Effectiveness of an Annular Closure Device to Prevent Recurrent Lumbar Disc Herniation: A Secondary Analysis with 5 Years of Follow-up
| Autor: | Thomé, Claudius, Kuršumović, Adisa, Klassen, Peter Douglas, Bouma, Gerrit J., Bostelmann, Richard, Martens, Frederic, Barth, Martin, Arts, Mark, Miller, Larry E., Vajkoczy, Peter, Hes, Robert, Eustacchio, Sandro, Nanda, Dharmin, Köhler, Hans-Peter, Brenke, Christopher, Flüh, Charlotte, van de Kelft, Erik, Assaker, Richard, Kienzler, Jenny C., Fandino, Javier |
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| Přispěvatelé: | Neurosurgery, ANS - Neurovascular Disorders, Annular Closure RCT Study Group |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: | |
| Zdroj: | JAMA network open, 4(12):e2136809. American Medical Association JAMA Network Open |
| ISSN: | 2574-3805 |
| Popis: | Importance: Patients with large annular defects following lumbar microdiscectomy for disc herniation are at increased risk for symptomatic recurrence and reoperation. Objective: To determine whether a bone-anchored annular closure device in addition to lumbar microdiscectomy resulted in lower reherniation and reoperation rates vs lumbar microdiscectomy alone. Design, Setting, and Participants: This secondary analysis of a multicenter randomized clinical trial reports 5-year follow-up for enrolled patients between December 2010 and October 2014 at 21 clinical sites. Patients in this study had a large annular defect (6-10 mm width) following lumbar microdiscectomy for treatment of lumbar disc herniation. Statistical analysis was performed from November to December 2020. Interventions: Lumbar microdiscectomy with additional bone-anchored annular closure device (device group) or lumbar microdiscectomy only (control group). Main Outcomes and Measures: The incidence of symptomatic reherniation, reoperation, and adverse events as well as changes in leg pain, Oswestry Disability Index, and health-related quality of life when comparing the device and control groups over 5 years of follow-up. Results: Among 554 randomized participants (mean [SD] age: 43 [11] years; 327 [59%] were men), 550 were included in the modified intent-to-treat efficacy population (device group: n = 272; 270 [99%] were White); control group: n = 278; 273 [98%] were White) and 550 were included in the as-treated safety population (device group: n = 267; control group: n = 283). The risk of symptomatic reherniation (18.8% [SE, 2.5%] vs 31.6% [SE, 2.9%]; P |
| Databáze: | OpenAIRE |
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