Total Disc Replacement Group Research Articles

Five-year Follow-up of a Prospective Food and Drug Administration Investigational Device Exemption Trial Evaluating a PEEK-on-Ceramic Cervical Disc Replacement.

Prospective trial comparing the investigation group to propensity matched historic control group. To evaluate 5-year results of single-level PEEK-on-ceramic cervical total disc replacement (TDR) compared to a propensity matched anterior cervical discectomy and fusion (ACDF) control group. Cervical TDR has gained acceptance as treatment for symptomatic disc degeneration. The design and materials used in these devices continue to evolve. Data were collected in the Food and Drug Administration Investigational Device Exemption trial for the PEEK-on-ceramic Simplify(®) Cervical Artificial Disc (n=150) with comparison to a propensity matched ACDF control group (n=117). All patients were treated for single-level cervical disc degeneration with radiculopathy and/or myelopathy. Clinical outcome was based on composite clinical success (CCS), Neck Disability Index (NDI), visual analog scales (VAS) assessing pain, re-operations, and satisfaction. Radiographic measures included segmental range of motion (ROM), disc space height, and heterotopic ossification (HO). Evaluations were performed pre-operatively and post-operatively within 2 and 6 weeks, and 3, 6, 12 months, and annually thereafter. At 5-year follow-up, CCS was significantly greater with TDR than ACDF (91.1% vs. 74.6%; P<0.01). In the TDR group, the mean NDI score was 63.3 pre-operatively, reduced significantly to 23.1 at 6 weeks and remained below 20 throughout 5-year follow-up. In the ACDF group, the mean pre-operative NDI score was 62.4, decreasing to 33.7 at 6 weeks, and ranged from 25.9 to 21.5 throughout follow-up. Mean NDI scores were significantly lower in TDR group at all post-operative points (P<0.05). Mean TDR ROM was 7.3o pre-operatively and 10.1o at 5 years. Bridging HO occurred in 9%. With TDR, there were 6 re-operations (4.0%) vs. 11 (9.4%) with ACDF (P>0.40). PEEK-on-ceramic TDR produced significantly improved outcomes maintained throughout 5-year follow-up, were similar or superior to ACDF, supporting TDR in appropriately selected patients.

Lumbar Total Disc Replacement Leads to Increased Subsequent Facet Injections Compared to Anterolateral Lumbar Interbody Fusions

Study Design Retrospective Matched Cohort. Objective Despite known consequences to the facet joints following lumbar total disc replacement (TDR), there is limited data on facet injection usage for persistent postoperative pain. This study uses real-world data to compare the usage of therapeutic lumbar facet injections as a measure of symptomatic facet arthrosis following single-level, stand-alone TDR vs anterolateral lumbar interbody fusion (ALIF/LLIF). Methods The PearlDiver database was queried for patients (2010-2021) with lumbar degenerative disc disease who received either a single-level, stand-alone TDR or ALIF/LLIF. All patients were followed for ≥2 years and excluded if they had a history of facet injections or spinal trauma, fracture, infection, or neoplasm. The two cohorts were matched 1:1 based on age, sex, insurance, year of operation, and medical comorbidities. The primary outcome was the use of therapeutic lumbar facet injections at 1-, 2-, and 5-year follow-up. Secondary outcomes included subsequent lumbar surgeries and surgical complications. Results After 1:1 matching, each cohort had 1203 patients. Lumbar facet injections occurred significantly more frequently in the TDR group at 1-year (6.07% vs 1.66%, P &lt; .0001), 2-year (8.40% vs 3.74%%, P &lt; .0001), and 5-year (11.47% vs 6.40%, P &lt; .0001) follow-up. 5-year injection-free probability curves demonstrated an 87.1% injection-free rate for TDR vs 92.9% for ALIF/LLIF. There was no clinical difference in the incidence of subsequent lumbar surgeries or complications. Conclusion Compared with ALIF/LLIF, patients who underwent TDR received significantly more facet injections, suggesting a greater progression of symptomatic facet arthrosis. TDR was not protective against reoperations compared to ALIF/LLIF.

Comparable long-term outcomes in patients undergoing total disc replacement or anterior cervical discectomy and noninstrumented fusion

BACKGROUND CONTEXTAnterior cervical discectomy and fusion (ACDF) is the leading surgical treatment for cervical radiculopathy. However, ACDF surgery has been suggested for to accelerate the degeneration of the adjacent cervical discs, which causes so-called adjacent segment disease (ASD). Over the past 2 decades, total disc replacement (TDR)/cervical disc arthroplasty (CDA) has become an increasingly common method for treating degenerative cervical diseases. The rationale is that a synthetic disc prosthesis may preserve motion at the operated level, which is expected to lead to reduced stress on the other cervical levels and thus decrease the risk of developing ASD. However, since the method was first introduced in the early 2000s, the long-term outcome after it is still not completely understood. PURPOSEOur goal was to compare the long-term outcomes of TDR and ACDF procedures. STUDY DESIGNRetrospective case-control study. PATIENT SAMPLEAll patients who underwent TDR due to degenerative cervical disease at Helsinki University Hospital between 2006 and 2012 (38 patients) and matched control patients who underwent ACDF during this period (76 patients) for degenerative disc disease. OUTCOME MEASURESThe primary outcome measure was the rate of reoperations and further cervical surgeries. Secondary outcome measures included neck symptoms (Neck Disability Index, or NDI), health-related quality of life (EQ-5D-3L), satisfaction with the surgery, radiological outcomes, and employment status. METHODSThe medical records of all patients who underwent TDR due to degenerative cervical disease at Helsinki University Hospital between 2006 and 2012 and those of the matched control patients were analyzed retrospectively. Questionnaires were sent to all available patients at the end of the follow-up (median 14 years) to evaluate their employment status, levels of satisfaction with the surgery, current neck symptoms, and health-related quality of life. Radiological outcomes were evaluated from the cervical plain radiographs, which were taken either at the end of the follow-up as a part of the present study or earlier on for other clinical reasons, but at least 2 years after index surgery. RESULTSThe total rate of reoperations and further cervical surgeries during the follow-up of a median of 14 years was 7/38 (18%) in the TDR group and 6/76 (8%) in the ACDF group (p=.096, ns.). Total disc replacement patients were reoperated earlier, and the 5-year reoperation rate was significantly higher in the TDR group (11% vs 1.3%, p=.026). None of the TDR patients underwent further cervical surgery more than 6 years after index surgery, whereas 5/6 (83%) of the reoperated ACDF patients were reoperated after that time. There were no significant differences in the NDIs between the patient groups. The employment rate and health-related quality of life were slightly higher in the TDR group, but the differences were statistically nonsignificant. TDR was significantly better at maintaining the angular range of motion at the operated level, and the fusion rate was significantly lower among this group. CONCLUSIONSThere were no significant differences in the long-term outcomes of ACDF and TDR when measured by reoperation rates, employment status, NDI, EuroQoL, and satisfaction with surgery. Reoperation rate and, on the other hand, employment rate and health-related quality of life, were higher in the TDR group, but the differences were statistically nonsignificant. However, TDR patients were reoperated earlier, and the 5-year reoperation rate was significantly higher in the TDR group. Randomized long-term studies in which these methods are compared are needed to further clarify the differences between them.

Early Experiences of One-Level Total Disc Replacement (Prestige LP) in Japan: A Comparison of Short-Term Outcomes with Anterior Cervical Discectomy with Fusion.

In Japan, cervical total disc replacement (TDR) was approved in 2017. However, because of its short history, no comparative study between cervical TDR and anterior cervical discectomy with fusion (ACDF) has been conducted in the country. Therefore, we examined and compared the surgical outcomes of TDR and ACDF for one-level cervical degenerative diseases. In total, 50 patients who had received anterior surgeries for one-level cervical degenerative diseases were investigated. Among them, 25 underwent TDR (Prestige LP; Medtronic), whereas the other 25 patients underwent ACDF. ACDF samples were selected from cases conducted before the approval of TDR (-2017.9) and were retrospectively judged to be indicated for TDR. Before and at 1 year after surgery, clinical and radiological outcomes were evaluated. No significant differences in terms of patient demographics between the two groups were observed. A longer operative time was observed in the TDR group than in the ACDF group. Postoperatively, no differences in the Japanese Orthopaedic Association score for cervical myelopathy (C-JOA) score, neck pain visual analog scale, C2-7 angle, and C2-7 range of motion (ROM) were determined. TDR tended to show better neck disability index (NDI) scores postoperatively when compared with ACDF. The local angle at operative level was larger in ACDF. In TDR, the local ROMs were maintained postoperatively; however, in ACDF, the local ROM at the operative level was decreased, and the local ROMs at adjacent levels were increased postoperatively. In the TDR group, although heterotopic ossification was observed in 11 patients (44.0%), and anterior bone loss was identified in 14 patients (56.0%), these issues did not affect surgical outcomes. Conclusively, no differences in terms of C-JOA score and neck pain between patients treated through TDR and ACDF were observed. However, a trend of better NDI scores was identified with TDR. While TDR maintained postoperative ROMs, ACDF showed an increase in the local ROMs at adjacent levels.

81. Mobility parameters in two level-lumbar TDR vs hybrid construct: clinical results in 235 patients

<h3>BACKGROUND CONTEXT</h3> Lumbar total disc replacement (TDR) is a treatment option with 30 years experience and extensive publications on clinical results. However, there are few publications on mid- and long-term mobility. There is also sparse literature on the quality of mobility or the difference between L4-S1 2-level TDR vs TDR/ALIF hybrid constructs. <h3>PURPOSE</h3> To measure mobility parameters in flexion-extension for two groups (L4-S1 TDR vs hybrid); compare motion at L4–L5; participation of pelvis mobility; global lumbar motion; and flexion-extension effectiveness by measuring L1 race. Besides determining the difference of mobility between TDR and hybrid, we discussed potential compensations above and below L5-S1 fusion/L4-L5 TDR, as compared to two-level TDR. <h3>STUDY DESIGN/SETTING</h3> Retrospective clinical study. <h3>PATIENT SAMPLE</h3> This study included 235 patients, operated between 2003-2013: 170 patients received 2-level TDR (TDR group) and 65 received L4-L5 TDR and L5-S1 ALIF (hybrid group). <h3>OUTCOME MEASURES</h3> Data collected included radiographic, neurological/physical assessment, self-evaluation using the Oswestry Disability Index (ODI) and visual analog back and leg pain scores (VAS). Complication, reoperation/revision rates, and perioperative data points were also assessed. <h3>METHODS</h3> Both groups were equivalent in age, body habitus and preoperative clinical parameters (ODI, VAS). Patient selection for evaluation was based on presence of clinical success criteria and pre- and postoperative sagittal X-rays and dynamic flexion-extension films at minimum 24-month follow-up. Pelvic parameters (Incidence, Pelvic Tilt, Sacral Slope) were measured. L4-L5 and L5-S1 flexion-extension range of motion (ROM) was measured pre- and postoperatively. Pelvic motion was determined by measuring sacral slope in flexion-extension. The influence on lumbar lordosis (L1-S1) was also analyzed. To show the effect the lumbopelvic complex has on global motion, we measured L1 race (flexion-extension L1 ROM). <h3>RESULTS</h3> The absolute motion and relative gain of 2-level TDR shows its superiority over hybrid constructs in all measured parameters. When L5-S1 is fused, there is no compensation from pelvic motion to overcome the loss of mobility. TDR group shows a pelvi-femoral ROM gain of 16.77°, vs a gain of only 6.11° in the Hybrid group. L5-S1 fusion also reduces L4-L5 TDR mobility in Hybrid group, compared to 2-level TDR, and decreases flexion compared to baseline. There is a mean reduction in ROM of 1.53° in Hybrid group vs 20.02° gain in TDR group. L1 race also reflects the superiority of 2-level TDR vs hybrid with a gain of 32.58° in TDR vs 4.68° in hybrid, demonstrating that reduced global motion is principally due to loss of L5-S1 motion. <h3>CONCLUSIONS</h3> This comparison between 2-level TDR and hybrid demonstrates a lack of compensation through lumbar mobility and pelvic motion when L5-S1 is fused, and debunks these preconceived ideas. Although clinical measures of activity (ODI) and pain (VAS back and leg pain) are equivalent between the groups, functional superiority of 2-level TDR is confirmed. Two new ROM parameters introduced here—pelvic motion and L1 race—must be integrated in all ROM studies as they quantify pelvic participation in mobility and the functional effectiveness of motion preservation. In this first long-term comparison of mobility between 2-level TDR vs L4-S1 hybrid, 2-level TDR demonstrates overall superiority. Consequently, 2-level TDR must be systematically indicated whenever TDR is indicated for both levels, and accepted as the "gold standard" for reimbursement purposes. <h3>FDA DEVICE/DRUG STATUS</h3> Prodisc L 1- and 2-level (Approved for this indication), Prodisc L hybrid constructs (Not approved for this indication)

Correlation between the degree of pain relief following discoblock and short-term surgical disability outcome among patients with suspected discogenic low back pain.

To evaluate how well the degree of pain relief after discoblock predicts the disability outcome of subsequent fusion or total disc replacement (TDR) surgery, based on short-term Oswestry Disability Index (ODI) scores. We retrospectively analyzed a set of patients who had undergone discoblock and subsequent fusion or TDR surgery of the same lumbar intervertebral disc due to suspected discogenic chronic LBP between 2011 and 2018. We calculated the degree of pain relief following discoblock (ΔNRS) and the changes in both absolute and percentual ODI scores (ΔODI and ΔODI%, respectively) following fusion or TDR surgery. We analyzed the statistical significance of ΔNRS and ΔODI and the correlation (Spearman's rho) between ΔNRS and ΔODI%. The fusion and TDR group were analyzed both in combination and separately. Fifteen patients were eligible for the current study (fusion n=9, TDR n=6). ΔNRS was statistically significant in all groups, and ΔODI was statistically significant in the combined group and in the fusion group alone. The parameters of both decreased. We found a Spearman's rho of 0.57 (p=0.026) between ΔNRS and ΔODI% for the combined group. The individual Spearman's rho values were 0.85 (p=0.004) for the fusion group and 0.62 (p=0.191) for the TDR group. We suggest that discoblock is a useful predictive criterion for disability outcome prior to surgery for discogenic LBP, especially when stabilizing spine surgery is under consideration. 174/2019 (Oulu University Hospital Ethics Committee).

Comparison of Different Hybrid Techniques for the Treatment of Multilevel Cervical Degenerative Disc Disease–Analysis of Prospectively Collected Clinical, Radiologic, and Psychological Parameters

Conventional surgical treatment of multilevel cervical disc disease is based on anterior cervical discectomy and fusion (ACDF). However, fusion alters the biomechanics of the spine, potentially resulting in accelerated adjacent segment degeneration. To improve clinical outcomes, hybrid surgery, combining cervical disc arthroplasty with fusion, has been developed. Cervical total disc replacement (TDR) has been shown to keep the motion of adjacent segment, and a dynamic cervical implant (DCI) was shown to provide cervical dynamic stability under nonfusion. However, curative and unwanted side effects of the new therapy options TDR and DCI for treating multilevel cervical degenerative disc disease are still unknown. This analysis is based on 88 patients treated for multilevel cervical degenerative disc disease with ACDF only (56 patients), DCI hybrid (17 patients), and TDR hybrid (15 patients) between June 2008 and November 2015. The mean follow-up was 19.5 months. Visual analog scale (VAS), Neck Disability Index, and quality-of-life measurements were assessed via questionnaires. The VAS scores decreased significantly in all 3 groups (P < 0.001), but the TDR group showed the greatest reduction in VAS score compared with ACDF and DCI (both P < 0.05). The overall range of motion (ROM) and the segmental ROM at the treated levels showed significant decreases in all 3 groups. Although there was no difference in the overall ROM at final follow-up among the operatively treated groups, the ROM of the treated segment was lowest in the ACDF group (P= 0.002). In terms of heterotopic ossification, patients undergoing TDR showed the best prognosis. These results indicate that both TDR hybrid and DCI hybrid are effective and safe procedures for the treatment of multilevel degenerative disc disease. However, there is no definitive evidence that DCI or TDR arthroplasty lead to better intermediate-term results than ACDF over an average observation time of 19.5 months.

In which cases do surgeons specializing in total disc replacement perform fusion in patients with cervical spine symptoms?

The purpose was to investigate reasons and their frequency for why total disc replacement (TDR) specialty surgeons performed anterior cervical discectomy and fusion (ACDF) rather than TDR. A consecutive series of 464 patients undergoing cervical spine surgery during a 5-year period by three TDR specialty surgeons was reviewed. For each ACDF, the reason for not performing TDR was recorded. TDR was performed in 76.7% of patients (n = 356) and ACDF in 23.3% (n = 108). The most common reason for ACDF versus TDR was anatomical (conditions that may not be adequately addressed with TDR and/or may interfere with device function), which occurred in 64 of 464 patients (13.79%). The second most common reason was insurance (denial/lack of coverage n = 17, 3.23%), and deformity/kyphosis not addressable with TDR was noted in 13 (2.80%). Pseudoarthrosis repair led to ACDF in three patients (0.65%), two did not receive TDR due to osteoporosis (0.43%), and in two others (0.43%) ACDF was undertaken due to high risk of heterotopic ossification. There was one case (0.22%) each of: nickel allergy, trauma with posterior element fracture, TDR removal, multiple prior cervical spine surgeries, concern about artifact on future imaging studies, benign osteoblastic bone, and limitation to adequate surgical approach for TDR. ACDF patients' mean age was significantly greater than TDR patients' (55.3 vs. 46.7years; p < 0.01). TDR group had significantly more single-level procedures than ACDF (60.8% vs. 43.5%; p < 0.05). The most common reason for ACDF versus TDR was anatomy that may compromise segmental stability and/or TDR functionality. Older age and greater number of operated levels may be related to anatomical factors, primarily significant osteophytes and severely degenerated facets. These factors, as well as deformity/kyphosis, are more common in older patients and require multi-level treatment. This study found that many patients are good cervical TDR candidates; however, even among TDR specialists, ACDF may be preferred where it is prudent to not take undue risks. These slides can be retrieved under Electronic Supplementary Material.

Segmental Motion of the Cervical Spine After Total Disc Replacement Using ActivC Versus Discectomy and Fusion Using Stand-alone Cage

Anterior cervical discectomy and fusion (ACDF) has been a widely accepted procedure for the treatment of cervical disc diseases. However, due to several reports regarding postfusion exacerbation of adjacent segments, a motion-preserving prosthesis was developed. In the present retrospective analysis, total disc replacement (TDR) using ActivC (Aesculap AG, Tuttlingen, Germany) was compared with ACDF using a stand-alone cage. Among patients diagnosed with cervical disc diseases, those who received either ACDF or TDR at a single level between C3 and C7 from January 2010 to December 2015 were reviewed. Clinical outcomes were assessed using the visual analogue scale for arm and neck pain and the neck disability index. Clinical scales, lateral neutral, and flexion-extension radiographs were taken for all patients preoperatively and 2 months, 6 months, 1 year, and 2 years postoperatively. Global lordosis, C2-C7 Sagittal vertical axis, and T1 slope were measured on lateral neutral radiographs. The segmental range of motion (ROM) of the operated level, cranial adjacent level, and caudal adjacent level were defined as the difference between Cobb angles on flexion-extension lateral radiographs. A total of 53 patients (mean age 48.5 years) were reviewed. Thirty patients were treated with ACDF and the remaining 23 patients received TDR. At the 2-year follow-up, the segmental ROM of operated level was significantly preserved in the TDR group compared with the ACDF group (P= 0.007). Conversely, no significant differences in the ROM at the adjacent segments were observed between the TDR and ACDF groups (P > 0.05). The clinical outcome was excellent in both ACDF and TDR groups and was maintained until the 2-year follow-up. In the present study, TDR using ActivC showed successful motion preservation at the operated level and equivalent results were observed with ACDF based on clinical and radiologic results.

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 Outcomes of Treating Cervical Adjacent Segment Disease by Anterior Cervical Discectomy and Fusion Versus Total Disc Replacement: A Systematic Review and Meta-Analysis

Study Design:Systematic review and meta-analysis.Objective:To compare clinical outcomes of all available adjacent segment disease (ASD) cohorts being treated by either anterior cervical discectomy and fusion (ACDF) or total disc replacement (TDR).Methods:We followed the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines for systematic reviews. Searches of electronic databases from inception to August 2017 identified 349 articles for screening. Data was extracted and analyzed using meta-analysis of proportions.Results:The search identified 1 double-armed study and 8 single-armed studies from which data of 5 TDR and 5 ACDF cohorts treating ASD were extracted. Between the 2 pooled TDR (n = 103) and ACDF (n = 258) groups, baseline characteristics were predominantly similar. Compared with ACDF, TDR demonstrated superior operation duration (107 vs 188 minutes, P = .011) and range of motion of C2-C7 at final follow-up at least 1 year after surgery (40.2° vs 35.1°, P = .001). Other surgical and performance parameters including estimated blood loss, complications, and Japanese Orthopedic Association score, Neck Disability Index, Visual Analog Scale neck, and Visual Analog Scale upper limb measures were comparable between cohorts.Conclusion:TDR confers similar surgical and postoperative outcomes to the treatment of ASD as ACDF. Both procedures lead to improvement in all performance outcomes. Larger, prospective, randomized studies will validate the findings of this meta-analysis. Longer term studies are required to ascertain the recurrence rates of ASD following either surgical treatment of primary ASD.

Comparison of sagittal parameters for anterior cervical discectomy and fusion, hybrid surgery, and total disc replacement for three levels of cervical spondylosis

PurposeTo analyze sagittal balance of the cervical spine after three operative methods for three consecutive levels. MethodsA retrospective case selection and observational study was performed from December 2012 to December 2015: 20 patients underwent anterior cervical discectomy and fusion, 22 patients underwent hybrid surgery (HS), and 20 patients underwent total disc replacement (TDR). Perioperative parameters, clinical outcomes, and preoperative and postoperative sagittal parameters were recorded. ResultsClinical outcomes improved. Fusion and hybrid groups were associated with more postoperative focal lordosis than the TDR group (no significant difference). The postoperative C2-7 sagittal vertical axis (SVA) was greater in the TDR group (no significant difference). In the fusion group, the postoperative C2-7 SVA was highly correlated with the preoperative C2-7 SVA and postoperative C7 slope (C7SL). Postoperative C2-7 lordosis (C2-7L) was highly correlated with the preoperative C2-7 SVA and preoperative and postoperative C7SL. In the hybrid group, postoperative C2-7L was highly correlated with preoperative C2-7L, preoperative and postoperative focal lordosis, and C7SL. In the TDR group, the postoperative C2-7 SVA was highly correlated with the preoperative C2-7 SVA and postoperative C7 slope. The postoperative C2-7 SVA was also negatively correlated with postoperative C2-7L and focal lordosis. Postoperative C2-7L was highly correlated with postoperative focal lordosis. ConclusionsFor three or more levels of cervical degenerative disease, good clinical outcomes can be achieved. TDR may not be a good choice for large preoperative C2-7 SVA. HS provides good cervical range of motion and restores cervical lordosis and C2-7 SVA.

Artificial Total Disc Replacement Versus Fusion for Lumbar Degenerative Disc Disease: An Update Systematic Review and Meta-Analysis.

To conduct an updated systematic review and meta-analysis to compare the efficacy and safety between total disc replacement (TDR) and fusion surgery for lumbar degenerative disc disease (LDDD). We comprehensively searched meta-analyses comparing TDR with fusion through the PubMed, Embase, and Cochrane Library databases. Only randomized controlled trials (RCTs) were selected and collected. The end of the retrieval time was June 2017. Two authors independently extracted the data from the studies after assessing their quality. The statistical software STATA version 12.0 was used to analyze the data. A total of seven RCTs (1706 patients) were included in our analysis. The patients in the TDR group had significantly improved. A greater percentage of these patients were satisfied with the surgery concerning Oswestry disability index, visual analog scale score, and complication rate. In addition, the clinical success in the TDR group was greater than that in the fusion group. Meanwhile, the TDR group had shorter operative time and hospital stay. However, there was no clinical significance regarding blood loss, work status, and reoperation rate between the two groups. Our current updated meta-analysis suggests that TDR could be an alternative treatment for LDDD, since it yielded better clinical success and patient satisfaction, shorter hospital stay and operative time, less pain, and lower complication rates than lumbar fusion.

Anterior cervical discectomy and fusion surgery versus total disc replacement: A comparative study with minimum of 10-year follow-up

Based on long-term follow-ups, this study was designed to investigate the incidence and risk factors for postoperative adjacent segment degeneration (ASD) after anterior cervical discectomy and fusion (ACDF) or total disc replacement (TDR) in treating cervical degenerative diseases. Between January 2000 and December 2005, 108 cases undergoing ACDF and 78 undergoing TDR, were enrolled into this study. All medical records were retrospectively collected. Every patient was followed up at least 10 years. Outcome assessment included visual analogue scale (VAS) score, Neck Disability Index (NDI) score, Japanese Orthopaedic Association (JOA) score, and radiographic parameters. Consequently, thirty-eight (35.2%) of 108 cases suffered from ASD in ACDF group, and 26 (33.3%) of 78 cases in TDR group. There was no statistical difference between the two groups regarding ASD incidence, VAS/NDI/JOA score, recovery rate. Logistic regression analysis showed that age (OR = 2.86, 95% CI, 1.58–4.14) and preoperative segmental lordosis (OR = 1.90, 95% CI, 1.05–3.20) were risk factors associated with increased odds of ASD regardless of surgical procedures. On the other hand, preoperative overall lordosis (OR = 0.54, 95% CI, 0.26–0.82) was most likely protective. In conclusion, advanced age and preoperative segmental lordosis were identified as risk factors for postoperative ASD, while preoperative overall lordosis proves to be a protective factor.

Total Disc Replacement Versus Anterior-Posterior Interbody Fusion in the Lumbar Spine and Lumbosacral Junction: A Cost Analysis.

Study Design:Prospective observational cohort study.Objectives:To analyze clinical and economic results in patients with degenerative disc disease in the lumbar area for patients who received combined anterior and posterior fusion or total disc replacement (TDR).Methods:The study included 75 patients, 38 in the fusion group and 37 in the TDR group, who received either anterior/posterior fusion or TDR for lumbar disc disease from January 2005 to December 2008 with a minimum follow-up of 24 months. We collected data with regard to clinical parameters, demographics, visual analogue scale scores, Oswestry Disability Index scores, SF-36 and SF-6D data, surgery time, amount of blood loss, transfusion of blood products, number of levels, duration of hospital stay, and complications. For cost analysis, general infrastructure, theatre costs, as well as implant costs were examined, leading to primary hospital costs. Furthermore, average revision costs were examined, based on the actual data. Statistical analysis was performed using t tests for normal contribution and Mann-Whitney test for skew distributed values. The significance level was set to .05.Results:There was a higher surgery time, more blood loss, and longer hospital stay for the fusion group, compared with the TDR group. In addition, the hospital costs for the primary procedure and revision were 35% higher in the fusion group. The clinical data in terms of SF-36 and SF-6D showed no difference between these 2 groups.Conclusions:TDR is a good alternative to anterior and posterior lumbar fusion in terms of short follow-up analysis for clinical data and cost analysis. General advice cannot be given due to missing data for long-term costs in terms of surgical treatment of adjacent level or further fusion techniques.

Is Total Disk Replacement a Cost-effective Treatment for Cervical Degenerative Disk Disease?

A retrospective study. The objective of this study was to assess the cost-effectiveness and clinical outcome of motion-preserving versus fusion procedures in cervical spine surgery. During the last decade there has been a huge growth in spine surgery with a concurrent increase in the economic burden. Currently, there appear to be no differences in clinical outcome between cervical total disk replacement (TDR) and spinal fusion (SF). For this reason it seems useful to know within the decision-making process whether there is a difference in actual cost between motion-preserving and fusion surgery. So far data that describe expenses involved in these procedures have not been available. This study offers a comparison of economic factors that should be considered in TDR and SF. The German statutory general healthcare insurance (GHI) provides anonymized patient-related data of their customers. A retrospective query using the codes of surgery of all TDR and SF surgery was performed from January 2003 to June 2008. A total of 467 cases with monosegmental or bisegmental surgery for degenerative disk pathologies were included. Both groups showed significant differences in independent variables such as age and sex (P<0.0001), but not in revision rates. Cost weight of diagnosis-related groups and length of hospitalization had a significant effect on total costs. Both groups obtained less pain medication postoperatively than preoperatively without a significant difference between each group. Postoperative absenteeism from work was significantly higher in the TDR group;however, patients with TDR underwent less rehabilitation covered by the GHI. Both groups had the same amount of preoperative and postoperative physiotherapy covered by the GHI. According to the collected data, there are no differences between the medical outcomes of cervical TDR in comparison with cervical SF. At the same time, while generating clinical results comparable with spinal fusion, TDR incurred significantly lower costs. Therefore, both from the medical and from the financial point of view, TDR is a viable choice in the treatment of degenerative disk pathology.

Long-term Evaluation of Cervical Disc Arthroplasty with the Mobi-C© Cervical Disc: A Randomized, Prospective, Multicenter Clinical Trial with Seven-Year Follow-up.

Cervical total disc replacement (TDR) is an increasingly accepted procedure for the treatment of symptomatic cervical degenerative disc disease. Multiple Level I evidence clinical trials have established cervical TDR to be a safe and effective procedure in the short-term. The objective of this study is to provide a long-term assessment of TDR versus anterior discectomy and fusion for the treatment of one- and two-level disc disease. This study was a continuation of a prospective, multicenter, randomized, US FDA IDE clinical trial comparing cervical TDR with the Mobi-C© Cervical Disc versus ACDF through 7 years follow-up. Inclusion criteria included a diagnosis of symptomatic cervical degenerative disc disease at one or two cervical levels. TDR patients were treated using a Mobi-C© artificial disc (Zimmer Biomet, Austin TX, USA). ACDF with allograft and anterior plate was used as a control treatment. Outcome measures were collected preoperatively and postoperatively at 6 weeks, at 3, 6, 12, 18 months, annually through 60 months, and at 84 months. Measured outcomes included Overall success, Neck Disability Index (NDI), VAS neck and arm pain, segmental range of motion (ROM), patient satisfaction, SF-12 MCS/PCS, major complications, and subsequent surgery rate. The primary endpoint was an FDA composite definition of success comprising clinical improvement and an absence of major complications and secondary surgery events. A total of 599 patients were enrolled and treated, with 164 treated with one-level TDR, 225 treated with two-level TDR, 81 treated with one-level ACDF, and 105 treated with two-level ACDF. At seven years, follow-up rates ranged from 73.5% to 84.4% (overall 80.2%).The overall success rates of two level TDR and ACDF patients were 60.8% and 34.2%, respectively (p<0.0001). The overall success rates of one level TDR and ACDF patients were 55.2% and 50%, respectively (p>0.05). Both the single and two level TDR and ACDF groups showed significant improvement from baseline NDI scores, VAS neck and arm pain scores, and SF-12 MCS/PCS scores (p<0.0001). In the single level cohort, there was an increased percentage of TDR patients who reported themselves as "very satisfied" (TDR 90.9% vs ACDF 77.8%; p= 0.028). There was a lower rate of adjacent level secondary surgery in the single level TDR patients (3.7%) versus the ACDF patients (13.6%; p = 0.007).In the two level TDR group, the NDI success rate was significantly greater in the TDR group (TDR: 79.0% vs. ACDF: 58.0%; p=0.001). There was significantly more improvement in NDI change score at 7 years in the TDR patients versus ACDF. The TDR group had a significantly higher rate of patients who were "very satisfied" with their treatment compared to the ACDF group (TDR: 85.9% vs. ACDF: 73.9%). The rate of subsequent surgery at the index level was significantly lower in the TDR group compared to the ACDF group (TDR: 4.4% vs. ACDF: 16.2%; p=0.001). The rate of adjacent level secondary surgery was significantly lower in the two level TDR (4.4%) patients compared to the ACDF (11.3%; p=0.03) patients. In both single and two level cohorts, the percentage of patients with worse NDI (2.5%-3.8% of two level surgeries and 1.2%-2.5% of single level surgeries) or worse neck pain (5%-6.8% of the two level surgeries and 1.3% - 3.8% of the single level surgeries) was strikingly low in both groups but trended lower in the TDR patients. At seven years, the composite success analysis demonstrated clinical superiority of two level TDR over ACDF and non-inferiority of single level TDR versus ACDF. There were lower rates of secondary surgery and higher adjacent level disc survivorship in both groups. Both surgeries were remarkably effective in alleviating pain relative to baseline and the rate of patients with worse disability or neck pain was surprisingly low. Overall, greater than 95% of patients (from both groups) who underwent TDR and 88% of patients who underwent ACDF were "very satisfied" at seven years. The differences in clinical effectiveness of TDR versus ACDF becomes more apparent as treatment increases from one to two levels, indicating a significant benefit for TDR over ACDF for two-level procedures. The Mobi-C Clinical Trial (ClinicalTrials.gov registration number: NCT00389597) was conducted at 24 sites in the US and was approved by the Institutional Review Board, Research Ethics Committee, or local equivalent of each participating site. 1.

Comparative Analysis between Total Disc Replacement and Posterior Foraminotomy for Posterolateral Soft Disc Herniation with Unilateral Radiculopathy : Clinical and Biomechanical Results of a Minimum 5 Years Follow-up.

ObjectiveTo compare the clinical outcomes and biomechanical effects of total disc replacement (TDR) and posterior cervical foraminotomy (PCF) and to propose relative inclusion criteria.MethodsThirty-five patients who underwent surgery between 2006 and 2008 were included. All patients had single-level disease and only radiculopathy. The overall sagittal balance and angle and height of a functional segmental unit (FSU; upper and lower vertebral body of the operative lesion) were assessed by preoperative and follow-up radiographs. C2–7 range of motion (ROM), FSU, and the adjacent segment were also checked.ResultsThe clinical outcome of TDR (group A) was tended to be superior to that of PCF (group B) without statistical significance. In the group A, preoperative and postoperative upper adjacent segment level motion values were 8.6±2.3 and 8.4±2.0, and lower level motion values were 8.4±2.2 and 8.3±1.9. Preoperative and postoperative FSU heights were 37.0±2.1 and 37.1±1.8. In the group B, upper level adjacent segment motion values were 8.1±2.6 and 8.2±2.8, and lower level motion values were 6.5±3.3 and 6.3±3.1. FSU heights were 37.1±2.0 and 36.2±1.8. The postoperative FSU motion and height changes were significant (p<0.05). The patient’s satisfaction rates for surgery were 88.2% in group A and 88.8% in group B.ConclusionTDR and PCF have favorable outcomes in patients with unilateral soft disc herniation. However, patients have different biomechanical backgrounds, so the patient’s biomechanical characteristics and economic status should be understood and treated using the optimal procedure.

What's New in Spine Surgery.

### Total Disc Replacement Adjacent segment disease and adjacent segment degeneration following total disc replacement at 1 or 2 levels in the cervical spine were assessed in a Level-II systematic review and a meta-analysis of randomized controlled trials and cohort studies. Adjacent segment disease occurred at a rate of 0.2% at 1 to 2 years after disc replacement, but adjacent segment degeneration was more common, at a rate of 5.1%. At a follow-up of longer than 2 years, these rates increased to 2.6% for adjacent segment disease and 16.6% for adjacent segment degeneration. Rates were slightly higher for patients who had undergone 2-level disc arthroplasty, although this increase did not reach significance1. In a separate Level-I study of 2-level total disc replacement as part of the Mobi-C Investigational Device Exemption randomized controlled trial, 4-year results were reported for 202 patients who underwent a total disc replacement compared with 89 patients who underwent anterior cervical discectomy and fusion. The patients who underwent total disc replacement had better patient-reported outcome measure results, with no difference in neurological improvement, return to work, or major complication rates. There was higher patient satisfaction and a lower subsequent surgical procedure rate in the total disc replacement group2. It should be noted that, although the rate of reoperation was potentially biased by the investigating surgeons’ decision to perform revisions (treatment and detection bias), the reported rate of adjacent segment disease was also higher than that reported in other studies and warrants further comparisons. A Level-I cost-effectiveness analysis compared 2-level cervical total disc replacement and anterior cervical discectomy and arthrodesis, revealing similar results. At 2 years, the total disc replacement group had a mean gain of 1.58 quality-adjusted life-years (QALYs) compared with 1.50 QALYs for the anterior cervical discectomy and arthrodesis group. Although there was a $2,139 increase …

Clinical and radiologic comparison of dynamic cervical implant arthroplasty and cervical total disc replacement for single-level cervical degenerative disc disease

Anterior cervical discectomy and fusion, to date the most successful spine procedure for the surgical treatment of cervical radiculopathy, has limitations that have led to the development of non-fusion cervical procedures, such as cervical total disc replacement (TDR) and dynamic cervical implant (DCI) arthroplasty. We compared the clinical and radiological results of DCI and cervical TDR for the treatment of single-level cervical degenerative disc disease in Chinese patients. A retrospective review of 179 patients with cervical spondylotic myelopathy who underwent DCI or TDR between April 2010 and October 2012 was conducted, and 152 consecutive patients (67 patients single-level DCI and 85 single-level TDR) who completed at least 2years of follow-up were included. Clinical and radiological assessments were performed preoperatively and at 1week and 3, 6, 12, and 24months postoperatively. The most common operative level was C5/C6 (49.3%). The differences in blood loss, duration of surgery, and duration of hospitalization were not statistically significant. The Japanese Orthopaedic Association scale, Visual Analog Scale, Neck Disability Index, and Short Form-36 scores improved significantly after surgery in both the DCI and TDR groups (P<0.05), but the differences were not statistically significant at the final follow-up. The rate of occurrence of heterotopic ossification was 22.4% and 28.2% in the DCI and TDR groups, respectively. As an effective non-fusion technique, DCI is a more economical procedure. Further prospective, randomized studies with long-term follow-up periods are needed to determine the long-term effects.