Condition: Spondylolisthesis, Lumbar Region · Spinal Trauma With Neurological Deficit · Degeneration of Lumbar Intervertebral Disc · Sponsor: Nitin Agarwal
The Viper Prime/Expedium spine systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracolumbar and sacral spine. The Fibergraft Bioactive Glass (BG) is engineered to mimic the body's natural bone healing process. While previous studies have compared the use of Viper prime/Expedium spine system in minimally invasive and open surgeries, these studies did not specifically study the clinical and radiographic outcomes of patients who have received these implants in addition to Fibergraft. We aim to recruit patients with degenerative disc disease, spondylolisthesis, trauma, and/or pseudarthrosis who require spine surgery under standard of care and use these implants. We will then follow these patients for a duration of two years to report their clinical and radiographic outcomes to determine fusion, complication rate, and revision surgeries if any.
This description comes directly from the study's public registry record.
Nitin Agarwal, MD · 9085311947 · nitin.agarwal@upmc.edu
Rida Mitha, MD · 3147327092 · mithar@upmc.edu
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| University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06704906