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

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ClinicalTrials.gov Identifier: NCT01406405
Recruitment Status : Active, not recruiting
First Posted : August 1, 2011
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Degenerative Disc Disease 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
Estimated Enrollment : 240 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prospective Randomized Clinical Trial Comparing PEEK and Allograft Spacers in Patients Undergoing Spinal Intervertebral Fusion Surgeries
Study Start Date : July 2011
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Boulder Neurosurgical Associates patients
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406405


Locations
United States, Colorado
Boulder Neurosurgical Associates
Boulder, Colorado, United States, 80304
Sponsors and Collaborators
Justin Parker Neurological Institute
Investigators
Principal Investigator: Alan T Villavicencio, MD Boulder Neurosurgical Associates

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Justin Parker Neurological Institute
ClinicalTrials.gov Identifier: NCT01406405     History of Changes
Other Study ID Numbers: JPNI2001-2
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Keywords provided by Justin Parker Neurological Institute:
Degenerative disc disease
spinal stenosis
herniated disc

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases