PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries

Following surgery study subjects will be evaluated at the following intervals: 3 (+/- 2
weeks), 6 (+/- 1 month), 12 (+/- 2 months), 24 (+/- 2 months) months.

Lumbar Fusion Patient Group

Inclusion Criteria:

- Skeletally mature adults between 18 and 70 years old

- Patients with back and leg pain due to degenerative disc disease, scheduled for
TLIF/PLIF approach utilizing an interbody spacer and supplemental posterior fixation
at 1, 2 or 3 adjacent levels

- 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 followup
requirements

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

Exclusion Criteria:

- More than 3 intervertebral levels to be fused

- Posterior fixation used at more than 1 level for 1-level intervertebral fusion

- Posterior fixation used at more than 2 levels for 2-level intervertebral fusion

- Posterior fixation used at more than 3 levels for 3-level intervertebral fusion

- Any additional approaches, e.g. anterior, XLIF

- Active local or systemic infection

- Prior interbody fusion surgery at the index level

- Prior fusion at the adjacent levels

- Previous known allergy to polyetheretherketone (PEEK) or titanium alloy

Cervical Fusion Patient Group

Inclusion Criteria:

- Skeletally mature adults between 18 and 70 years old

- Patients with neck and/or arm pain due to degenerative disc disease, scheduled for
ACDF approach utilizing an interbody spacer and anterior cervical plate at 1, 2 or 3
adjacent levels

- Completed at least 6 weeks of conservative therapy 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 followup
requirements

- Willing and able to sign a study specific informed consent

Exclusion Criteria:

- More than 3 vertebral levels to be fused

- Any additional approaches, e.g. posterior cervical fusion

- Active local or systemic infection

- Prior interbody fusion surgery at the index level

- Prior fusion at the adjacent level

- Previous known allergy to polyetheretherketone (PEEK) or titanium alloy