Martin Barth1, Christel Weiß2, Gerrit J Bouma3, Richard Bostelmann4, Adisa Kursumovic5, Javier Fandino6, Claudius Thomé7. 1. Department of Neurosurgery, Knappschafts-Krankenhaus Bochum, Ruhr-University Bochum, In der Schornau 23-25, 44892, Bochum, Germany. martin.barth@kk-bochum.de. 2. Department of Medical Statistics, University Medicine Mannheim, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany. 3. Department of Neurosurgery, OLVG, Academic Medical Center, Amsterdam, Netherlands. 4. Department of Neurosurgery, Heinrich Heine University, Duesseldorf, Germany. 5. Department of Neurosurgery, DONAUISAR Klinikum, Deggendorf, Germany. 6. Department of Neurosurgery, Kantonsspital Aarau, Aarau, Switzerland. 7. Department of Neurosurgery, Medical University Innsbruck, Innsbruck, Austria.
Abstract
BACKGROUND: The implantation of a bone-anchored annular closure device (ACD) might be associated with the developed new endplate changes (EPC) after surgery. METHODS: A post hoc analysis has been done in patients from a prospective randomized multicenter study. All patients underwent limited lumbar discectomy with intraoperative randomization into the groups limited lumbar discectomy alone or additional ACD implantation. Low-dose lumbar computed tomography (CT) and clinical investigations were performed preoperatively and 12 months after the operation. RESULTS: A total of 554 patients were randomized. After exclusion of dropouts, the per-protocol population included 493 patients (251 in the control group and 242 in the ACD group); the follow-up rate was ≥ 90%. The number of patients showing EPC at baseline was similar in both groups. The number of patients showing EPC and the total EPC lesion area significantly increased in both groups over time, but significantly increased more in the EPC group for the superior and inferior endplate (all P < 0.0001). There was no association of pre-existing number and size of EPC with sex, age, or smoking habits. Correlation of clinical variables showed no relation with number, size, and increase of EPC area after surgery. CONCLUSIONS:Patients with primary lumbar disc herniation show EPC in the corresponding segments. There is a significant increase of lesion number and size within 12 months after discectomy. This increase is significantly more pronounced in the ACD group. Presence and growth of EPC is not correlated with low-back pain or ODI.
RCT Entities:
BACKGROUND: The implantation of a bone-anchored annular closure device (ACD) might be associated with the developed new endplate changes (EPC) after surgery. METHODS: A post hoc analysis has been done in patients from a prospective randomized multicenter study. All patients underwent limited lumbar discectomy with intraoperative randomization into the groups limited lumbar discectomy alone or additional ACD implantation. Low-dose lumbar computed tomography (CT) and clinical investigations were performed preoperatively and 12 months after the operation. RESULTS: A total of 554 patients were randomized. After exclusion of dropouts, the per-protocol population included 493 patients (251 in the control group and 242 in the ACD group); the follow-up rate was ≥ 90%. The number of patients showing EPC at baseline was similar in both groups. The number of patients showing EPC and the total EPC lesion area significantly increased in both groups over time, but significantly increased more in the EPC group for the superior and inferior endplate (all P < 0.0001). There was no association of pre-existing number and size of EPC with sex, age, or smoking habits. Correlation of clinical variables showed no relation with number, size, and increase of EPC area after surgery. CONCLUSIONS:Patients with primary lumbar disc herniation show EPC in the corresponding segments. There is a significant increase of lesion number and size within 12 months after discectomy. This increase is significantly more pronounced in the ACD group. Presence and growth of EPC is not correlated with low-back pain or ODI.