Degenerative Disc Disease
Conditions
Keywords
Degenerative disc disease, spinal stenosis, herniated disc
Brief summary
Purpose The primary purpose of this study is to prospectively compare clinical and radiographic clinical outcomes in patients undergoing cervical or lumbar interbody fusions and randomized to receive either polyetheretherketone (PEEK) or cortical allografts.
Detailed description
Following surgery study subjects will be evaluated at the following intervals: 3 (+/- 2 weeks), 6 (+/- 1 month), 12 (+/- 2 months), 24 (+/- 2 months) months.
Interventions
PROCEDUREPosterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)
Lumbar or cervical fusion
Sponsors
Justin Parker Neurological Institute
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Scores | 24 (+/- 2) months | Improvement in the Neck/Arm or Low Back/Leg Visual Analog pain Scale (VAS) scores. A 30% reduction in pain intensity will be considered to be a successful response to treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical and Radiographic Outcomes | 3 (+/-2) weeks and 24 (+/- 2) months | * Assessment of Neck or Lower Back Disability Scores * Assessment of SF-36 Health Survey * Assessment of restoration of vertebral height, sagittal alignment, and graft subsidence * Assessment of fusion rates |
Countries
United States
Outcome results
None listed