Ardeshir Ardeshiri1, Larry E Miller2, Claudius Thomé3. 1. Section for Spine Surgery, Klinikum Itzehoe, Robert-Koch-Str. 2, 25524, Itzehoe, Germany. aardeshiri@aol.com. 2. Miller Scientific Consulting, Inc., 1854 Hendersonville Road, #231, Asheville, NC, USA. 3. Department for Neurosurgery, Medical University Innsbruck, Anichstraße 35, 6020, Innsbruck, Austria.
Abstract
PURPOSE: To determine the safety and effectiveness of limited lumbar discectomy with additional implantation of an annular closure device (ACD) among patients at high risk of herniation recurrence treated in routine clinical practice. METHODS: This was a prospective, single-center study of lumbar discectomy for sciatica caused by intervertebral disc herniation with adjunctive ACD implantation to reduce herniation recurrence risk among high-risk patients with large annular defects. Patients returned for follow-up visits at 6 weeks, 12 weeks, 26 weeks, 1 year, and 2 years. Main outcomes included reoperation, herniation recurrence, back pain severity, leg pain severity, and Oswestry Disability Index (ODI). The minimum important difference was defined as ≥ 20 mm decrease relative to baseline for leg pain severity, ≥ 20 mm decrease for back pain severity, and ≥ 15-point decrease for ODI. RESULTS: Among 75 high-risk patients (mean age 45 years, 59% female), the cumulative event incidence through 2 years was 4.0% for reoperation and 1.4% for herniation recurrence. Mean leg pain severity decreased from 73 to 6 (p < 0.001), back pain severity decreased from 51 to 13 (p < 0.001), and ODI decreased from 49 to 7 (p < 0.001). The percentage of patients achieving the minimum important difference was 91% for leg pain, 65% for back pain, and 94% for ODI. CONCLUSION: In patients at high risk of herniation recurrence following limited lumbar discectomy in routine clinical practice, additional implantation of an ACD was safe and reherniation recurrence rates were low at 2-year follow-up, which is favorably compared to reported rates in high-risk patients.
PURPOSE: To determine the safety and effectiveness of limited lumbar discectomy with additional implantation of an annular closure device (ACD) among patients at high risk of herniation recurrence treated in routine clinical practice. METHODS: This was a prospective, single-center study of lumbar discectomy for sciatica caused by intervertebral disc herniation with adjunctive ACD implantation to reduce herniation recurrence risk among high-risk patients with large annular defects. Patients returned for follow-up visits at 6 weeks, 12 weeks, 26 weeks, 1 year, and 2 years. Main outcomes included reoperation, herniation recurrence, back pain severity, leg pain severity, and Oswestry Disability Index (ODI). The minimum important difference was defined as ≥ 20 mm decrease relative to baseline for leg pain severity, ≥ 20 mm decrease for back pain severity, and ≥ 15-point decrease for ODI. RESULTS: Among 75 high-risk patients (mean age 45 years, 59% female), the cumulative event incidence through 2 years was 4.0% for reoperation and 1.4% for herniation recurrence. Mean leg pain severity decreased from 73 to 6 (p < 0.001), back pain severity decreased from 51 to 13 (p < 0.001), and ODI decreased from 49 to 7 (p < 0.001). The percentage of patients achieving the minimum important difference was 91% for leg pain, 65% for back pain, and 94% for ODI. CONCLUSION: In patients at high risk of herniation recurrence following limited lumbar discectomy in routine clinical practice, additional implantation of an ACD was safe and reherniation recurrence rates were low at 2-year follow-up, which is favorably compared to reported rates in high-risk patients.
Authors: Claudius Thomé; Peter Douglas Klassen; Gerrit Joan Bouma; Adisa Kuršumović; Javier Fandino; Martin Barth; Mark Arts; Wimar van den Brink; Richard Bostelmann; Aldemar Hegewald; Volkmar Heidecke; Peter Vajkoczy; Susanne Fröhlich; Jasper Wolfs; Richard Assaker; Erik Van de Kelft; Hans-Peter Köhler; Senol Jadik; Sandro Eustacchio; Robert Hes; Frederic Martens Journal: Spine J Date: 2018-05-03 Impact factor: 4.166
Authors: Johannes L Bron; Albert J van der Veen; Marco N Helder; Barend J van Royen; Theodoor H Smit Journal: Eur Spine J Date: 2010-04-17 Impact factor: 3.134
Authors: Wilco C Peul; Hans C van Houwelingen; Wilbert B van den Hout; Ronald Brand; Just A H Eekhof; Joseph T J Tans; Ralph T W M Thomeer; Bart W Koes Journal: N Engl J Med Date: 2007-05-31 Impact factor: 91.245