PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries

Justin Parker Neurological Institute

Status: Completed

Conditions: Degenerative Disc Disease

Treatments: Procedure: Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)

Study type: Observational

Funder types: Other

Identifiers

NCT01406405

JPNI2001-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

240 participants in 2 patient groups

PEEK cages

Description:

Patients will have fusion surgery performed using polyetheretherketone (PEEK) cages

Treatment:

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

Allograft spacers

Description:

Patients will have fusion surgery performed using allograft spacers

Treatment:

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