PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries

Completed

• Conditions: Degenerative Disc Disease
• Interventions: Procedure: Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)

• Registration Number: NCT01406405
• Lead Sponsor: Justin Parker Neurological Institute

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-27
• Study First Submitted QC: 2011-07-29
• Study First Posted: 2011-08-01
• Primary Completion: 2018-05-16
• Study Completion: 2018-05-16
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PEEK cages	Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)	Patients will have fusion surgery performed using polyetheretherketone (PEEK) cages
Allograft spacers	Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)	Patients will have fusion surgery performed using allograft spacers

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Boulder Neurosurgical Associates; 🇺🇸 Boulder, Colorado, United States