PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries
Completed
Conditions studied: Degenerative Disc Disease
In brief
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.
Key facts
- Study ID
- NCT01406405
- Run by
- Justin Parker Neurological Institute
- People needed
- 240
- Starts
- 2011-07-01
- Expected to finish
- 2018-05-16
- Last updated by the study team
- 2019-02-27
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Boulder Neurosurgical Associates — Boulder, Colorado, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.