spine level from L2 to the sacrum
• Subject has a positive CT discogram at the affected level based on the Dallas discogram scale as determined by the investigator.
• Subject is between 18 and 70 years old
• Subject has persistent pain and or symptoms despite at least 6 months of non-operative care
• Subject has an Oswestry score ≥ 40 (based on 100 point scale)
• Subject has a back pain score of at least 5 on a 10 point visual analogue scale (VAS)
• Subject is able to understand and sign the consent form
• Subject is willing and able to comply with the protocol

Exclusion Criteria

• Subject has a disc herniation or re-herniation with radicular pain requiring posterior discectomy
• Subject has had a prior invasive treatment of the disc at the implant level (e.g. discectomy)
• Subject has previous diagnosis of osteopenia or osteoporosis.
• Subject has had prior lumbar fusion surgery at any level
• Subject has a significant medical illness that would pose a risk for surgery (e.g. cardiac, respiratory disease, or Addison’s disease), or that might interfere with post-operative evaluations (e.g. Multiple Sclerosis (MS), Parkinson’s disease, etc.)
• Subject has a history of a significant communicable disease (i.e. Human Immunodeficiency Virus (HIV), Hepatitis, etc.) that may increase the risk of surgery
• Subject has an active systemic or local infection in the area of the planned surgery
• Subject is participating in another investigational drug, device or biologic study
• Subject is a prisoner, or alcohol abuser, or substance abuser

Sites that are participating in the DASCOR™ pilot study

• Phoenix, Arizona
• Scottsdale, Arizona
• St. Louis Park, Minnesota
• Utica, New York
• Santa Monica, California

Caution: Investigational Device, Limited by United States Law to Investigational Use.