Prospective Randomized Clinical Trial Comparing PEEK and Allograft Spacers in Patients Undergoing Spinal Intervertebral Fusion Surgeries

Justin Parker Neurological Institute1 site in 1 country240 target enrollmentJuly 2011

ConditionsDegenerative Disc Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Degenerative Disc Disease
Sponsor: Justin Parker Neurological Institute
Enrollment: 240
Locations: 1
Primary Endpoint: Pain Intensity Scores
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

May 16, 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Justin Parker Neurological Institute

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pain Intensity Scores

Time Frame: 24 (+/- 2) months

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.