A Comparison of Stryker's Tritanium Posterior Lumbar Cage and PEEK Implant
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|ClinicalTrials.gov Identifier: NCT03817606|
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : June 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Disc Disease Degenerative Scoliosis||Device: Tritanium Posterior Lumbar Cage Device: AVS UniLIF PEEK Posterior Lumbar Cage||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel randomized controlled trial|
|Masking Description:||Study participants will not know which posterior lumbar cage they receive.|
|Official Title:||A Comparison of Stryker's Tritanium Posterior Lumbar Cage and PEEK Implant on Spinal Fusion in Patients With Degenerative Disc Disease|
|Actual Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||February 28, 2021|
|Estimated Study Completion Date :||April 1, 2021|
Experimental: Tritanium Posterior Lumbar Cage
Surgical placement of the Tritanium Posterior Lumbar Cage
Device: Tritanium Posterior Lumbar Cage
Placement of Tritanium Posterior Lumbar Cage via TLIF procedure
Active Comparator: AVS PEEK UniLIF
Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage
Device: AVS UniLIF PEEK Posterior Lumbar Cage
Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.
- Number of Participants with Fusion Success [ Time Frame: 12 Months ]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
- Change in Visual Analogue Scale [ Time Frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation ]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.
- Change in Low Back Function [ Time Frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation ]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).
- Change in Quality of Life: SF-36 PCS [ Time Frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation. ]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).
- Number of Participants that return to Work [ Time Frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation ]Subjects who were unable to work due to their back pain who return to work.
- Ambulatory Status [ Time Frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation ]Amount of time to full ambulation without assistance for study participants who had no or partial ambulation at baseline.
- Number of Participants with Serious Adverse Events [ Time Frame: 6 weeks; 3 months; 6 months; and 12 months post operation ]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
- Change in Quality of Life: EQ-5d [ Time Frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817606
|Contact: Joseph Hanks||815-935-7256 ext 6151||jhanks@RHC.net|
|Contact: Juan Jimenez, MD||(815) 932-7200||jjimenez@RHC.net|
|Study Director:||Lisa Zipsie||Riverside Medical Center|