OrthoFix - Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF) (TLF)

The purpose of this study is to utilize Trinity Evolution in conjunction with an interbody spacer and supplemental posterior fixation of the surgeon's choice and to follow the patients to measure the clinical outcomes and rate of fusion. The hypothesis of the study is that Trinity Evolution combined with an interbody spacer and supplemental posterior fixation will result in fusion rates and clinical outcomes similar to those with other routinely used autograft and allograft materials including: fusion, improvement in pain and function, maintenance of lower extremity neurological function, and absence of serious adverse events related to the use of the Trinity Evolution product.

Requirements:

·          Symptomatic lumbar degenerative disc disease at 1 or 2 adjacent levels between L3 and S1

·          Patients with back and/or leg pain scheduled for stabilization with or without decompression via a TLIF or PLIF approach utilizing an interbody spacer and supplemental posterior fixation.

·          Greater than 18 years of age

·          Unresponsive to conservative care over a period of at least 6 months or has progressive neurological signs and/or symptoms of neurological compromise that mandate urgent surgical intervention

·          Willing and able to comply with the requirements of the protocol including follow-up requirements

·          Willing and able to sign a study specific informed consent.

For more information contact Crystal Hill at (919) 281-1784 or chill@triangleortho.com .