About TruFUSE®

The TruFUSE procedure can be performed minimally invasive and is utilized by surgeons for earlier use in the continuum of care as a conservative measure to address degenerative facet disease, prevent minor instability and prevention of mechanical back pain symptoms. TruFUSE can be used either as a stand-alone procedure or as an adjunct to augment other fusion techniques and motion limiting products.

We believe that TruFUSE will improve the rate of successful outcomes with a favorable risk-benefit profile and lower complexity relative to it’s alternatives. TruFUSE could be used for conservative treatments before major surgical options and as a supplement to other fusion procedures in the spine. One primary attraction is minimal tissue disruption and that it does not preclude other future medical/surgical options if necessary.

The TruFUSE Procedure

TruFUSE addresses back pain resulting from facet joint degeneration and from mild joint instability. This procedure can be provided through a minimally invasive incision utilizing fluoroscopy to locate the affected joint. Once the joint is located, a Steinmann pin is inserted between the facet walls. A self centering spatula is inserted for drill guide alignment. After the drill guide is inserted over the spatula, the spatula and pin are removed and a drill bit is inserted into the drill guide. The drill bit is designed to provide compaction and to drill a Morse taper shaped canal of bleeding bone to receive the tapered dowel.

We believe the TruFUSE dowels perform several functions:
  • Separate the joint surfaces to stabilize and reduce inflammation
  • Stretch the anterior joint capsule and create a press fit to enhance stability
  • Optimize the environment for facet fusion
The following exhibits depict TruFUSE® implanted in facet joints:

The TruFUSE procedure takes approximately 30 minutes and can be performed minimally invasive.

Potential Indications
  • Isolated facet based symptomatic back pain that is refractory to conservative measures
  • Stabilization of the lumbar spine following decompressive procedures or where minor instability exists or presents post operatively
  • Minor instability (1-2mm listhesis)
  • Posterior supplemental fixation to interbody fusion
  • Adjunct to motion limiting devices
Contraindications
  • Trauma
  • High grade instability
  • Tumors
  • Infections
  • Spondylolysis
  • Spondylothesis – greater than grade one
For additional information about TruFUSE, please review our Frequently Asked Questions.