Peter D Klassen1, Geoffrey Lesage2, Larry E Miller3, Robert Hes4, Jasper F C Wolfs5, Sandro Eustacchio6, Peter Vajkoczy7. 1. Department of Neurosurgery, Bonifatius Hospital, Lingen, Germany. Electronic address: PeterDouglas.Klassen@hospital-lingen.de. 2. Department of Neurosurgery, OLV Ziekenhuis, Aalst, Belgium. 3. Miller Scientific Consulting, Inc., Asheville, North Carolina, USA. 4. Department of Neurosurgery, AZ Klina, Brasschaat, Belgium. 5. Department of Neurosurgery, Haaglanden Medical Center Westeinde Antoniushove, Leidschendam, The Netherlands. 6. Department of Neurosurgery, Medical University Graz, Graz, Austria. 7. Department of Neurosurgery, Charité Universitätsmedizin, Berlin, Germany.
Abstract
OBJECTIVE: To determine whether presence of a bone-anchored annular closure device (ACD) impacts reoperation strategies and subsequent outcomes. METHODS:Patients with large annular defects after single-level limited lumbar discectomy were randomly allocated to receive an ACD or discectomy alone (controls) and were followed for at least 3 years. RESULTS: Among 550 patients, reoperation risk was lower with ACD (11.0% vs. 19.3%). The types of reoperations and operative time were similar in each group, and the ACD did not interfere with surgical planning or operative technique. Fusion success was 87% with ACD versus 85% for controls. Perioperative complications occurred in 22% and 19% of reoperations, respectively. Leg pain and back function were improved with ACD versus controls after fusion procedures, and no group differences were observed after non-fusion reoperations. CONCLUSIONS: In patients undergoing post-discectomy reoperation, patients with an ACD were treated with similar operative techniques, were not exposed to additional surgical risks, and reported comparable clinical outcomes versus those without an ACD.
RCT Entities:
OBJECTIVE: To determine whether presence of a bone-anchored annular closure device (ACD) impacts reoperation strategies and subsequent outcomes. METHODS:Patients with large annular defects after single-level limited lumbar discectomy were randomly allocated to receive an ACD or discectomy alone (controls) and were followed for at least 3 years. RESULTS: Among 550 patients, reoperation risk was lower with ACD (11.0% vs. 19.3%). The types of reoperations and operative time were similar in each group, and the ACD did not interfere with surgical planning or operative technique. Fusion success was 87% with ACD versus 85% for controls. Perioperative complications occurred in 22% and 19% of reoperations, respectively. Leg pain and back function were improved with ACD versus controls after fusion procedures, and no group differences were observed after non-fusion reoperations. CONCLUSIONS: In patients undergoing post-discectomy reoperation, patients with an ACD were treated with similar operative techniques, were not exposed to additional surgical risks, and reported comparable clinical outcomes versus those without an ACD.
Authors: Claudius Thomé; Adisa Kuršumovic; Peter Douglas Klassen; Gerrit J Bouma; Richard Bostelmann; Frederic Martens; Martin Barth; Mark Arts; Larry E Miller; Peter Vajkoczy; Robert Hes; Sandro Eustacchio; Dharmin Nanda; Hans-Peter Köhler; Christopher Brenke; Charlotte Flüh; Erik Van de Kelft; Richard Assaker; Jenny C Kienzler; Javier Fandino Journal: JAMA Netw Open Date: 2021-12-01
Authors: Han Wang; Di Wang; Beier Luo; Dong Wang; Haoruo Jia; Pandi Peng; Qiliang Shang; Jianxin Mao; Chu Gao; Ye Peng; Lu Gan; Junjie Du; Zhuojing Luo; Liu Yang Journal: Bioact Mater Date: 2022-02-03