PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries (PEEK)

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 240

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80304
      • Boulder Neurosurgical Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Boulder Neurosurgical Associates patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PEEK cages; Patients will have fusion surgery performed using polyetheretherketone (PEEK) cages	Procedure: Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF); Lumbar or cervical fusion
Allograft spacers; Patients will have fusion surgery performed using allograft spacers	Procedure: Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF); Lumbar or cervical fusion

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Justin Parker Neurological Institute
• Investigators: Principal Investigator: Alan T Villavicencio, MD, Boulder Neurosurgical Associates

Publications and helpful links

General Publications

• Villavicencio AT, Nelson EL, Kantha V, Burneikiene S. Prediction based on preoperative opioid use of clinical outcomes after transforaminal lumbar interbody fusions. J Neurosurg Spine. 2017 Feb;26(2):144-149. doi: 10.3171/2016.7.SPINE16284. Epub 2016 Sep 30.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2011
• Primary Completion (Actual): May 16, 2018
• Study Completion (Actual): May 16, 2018

Study Registration Dates

• First Submitted: July 27, 2011
• First Submitted That Met QC Criteria: July 29, 2011
• First Posted (Estimate): August 1, 2011

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Degenerative disc disease; herniated disc; spinal stenosis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: JPNI2001-2