RAMP Study: A Study Comparing Two Lumbar Fusion Procedures

Study Treatment Arms:

The transacral lumbar interbody fusion (including 1L+ and 2L+) is a minimally invasive
technique that uses a transacral approach to achieve fusion at the L5-S1 or L4-L5-S1 spinal
levels. The transforaminal lumbar interbody fusion (TLIF) is performed by using a posterior
unilateral or bilateral incision in which the lumbar spine is accessed. Both study
procedures are approved for use and conform to US regulatory requirements. The study
employs these procedures and devices for uses that are consistent with their 510(k), legally
cleared, labeling.

Study Design, Objective:

The study objective is to demonstrate non-inferiority between the transacral lumbar
interbody fusion procedure and the transforaminal lumbar interbody fusion procedure (TLIF)
by meeting the primary and secondary study endpoints as listed below.

Study design, Endpoints:

Primary Endpoint:

Efficacy: Fusion of the targeted vertebral bodies (L4-L5 or L5-S1) by 24 months as
determined by Central Radiographic Reviewer's interpretation of high resolution Computed
Tomography (CT) scan.

Secondary Endpoints:

Safety: Incidence of major device-related adverse events and/or failures by 24 months,
defined as those requiring revision surgery or a secondary operation, or events resulting in
permanent disability or death.

Clinical Effectiveness: A 20% decrease in back pain compared to baseline by 24 months as
measured by the Visual Analog Scale (VAS) score.

Clinical Effectiveness: A 20% decrease in disability compared to baseline by 24 months as
measured by the Oswestry Disability Index (ODI).

Study Design, Enrollment and Analyses:

Approximately 200 subjects will be enrolled in this study and will receive one of two study
treatments in the study. The enrollment period is expected to last approximately 18 months,
with a 24 month follow up period. Approximately 15-20 sites will participate, and
Investigators must be proficient in both of the lumbar fusion procedures.

Analyses:

Eight evaluations: Pre-Operative, Operative, Discharge, and at 1, 3, 6, 12, and 24 Months.

Safety and efficacy analyses will be performed at all follow-up points during the study as
well as a final analysis when all subjects have completed the study.

Inclusion Criteria:

- Male or female subject that is eligible for both study procedures only at the
L4-L5-S1 or L5-S1 levels with bilateral pedicle screws;

- The subject has a diagnosis of one or more of the following conditions at the
L4-L5-S1 or L5-S1 levels:

- Spinal stenosis;

- Spondylolisthesis;

- Degenerative Disc Disease (DDD) defined as back pain and/or radicular pain with
degeneration of the disc as confirmed by history, physical examination and
radiographic studies, either by CT, MRI, plain film, myelography, or
discography;

- Adult 18 years of age or older;

- The subject has undergone at least 6 consecutive months of Conservative Care
Therapy(ies);

- The subject is able and willing to give written informed consent and to comply with
the requirements of this study protocol.

Exclusion Criteria:

- Coagulopathy;

- Bowel disease (e.g. Crohn's, ulcerative colitis);

- Severe scoliosis (curves > 60°);

- Sacral agenesis;

- Spondylolisthesis greater than Grade 1 at the L4-L5-S1 levels, or greater than Grade
2 at the L5-S1 level;

- Spinal tumor (or history of sacral tumor);

- History of fracture at L4, L5 and/or S1 vertebral bodies;

- The subject has undergone a prior fusion procedure of the lumbar spine;

- Osteoporosis; or, if the subject is at high risk for development of osteoporosis,
further screening to be conducted at Investigator's discretion;

- Per the Investigator, body weight is exclusionary only if concomitant medical issues
are present that preclude the subject from being a candidate for spinal surgery; The
subject is a current cigarette smoker;

- For women of childbearing potential, pregnancy at the time of enrollment, or planning
to become pregnant during the course of the study;

- The subject has a history of substance abuse (illegal drugs, prescription drugs, or
alcohol) that, in the Investigator's opinion, may interfere with protocol assessments
and/or the subject's ability to comply with the protocol;

- Per the Investigator, the subject is in poor general health or undergoing any
concurrent disease process that would place the subject in excessive risk to surgery
(e.g. significant circulatory problems, cardiac disease, history of bowel surgery);

- The subject is participating in another spine study, which, in the opinion of the
Investigator, could skew results;

- The subject is involved in litigation related to their back condition;

- The subject is contraindicated to receive either study procedure;

- The subject is contraindicated to receive bilateral pedicle screws;

- The subject has a history of allergy to any component of the devices or biologic
material to be implanted in either procedure;

- The subject is a prisoner, transient, or an illegal alien.