PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries

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

Official Title
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Prospective Randomized Clinical Trial Comparing PEEK and Allograft Spacers in Patients Undergoing Spinal Intervertebral Fusion Surgeries

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Procedure: Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PEEK cages<br>Patients will have fusion surgery performed using polyetheretherketone (PEEK) cages | Procedure: Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)<br>* Lumbar or cervical fusion<br>|
| Allograft spacers<br>Patients will have fusion surgery performed using allograft spacers | Procedure: Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)<br>* Lumbar or cervical fusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity Scores | 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. | 24 (+/- 2) months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and Radiographic Outcomes | 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 | 3 (+/-2) weeks and 24 (+/- 2) months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Degenerative disc disease, spinal stenosis, herniated disc