Bone-anchored annular closure following lumbar discectomy reduces risk of complications and reoperations within 90 days of discharge
Authors Klassen PD, Bernstein DT, Köhler HP, Arts MP, Weiner B, Miller LE, Thomé C
Received 21 June 2017
Accepted for publication 1 August 2017
Published 26 August 2017 Volume 2017:10 Pages 2047—2055
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Colin Mak
Peer reviewer comments 2
Editor who approved publication: Professor Michael Schatman
Peter Douglas Klassen,1 Derek Thomas Bernstein,2 Hans-Peter Köhler,3 Mark P Arts,4 Bradley Weiner,2 Larry E Miller,5 Claudius Thomé6
On behalf of the Annular Closure RCT Study Group
1Department of Neurosurgery, St. Bonifatius Hospital, Lingen, Germany; 2Department of Orthopaedic Surgery, Methodist Hospital, Houston, TX, USA; 3Department of Neurosurgery, Asklepios Westklinikum Hamburg, Hamburg, Germany; 4Department of Neurosurgery, Haaglanden Medical Center, The Hague, The Netherlands; 5Miller Scientific Consulting, Inc., Asheville, NC, USA; 6Department of Neurosurgery, Medical University Innsbruck, Innsbruck, Austria
Purpose: The purpose of this study was to evaluate perioperative complications of lumbar discectomy with or without bone-anchored annular closure device (ACD) implant in patients at high risk of recurrent disc herniation.
Methods: This was a post hoc analysis of a randomized controlled trial that compared outcomes of lumbar discectomy with or without additional placement of an ACD. Patients presented with imaging evidence of lumbar disc herniation and radicular pain that was unresponsive to conservative care. Randomization occurred intraoperatively following discectomy completion and confirmation of annular defect width ≥6 mm. Main outcomes included serious adverse events (SAEs) from any cause, device- or procedure-related SAEs, and reoperations at the index level. The perioperative period included all outcomes occurring between the day of surgery and 90 days following hospital discharge.
Results: Analyses were performed on a modified intention-to-treat population consisting of 272 patients treated with ACD and 278 patients treated with lumbar discectomy only (controls). Mean patient age was 44 years, 59% were men, and mean body mass index was 26 kg/m2. Baseline patient characteristics and operative outcomes were comparable between groups. The risks of all-cause SAE (9.7% vs 16.3%, p=0.056), device- or procedure-related SAE (4.5% vs 10.2%, p=0.02), and index-level reoperation (1.9% vs 5.4%, p=0.03) were lower with ACD vs controls. In multivariable logistic regression, control group assignment and female gender were independently associated with higher risk of device- or procedure-related SAE and index-level reoperation, respectively.
Conclusion: In patients undergoing lumbar discectomy to treat symptomatic intervertebral disc herniation, adjunctive placement of an ACD reduces the risk for perioperative complications occurring through 90 days following hospital discharge.
Keywords: annular closure, complications, herniation, lumbar discectomy, randomized controlled trial, reoperation
Corrigendum for this paper has been published
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