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ABSTRACT: Background
Reherniation rates following lumbar discectomy are low for most patients; however, patients with a large defect in the annulus fibrosis have a significantly higher risk of recurrence. Previous results from a randomized controlled trial (RCT) demonstrated that the implantation of a bone-anchored annular closure device (ACD) during discectomy surgery lowered the risk of symptomatic reherniation and reoperation over one year with fewer serious adverse events (SAEs) compared to discectomy alone.Objective
The objective of this prospective, post-market, historically controlled study was to evaluate the use of an ACD during discectomy, and to confirm the results of the RCT that was used to establish regulatory approval in the United States.Methods
In this post-m
SUBMITTER: Nunley P
PROVIDER: S-EPMC10263173 | biostudies-literature | 2023 Jun
REPOSITORIES: biostudies-literature