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Adisa Kuršumović, Stefan A Rath Department of Neurosurgery, Spinal Surgery and Interventional Neuroradiology, Donauisar Klinikum Deggendorf, Deggendorf, Germany Purpose: Increased focus has been put on the use of “‘real-world” data to support randomized clinical trial (RCT) evidence for clinical decision-making. The objective of this study was to assess the performance of an annular closure device (ACD) after stratifying a consecutive series of “real-world” patients by the screening criteria of an ongoing RCT. Materials and methods: This was a single-center registry analysis of 164 subjects who underwent limited discectomy combined with ACD for symptomatic lumbar disc herniation. Patients were stratified into two groups using the selection criteria of a pivotal RCT on the same device: Trial (met inclusion; n=44) or non-Trial (did not meet inclusion; n=120). Patient-reported outcomes, including Oswestry Disability Index (ODI) and visual analog scale (VAS) for leg and back pain, and adverse events were collected from baseline to last follow-up (mean: Trial – 15.6 months; non-Trial – 14.6 months). Statistical analyses were performed with significance set at p |
