PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries

Degenerative Disc Disease Clinical Trial

— PEEK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406405
• Other study ID #: JPNI2001-2
• Status: Completed
• Start date: July 2011
• Est. completion date: May 16, 2018

Study information

• Verified date: February 2019
• Source: Justin Parker Neurological Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: May 16, 2018
• Est. primary completion date: May 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Procedure:
• Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)
Lumbar or cervical fusion

Locations

Country	Name	City	State
United States	Boulder Neurosurgical Associates	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Justin Parker Neurological Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity Scores	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.	24 (+/- 2) months
Secondary	Clinical and Radiographic Outcomes	Assessment of Neck or Lower Back Disability Scores; Assessment of SF-36 Health Survey; Assessment of restoration of vertebral height, sagittal alignment, and graft subsidence; Assessment of fusion rates	3 (+/-2) weeks and 24 (+/- 2) months