Ripul R Panchal1, Kee D Kim2, Robert Eastlack3, John Lopez4, Andrew Clavenna5, Daina M Brooks6, Gita Joshua6. 1. Department of Neurological Surgery, University of California, Davis Medical Center, Sacramento, California, USA. Electronic address: rrpanchal@ucdavis.edu. 2. Department of Neurological Surgery, University of California, Davis Medical Center, Sacramento, California, USA. 3. Scripps Clinic Torrey Pines, La Jolla, California, USA. 4. Spine Care Specialists of Alaska, Fairbanks, Arkansas, USA. 5. North Central Surgery Center, Dallas, Texas, USA. 6. Musculoskeletal Education and Research Center (MERC), A Division of Globus Medical, Inc., Audubon, Pennsylvania, USA.
Abstract
OBJECTIVE: To compare radiologic and clinical outcomes, including rates of dysphagia and dysphonia, using a no-profile stand-alone intervertebral spacer with integrated screw fixation versus an anterior cervical plate and spacer construct for single-level anterior cervical discectomy and fusion (ACDF) procedures. METHODS: This multicenter, randomized, prospective study included 54 patients with degenerative disc disease requiring ACDF at a single level at C3-C7. Twenty-six patients underwent single-level ACDF with stand-alone spacers, and 28 with plate fixation and spacers. Analyses were based on comparison of perioperative outcomes, radiologic and clinical metrics, and incidence of dysphagia and/or dysphonia. RESULTS:Mean patient age was 48.8 ± 10.1years (53.7% female). No significant differences were observed between groups in operative time (101.8 ± 34.4 minutes, 114.4 ± 31.5 minutes), estimated blood loss (44.8 ± 76.5 mL, 82.5 ± 195.1 mL), or length of hospital stay (1.2 ± 0.6 days, 1.3 ± 0.6 days). Mean visual analog scale pain scores and Neck Disability Index scores improved significantly from preoperative to last follow-up (10.8 ± 2.6 months) in both groups (P < 0.05). Mean Voice Handicap Index andEating Assessment Tool scores improved significantly from discharge to last follow-up in both groups (P < 0.05). From discharge to 6 months, the stand-alone spacers group consistently demonstrated greater improvement in Voice Handicap Index. Preoperative intervertebral disc and neuroforaminal heights increased significantly across treatment groups (P < 0.01), and no cases required surgical revision at index or adjacent levels. CONCLUSIONS:Anterior cervical discectomy and fusion with stand-alone spacers resulted in similar clinical and radiologic outcomes as compared with plate and spacers and may help minimize postoperative dysphonia.
RCT Entities:
OBJECTIVE: To compare radiologic and clinical outcomes, including rates of dysphagia and dysphonia, using a no-profile stand-alone intervertebral spacer with integrated screw fixation versus an anterior cervical plate and spacer construct for single-level anterior cervical discectomy and fusion (ACDF) procedures. METHODS: This multicenter, randomized, prospective study included 54 patients with degenerative disc disease requiring ACDF at a single level at C3-C7. Twenty-six patients underwent single-level ACDF with stand-alone spacers, and 28 with plate fixation and spacers. Analyses were based on comparison of perioperative outcomes, radiologic and clinical metrics, and incidence of dysphagia and/or dysphonia. RESULTS: Mean patient age was 48.8 ± 10.1years (53.7% female). No significant differences were observed between groups in operative time (101.8 ± 34.4 minutes, 114.4 ± 31.5 minutes), estimated blood loss (44.8 ± 76.5 mL, 82.5 ± 195.1 mL), or length of hospital stay (1.2 ± 0.6 days, 1.3 ± 0.6 days). Mean visual analog scale pain scores and Neck Disability Index scores improved significantly from preoperative to last follow-up (10.8 ± 2.6 months) in both groups (P < 0.05). Mean Voice Handicap Index and Eating Assessment Tool scores improved significantly from discharge to last follow-up in both groups (P < 0.05). From discharge to 6 months, the stand-alone spacers group consistently demonstrated greater improvement in Voice Handicap Index. Preoperative intervertebral disc and neuroforaminal heights increased significantly across treatment groups (P < 0.01), and no cases required surgical revision at index or adjacent levels. CONCLUSIONS: Anterior cervical discectomy and fusion with stand-alone spacers resulted in similar clinical and radiologic outcomes as compared with plate and spacers and may help minimize postoperative dysphonia.
Authors: Mostafa A Gabr; Elisabeth Touko; Amol P Yadav; Isaac Karikari; C Rory Goodwin; Michael W Groff; Luis Ramirez; Muhammad M Abd-El-Barr Journal: Global Spine J Date: 2019-12-26
Authors: Ian Caplan; Saurabh Sinha; James Schuster; Matthew Piazza; Gregory Glauser; Benjamin Osiemo; Scott McClintock; William C Welch; Nikhil Sharma; Ali Ozturk; Neil Rainer Malhotra Journal: Asian J Neurosurg Date: 2019 Apr-Jun