Retrospective, Multicenter Clinical Evaluation of Health Economic Drivers and Complications for Two Lumbar Fusion Procedures

Study Objective:

The study objective is to demonstrate via retrospective data review the relative value of
two lumbar fusion procedures: transsacral lumbar interbody fusion and the transforaminal
lumbar interbody fusion when used in conjunction with bilateral supplemental screw fixation
as an adjunct to fusion. Subject candidates are those who had required fusion at L5-S1 where
this was the only lumbar level treated for spinal stenosis, spondylolisthesis, or
degenerative disc disease (DDD).

Consecutive subjects who were treated with the transsacral lumbar interbody fusion or
transforaminal lumbar interbody fusion procedure at least 1 year (- 2 months) prior to the
date the data is collected will be evaluated.

Study Design, Endpoints:

Primary Endpoint:

Safety: Incidence of reported adverse events, including those requiring medical
intervention, by 3 months post-operative.

Secondary Endpoints:

Health Economic: Operative measures, including the direct and surrogate measurement of
estimated blood loss, anesthesia time, transfusions, length of surgery and time to hospital
discharge, as applicable.

Health Economic: Comparative hospital data (from time of admission through time of
discharge)

Clinical Effectiveness: A decrease in back pain compared to baseline at 3 months (+/-2
weeks) as measured by Visual Analog Scale (VAS).

Clinical Effectiveness: A decrease in disability compared to baseline at 3 months (+/-2
weeks) as measured by the Oswestry Disability Index (ODI).

Study Design, Enrollment:

Approximately 200 subjects will be enrolled in this study, 100 subjects who have been
treated with transsacral lumbar interbody fusion and 100 subjects who have been treated with
transforaminal lumbar interbody fusion.

Study Design, Analyses:

The retrospective clinical evaluation will collect and compare results for the procedure
transsacral lumbar interbody fusion versus transforaminal lumbar interbody fusion as defined
by the primary and secondary endpoints.

Inclusion Criteria:

- Adult aged 18 years or older

- Male or Female subject that had previously received transsacral single-level
procedure when used in conjunction with bilateral pedicle screw fixation or TLIF
single-level procedure with bilateral supplemental screw fixation (e.g. pedicle
screws, anterior devices with screw anchoring, anterior lumber plates) as an adjunct
to fusion at L5-S1 to treat spinal stenosis, spondylolithesis or degenerative disc
disease (DDD)

- Subject that was treated no less than 1 year (-2 months) prior to this evaluation
with a transsacral or TLIF procedure by participating surgeons

Exclusion Criteria:

- Subject had history of previous back operations at the time of the index procedure

- Subject had extraspinal cause of back pain or sciatica at the time of the index
procedure

- Severe scoliosis in the lumbar region

- Subject was or is currently involved in active litigation

- Subject that had a diagnosis and received a transsacral or TLIF procedure at L5-S1
levels and did not require treatment at any other lumbar levels at the time of
surgery.