Lumbar Fusion With Porous Versus Non-Porous Cages

Spondylolisthesis Clinical Trial

Official title: Lumbar Fusion With Porous Titanium Versus Non-Porous Titanium-Coated PEEK Interbody Cages - A Randomized Controlled Trial

Status Recruiting

Clinical Trial Summary

The objective of this single site, randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo lumbar interbody fusion procedures (TLIF), supplemented with pedicle screw instrumentation, using one of the following interventions:

1. Porous titanium cages

2. Non-porous titanium-coated poly-ether-ether-ketone (PEEK) cages.

Clinical Trial Description

This single-center randomized controlled trial will prospectively evaluate the safety and efficacy of porous titanium cages supplemented with a pedicle screw system as compared to titanium-coated PEEK cages currently used in routine fashion for lumbar interbody fusion procedures.

These cages are FDA approved and the study is designed to compare the outcomes of subjects receiving either implant. This study will capture clinical and radiographic outcomes on patients up to 2 years post-operatively. Both cages will be used in conjunction with milled local autograft bone generated as part of the spinal fusion procedure (no iliac crest autograft will be utilized).

This study will enroll a maximum of 108 subjects (approximately n = 54 per group), with subjects followed for a minimum of 12 months post-surgery. A total cage sample size of 108 cages (n = 54 cages per group) was calculated with a power of 80% (alpha =0.05) and based on the assumption that 55% of cages in the titanium-coated PEEK group would achieve a solid fusion by 6 months, as compared to 80% in the porous titanium group. Up to two cages may be placed in a single subject. Therefore, it is possible that the maximum number of human subjects would be 54 if all are multi-level procedures. Since there are always mixtures of single and multi-level procedures, the actual number of subjects will be closer to 80, with a maximum ceiling of 108.

These assumptions are based on prior imaging findings in patients undergoing TLIF procedures using these cages. An interim analysis is planned once, at minimum, half of the cage accrual is met. In the case early findings show a statistical difference in the primary outcome between the two cages, enrollment will be allowed to cease as investigators are unlikely to maintain clinical equipoise to continue randomizing patients. Conversely, if the interim analysis suggests that statistical significance is unlikely, the investigators will be allowed to choose to close the trial early for futility.

Randomization will occur in 4 and 6 subject blocks to ensure comparability and enhance blinding for this sample size. Subjects will be further stratified for smoking due to the significant risk it places on successful fusion outcomes. ;

Related Conditions & MeSH terms

• Arthrodesis
• Lumbar Fusion
• Pseudarthrosis
• Spinal Fusion
• Spondylolisthesis

• NCT number: NCT05583864
• Study type: Interventional
• Source: University of Kentucky
• Contact: Francis Farhadi, MD, PhD
• Phone: 859-323-5661
• Email: francis.farhadi@uky.edu
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Completion date: May 2026