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      What’s the best surgical treatment for patients with cervical radiculopathy due to single-level degenerative disease? A randomized controlled trial

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          Abstract

          Background

          To investigate the efficacy of adding supplemental fusion or arthroplasty after cervical anterior discectomy for symptomatic mono-level cervical degenerative disease (radiculopathy), which has not been substantiated in controlled trials until now.

          Methods

          A randomized controlled trial is reported with 9 years follow up comparing anterior cervical anterior discectomy without fusion, with fusion by cage standalone, or with disc prosthesis. Patients suffering from symptomatic cervical disk degeneration at one level referred to spinal sections of department of neurosurgery or orthopedic surgery of a large general hospital with educational facilities were eligible. Neck Disability Index (NDI), McGill Pain Questionnaire Dutch language version (MPQ-DLV), physical-component summary (PCS), and mental-component summary (MCS) of the 36-item Short-Form Health Survey (SF-36), and re operation rate were evaluated.

          Findings

          142 patients between 18 and 55 years were allocated. The median follow-up was 8.9±1.9 years (5.6 to 12.2 years). The response rate at last follow-up was 98.5%. NDI at the last follow-up did not differ between the three treatment groups, nor did the secondary outcomes as MPQ-DLV and PCS or MCS from SF-36. The major improvement occurred within the first 6 weeks after surgery. Afterward, it remained stable. Eleven patients underwent surgery for recurrent symptoms and signs due to nerve root compression at the index or adjacent level.

          Conclusions

          This randomized trial could not detect a difference between three surgical modalities for treating a single-level degenerative disk disease. Anterior cervical discectomy without implant seems to be similar to anterior cervical discectomy with fusion by cage stand-alone or with disk prosthesis. Due to the small study sample size, this statement should be considered as inconclusive so far.

          Trial registration

          ISRCTN41681847

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          Most cited references21

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          Cervical radiculopathy: epidemiology, etiology, diagnosis, and treatment.

          Barrett Woods, Alan Hilibrand (2015)
          Cervical radiculopathy is a relatively common neurological disorder resulting from nerve root dysfunction, which is often due to mechanical compression; however, inflammatory cytokines released from damaged intervertebral disks can also result in symptoms. Cervical radiculopathy can often be diagnosed with a thorough history and physical examination, but an magnetic resonance imaging or computed tomographic myelogram should be used to confirm the diagnosis. Because of the ubiquity of degenerative changes found on these imaging modalities, the patient's symptoms must correlate with pathology for a successful diagnosis. In the absence of myelopathy or significant muscle weakness all patients should be treated conservatively for at least 6 weeks. Conservative treatments consist of immobilization, anti-inflammatory medications, physical therapy, cervical traction, and epidural steroid injections. Cervical radiculopathy typically is self-limiting with 75%-90% of patients achieving symptomatic improvement with nonoperative care. For patients who are persistently symptomatic despite conservative treatment, or those who have a significant functional deficit surgical treatment is appropriate. Surgical options include anterior cervical decompression and fusion, cervical disk arthroplasty, and posterior foraminotomy. Patient selection is critical to optimize outcome.
          Article 0 comments Cited 75 times – based on 0 reviews     Review now
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            National trends in anterior cervical fusion procedures.

            Victor Pui-Yan Ma, Andrew Sama, Christopher Baylis … (2010)
            Population-based database analysis. To analyze trends in patient- and healthcare-system-related characteristics, utilization and outcomes associated with anterior cervical spine fusions. Anterior cervical decompression and spine fusion (ACDF) is one of the most commonly performed surgical procedures of the spine. However, few data analyzing trends in patient- and healthcare-system-related characteristics, utilization and outcomes exist. Data from 1990 to 2004 collected in the National Hospital Discharge Survey were accessed. ACDF procedures were identified. Five-year periods of interest (POI) were created for temporal analysis and changes in the prevalence and utilization of this procedure as well as in patient- and healthcare-system-related variables were examined. The changes in the occurrence of procedure-related complications were evaluated. An estimated total of 771,932 discharges after ACDF were identified. Temporally, an almost 8-fold increase in total prevalence was accompanied by a similar increase in utilization (23/100.000 civilians/POI to 157/100.000/civilians/POI). The highest increase in utilization was observed in those > or =65 years (28-fold). Average age increased from 47.2 years to 50.5 years over time. Length of hospital stay decreased from 5.17 days to 2.38 days. Overall procedure-related complication rates decreased from 4.6% to 3.03%. The prevalence of hypertension, diabetes mellitus, hypercholesterolemia, obesity, pulmonary, and coronary artery increased over time among patients undergoing ACDF. Despite limitations inherent to secondary analysis of large databases, we identified a number of significant changes in the utilization, demographics, and outcomes associated with ACDF, which can be used to assess the effect of changes in medical care, direct health care resources, and future research. The effect of the increased prevalence of comorbidities on medical practice remains to be evaluated. Further studies are necessary to evaluate causal relationships.
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              Clinically meaningful differences in pain, disability and quality of life for chronic nonspecific neck pain - a reanalysis of 4 randomized controlled trials of cupping therapy.

              G Dobos, Romy Lauche, Holger Cramer … (2013)
              The assessment of clinically meaningful differences in patients' self-reported outcomes has become increasingly important when interpreting the results of clinical studies. Although these assessments have become quite common there are hardly any data for nonspecific neck pain, especially in the context of complementary and alternative medicine. The aim of this analysis is the determination of minimal clinically important differences (MCID) and substantial clinical benefits (SCB) in patients with chronic nonspecific neck pain after cupping treatment. The data set comprised a total of 200 patients with chronic nonspecific neck pain participating in clinical trials on cupping therapy. The MCID and SCB for pain intensity (VAS), neck disability index (NDI) and the subscale bodily pain (SF-36-BP) as well as physical component summary (SF-36-PCS) of the SF-36 were determined using receiver operating characteristic (ROC) curve analysis with an adapted assessment of change in health status (SF-36), i.e. a 5-point Likert scale ranging from "much better" to "much worse", as anchor. MCID derived from the ROC was the score to distinguish "somewhat better" from "about the same", and the SCB was the score to distinguish "much better" from "somewhat better". The calculated MCIDs were: -8mm (-21%) for VAS, -3 points (-10.2%) for NDI, +10 points (+20.5%) for SF-36-BP and +2.6 points (+7.7%) for SF-36-PCS. The SCBs were: -26.5mm (-66.8%) for VAS, -8.4 points (-29%) for NDI, +15.5 points (+43.1%) for SF-36-BP and +5.1 points (+12.9%) for SF-36-PCS. Accuracy of the estimations was good for MCID in general and for SCB regarding VAS and NDI. The results support the assumption that patients' perceptions of treatment benefits measured by VAS in these trials might be comparable to others in conventional therapies. For NDI and SF-36-PCS the estimated differences were smaller than in previous reports indicating that context factors such as patient characteristics and specific treatment conditions might play an important role. Further studies on MCIDS and SCBs for chronic nonspecific neck pain seem warranted. Copyright © 2013 Elsevier Ltd. All rights reserved.
              Article 0 comments Cited 33 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Roland D. Donk: Role: ConceptualizationRole: Data curationRole: InvestigationRole: MethodologyRole: Project administrationRole: SupervisionRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                André L. M. Verbeek: Role: ConceptualizationRole: MethodologyRole: SupervisionRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Wim I. M. Verhagen: Role: SupervisionRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Hans Groenewoud: Role: Data curationRole: Formal analysisRole: MethodologyRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Allard J. F. Hosman: Role: SupervisionRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Ronald H. M. A. Bartels:
                ORCID: http://orcid.org/0000-0002-8638-4660
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: Project administrationRole: SupervisionRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Robert J. Jackson: Role: Editor
                Journal
                Journal ID (nlm-ta): PLoS One
                Journal ID (iso-abbrev): PLoS ONE
                Journal ID (publisher-id): plos
                Journal ID (pmc): plosone
                Title: PLoS ONE
                Publisher: Public Library of Science (San Francisco, CA USA )
                ISSN (Electronic): 1932-6203
                Publication date (Electronic): 29 August 2017
                Publication date Collection: 2017
                Volume: 12
                Issue: 8
                Electronic Location Identifier: e0183603
                Affiliations
                [1 ] Via Sana Clinics, Department of Orthopedic Surgery, Mill, the Netherlands
                [2 ] Radboud university medical center, Department for Health Evidence, Nijmegen, the Netherlands
                [3 ] Canisius Wilhelmina Hospital, Department of Neurology, Nijmegen, the Netherlands
                [4 ] Radboud university medical center, Department of Orthopedic Surgery, Nijmegen, the Netherlands
                [5 ] Radboud university medical center, Department of Neurosurgery, Nijmegen, the Netherlands
                [6 ] Canisius Wilhelmina Hospital, Department of Neurosurgery, Nijmegen, the Netherlands
                UNITED STATES
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Author information
                http://orcid.org/0000-0002-8638-4660
                Article
                Publisher ID: PONE-D-16-47566
                DOI: 10.1371/journal.pone.0183603
                PMC ID: 5574537
                PubMed ID: 28850600
                SO-VID: 221e65c2-f1da-47dd-ae7f-08246c7db475
                Copyright © © 2017 Donk et al
                License:

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                Date received : 6 December 2016
                Date accepted : 7 August 2017
                Page count
                Figures: 5, Tables: 6, Pages: 17
                Funding
                The author(s) received no specific funding for this work.
                Categories
                Subject: Research Article
                Subject: Medicine and Health Sciences
                Subject: Surgical and Invasive Medical Procedures
                Subject: Biology and Life Sciences
                Subject: Biotechnology
                Subject: Medical Devices and Equipment
                Subject: Assistive Technologies
                Subject: Prosthetics
                Subject: Medicine and Health Sciences
                Subject: Medical Devices and Equipment
                Subject: Assistive Technologies
                Subject: Prosthetics
                Subject: Medicine and Health Sciences
                Subject: Health Care
                Subject: Health Care Providers
                Subject: Medical Doctors
                Subject: Surgeons
                Subject: People and Places
                Subject: Population Groupings
                Subject: Professions
                Subject: Medical Doctors
                Subject: Surgeons
                Subject: Medicine and Health Sciences
                Subject: Health Care
                Subject: Health Care Providers
                Subject: Medical Doctors
                Subject: Physicians
                Subject: Surgeons
                Subject: People and Places
                Subject: Population Groupings
                Subject: Professions
                Subject: Medical Doctors
                Subject: Physicians
                Subject: Surgeons
                Subject: Research and Analysis Methods
                Subject: Research Design
                Subject: Survey Research
                Subject: Questionnaires
                Subject: Medicine and Health Sciences
                Subject: Surgical and Invasive Medical Procedures
                Subject: Musculoskeletal System Procedures
                Subject: Arthroplasty
                Subject: Medicine and Health Sciences
                Subject: Health Care
                Subject: Patient Advocacy
                Subject: Medicine and Health Sciences
                Subject: Health Care
                Subject: Health Care Providers
                Subject: Medical Doctors
                Subject: Physicians
                Subject: People and Places
                Subject: Population Groupings
                Subject: Professions
                Subject: Medical Doctors
                Subject: Physicians
                Subject: Medicine and Health Sciences
                Subject: Urology
                Subject: Urinary Tract Infections
                Custom metadata
                Data Availability All relevant data are within the paper and its Supporting Information files.

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