NCT03817606

A Comparison of Stryker's Tritanium Posterior Lumbar Cage and PEEK Implant

A Comparison of Stryker's Tritanium Posterior Lumbar Cage and PEEK Implant on Spinal Fusion in Patients With Degenerative Disc Disease

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Riverside Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare outcomes of patients with degenerative disc disease undergo lumbar spinal fusion with Stryker's Tritanium® Posterior Lumbar Cage or the UniLIF PEEK implant.

Detailed description

This study protocol intends to examine the difference in efficacy between the Tritanium Posterior Lumbar Cage and the UniLIF PEEK implant with respect to how long it takes to achieve fusion of the spine. Study participants will undergo a transforaminal lumbar interbody fusion (TLIF) surgery and return for CT and x-ray follow-up to measure the degree to which fusion has been achieved. Survey methodology to assess perceived pain, level of disability, and quality of life will also be used to measure the differences between groups on these components.

Conditions

• Degenerative Disc Disease
• Degenerative Scoliosis

Interventions

Type	Name	Description
DEVICE	Tritanium Posterior Lumbar Cage	Placement of Tritanium Posterior Lumbar Cage via TLIF procedure
DEVICE	AVS UniLIF PEEK Posterior Lumbar Cage	Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-06-30
• Completion: 2021-04-27
• First posted: 2019-01-25
• Last updated: 2023-01-10
• Results posted: 2021-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study