PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Justin Parker Neurological Institute
Sponsor:
Collaborator:
Boulder Neurosurgical Associates
Information provided by (Responsible Party):
Justin Parker Neurological Institute
ClinicalTrials.gov Identifier:
NCT01406405
First received: July 27, 2011
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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

Study Type: Observational
Study Design: 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

Further study details as provided by Justin Parker Neurological Institute:

Primary Outcome Measures:
  • Pain Intensity Scores [ Time Frame: 24 (+/- 2) months ] [ Designated as safety issue: No ]
    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:
  • Clinical and Radiographic Outcomes [ Time Frame: 3 (+/-2) weeks and 24 (+/- 2) months ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 240
Study Start Date: July 2011
Estimated Study Completion Date: July 2014
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406405

Contacts
Contact: Sigita Burneikiene, MD 303-938-5700 sigitab@bnasurg.com

Locations
United States, Colorado
Boulder Neurosurgical Associates Recruiting
Boulder, Colorado, United States, 80304
Contact: Sigita Burneikiene, MD    303-938-5700      
Sponsors and Collaborators
Justin Parker Neurological Institute
Boulder Neurosurgical Associates
Investigators
Principal Investigator: Alan T Villavicencio, MD Boulder Neurosurgical Associates
  More Information

No publications provided

Responsible Party: Justin Parker Neurological Institute
ClinicalTrials.gov Identifier: NCT01406405     History of Changes
Other Study ID Numbers: JPNI2001-2
Study First Received: July 27, 2011
Last Updated: June 4, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 26, 2014