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.
- 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
- High grade instability
- Spondylothesis – greater than grade one
For additional information about TruFUSE, please review our Frequently Asked Questions