Jarle Sundseth1,2, Oddrun Anita Fredriksli3,4,5, Frode Kolstad6, Lars Gunnar Johnsen4,5,7, Are Hugo Pripp8, Hege Andresen4,5, Erling Myrseth9, Kay Müller10, Øystein P Nygaard3,4,5, John-Anker Zwart11,12. 1. Department of Neurosurgery, Oslo University Hospital Rikshospitalet, Postboks 4950 Nydalen, 0424, Oslo, Norway. jarle.sundseth@rikshospitalet.no. 2. Faculty of Medicine, University of Oslo, Oslo, Norway. jarle.sundseth@rikshospitalet.no. 3. Department of Neurosurgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway. 4. National Advisory Unit on Spinal Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway. 5. Department of Neuroscience, Faculty of Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway. 6. Department of Neurosurgery, Oslo University Hospital Rikshospitalet, Postboks 4950 Nydalen, 0424, Oslo, Norway. 7. Department of Orthopaedic Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway. 8. Oslo Centre of Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Oslo, Norway. 9. Department of Neurosurgery, Haukeland University Hospital, Bergen, Norway. 10. Department of Neurosurgery, University Hospital of North Norway, Tromsø, Norway. 11. Faculty of Medicine, University of Oslo, Oslo, Norway. j.a.zwart@medisin.uio.no. 12. Department of Neurology and FORMI, Oslo University Hospital Ullevaal, Oslo, Norway. j.a.zwart@medisin.uio.no.
Abstract
PURPOSE: Standard surgical treatment for symptomatic cervical disc disease has been discectomy and fusion, but the use of arthroplasty, designed to preserve motion, has increased, and most studies report clinical outcome in its favor. Few of these trials, however, blinded the patients. We, therefore, conducted the Norwegian Cervical Arthroplasty Trial, and present 2-year clinical outcome after arthroplasty or fusion. METHODS: This multicenter trial included 136 patients with single-level cervical disc disease. The patients were randomized to arthroplasty or fusion, and blinded to the treatment modality. The surgical team was blinded to randomization until nerve root decompression was completed. Primary outcome was the self-rated Neck Disability Index. Secondary outcomes were the numeric rating scale for pain and quality of life questionnaires ShortForm-36 and EuroQol-5Dimension-3 Level. RESULTS: There was a significant improvement in the primary and all secondary outcomes from baseline to 2-year follow-up for both arthroplasty and fusion (P < 0.001), and no observed significant between-group differences at any follow-up times. However, linear mixed model analyses, correcting for baseline values, dropouts and missing data, revealed a difference in Neck Disability Index (P = 0.049), and arm pain (P = 0.027) in favor of fusion at 2 years. The duration of surgery was longer (P < 0.001), and the frequency of reoperations higher (P = 0.029) with arthroplasty. CONCLUSION: The present study showed excellent clinical results and no significant difference between treatments at any scheduled follow-up. However, the rate of index level reoperations was higher and the duration of surgery longer with arthroplasty. TRIAL REGISTRATION: http://www.clinicaltrials.gov NCT 00735176.19.
RCT Entities:
PURPOSE: Standard surgical treatment for symptomatic cervical disc disease has been discectomy and fusion, but the use of arthroplasty, designed to preserve motion, has increased, and most studies report clinical outcome in its favor. Few of these trials, however, blinded the patients. We, therefore, conducted the Norwegian Cervical Arthroplasty Trial, and present 2-year clinical outcome after arthroplasty or fusion. METHODS: This multicenter trial included 136 patients with single-level cervical disc disease. The patients were randomized to arthroplasty or fusion, and blinded to the treatment modality. The surgical team was blinded to randomization until nerve root decompression was completed. Primary outcome was the self-rated Neck Disability Index. Secondary outcomes were the numeric rating scale for pain and quality of life questionnaires Short Form-36 and EuroQol-5Dimension-3 Level. RESULTS: There was a significant improvement in the primary and all secondary outcomes from baseline to 2-year follow-up for both arthroplasty and fusion (P < 0.001), and no observed significant between-group differences at any follow-up times. However, linear mixed model analyses, correcting for baseline values, dropouts and missing data, revealed a difference in Neck Disability Index (P = 0.049), and arm pain (P = 0.027) in favor of fusion at 2 years. The duration of surgery was longer (P < 0.001), and the frequency of reoperations higher (P = 0.029) with arthroplasty. CONCLUSION: The present study showed excellent clinical results and no significant difference between treatments at any scheduled follow-up. However, the rate of index level reoperations was higher and the duration of surgery longer with arthroplasty. TRIAL REGISTRATION: http://www.clinicaltrials.gov NCT 00735176.19.
Authors: Caroline M W Goedmakers; Tessa Janssen; Xiaoyu Yang; Mark P Arts; Ronald H M A Bartels; Carmen L A Vleggeert-Lankamp Journal: Eur Spine J Date: 2019-10-22 Impact factor: 3.134
Authors: David Christopher Kieser; Derek Thomas Cawley; Cecile Roscop; Simon Mazas; Pierre Coudert; Louis Boissiere; Ibrahim Obeid; Jean-Marc Vital; Vincent Pointillart; Olivier Gille Journal: Eur Spine J Date: 2018-03-31 Impact factor: 3.134
Authors: Jordan C Xu; Chandni Goel; Michael F Shriver; Joseph E Tanenbaum; Michael P Steinmetz; Edward C Benzel; Thomas E Mroz Journal: Global Spine J Date: 2017-08-15