Efficacy Of Total Disc Replacement Research Articles

Cervical Arthroplasty: Long-Term Outcomes of FDA IDE Trials.

Study Design:Special Issues MIS/Navigation.Objectives:Over the past decade, cervical total disc replacement has been established in numerous randomized clinical trials as an alternative to anterior cervical discectomy and fusion. The purpose of this review is to evaluate the long-term outcomes after cervical arthroplasty.Methods/Results:Early outcomes (studies with 2-year follow-up) after arthroplasty established the efficacy of total disc replacement and, more recently, long-term studies have shown the durability of these good clinical outcomes. Biomechanical and clinical data have demonstrated that this motion preservation technology decreases adjacent-level stresses compared with fusion. Additionally, long-term outcomes as well as outcomes after multilevel arthroplasty have now established the role of arthroplasty in select patient populations, namely patients with 1- and 2-level spondylosis/stenosis causing radiculopathy from C3-7.Conclusions:Data on adjacent segment deterioration and adjacent segment reoperation remains controversial but suggest a positive effect after arthroplasty. But these are multifactorial issues and we still do not fully understand all the factors affecting adjacent segment pathology and longer-term studies after arthroplasty will continue to address this issue.

The short-term efficacy and safety of artificial total disc replacement for selected patients with lumbar degenerative disc disease compared with anterior lumbar interbody fusion: A systematic review and meta-analysis.

PurposeTo systematically compare the efficacy and safety of lumbar total disc replacement (TDR) with the efficacy and safety of anterior lumbar interbody fusion (ALIF) for the treatment of lumbar degenerative disc disease (LDDD).MethodsThe electronic databases PubMed, Web of Science and the Cochrane Library were searched for the period from the establishment of the databases to March 2018. The peer-reviewed articles that investigate the safety and efficacy of TDR and ALIF were retrieved under the given search terms. Quality assessment must be done independently by two authors according to each item of criterion. The statistical analyses were performed using RevMan (version 5.3) and Stata (version 14.0). The random-effect model was carried out to pool the data. The I2 statistic was used to evaluate heterogeneity. The sensitivity analysis was carried out to assess the robustness of the results of meta-analyses by omitting the articles one by one.ResultsSix studies (5 randomized controlled trials (RCT) and 1 observational study) involving 1093 patients were included in this meta-analysis. The risk of bias of the studies could be considered as low to moderate. Operative time (MD = 4.95; 95% CI -18.91–28.81; P = 0.68), intraoperative blood loss (MD = 4.95; 95% CI -18.91–28.81; P = 0.68), hospital stay (MD = -0.33; 95% CI, -0.67–0.01; P = 0.05), complications (RR = 0.96; 95% CI 0.91–1.02; P = 0.18) and re-operation rate (RR = 0.54; 95% CI 0.14–2.12; P = 0.38) were without significant clinical difference between groups. Patients in the TDR group had higher postoperative satisfaction (RR = 1.19; 95% CI 1.07–1.32; P = 0.001) and, better improvements in ODI (MD = -10.99; 95% CI -21.50- -0.48; P = 0.04), VAS (MD = -10.56; 95% CI -19.99- -1.13; P = 0.03) and postoperative lumbar mobility than did patients in the ALIF group.ConclusionsThe results showed that TDR has significant superiority in term of reduced clinical symptoms, improved physical function and preserved range of motion for the treatment of LDDD compared to ALIF. TDR may be an ideal alternative for the selected patients with LDDD in the short-term. However, the results of this study cannot suggest the use of TDR instead of ALIF in lumbar spine treatment only in the light of short term results. More studies that are well-designed, that are of high-quality and that have larger samples are needed to further evaluate the efficacy and safety of TDR with at the long-term follow-up.Level of evidenceTherapeutic Level 3

Clinical and Radiological Mid-Term Outcomes of Lumbar Single-Level Total Disc Replacement

Prospective single-center case cohort study. Evaluation of clinical and radiographic outcomes of a consecutive 122-patient cohort with discogenic back pain, at 2- to 10-year follow-up periods, treated by a single surgeon, with CHARITÉ Artificial Disc (DePuy Spine, Raynham, MA). Minimum 2-year clinical and radiographic level 1 data for the first lumbar artificial disc, the CHARITÉ Artificial Disc (DePuy Spine), have recently been published, demonstrating sustained clinical benefit of the device for the treatment of degenerative disc disease. Patients were assessed preoperatively using clinical outcome measures, including visual analog scale (VAS) score back and leg, Oswestry Disability Index (ODI), 36-Item Short Form Health Survey (SF-36), and Roland-Morris Questionnaires (RMDQ), and further assessed postoperatively, 3-, 6-, 12-months, and yearly thereafter. Average follow-up was 44.9 ± 23.3 months (n = 122). The median age at surgery was 43.0 ± 9.0 years. Preoperative diagnosis included degenerative disc disease in 118 (96.7%) and internal disc disruption in 4 (3.3%). Surgery was performed at L5-S1 in 96 (77.9%) patients and at L4-L5 in 27 (22.1%). Statistically significant clinical improvements from baseline were observed on VAS (back and leg), ODI, SF-36 PCS, SF-36 MCS, and RMDQ 3 months onward. Back VAS scores decreased from 78.2 ± 21.3 preoperatively to 21.9 ± 27.8 by final follow-up. ODI scores decreased from 51.1 ± 17.3 to 16.2 ± 17.9 at last follow-up. The RMDQ scores also decreased from 16.7 ± 4.7 to 4.2 ± 5.8. SF-36 PCS and MCS increased from 25.7 ± 11.0 to 46.4 ± 10.3 for PCS and from 35.5 ± 17.4 to 51.6 ± 10.8 for MCS. Patient satisfaction surveys indicated that 90.56% patients rated their satisfaction with the surgery as "excellent" or "good" at 2 years. Range of motion averaged 8.6 ± 3.5 (median = 8.0°) at the last follow-up time point. Outcomes verify the clinical efficacy of total disc replacement for treatment of discogenic back pain with or without radiculopathy. The outcomes instruments demonstrated statistically significant improvements 3 months onward. N/A.

Prospective, Randomized Comparison of One-level Mobi-C Cervical Total Disc Replacement vs. Anterior Cervical Discectomy and Fusion: Results at 5-year Follow-up.

There is increasing interest in the role of cervical total disc replacement (TDR) as an alternative to anterior cervical discectomy and fusion (ACDF). Multiple prospective randomized studies with minimum 2 year follow-up have shown TDR to be at least as safe and effective as ACDF in treating symptomatic degenerative disc disease at a single level. The purpose of this study was to compare outcomes of cervical TDR using the Mobi-C(®) with ACDF at 5-year follow-up. This prospective, randomized, controlled trial was conducted as a Food and Drug Administration regulated Investigational Device Exemption trial across 23 centers with 245 patients randomized (2:1) to receive TDR with Mobi-C(®) Cervical Disc Prosthesis or ACDF with anterior plate and allograft. Outcome assessments included a composite overall success score, Neck Disability Index (NDI), visual analog scales (VAS) assessing neck and arm pain, Short Form-12 (SF-12) health survey, patient satisfaction, major complications, subsequent surgery, segmental range of motion, and adjacent segment degeneration. The 60-month follow-up rate was 85.5% for the TDR group and 78.9% for the ACDF group. The composite overall success was 61.9% with TDR vs. 52.2% with ACDF, demonstrating statistical non-inferiority. Improvements in NDI, VAS neck and arm pain, and SF-12 scores were similar between groups and were maintained from earlier follow-up through 60 months. There was no significant difference between TDR and ACDF in adverse events or major complications. Range of motion was maintained with TDR through 60 months. Device-related subsequent surgeries (TDR: 3.0%, ACDF: 11.1%, p<0.02) and adjacent segment degeneration at the superior level (TDR: 37.1%, ACDF: 54.7%, p<0.03) were significantly lower for TDR patients. Five-year results demonstrate the safety and efficacy of TDR with the Mobi-C as a viable alternative to ACDF with the potential advantage of lower rates of reoperation and adjacent segment degeneration, in the treatment of one-level symptomatic cervical degenerative disc disease. This prospective, randomized study with 5-year follow-up adds to the existing literature indicating that cervical TDR is a viable alternative to ACDF in appropriately selected patients. This is a Level I study.

Effect of total disc replacement on atypical symptoms associated with cervical spondylosis

To determine the efficacy of total disc replacement (TDR) for the treatment of cervical spondylosis associated with atypical symptoms. In this retrospective study, patients with myelopathy and/or radiculopathy related to cervical spondylosis that were treated with TDR were contacted by phone. Atypical symptoms involved in the questionnaire included dizziness, headache, nausea, vomiting, blurred vision, tinnitus, palpitations, hypomnesia, and abdominal discomfort. The severity of each atypical symptom was evaluated separately based on an numerical rating scale. The radiographs and charts before and after the surgery were reviewed. Paired samples t tests were used to compare the severity of the symptoms before and after surgery. Between 2003 and 2010, 73 of 133 patients diagnosed with cervical spondylotic myelopathy and/or radiculopathy treated by TDR experienced atypical symptoms before surgery. The mean follow-up was 34.6 months. There were 47 males and 26 females (mean age 48.9 years). Of the 73 patients, 41 were diagnosed with myelopathy; 13 with radiculopathy; and 19 with mixed-type spondylosis. The incidence of each symptom before surgery was dizziness (46.6%), tinnitus (41.1 %), facial flushing and sweating (41.1 %), palpitations (39.7%), headache (35.6%), hypomnesia (30.1%), nausea and vomiting (20.5%), blurred vision (20.5%), and gastroenterologic discomfort (5.5%). The severity of the following symptoms improved after surgery: dizziness (p = 0.000, α = 0.05), headache (p = 0.000, α = 0.05), nausea and vomiting (p = 0.000, α = 0.05), blurred vision (p = 0.004, α = 0.05), tinnitus (p = 0.000, α = 0.05), palpitations (p = 0.000, α = 0.05), hypomnesia (p = 0.010, α = 0.05), and other symptoms (p = 0.030, α = 0.05). The gastroenterologic discomfort did not improve (p = 0.731, α = 0.05). TDR may have a positive effect on atypical symptoms associated with cervical spondylotic myelopathy and/or radiculopathy.