Clinical Trials Directory

Trials / Completed

CompletedNCT01406405

PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries

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

Status
Completed
Phase
Study type
Observational
Enrollment
240 (actual)
Sponsor
Justin Parker Neurological Institute · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPosterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)Lumbar or cervical fusion

Timeline

Start date
2011-07-01
Primary completion
2018-05-16
Completion
2018-05-16
First posted
2011-08-01
Last updated
2019-02-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01406405. Inclusion in this directory is not an endorsement.