Summary

Eligibility
for people ages 25-80 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

The LimiFlex™ Clinical Trial is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of decompression and stabilization with the Empirical Spine LimiFlex™ Paraspinous Tension Band compared to decompression and transforaminal lumbar interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) for the treatment of lumbar degenerative spondylolisthesis (Grade I per Meyerding classification) with spinal stenosis. Clinical trial sites will enroll solely LimiFlex subjects or solely TLIF/PLF subjects.

Official Title

A Concurrently Controlled Study of the LimiFlex™ Paraspinous Tension Band in the Treatment of Lumbar Degenerative Spondylolisthesis with Spinal Stenosis

Details

The LimiFlex™ Paraspinous Tension Band is a new stabilization option for patients being treated with surgical decompression for degenerative spondylolisthesis. The LimiFlex does not require pedicle screws to anchor to the spine; instead, two dynamic rods are attached to pedicle-sparing straps which encircle adjacent spinous processes.

Keywords

Degenerative Spondylolisthesis, Lumbar Spinal Stenosis, Spinal Stenosis, Spondylolisthesis, Pathologic Constriction, LimiFlex, Fusion Instrumentation, Decompression, Fusion

Eligibility

Locations

  • UCSF Dept of Orthopaedic Surgery
    San Francisco California 94143 United States
  • Kaiser Permanente Division of Research
    Oakland California 94611 United States
  • Stanford University Medical Center
    Redwood City California 94063 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Empirical Spine, Inc.
ID
NCT03115983
Study Type
Interventional
Participants
About 299 people participating
Last Updated