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Completed

NCT Number: NCT01406405

PEEK and Allograft Spacers Evaluation in Spinal 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.

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Hernia Intervertebral Disc Degeneration Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases Spinal Stenosis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boulder Neurosurgical Associates

Boulder, Colorado, 80304, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)

Procedure

Lumbar or cervical fusion

Primary outcomes

  1. Pain Intensity Scores

    Time frame: 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 outcomes

  1. Clinical and Radiographic Outcomes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Justin Parker Neurological Institute

Other

Registry information

Official study title

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

Acronym: PEEK

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Aug 1, 2011
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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