Claudius Thomé1, Peter Douglas Klassen2, Gerrit Joan Bouma3, Adisa Kuršumović4, Javier Fandino5, Martin Barth6, Mark Arts7, Wimar van den Brink8, Richard Bostelmann9, Aldemar Hegewald10, Volkmar Heidecke11, Peter Vajkoczy12, Susanne Fröhlich13, Jasper Wolfs14, Richard Assaker15, Erik Van de Kelft16, Hans-Peter Köhler17, Senol Jadik18, Sandro Eustacchio19, Robert Hes20, Frederic Martens21. 1. Department of Neurosurgery, Medical University Innsbruck, Anichstrasse 35, A-6020, Innsbruck, Austria. Electronic address: claudius.thome@tirol-kliniken.at. 2. Department of Neurosurgery, St. Bonifatius Hospital, Wilhelmstrasse 13, 49808, Lingen, Germany. 3. Department of Neurosurgery, OLVG-West and Academic Medical Center, Jan Tooropstraat 164, 1006 AE, Amsterdam, The Netherlands. 4. Department of Neurosurgery, Donauisar Klinikum Deggendorf, Perlasbergerstrasse 41, 94469, Deggendorf, Germany. 5. Department of Neurosurgery, Kantonsspital Aarau, Tellstrasse 25, CH-5001, Aarau, Switzerland. 6. Department of Neurosurgery, University Hospital Bochum, In der Schornau 23-25, D-44892, Bochum, Germany. 7. Department of Neurosurgery, MCH Antoniushove, Albinusdreef 2, 2333 ZA Leiden, The Hague, The Netherlands. 8. Neurochirurgisch Centrum Zwolle, Isala Ziekenhuis, Location Sophia P2.25, Dr van Heesweg 2, 8025 AB, Zwolle, The Netherlands. 9. Department of Neurosurgery, University Hospital Düsseldorf, Moorenstrasse 5, House 13.71, D-40225, Düsseldorf, Germany. 10. Department of Neurosurgery, Universitätsmedizin Mannheim, Theodore-Kutzer-Ufer 1-3, 68167, Mannheim, Germany. 11. Department of Neurosurgery, Klinikum Augsburg, Stegelinstrasse 2, 86156, Augsburg, Germany. 12. Department of Neurosurgery, Charité Universitätsmedizin, Augustenburger Platz 1, 13353, Berlin, Germany. 13. Department of Orthopedics, Universität Rostock, Doberaner Str. 142, 18055, Rostock, Germany. 14. Department of Neurosurgery, MCH Westenide, Albinusdreef 2, 2333 ZA Leiden, The Hague, The Netherlands. 15. Department of Neurosurgery, Centre Hospitalier Régional Universitaire de Lille, 2 Avenue Oscar Lambret, 59000, Lille, France. 16. Department of Neurosurgery, AZ Nikolaas, Moerlandstraat 1, B-9100, Sint-Niklaas, Belgium. 17. Department of Neurosurgery, Asklepios Westklinikum Hamburg, Suurheid 20, D-22559, Hamburg, Germany. 18. Department of Neurosurgery, University Hospital Kiel, University Medical Center Schleswig-Holstein, Arnold-Heller-Str. 3, Haus 41, 24105, Kiel, Germany. 19. Department of Neurosurgery, LKH University Klinikum Graz, Auenbrugggerplatz 1, 8036, Graz, Austria. 20. Department of Neurosurgery, AZ Klina, Augustijnslei 100, 2930, Brasschaat, Belgium. 21. Department of Neurosurgery, OLV Ziekenhuis, Moorselbaan 164, 9300, Aalst, Belgium.
Abstract
BACKGROUND CONTEXT: Patients with large annular defects after lumbar discectomy for disc herniation are at high risk of symptomatic recurrence and reoperation. PURPOSE: The present study aimed to determine whether a bone-anchored annular closure device, in addition to lumbar microdiscectomy, resulted in lower reherniation and reoperation rates plus increased overall success compared with lumbar microdiscectomy alone. DESIGN: This is a multicenter, randomized superiority study. PATIENT SAMPLE: Patients with symptoms of lumbar disc herniation for at least 6 weeks with a large annular defect (6-10 mm width) after lumbar microdiscectomy were included in the study. OUTCOME MEASURES: The co-primary end points determined a priori were recurrent herniation and a composite end point consisting of patient-reported, radiographic, and clinical outcomes. Study success required superiority of annular closure on both end points at 2-year follow-up. METHODS: Patients received lumbar microdiscectomy with additional bone-anchored annular closure device (n=276 participants) or lumbar microdiscectomy only (control; n=278 participants). This research was supported by Intrinsic Therapeutics. Two authors received study-specific support morethan $10,000 per year, 8 authors received study-specific support less than $10,000 per year, and 11 authors received no study-specific support. RESULTS: Among 554 randomized participants, 550 (annular closure device: n=272; control: n=278) were included in the modified intent-to-treat efficacy analysis and 550 (annular closure device: n=267; control: n=283) were included in the as-treated safety analysis. Both co-primary end points of the study were met, with recurrent herniation (50% vs. 70%, P<.001) and composite end point success (27% vs. 18%, P=.02) favoring annular closure device. The frequency of symptomatic reherniation was lower with annular closure device (12% vs. 25%, P<.001). There were 29 reoperations in 24 patients in the annular closure device group and 61 reoperations in 45 control patients. The frequency of reoperations to address recurrent herniation was 5% with annular closure device and 13% in controls (P=.001). End plate changes were more prevalent in the annular closure device group (84% vs. 30%, P<.001). Scores for back pain, leg pain, Oswestry Disability Index, and health-related quality of life at regular visits were comparable between groups over 2-year follow-up. CONCLUSIONS: In patients at high risk of herniation recurrence after lumbar microdiscectomy, annular closure with a bone-anchored implant lowers the risk of symptomatic recurrence and reoperation. Additional study to determine outcomes beyond 2 years with a bone-anchored annular closure device is warranted.
RCT Entities:
BACKGROUND CONTEXT: Patients with large annular defects after lumbar discectomy for disc herniation are at high risk of symptomatic recurrence and reoperation. PURPOSE: The present study aimed to determine whether a bone-anchored annular closure device, in addition to lumbar microdiscectomy, resulted in lower reherniation and reoperation rates plus increased overall success compared with lumbar microdiscectomy alone. DESIGN: This is a multicenter, randomized superiority study. PATIENT SAMPLE: Patients with symptoms of lumbar disc herniation for at least 6 weeks with a large annular defect (6-10 mm width) after lumbar microdiscectomy were included in the study. OUTCOME MEASURES: The co-primary end points determined a priori were recurrent herniation and a composite end point consisting of patient-reported, radiographic, and clinical outcomes. Study success required superiority of annular closure on both end points at 2-year follow-up. METHODS:Patients received lumbar microdiscectomy with additional bone-anchored annular closure device (n=276 participants) or lumbar microdiscectomy only (control; n=278 participants). This research was supported by Intrinsic Therapeutics. Two authors received study-specific support morethan $10,000 per year, 8 authors received study-specific support less than $10,000 per year, and 11 authors received no study-specific support. RESULTS: Among 554 randomized participants, 550 (annular closure device: n=272; control: n=278) were included in the modified intent-to-treat efficacy analysis and 550 (annular closure device: n=267; control: n=283) were included in the as-treated safety analysis. Both co-primary end points of the study were met, with recurrent herniation (50% vs. 70%, P<.001) and composite end point success (27% vs. 18%, P=.02) favoring annular closure device. The frequency of symptomatic reherniation was lower with annular closure device (12% vs. 25%, P<.001). There were 29 reoperations in 24 patients in the annular closure device group and 61 reoperations in 45 control patients. The frequency of reoperations to address recurrent herniation was 5% with annular closure device and 13% in controls (P=.001). End plate changes were more prevalent in the annular closure device group (84% vs. 30%, P<.001). Scores for back pain, leg pain, Oswestry Disability Index, and health-related quality of life at regular visits were comparable between groups over 2-year follow-up. CONCLUSIONS: In patients at high risk of herniation recurrence after lumbar microdiscectomy, annular closure with a bone-anchored implant lowers the risk of symptomatic recurrence and reoperation. Additional study to determine outcomes beyond 2 years with a bone-anchored annular closure device is warranted.
Authors: Jenny C Kienzler; Javier Fandino; Erik Van de Kelft; Sandro Eustacchio; Gerrit Joan Bouma Journal: Acta Neurochir (Wien) Date: 2021-03-26 Impact factor: 2.216
Authors: Garrett K Harada; Zakariah K Siyaji; G Michael Mallow; Alexander L Hornung; Fayyazul Hassan; Bryce A Basques; Haseeb A Mohammed; Arash J Sayari; Dino Samartzis; Howard S An Journal: Eur Spine J Date: 2021-06-07 Impact factor: 3.134
Authors: Jenny C Kienzler; Javier Fandino; Erik Van de Kelft; Sandro Eustacchio; Gerrit Joan Bouma Journal: Acta Neurochir (Wien) Date: 2020-10-21 Impact factor: 2.216