Clinical Trial Finder

Titanium vs. PEEK Fusion Devices in 1 Level TLIF

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria. 1. Patients undergoing 1 level TLIF for the treatment of lumbar stenosis and spondylolisthesis who have failed at least 6 weeks of non-operative treatment. 2. Patients between 18-70 years of age at the time of surgery. Exclusion Criteria. 1. Patients under 18 or over 70 years of age at the time of surgery. 2. Patients undergoing more than 1 level of surgery. 3. Patients who have had prior lumbar fusion. 4. Patients requiring surgery for the management of infection, tumor, or trauma. 5. Patients who are pregnant.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05691062
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Twin Cities Spine Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Spine Fusion, Lumbar Spondylolisthesis, Lumbar Stenosis
Additional Details

Transforaminal lumbar interbody fusion (TLIF) remains a common surgical technique for the management of lumbar spondylosis requiring decompression and fusion. The choice of interbody spacer remains dependent on surgeon preference with a variety of options available for use. Two of the most commonly used interbody spacers are made of polyetheretherketone (PEEK) and titanium.1 While both spacers have produced reliable rates of fusion with good clinical outcomes, debate remains as to which interbody spacer is superior. Proponents of PEEK argue that it is radiolucent and has an elastic modulus similar to bone thus decreasing rates of subsidence. However, PEEK is a hydrophobic material that does not integrate with bone. Titanium on the other hand demonstrates osseointegration and may lead to increased rates of fusion.While there are retrospective studies available comparing the two materials, the studies are small and there is a paucity of prospective data comparing the radiographic and clinical outcomes of these spacers. Given the frequency with which these spacers are used, it is important to determine which spacer produces better clinical and radiographic outcomes for patients.

Arms & Interventions

Arms

Experimental: PEEK

Medtronic Capstone

Experimental: Titanium

Medtronic Adaptix

Interventions

Device: - Titanium Fusion Device

Titanium fusion device will be utilized for one-level lumbar fusion.

Device: - PEEK Fusion Device

PEEK fusion device will be utilized for one-level lumbar fusion.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Twin Cities Spine Center, Minneapolis, Minnesota

Status

Address

Twin Cities Spine Center

Minneapolis, Minnesota, 55404

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