Nanotube Surface Architecture Versus Simple Titanium Coating on PEEK Interbody Cages in Adults Undergoing 1- and 2-Level Transforaminal Lumbar Interbody Fusion: A Randomized Controlled Superiority Trial
Francis Farhadi
Summary
This study is comparing two FDA-approved cages used during lower back surgery. The study will look at whether one cage helps the bones in the back fuse together better than the other. Adults who are having a 1 or 2 level lumbar fusion surgery will be randomly assigned to receive either the Adaptix nanoPEEK cage or the Capstone PTC cage. Participants will have follow-up visits with imaging and questionnaires to evaluate bone fusion, back and leg pain, physical function, and overall health.
Description
This study is a single-center, single-blind, randomized controlled superiority trial at the University of Kentucky. The study will enroll adults who are undergoing a 1 or 2 level transforaminal lumbar interbody fusion (TLIF) for degenerative disc disease. Participants will be randomly assigned in a 1:1 ratio to receive either the Adaptix nanoPEEK cage or the Capstone PTC cage during their lumbar fusion surgery. Both cages are FDA-Approved and are used as part of the standard-of-care lumbar fusion surgery. The study is comparing the outcomes of the two cages to determine whether one results in…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subject is scheduled to undergo 1- or 2-level TLIF with the principal investigator. * Subject has failed nonoperative management for a minimum of 3 months prior to enrollment. * Diagnosis is degenerative disc disease (DDD), defined as discogenic back pain with disc degeneration confirmed by history and radiographic studies, at 1 or 2 contiguous spinal levels from L2 to S1. Subjects may have up to grade 1-2 spondylolisthesis or retrolisthesis at the index level(s). * Subject is able to provide written informed consent. * Subject is, in the investigator's opinion, psychoso…
Interventions
- DeviceAdaptix nanoPEEK Cage
FDA- approved interbody cage used during lumbar fusion surgery.
- DeviceCapstone PTC Cage
FDA- approved interbody cage used during lumbar fusion surgery.
Location
- University of KentuckyLexington, Kentucky