Clinical trial NCT01406405: PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries
Official title: Prospective Randomized Clinical Trial Comparing PEEK and Allograft Spacers in Patients Undergoing Spinal Intervertebral Fusion Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Keywords: Degenerative disc disease
spinal stenosis
herniated disc
Lead sponsor: Justin Parker Neurological Institute
Sponsor class: OTHER
First posted: 2011-08-01
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Boulder Neurosurgical Associates patients

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.

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: 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

Primary outcomes:
measure: Pain Intensity Scores
timeFrame: 24 (+/- 2) months
Secondary outcomes:
measure: Clinical and Radiographic Outcomes
timeFrame: 3 (+/-2) weeks and 24 (+/- 2) months
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Boulder Neurosurgical Associates
state: Colorado
Study officials:
affiliation: Boulder Neurosurgical Associates
name: Alan T Villavicencio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.