Cervical total disc replacement C5/6.
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ABSTRACT:
SUBMITTER: Suchomel P
PROVIDER: S-EPMC3676548 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Purpose of reviewCervical disc replacement (CDR) has emerged as a motion-preserving alternative to anterior cervical discectomy and fusion in selected cases. Despite favorable literature, CDR is not universally accepted because of concerns regarding bias in the existing literature. The purpose of this review is to identify the possible biases in the disc replacement literature.Recent findingsRecent studies that compare CDR and ACDF have demonstrated equivalent or superior outcomes, lower rates of secondary surgery, and equivalent safety at medium- and long-term follow-up. In our review, we identified four types of bias that may affect the CDR literature: publication bias, external validity, confounding bias, and financial conflicts of interest. Bias, whether intentional or unintentional, can impact the interpretation and outcome of CDR studies. Recognition of this issue is critical when utilizing the existing literature to determine the efficacy of CDR and designing future studies.
| S-EPMC5435630 | biostudies-literature
Project description:The most common reason that adults in the United States see their physician is lower back or neck pain secondary to degenerative disc disease. To date, approaches to treat degenerative disc disease are confined to purely mechanical devices designed to either eliminate or enable flexibility of the diseased motion segment. Tissue engineered intervertebral discs (TE-IVDs) have been proposed as an alternative approach and have shown promise in replacing native IVD in the rodent tail spine. Here we demonstrate the efficacy of our TE-IVDs in the canine cervical spine. TE-IVD components were constructed using adult canine annulus fibrosis and nucleus pulposus cells seeded into collagen and alginate hydrogels, respectively. Seeded gels were formed into a single disc unit using molds designed from the geometry of the canine spine. Skeletally mature beagles underwent discectomy with whole IVD resection at levels between C3/4 and C6/7, and were then divided into two groups that received only discectomy or discectomy followed by implantation of TE-IVD. Stably implanted TE-IVDs demonstrated significant retention of disc height and physiological hydration compared to discectomy control. Both 4-week and 16-week histological assessments demonstrated chondrocytic cells surrounded by proteoglycan-rich matrices in the NP and by fibrocartilaginous matrices in the AF portions of implanted TE-IVDs. Integration into host tissue was confirmed over 16 weeks without any signs of immune reaction. Despite the significant biomechanical demands of the beagle cervical spine, our stably implanted TE-IVDs maintained their position, structure and hydration as well as disc height over 16 weeks in vivo.
| S-EPMC5650136 | biostudies-literature
Project description:BackgroundAuthors aim to evaluate the correct placement of TDR using the instant center of rotation (ICR) as a guide.MethodsPlacement of disc would be divided into three groups using a standard of 1 mm from the ICR: Posterior to ICR, In line with ICR and Anterior to ICR.Results49 patients, mean age was 39.96 ± 1.45 years. 42 intraop fluoroscopy images compared to 41 post op radiographic images demonstrated TDR in line with ICR.ConclusionTotal discs replacements can be placed intraoperatively using proper technique with verification confirmed using the ICR postoperatively.KeywordsTotal disc replacement; instant center of rotation; ideal placement; fluoroscopy; adjacent segment disease; less exposure surgery.
| S-EPMC6512561 | biostudies-literature
Project description:BackgroundThe purpose of this study is to present clinical outcome data from a 2-year post-market study of a viscoelastic one-piece cervical total disc replacement (TDR) in Europe.MethodsThirty-nine patients were implanted at five surgical sites in an European post-market clinical study. Clinical outcomes included improvement of neck disability index (NDI) and visual analog scale scores for neck and arm pain from baseline to 2-year follow-up, neurological examinations, patients view on the success of surgery, complications, and subsequent surgical interventions.ResultsThirty patients had the Freedom® Cervical Disc (FCD) implanted at a single level, and nine patients were implanted at two adjacent levels. The population had a similar distribution of male [20] and female [19] subjects, with a mean age of 45 years. All self-administered outcome measures showed significant clinically important improvements from baseline to the 2-year follow-up. Mean preoperative NDI score improved from 48% to 20%, 13%, 8%, 6% and 4% at 6 weeks, 3, 6, 12, and 24 months, respectively. Average preoperative visual analog scale (VAS) scores of the neck, right and left arm pain intensity and frequency showed significant improvement. All neurological outcome measurements showed immediate improvement from preoperative values and continued improvement throughout 2 years follow-up. From pre-op to 24 months, neurological deficits declined in the population from 21% to 6% for reflex function, 62% to 17% for sensory function, and 38% to 3% for motor function. No patients experienced a deterioration in any measured outcomes compared with the preoperative situation. Patient satisfaction increased over 2 years post-op, with 83% of patients responding that they would "definitely" choose to have the same treatment for their neck/arm condition and another 11% responding that they would "probably" choose to have the same treatment.ConclusionsThe FCD performs as expected in patients with single-level and two-level degenerative disc disease.
| S-EPMC5760417 | biostudies-literature
Project description:BACKGROUND:Cervical disc replacement (CDR) has been widely used as an effective treatment for cervical degenerative disc diseases in recent years. However, the cost of this procedure is very high and may bring a great economic burden to patients and the health care system. It is reported that outpatient procedures can reduce nearly 30% of the costs associated with hospitalization compared with inpatient procedures. However, the safety profile surrounding outpatient CDR remains poorly resolved. This study aims to evaluate the current evidence on the safety of outpatient CDR METHODS:: Four English databases were searched. The inclusion and exclusion criteria were developed according to the PICOS principle. The titles and abstracts of the records will be screened by 2 authors independently. Records that meet the eligibility criteria will be screened for a second time by reading the full text. An extraction form will be established for data extraction. Risk of bias assessment will be performed by 2 authors independently using Cochrane risk of bias tool or Newcastle-Ottawa scale. Data synthesis will be conducted using Stata software. Heterogeneity among studies will be assessed using I test. The funnel plot, Egger regression test, and Begg rank correlation test will be used to examine the publication bias. RESULTS:The results of this meta-analysis will be published in a peer-review journal. CONCLUSION:This will be the first meta-analysis that compares the safety of outpatient CDR with inpatient CDR. Our study will help surgeons fully understand the complications and safety profile surrounding outpatient CDR. OSF REGISTRATION NUMBER:: doi.org/10.17605/OSF.IO/3597Z.
| S-EPMC7458200 | biostudies-literature
Project description:Study designA systematic review and meta-analysis.ObjectivesOutpatient cervical disc replacement (CDR) has been performed with an increasing trend in recent years. However, the safety profile surrounding outpatient CDR remains insufficient. The present study systematically reviewed the current studies about outpatient CDR and performed a meta-analysis to evaluate the current evidence on the safety of outpatient CDR as a comparison with the inpatient CDR.MethodsWe searched the PubMed, Embase, Web of Science, and Cochrane Library databases comprehensively up to April 2020. Patient demographic data, overall complication, readmission, returning to the operation room, operating time were analyzed with the Stata 14 software and R 3.4.4 software.ResultsNine retrospective studies were included. Patients underwent outpatient CDR were significantly younger (mean difference [MD] = -1.97; 95% CI -3.80 to -0.15; P = .034) and had lower prevalence of hypertension (OR = 0.68; 95% CI 0.53-0.87; P = .002) compared with inpatient CDR. The pooled prevalence of overall complication was 0.51% (95% CI 0.10% to 1.13%) for outpatient CDR. Outpatient CDR had a 59% reduction in risk of developing complications (OR = 0.41; 95% CI 0.18-0.95; P = .037). Outpatient CDR showed significantly shorter operating time (MD = -18.37; 95% CI -25.96 to -10.77; P < .001). The readmission and reoperation rate were similar between the 2 groups.ConclusionsThere is a lack of prospective studies on the safety of outpatient CDR. However, current evidence shows outpatient CDR can be safely performed under careful patient selection. High-quality, large prospective studies are needed to demonstrate the generalizability of this study.
| S-EPMC8351065 | biostudies-literature
Project description:BackgroundDespite being considered the standard surgical procedure for symptomatic cervical disc disease, anterior cervical decompression and fusion invariably accelerates adjacent segment degeneration. Cervical total disc replacement is a motion-preserving procedure developed as a substitute to fusion. Whether cervical total disc replacement is superior to fusion remains unclear.MethodsWe comprehensively searched PubMed, EMBASE, Medline, and the Cochrane Library in accordance with the inclusion criteria to identify possible studies. The retrieved results were last updated on December 12, 2014. We classified the studies as short-term and midterm follow-up.ResultsNineteen randomized controlled trials involving 4516 cases were identified. Compared with anterior cervical decompression and fusion, cervical total disc replacement had better functional outcomes (neck disability index [NDI], NDI success, neurological success, neck pain scores reported on a numerical rating scale [NRS], visual analog scales scores and overall success), greater segmental motion at the index level, fewer adverse events and fewer secondary surgical procedures at the index and adjacent levels in short-term follow-up (P < 0.05). With midterm follow-up, the cervical total disc replacement group indicated superiority in the NDI, neurological success, pain assessment (NRS), and secondary surgical procedures at the index level (P < 0.05). The Short Form 36 (SF-36) and segmental motion at the adjacent level in the short-term follow-up showed no significant difference between the two procedures, as did the secondary surgical procedure rates at the adjacent level with midterm follow-up (P > 0.05).ConclusionsCervical total disc replacement presented favorable functional outcomes, fewer adverse events, and fewer secondary surgical procedures. The efficacy and safety of cervical total disc replacement are superior to those of fusion. Longer-term, multicenter studies are required for a better evaluation of the long-term efficacy and safety of the two procedures.
| S-EPMC4379027 | biostudies-literature
Project description:BackgroundAnterior cervical discectomy and fusion (ACDF) has been widely used in cervical spondylosis, but adjacent segment degeneration/disease (ASD) was inevitable. Cervical total disc replacement (TDR) could reduce the stress of adjacent segments and retard ASD in theory, but the superiority has not been determined yet. This analysis aimed that whether TDR was superior to ACDF for decreasing adjacent segment degeneration (ASDeg) and adjacent segment disease (ASDis).MethodsA meta-analysis was performed according to the guidelines of the Cochrane Collaboration with PubMed, EMBASE, Cochrane Library and CBM (China Biological Medicine) databases. It included randomized controlled trials (RCTs) that reported ASDeg, ASDis, and reoperation on adjacent segments after TDR and ACDF. Two investigators independently selected trials, assessed methodological quality, and evaluated the quality of this meta-analysis using the grades of recommendation, assessment, development, and evaluation (GRADE) approach.ResultsEleven studies with 2632 patients were included in the meta-analysis. The overall rate of ASD in TDR group was lower than ACDF group (OR?=?0.6; 95% CI [0.38, 0.73]; P?<?0.00001). Both the incidence of ASDeg and the reoperation rate were statistically lower in the TDR group than in the ACDF group (OR?=?0.58, P?<?0.00001; OR?=?0.52, P?=?0.01, respectively). Subgroup analysis was performed according to the follow-up time and trial site; the rate of ASDeg was lower in patients underwent TDR no matter the follow-up time, and TDR tended to increase the superiority across time. The rate of ASDeg was also lower with TDR both in the USA and China (P?<?0.0001, P?=?0.03, respectively). But the cost-effectiveness result might be prone to neither of the two surgery approaches. According to GRADE, the overall quality of this meta-analysis was moderate.ConclusionsTDR decreased the rates of ASDeg and reoperation compared with that of ACDF, and the superiority may become more apparent over time. We cautiously and slightly suggest adopting TDR according to the GRADE but may not believe it excessively.
| S-EPMC6169069 | biostudies-literature
Project description:BackgroundHeterotopic ossification (HO) is a known risk following cervical total disc replacement (CTDR) surgery, but the cause and effect of HO are not well understood. Reported HO rates vary, and few studies are specifically designed to report HO. The effects on outcomes, and the risk factors for the development of HO have been hypothesized and reported in small-population, retrospective analyses, using univariate statistics.MethodsPosthoc, multiple-phase analysis of radiographic, clinical, and demographic data for CTDR as it relates to HO was performed. HO was radiographically graded for 164 one-level and 225 two-level CTDR patients using the McAfee and Mehren system. Analysis was performed to correlate HO grades to clinical outcomes and to evaluate potential risk factors for the development of HO using demographics and baseline clinical measures.ResultsAt 7 years, 1-level clinically relevant HO grades were 17.6% grade 3 and 11.1% grade 4. Two-level clinically relevant HO grades, evaluated using the highest patient grade, were 26.6% grade 3 and 10.8% grade 4. Interaction between HO and time revealed significance for neck disability index (NDI; P = .04) and Visual Analog Scale (VAS) neck pain (P = .02). When analyzed at each time point NDI was significant at 48-84 months and VAS neck at 60 months. For predictors 2 analyses were run; odds ratios indicated follow-up visit, male sex, and preoperative VAS neck pain are related to HO development, whereas hazard ratios indicated male sex, obesity, endplate coverage, levels treated, and preoperative VAS neck pain.ConclusionsThis is the largest study to report HO rates, and related outcomes and risk factors. To develop an accurate predictive model, further large-scale analyses need to be performed. Based on the results reported here, clinically relevant HO should be more accurately described as motion-restricting HO until a definitive link to outcomes has been established.
| S-EPMC6159737 | biostudies-literature
Project description:We reviewed charts and radiologic studies of 30 patients operated upon by ADR with Mobi-C® in single level since 2006. All patients had healthy cervical facet joints (less than or equal to grade 1 according to grading systems for cervical facet joint degeneration) preoperatively. We assessed clinical outcomes with NDI and VAS on neck and arm over follow-up and also measured ROM at implanted segment on dynamic radiographs during follow-up. The mean follow-up period was 42.4 ± 15.9 months. We then assessed the linearity of changes in ROM at implanted segment through linear mixed model. All patients showed significantly improved clinical outcomes. ROMs at implanted segment were maintained at slightly increased levels until 24 months postoperatively (P = 0.529). However, after 24 months, ROMs at implanted segment decreased significantly until last follow-up (P = 0.001). In addition, the decreasing pattern after 24 months showed a regular regression (P = 0.001). This decline was correlated with decline of extension angle at implanted segment. Based on this regular regression, we estimated that ROMs at implanted segments would be less than 2 degrees at 10.24 years postoperatively. Even though implanted segment maintains its motion for some length of time, we could assume that an artificial disc would have limited life expectancy correlated with the decline of extension angle.
| S-EPMC7041810 | biostudies-literature