The purpose of this study is to compare outcomes of patients with degenerative disc disease undergo lumbar spinal fusion with Stryker's Tritanium® Posterior Lumbar Cage or the UniLIF PEEK implant.
This study protocol intends to examine the difference in efficacy between the Tritanium Posterior Lumbar Cage and the UniLIF PEEK implant with respect to how long it takes to achieve fusion of the spine. Study participants will undergo a transforaminal lumbar interbody fusion (TLIF) surgery and return for CT and x-ray follow-up to measure the degree to which fusion has been achieved. Survey methodology to assess perceived pain, level of disability, and quality of life will also be used to measure the differences between groups on these components.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
4
Placement of Tritanium Posterior Lumbar Cage via TLIF procedure
Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.
Riverside Medical Center
Kankakee, Illinois, United States
Number of Participants With Fusion Success
CT and X-ray imaging will be obtained at study visits and Fusion Success will be defined by the following criteria: no lucent area around the implant; no presences of herniated disk, central stenosis, lateral recess stenosis, foraminal stenosis, facet anthropathy; no fracture of the device, graft or vertebra; visible bone formation in or about the graft material; less than 3 degrees of inter-segmental position change on flexion and extension views; presence of subsidence: a migration of more than 3mm into the adjacent vertebra; and the proportion of bridging bone visually estimated over the surface area of the joint
Time frame: 12 Months
Change in Visual Analogue Scale
Change in low back pain as indicated by Visual Analogue Scale (VAS). The VAS measures subjects' self-reported pain level on a 100 mm line on which the subject indicates their level of pain, where 0 is no pain and 100 is worst imaginable pain.
Time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Change in Low Back Function
Change in Oswestry Disability Index (ODI) score. The ODI assesses disability related to lower back pain using a Likert 0 to 5 scale. There are 10 sections to the assessment, and the scores are represented as a percentage ranging from 0 (no disability) to 100 (completely disabled).
Time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Change in Quality of Life: SF-36 PCS
Change in perception of quality of life, as measured by Short Form 36 Health Survey (SF-36 PCS). The SF-36 PCS is a 36-item patient reported health questionnaire to measure perceived quality of life across 8 domains. Higher scores indicate higher quality of life, and lower scores indicate lower quality of life. Scores range from 5 (poor physical function) to 80 (excellent clinical function).
Time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of Participants That Return to Work
Subjects who were unable to work due to their back pain who return to work.
Time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Ambulatory Status
Amount of time to full ambulation without assistance for study participants who had no or partial ambulation at baseline.
Time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Number of Participants With Serious Adverse Events
Any event meeting the Serious Adverse Event reporting criteria detailed in the study protocol occurring at the following time intervals: TLIF procedure, hospital recovery and discharge, and 6 weeks-, 3 months-, 6 months- and 12 months post operation
Time frame: 6 weeks; 3 months; 6 months; and 12 months post operation
Change in Quality of Life: EQ-5d
Change in perception of quality of life, as measured by the EuroQol-5d (EQ-5d). The EuroQol-5d is a five question broad quality of life measure that can be combined into a single index and represents current health. A score of 0.0 is the worst imaginable health while a score of 1.0 would be the best imaginable health.
Time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation