Titanium vs. PEEK Devices for Spinal Fusion
(TLIF Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the PEEK and Titanium Fusion Devices for spinal fusion treatment?
Research shows that PEEK devices have advantages like being more similar to bone and causing fewer imaging issues, while titanium-coated PEEK devices may lead to better early fusion rates and pain reduction. Both materials have been used successfully in spinal surgeries with low rejection rates.12345
Is it safe to use Titanium and PEEK devices for spinal fusion in humans?
How do PEEK and Titanium devices for spinal fusion differ from other treatments?
PEEK devices are unique because they have a density similar to bone, are radiolucent (allowing X-rays to pass through), and do not cause artifacts in CT and MRI scans, unlike titanium. Titanium devices, while strong, can be too stiff, potentially leading to stress shielding, whereas PEEK offers a more flexible alternative that may reduce this risk.12789
What is the purpose of this trial?
The objective of this study is to evaluate and follow the clinical and radiographic outcomes of patients undergoing 1 level TLIF randomized to either a titanium or a PEEK spacer to 24 months after surgery.
Eligibility Criteria
This trial is for adults aged 18-70 who need a single-level spinal fusion (TLIF) to treat lumbar stenosis and spondylolisthesis, after not improving with at least 6 weeks of non-surgical care. It's not open to those who've had previous lumbar fusions, are pregnant, or need surgery due to infection, tumors, or trauma.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Initial Recovery
Participants undergo 1 level TLIF surgery with either a titanium or PEEK spacer
Follow-up
Participants are monitored for safety and effectiveness, including fusion status and complications
Treatment Details
Interventions
- PEEK Fusion Device
- Titanium Fusion Device
Find a Clinic Near You
Who Is Running the Clinical Trial?
Twin Cities Spine Center
Lead Sponsor