Lumbar Spondylolisthesis, Lumbar Stenosis, Spine Fusion
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICETitanium Fusion Device
Titanium fusion device will be utilized for one-level lumbar fusion.
DEVICEPEEK Fusion Device
PEEK fusion device will be utilized for one-level lumbar fusion.
Sponsors
Twin Cities Spine Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Subjects will be blinded to fusion device.
Intervention model description
Prospective randomized clinical trial with two cohorts.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fusion Status of 1 level Lumbar TLIF | 12 months Post-Op | Assess fusion status of 1 level Lumbar TLIF by reviewing patient CT Scan completed for study purposes. |
| Revision Surgeries | Up to 24 months Post-op | Monitor and Record Complications and Revision Surgeries |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcome Measures | Preoperative time frame up to 24 months Post-op | Data collected from patient self reported outcome tools |
Countries
United States
Outcome results
None listed