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      Effect of Myelopathy on Early Clinical Improvement After Cervical Disc Replacement: A Study of a Local Patient Cohort and a Large National Cohort

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          Abstract

          Objective

          Cervical disc replacement (CDR) is an effective long-term treatment for both cervical radiculopathy and myelopathy. However, there may be unique differences in the early postoperative clinical improvement for patients with and without myelopathy. In addition, previous studies using CDR to treat cervical myelopathy were underpowered to determine risk factors for relatively postoperative medical complications.

          Methods

          Two different cohorts were studied. A local cohort of patients undergoing CDR by a single surgeon was utilized to study the early postoperative course of clinical improvement. In addition, a national cohort of patients undergoing CDR in the 2015 and 2016 National Surgical Quality Improvement Program database was utilized to study differences in postoperative medical complications after CDR. Patients with a preoperative diagnosis of cervical myelopathy were identified in both cohorts, and perioperative outcomes and complications were compared to patients without myelopathy.

          Results

          A total of 43 patients undergoing CDR were included in the institutional cohort, of those 16 patients (37% of cohort) had a preoperative diagnosis of cervical myelopathy. A total of 3,023 patients undergoing CDR were included in the national cohort, of those 411 (13% of cohort) had a preoperative diagnosis of cervical myelopathy. In the institutional cohort, the nonmyelopathy group had a lower initial Neck Disability Index (NDI) and saw a faster improvement in NDI by 2 weeks postoperative. However, at 24 weeks there was no significant difference between groups in terms of NDI. Interestingly, only the nonmyelopathy cohort had a significant improvement in modified Japanese Orthopaedic Association score by 6 weeks (p<0.05). In the national cohort, myelopathy was associated with longer operative time and length of stay (p<0.05). However, there was no significant difference in perioperative complications (p>0.05) between myelopathy and nonmyelopathy patients.

          Conclusion

          Significant improvements in NDI, visual analogue scale (VAS)-arm pain, and VAS-neck pain are seen in both myelopathy and nonmyelopathy populations undergoing CDR by 6 weeks postoperatively. However, nonmyelopathy populations improve faster by 2 weeks postoperatively. In the national cohort analysis, medical complications were similarly low in both myelopathy and nonmyelopathy groups.

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          Most cited references23

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          Trends in resource utilization and rate of cervical disc arthroplasty and anterior cervical discectomy and fusion throughout the United States from 2006 to 2013

          The typically accepted surgical procedure for cervical disc pathology has been the anterior cervical discectomy and fusion (ACDF), although recent trials have demonstrated equivalent or improved outcomes with cervical disc arthroplasty (CDA). Trends for these two procedures regarding utilization, revision procedures, and other demographic information have not been sufficiently explored.
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            Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial

            The authors assessed the 10-year clinical safety and effectiveness of cervical disc arthroplasty (CDA) to treat degenerative cervical spine disease at 2 adjacent levels compared to anterior cervical discectomy and fusion (ACDF). A prospective, randomized, controlled, multicenter FDA-approved clinical trial was conducted comparing the low-profile titanium ceramic composite–based Prestige LP Cervical Disc (n = 209) at two levels with ACDF (n = 188). Ten-year follow-up data from a postapproval study were available on 148 CDA and 118 ACDF patients and are reported here. Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at regular postoperative follow-up intervals for up to 10 years. The primary endpoint was overall success, a composite variable that included key safety and efficacy considerations. Ten-year follow-up rates were 86.0% for CDA and 84.9% for ACDF. From 2 to 10 years, CDA demonstrated statistical superiority over ACDF for overall success, with rates at 10 years of 80.4% versus 62.2%, respectively (posterior probability of superiority [PPS] = 99.9%). Neck Disability Index (NDI) success was also superior, with rates at 10 years of 88.4% versus 76.5% (PPS = 99.5%), as was neurological success (92.6% vs 86.1%; PPS = 95.6%). Improvements from preoperative results in NDI and neck pain scores were consistently statistically superior for CDA compared to ACDF. All other study effectiveness measures were at least noninferior for CDA compared to ACDF through the 10-year follow-up period, including disc height. Mean angular ranges of motion at treated levels were maintained in the CDA group for up to 10 years. The rates of grade IV heterotopic ossification (HO) at the superior and inferior levels were 8.2% and 10.3%, respectively. The rate of severe HO (grade III or IV) did not increase significantly from 7 years (42.4%) to 10 years (39.0%). The CDA group had fewer serious (grade 3–4) implant-related or implant/surgical procedure–related adverse events (3.8% vs 8.1%; posterior mean 95% Bayesian credible interval [BCI] of the log hazard ratio [LHR] −0.92 [−1.88, −0.01]). The CDA group also had statistically fewer secondary surgical procedures at the index levels (4.7%) than the ACDF group (17.6%) (LHR [95% BCI] −1.39 [−2.15, −0.61]) as well as at adjacent levels (9.0% vs 17.9%). The Prestige LP Cervical Disc, implanted at two adjacent levels, maintains improved clinical outcomes and segmental motion 10 years after surgery and is a safe and effective alternative to fusion. Clinical trial registration no.: NCT00637156 (clinicaltrials.gov)
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              Single-level cervical radiculopathy: clinical outcome and cost-effectiveness of four techniques of anterior cervical discectomy and fusion and disc arthroplasty.

              Although there are several accepted methods of surgical treatment for single-level cervical radiculopathy, the choice depend on the surgeon's preference. The techniques may vary in peri-operative morbidity, short- and long-term outcome, but no study so far has analyzed their cost-effectiveness. This study might give some insight in balancing cost and effectiveness and deciding the right technique. Sixty consecutive patients (15 each group), mean age 36 (range 24-76 years) with single-level cervical disc disease underwent surgical treatment with four different techniques in two centers over the period of 1999-2005. The four groups were--(1) plate and tricortical autograft, (2) plate, cage, and bone substitute, (3) cage only, and (4) disc arthroplasty. The data was collected prospectively according to our protocol and subsequently analyzed. The clinical outcome was assessed comparing visual analog scale (VAS) of neck pain and, short form 12 (SF12) questionnaire both pre- and postoperatively. The radiological assessment was done for fusion rate and postoperative related possible complications at 3 months, 6 months, 1 year, and final follow-up. The cost analysis was done calculating the operative time, hospital stay, implant cost together. The mean follow-up period was 31 months (range 28-43 months). The clinical outcome in terms of VAS of neck and arm pain and SF12 physical and mental score improvement (P=0.001) were comparable with all four techniques. The radiological fusion rate was comparable to current available data. As the hospital stay was longer (average 5 days) with plate and autograft group, the total cost was maximum (average 2,920 pound sterling) with this group. There was satisfactory clinical and radiological outcome with all four techniques. Using the cage alone was the most cost-effective technique, but the disc arthroplasty was comparable to the use of cage and plate. Anterior cervical discectomy and fusion is an established surgical treatment for cervical radiculopathy. Single-level cervical radiculopathy was treated with four different techniques. The clinical outcome and cost-effectiveness were compared in this study.
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                Author and article information

                Journal
                Neurospine
                Neurospine
                NS
                Neurospine
                Korean Spinal Neurosurgery Society
                2586-6583
                2586-6591
                September 2019
                30 September 2019
                : 16
                : 3
                : 563-573
                Affiliations
                [1 ]Hospital for Special Surgery, New York, NY, USA
                [2 ]Weill Cornell Medical College, New York, NY, USA
                Author notes
                Corresponding Author Sheeraz A. Qureshi https://orcid.org/0000-0002-7177-1756 Hospital for Special Surgery, 535 E. 70th St., New York, NY 10021, USA Tel: +1-212-606-1585 Fax: +1-917-260-3185 E-mail: sheerazqureshimd@ 123456gmail.com
                Author information
                http://orcid.org/0000-0002-7177-1756
                Article
                ns-1938220-110
                10.14245/ns.1938220.110
                6790731
                31607089
                54284740-a4cc-4686-929b-89f3deec4b1f
                Copyright © 2019 by the Korean Spinal Neurosurgery Society

                This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 27 June 2019
                : 10 September 2019
                : 15 September 2019
                Categories
                Original Article

                cervical disc arthroplasty,myelopathy,radiculopathy,outcomes

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