Clinical Study to assess the safety and effectiveness of the Premia Spine TOPS system

Study Identifier: NCT03012776

Description: The purpose of this trial is to assess whether the Total Posterior Spine System (TOPS System) is more effective than transforaminal lumbar interbody fusion (TLIF) when used to stabilize a single lumbar level (L2 - L5) following surgical decompression in patients diagnosed with (1) at least moderate lumbar spinal stenosis, and (2) Grade 1 spondylolisthesis (or retrolisthesis), and (3) thickening of the ligamentum flavum or scarring of the facet joint capsule.

Success will be assessed by means of a composite endpoint that measures improvement in in patient reported outcomes and the absence of any major device related complications.

Main Eligibility Criteria:

  • Between 35 and 80 years of age
  • Must demonstrate at a single level to be treated (L2/3, L3/4 or L4/5) all three of the following:
    • Degenerative spondylolisthesis or retrolisthesis up to Grade I, as determined by the investigator based on flexion/extension X-rays,
    • At least moderate lumbar spinal stenosis, defined as at least a 25% reduction in either the central canal, the lateral recess space, and/or the foramen when compared to an adjacent level, as determined by the investigator based on MRI,
    • Thickening of the ligamentum flavum and/or scarring of the facet joint capsule as identified by the investigator based on MRI.
  • Have had at least six (6) months of failed conservative treatment prior to surgery (e.g., physical therapy, use of anti-inflammatory medications at maximum recommended dosage; administration of epidural/facet injections and/or nerve block)

 

SponsorPremia Spine

Ascension Wisconsin Investigator(s):  Stephen Robbins, MD

Contact Information:     Clinical Research Coordinator 

414-961-0304; marty@wiscboneandjoint.com