Status:
COMPLETED
PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries
Lead Sponsor:
Justin Parker Neurological Institute
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18-70 years
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 ...
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 Criteria
Inclusion
- Lumbar Fusion Patient Group
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 16 2018
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01406405
Start Date
July 1 2011
End Date
May 16 2018
Last Update
February 27 2019
Active Locations (1)
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1
Boulder Neurosurgical Associates
Boulder, Colorado, United States, 80304