J Neurol Surg A Cent Eur Neurosurg 2015; 76 - P012
DOI: 10.1055/s-0035-1564515

Perioperative Demographics, Intraoperative Findings, and Complications in Lumbar Microdiscectomy: Comparison of Annular Closure to Discectomy Alone

J. C. Kienzler 1, J. Fandino 1, C. Thomé 2, R. Hes 3, R. Bostelmann 4, F. Martens 5, G. J. Bouma 6, M. Barth 7, P. Vajkoczy 8, O. Yeh 9, J. Einhorn 9, P. D. Klassen 10
  • 1Department of Neurosurgery, Kantonsspital Aarau, Aarau, Switzerland
  • 2Department of Neurosurgery, University of Innsbruck, Innsbruck, Austria
  • 3Department of Neurosurgery, AZ Klina, Antwerp, Belgium
  • 4Department of Neurosurgery, University of Düsseldorf, Düsseldorf, Germany
  • 5Department of Neurosurgery, OLV Ziekenhuis, Aalst, Belgium
  • 6Department of Neurosurgery, St. Lucas-Andreas Ziekenhuis, Amsterdam, The Netherlands
  • 7Department of Neurosurgery, University of Bochum, Bochum, Germany
  • 8Department of Neurosurgery, Charité University of Berlin, Berlin, Germany
  • 9Intrinsic Therapeutics, Inc., Woburn MA, United States
  • 10Department of Neurosurgery, Bonifatius Hospital, Lingen, Germany

Aim: To evaluate intraoperative findings, complications, and outcome (<90 days) in patients undergoing LD with or without implantation of an annular closure device (ACD). Methods: This study is based on the analysis of data of a postmarketing, prospective, multicenter RCT in Europa including patients undergoing standard LD with or without implantation of an ACD (Barricaid, Intrinsic Therapeutics, Inc., Woburn, Massachusetts, United States). Enrollment of 554 patients in 21 centers in Europa (DE, CH, AT, BE, NL, FR) started in 2010 and was completed by October 2014. A total of 276 patients were randomized to the ACD group and 278 to the control group. Results: Mean operation time was 70 minutes in ACD group and 52 minutes in control group. On average, the ACD group showed a 35% longer duration of surgery (p < 0.0001). The intraoperative fluoroscopy time was on average 3.3 times higher in the ACD group (7 vs. 23 seconds, p < 0.0001). Median blood loss (BL) was 94.2 mL in the ACD group and 63.5 mL in the control group. There was on average a 48% higher amount of BL in the ACD group (p = 0.0001). Amount of bone removed above average was reported in 23.4% in control group and in 50.7% in ACD group (p < 0.001). In our series, a total of 21 serious device or procedure related AEs occurred in the ACD group and 36 in the control group. Dural injuries occurred in 13 (4.8%) patients in the ACD group and 7 (2.5%) in the control group. There was one device-related nerve root injury resulting in a nerve root amputation. Mean duration of hospital stay was 3 days in both groups. Surgical complications included three hematoma and three infections in both groups. Device migrations were documented in three patients. Patients of the ACD group (n = 7) underwent less reoperations compared with the control group (n = 13). Mean VAS leg pain at 3 months was 11.9 in the ACD and 15 in the control group. Regarding neurological status in the ACD group occurred until the 3 months FU, 7.3% new deficits, 11% had a paresis, and 24% a sensory deficit at the 3 months FU. In the control group, 6.6% had a new deficit until the 3 months FU, 9% had a paresis, and 20% a sensory deficit at the 3 months FU. Conclusion: Despite longer operation time and higher amount of BL in the ACD group, the postoperative pain and neurological outcome were equal in both groups. Patients included in the ACD group had less reoperations. These findings suggest that ACD implantation after LD is a safe procedure and is not associated with an increase of morbidity.