PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries
NCT ID: NCT01406405
Last Updated: 2019-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
240 participants
OBSERVATIONAL
2011-07-31
2018-05-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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PEEK cages
Patients will have fusion surgery performed using polyetheretherketone (PEEK) cages
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
Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)
Lumbar or cervical fusion
Interventions
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Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)
Lumbar or cervical fusion
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Justin Parker Neurological Institute
OTHER
Responsible Party
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Principal Investigators
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Alan T Villavicencio, MD
Role: PRINCIPAL_INVESTIGATOR
Boulder Neurosurgical Associates
Locations
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Boulder Neurosurgical Associates
Boulder, Colorado, United States
Countries
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References
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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.
Other Identifiers
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JPNI2001-2
Identifier Type: -
Identifier Source: org_study_id
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