ProDisc-C versus fusion with Cervios chronOS prosthesis in cervical degenerative disc disease: Is there a difference at 12 months?
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ABSTRACT: STUDY DESIGN: Prospective cohort study. OBJECTIVE: The aim of the study was to compare clinical results and to determine differences in outcomes between anterior cervical discectomy and fusion (ACDF) and disc arthroplasty in patients treated for symptomatic cervical degenerative disc disease. METHODS: Forty patients with cervical degenerative disc disease were treated with ProDisc-C disc arthroplasty and 40 patients with fusion using an intervetebral spacer with integrated fixation (Cervios chronoOS) implants without additional anterior fixation. Fifty disc prostheses were placed in the first group and 52 intervertebral spacers were implanted in the second group. Clinical outcomes were assessed before and 12 months following the procedure using the neck disability index (NDI) and visual analog scale (VAS) for neck and arm pain, with 15% improvement in NDI and 20% in VAS defined as a clinically significant. RESULTS: Eighty patients with cervical degenerative disc disease with a mean age of 49.7 years were included in the study with a minimum follow-up of 12 months. The groups were similar at baseline both clinically and statistically (P > .05) except for age and VAS for arm pain. Both groups had a statistically significant improvement in NDI and VAS for neck and arm pain (P < .05) and the arthroplasty group had a better improvement according to NDI (74.3% of patients in the arthroplasty group achieved ≥15% improvement in NDI versus 65.7% of patients in ACDF group). CONCLUSIONS: Both ProDisc C and Cervios chronoOS prostheses resulted in significant pain reduction and functional outcome for the patients with slightly better results in the group treated with disc arthroplasty 12 months after the surgery. [Table: see text] The definiton of the different classes of evidence is available on page 83.
Project description:The purpose of this meta-analysis was to explore whether cervical disc arthroplasty (CDA) was superior to anterior cervical discectomy and fusion (ACDF) in reducing secondary surgery. PubMed, EMBASE, and the Cochrane Library databases were systematically searched. Outcomes were reported as relative risk (RR) with the corresponding 95% confidence interval (CI). The pooled data was calculated using a random-effect model. We also used the trial sequential analysis (TSA) to further verify our results and obtain more moderate estimates. Twenty-one studies with 4208 patients were included in this meta-analysis. The results indicated that compared with ACDF, CDA had fewer frequency of secondary surgery at the index level (RR, 0.47; 95%CI, 0.36-0.63; P < 0.05) and adjacent level (RR, 0.48; 95%CI, 0.36-0.65; P < 0.05), and the differences were statistically significant. In addition, in terms of the overall frequency of secondary surgery at the index and adjacent level, CDA was also significantly superior to ACDF (RR, 0.49; 95%CI, 0.41-0.60; P < 0.05). TSA demonstrated that adequate and decisive evidence had been established. Regarding the frequency of secondary surgery, CDA was significantly superior to ACDF. It was supposed that CDA may be a better surgical intervention to reduce the rate of secondary surgery for patients with cervical degenerative disc disease.
Project description:The objective of this meta-analysis is to compare hybrid surgery (HS) and cervical discectomy and fusion (ACDF) for multilevel cervical degenerative disc diseases (DDD). Systematic searches of all published studies through March 2015 were identified from Cochrane Library, Medline, PubMed, Embase, ScienceDirect, CNKI, WANFANG DATA and CQVIP. Randomized controlled trials (RCTs) and non-RCTs involving HS and ACDF for multilevel DDD were included. All literature was searched and assessed by two independent reviewers according to the standard of Cochrane systematic review. Data of functional and radiological outcomes in two groups were pooled, which was then analyzed by RevMan 5.2 software. One RCT and four non-RCTs encompassing 160 patients met the inclusion criteria. Meta-analysis revealed significant differences in blood loss (p = 0.005), postoperative C2-C7 ROM (p = 0.002), ROM of superior adjacent segment (p < 0.00001) and ROM of inferior adjacent segment (p = 0.0007) between the HS group and the ACDF group. No significant differences were found regarding operation time (p = 0.75), postoperative VAS (p = 0.18) and complications (p = 0.73) between the groups. Hybrid surgery demonstrated excellent clinical efficacy and radiological results. Postoperative C2-C7 ROM was closer to the physiological status. No decrease in the ROM of the adjacent segment was noted in the hybrid surgery group.
Project description:Determining important links between medical comorbidities and cervical spine degenerative disc disease (DDD) will help elucidate pathomechanisms of disc degeneration. Electronic medical records and magnetic resonance imaging were retrospectively reviewed to evaluate 799 patients assessed for cervical spine pathology. Bivariate analysis identified older age, diabetes, ASA class, cancer, COPD, depression, hypertension, hypothyroidism, Medicare status, peripheral vascular disease, history of previous cervical spine surgery, smoking, and lower median household income as having strong associations with increased cumulative grade of cervical spine DDD. This study provides evidence suggesting aging and accumulation of medical comorbidities influence severity of cervical spine DDD.
Project description:The authors performed a retrospective controlled study of patients diagnosed with lumbar degenerative disc disease who received surgical intervention (either total disc replacement [TDR]/Activ-L or anterior lumbar interbody fusion [ALIF]) at a single tertiary-care hospital from 2007-2010.To investigate the clinical outcomes after TDR in comparison with ALIF for surgical treatment of lumbar degenerative disc disease (DDD).Analyzed data included intra-operative blood loss, time to return to work, and clinical outcomes as evaluated through the Oswestry Disability Index (ODI) and the Visual Analog Scale (VAS) pain questionnaires pre-operatively and at 6 weeks, 3 months, 6 months, and 1 year postoperative follow-up.At the univariate analysis, patients submitted to TDR presented significantly lower VAS pain scores than patients who received ALIF starting at 6 weeks (P < .001) and continuing through one year postoperatively (P = .007). Patients submitted to TDR also presented significantly lower ODI disability scores at all time points. There was a significant difference in the number of days to return to work, with TDR patients returning to work on average 65 days sooner than ALIF patients (P = .011). There was no significant difference in the total blood loss between both groups.The results of this retrospective controlled study suggest that, in comparison with patients submitted to ALIF, patients submitted to TDR present quicker return to work, less back pain, and lower disability scores at 1 year follow-up.
Project description:Study DesignA retrospective cohort utilizing the PearlDiver Patient Claims Database.ObjectiveCervical disc arthroplasty (CDA) is accepted treatment for cervical radiculopathy; however, it may also be safe and effective in myelopathy. Thus, we compared clinical characteristics and outcomes in patients undergoing CDA and anterior cervical discectomy and fusion (ACDF) for degenerative cervical myelopathy (DCM) specifically.MethodsPatients undergoing CDA or ACDF between 2015-2019 were identified with follow-up through 2021. Univariate and multivariable analyses were performed to identify factors associated with either procedure. Reoperation rates were compared using propensity-matched analysis.ResultsWe identified n = 2391 CDA and n = 50 845 ACDF procedures for DCM. Factors favoring CDA included: female sex, younger age, lower CCI, lower incidence of obesity, osteoporosis, diabetes, or smoking (P ≤ .001); remaining significant after multivariable logistic regression except for sex (P = .06). Single-level surgery was more predictive for undergoing CDA. CDA patients had lower 90-day readmissions, complications, and lower opioid utilization. The overall reoperation rate was 5%. Predictors of reoperation included: male sex, younger age, greater CCI, obesity, osteoporosis, diabetes, smoking, and multi-level surgery; all remaining significant after multivariable analysis except for diabetes (P = .23) and CCI (P = .05). After propensity-matching CDA and ACDF patients (n = 2391), there was no difference in re-operation rates (P = .47).ConclusionsCDA patients were healthier (less obesity, smoking, diabetes, better CCI) and represented 4.5% of anterior procedures for DCM. In univariate analysis, readmission rates, medical complications, and opioid use were lower in CDA patients, despite a similar reoperation rate. Considering these findings, CDA might be used very selectively for DCM.
Project description:ObjectiveSymptomatic cervical disc disease (SCDD) is a common degenerative disease, and Discover artificial cervical disc, a new-generation nonconstrained artificial disk, has been developed and performed gradually to treat it. We performed this meta-analysis to compare the efficacy and safety between Discover cervical disc arthroplasty (DCDA) and anterior cervical discectomy and fusion (ACDF) for SCDD.MethodsAn exhaustive literature search of PubMed, EMBASE, and the Cochrane Library was conducted to identify randomized controlled trials that compared DCDA with ACDF for patients suffering SCDD. A random-effect model was used. Results were reported as standardized mean difference or risk ratio with 95% confidence interval.ResultsOf 33 articles identified, six studies were included. Compared with ACDF, DCDA demonstrated shorter operation time (P < 0.0001), and better range of motion (ROM) at the operative level (P < 0.00001). But no significant differences were observed in blood loss, neck disability index (NDI) scores, neck and arm pain scores, Japanese orthopaedic association (JOA) scores, secondary surgery procedures and adverse events (P > 0.05). Subgroup analyses did not demonstrated significant differences.ConclusionIn conclusion, DCDA presented shorter operation time, and better ROM at the operative level. However, no significant differences were observed in blood loss, NDI scores, neck and arm pain scores, JOA scores, secondary surgery procedures and adverse events between the two groups. Additionally, more studies of high quality with mid- to long-term follow-up are required in future.
Project description:BackgroundCervical disc arthroplasty (CDA) has emerged as an alternative to anterior cervical discectomy and fusion (ACDF) for the treatment of cervical pathologies. Studies are on-going to assess the long term outcomes of CDA. This study assessed the safety and efficacy of the Prestige(®) LP Disc at 84-months follow up.MethodsProspective data from 280 CDA patients with single-level cervical disc disease with radiculopathy or myelopathy were compared with 265 historical control ACDF patients. Clinical and radiographic follow up was completed pre-operatively, intraoperatively, and at intervals up to 84 months.ResultsFollow-up rate was 75.9% for CDA and 70.0% for ACDF patients. Statistical improvements (p < 0.001) in Neck Disability Index (NDI), neck/arm pain, and SF-36 were achieved by 1.5 months in both groups and maintained through 84 months. At 84 months, 86.1% of CDA versus 80.1% of ACDF patients achieved NDI success, (≥15-point improvement over baseline). Mean NDI score improvements exceeded 30 points in both groups. SF-36 PCS/MCS mean improvements were 13.1±11.9/8.2±12.3 points for CDA and 10.7±11.8/8.3±13.6 points for ACDF. Neurological success was 92.8% for CDA and 79.7% for ACDF patients. The rate of Overall Success was 74.9% for CDA and 63.2% for ACDF. At 84 months, 17.5% of CDA and 16.6% of ACDF patients had a possibly implant- or implant-surgical procedure-related adverse event. Eighteen (6.4%) CDA and 29 (10.9%) ACDF patients had a second surgery at the index level. In CDA patients, mean angular motion at the target level was maintained at 24 (7.5°) and 84 (6.9°) months. Bridging bone was reported in 5.9%/9.5%/10.2%/13.0% of CDA patients at 24/36/60/84 months. Change in mean preoperative angulation of the adjacent segment above/below the index level was1.06±4.39/1.25±4.06 for CDA and (-0.23)±5.37/1.25±5.07 for ACDF patients. At 84 months, 90.9% of CDA and 85.6% of ACDF patients were satisfied with the results of their treatment.ConclusionsPrestige LP maintained significantly improved clinical outcomes and segmental motion; statistical superiority of CDA was concluded for overall success. This investigational device exemption study was sponsored by Medtronic Spinal and Biologics, Memphis, TN. Study approved by the Hughston Sports Medicine Center Institutional Review Board on January 7, 2005. Clinical trial registered at clinicaltrials.gov: NCT00667459. All participants signed an informed consent.
Project description:BackgroundThis meta-analysis was designed to investigate the long-term efficacy and safety between cervical disc arthroplasty (CDA) and anterior cervical discectomy and fusion (ACDF) in treating cervical disc degenerative diseases (CDDDs).MethodsLiterature search was performed on Pubmed, Embase, Cochrane Library, and Web of Science before Jan 2019. Surgical details, clinical outcomes, range of motion (ROM), complications, and reoperation rates between CDA and ACDF groups were compared and analyzed. A fixed- or random-effects model was applied based on different heterogeneity. STATA (Version 11.0) software was used to perform data analysis.ResultsA total of 13 randomized controlled trial studies with more than 60 months of follow-up (mean 83.1 months) were enrolled in this meta-analysis. Pool results indicated that the CDA group exhibited significantly better outcomes in clinical scores (odds ratio [OR] = 1.54, 95% confidence interval [CI]: 1.15-2.08, p = 0.004) and preservation of ROM (mean difference = 1.77, 95% CI: 1.60-1.95, p < 0.001) than the ACDF group. Meanwhile, the incidence of adjacent segment disease (ASD) (OR = 0.51, 95% CI: 0.35-0.76, p = 0.001) and occurrence of reoperation (OR = 0.41, 95% CI: 0.25-0.69, p = 0.001) were lower in the CDA group than in the ACDF group.ConclusionsAt long-term follow-up, CDA showed better efficacy in terms of clinical outcomes, ROM, ASD, and reoperation than ACDF for treating CDDDs. However, our results require further validation in large-sample and high-quality studies.