Clinical Trials Logo

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. ;


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Recruiting NCT03883022 - Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery N/A
Active, not recruiting NCT04542577 - PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D
Recruiting NCT04477447 - PMCF Study on the Safety and Performance of CESPACE 3D
Completed NCT02558621 - New Robotic Assistance System for Spinal Fusion Surgery N/A
Terminated NCT01461005 - A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS) N/A
Completed NCT00405691 - Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis Phase 3
Completed NCT00205101 - Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion
Enrolling by invitation NCT04204135 - The Course of Hip Flexion Weakness Following LLIF or ALIF
Recruiting NCT05238740 - Comparison of Standalone Anterior Lumbar Interbody Fusion (ALIF) L5/S1 Performed With Either rhBMP-2 or ViviGen® N/A
Not yet recruiting NCT02805985 - Post-market Surveillance Study of FLXfit™ TLIF Interbody Fusion Device N/A
Completed NCT02966639 - Validation of Appropriateness Criteria for the Surgical Treatment of Lumbar Degenerative Spondylolisthesis
Completed NCT02931279 - PASS OCT® Post-market Clinical Follow-up
Active, not recruiting NCT02057744 - MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries
Completed NCT01711203 - The Addition of a Pilates Program for Short-Term Improvements in Patients With Spondylolysis or Spondylolisthesis N/A
Completed NCT00549913 - Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF) Phase 1/Phase 2
Terminated NCT00254852 - Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft N/A
Terminated NCT00095095 - Lumbar Interbody Fusion Using the Telamon® Peek™ Versus the Telamon® Hydrosorb™ Fusion Device Phase 4
Active, not recruiting NCT03956537 - PMCF Neo Pedicle Screw and Cage Systems
Recruiting NCT05182489 - Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages N/A
Completed NCT02884440 - Transverse Abdominis Plane Block for Anterior Approach Spine Surgery Phase 2