Condition: Degenerative Instability · Spondylolisthesis · Post-discectomy Syndrome · Sponsor: Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd.
The primary objective of this study is to confirm superiority for the efficacy of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion compared to state-of-the-art. The secondary objective of the study is to evaluate further efficacy and safety of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion with the following secondary efficacy and safety objectives: * To evaluate if implantation causes significant reduction in patient's back, hip/buttock, and leg pain. * To evaluate if implantation causes significant increase quality of life of the patients. * To evaluate if using the device can be considered as safe overall.
This description comes directly from the study's public registry record.
Bálint Kozma · +3630 6861784 · bkozma@sanatmetal.hu
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| National Center for Spinal Disorders | Budapest, Pest County, Hungary | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06265038