Heterotopic ossification, osteolysis and implant failure following cervical total disc replacement with the M6-C™ artificial disc.

INTRODUCTION: A recent study reported a 34% mid-term revision rate after M6-C™ cervical total disc replacement (CTDR) for wear-related osteolysis. Here, we aim to investigate the prevalence, risk factors, and radiographic characteristics of periprosthetic bony changes and implant failure of the M6-C™ artificial disc. METHODS: We retrospectively analysed radiographic (conventional X-ray, CT scan) and clinical outcomes (EQ-5D-5L, Neck Disability Index (NDI), and Visual Analog Scale (VAS) for neck and arm pain) data collected during routine follow-up of patients who underwent CTDR with the M6-C™ between 2011 and 2015. RESULTS: In total, 85 patients underwent CTDR with the M6-C™. Follow-up data were available for 43 patients (54% female, mean age 44 years) with 50 implants and a mean follow-up of 8.1 years (6.5-11 years). Implant failure with the presence of severe osteolysis was identified in 5 (12%) patients who were all male (p = 0.016) and implanted at the C5/6 level (p = 0.11). All failed implants required revision surgery. The overall prevalence of osteolysis was 44% (22/50 implants) and 34% (17/50 implants) for significant heterotopic ossification. Patients with high-grade osteolysis showed higher VAS arm pain (p = 0.05) and lower EQ-5D-VAS health VAS (p = 0.03). CONCLUSION: We report a lower reoperation rate for failed M6-C™ implants than previously published, but confirmed that osteolysis and heterotopic ossification are common following CTDR with the M6-C™ and may be asymptomatic. Therefore, we strongly recommend ongoing clinical and radiographic monitoring after CTDR with the M6-C™, particularly for male patients implanted at the C5/6 level.

Lumbar Total Disk Replacement Device Removals and Revisions Performed During a 20-Year Experience with 2141 Patients.

STUDY DESIGN: This was a retrospective study with prospective patient contact attempted to collect current data. OBJECTIVE: The purpose was to investigate the incidence and reasons for lumbar total disk replacement (TDR) removal or revision. SUMMARY OF BACKGROUND DATA: A concern regarding lumbar TDR was safety, particularly the need for device removal or revision. This may be particularly important considering removal/revision requires repeat anterior exposure with an increased risk of vascular injury. METHODS: Data were collected for a series of 2141 lumbar TDR patients, beginning with the first case experience in 2000. The mean follow-up was 78.6 months. For each case of device removal/revision, the reason, duration from index surgery, and procedure performed were recorded. RESULTS: Of 2141 patients, 27 (1.26%) underwent TDR removal or revision. Device removal was performed in 24 patients (1.12%), while three patients underwent revision (0.14%). Of the 24 removals, 12 were due to migration and/or loosening, three developed problems post-trauma, two developed lymphocytic reaction to device materials, two had ongoing pain, and there was one case of each: TDR was too large, vertebral body fracture (osteoporosis), lytic lesion, device subsidence and facet arthrosis, and infection seeded from a chest infection 146 months post-TDR. The three revisions were for Core repositioning (technique error), device repositioning after displacement, and core replacement due to wear/failure. With respect to timing, 37.0% of removals/revisions occurred within one-month postimplantation. Of note, 40.7% of removals/revisions occurred in the first 25 TDR cases performed by individual surgeons. There was one significant vascular complication occurring in a patient whose TDR was removed due to trauma. This was also the only patient among 258 with ≥15-year follow-up who underwent removal/revision. CONCLUSION: In this large consecutive series, 1.26% of TDRs were removed/revised. The low rate over a 20 year period supports the safety of these devices.

Comparing outcomes between anterior cervical disc replacement (ACDR) and minimally invasive posterior cervical foraminotomy (MI-PCF) in the treatment of cervical radiculopathy.

BACKGROUND CONTEXT: Anterior cervical disc replacement (ACDR) and minimally invasive posterior cervical foraminotomy (MI-PCF) have emerged as two increasingly popular alternatives to anterior cervical discectomy and fusion (ACDF) for the management of cervical radiculopathy. Both techniques provide advantages of segmental motion preservation and lower rates of adjacent segment degeneration (ASD) compared to ACDF. PURPOSE: The purpose of this study was to analyze the clinical and functional outcomes of patients undergoing ACDR or MI-PCF for the treatment of unilateral cervical radiculopathy. STUDY DESIGN/SETTING: Retrospective Cohort Review. PATIENT SAMPLE: A total of 152 patients were included (86 ACDR and 66 MI-PCF). OUTCOME MEASURES: (1) Patient demographics; (2) perioperative data; (3) rates of complications and revisions; (5) visual analogue scale (VAS) and Neck Disability Index (NDI) scores. METHODS: A retrospective cohort review was performed to identify all patients at a single institution between 2012-2020 who underwent 1- or 2- level ACDR or MI-PCF from C3-C7 with a minimum follow-up of 24 months. Patient demographics, perioperative data, postoperative complications, and revisions were analyzed. Patient reported outcome measures including VAS and NDI scores were compared. RESULTS: The ACDR group had a significantly greater mean operative time (99.8 minutes vs 79.2 minutes, p<.001), but comparable estimated blood loss and length of stay following surgical intervention (p=.899). The overall complication rate was significantly greater in the ACDR group than the MI-PCF group (24.4% vs 6.2%; p=.003) but was largely driven by approach-related dysphagia in 20.9% of ACDR patients. The MI-PCF group had significantly greater revision rates (13.6% vs 1.2%; p=.002) with an average time to revision of 20.7 months in the MI-PCF group compared to 40.3 months in the ACDR group. The ACDR cohort had significantly greater improvements in NDI scores at the final follow-up (25.0 vs 21.3, p<.001). CONCLUSION: Our results suggest that ACDR offer clinically relevant advantages over MI-PCF in terms of long-term revision rates despite an increased approach-related risk of transient postoperative dysphagia. Additionally, patients in the ACDR cohort achieved greater mean improvements in NDI scores but these results may have limited clinical significance due to inability to reach minimally clinically important difference (MCID) thresholds.

Adjacent segment degeneration after single- and double-level cervical total disc replacement: a cohort with an over 12-year follow-up.

PURPOSE: To characterize the change of adjacent segment degeneration (ASD) after cervical total disc replacement (CTDR) with more than 12-year follow-up, and identify the risk factors for ASD. METHOD: This process included 75 patients underwent CTDR from February 2004 to December 2012, with the follow-up of 151.9 ± 36.0 (m). The artificial disc included ProDisc-C, Prestige-LP and Mobi-C. ASD was followed up at 1 week, 6 months, 1 year, 2 years, 5 years, 10 years after CTDR and at the endpoint of June 2022. The radiographic measurements were cervical mobility, intervertebral disc height (IDH), cervical lordosis and balance status. The complications were implant migration, subsidence and heterotopic ossification (HO). RESULTS: Cervical mobility in adjacent segments, IDH and lordosis showed no statistical differences between ASD and NASD group. Balance status, subsidence and migration showed no relationship with ASD. Postoperative ASD increased at 6 m and especially between 6 m to 2y. There was no difference between the incidence of upper ASD and lower ASD all the time and few ASD-related reoperation. The majority of adjacent segments were C4/5 (33.6%) and C6/7 (34.2%), and ASD of C5/6 had the highest incidence (61.5%). Cox regression showed ASD was not related to the types of prosthesis or operated numbers. Generalized estimating equations (GEE) analysis showed severe HO had a higher (2.68 times) probability to suffer from ASD. CONCLUSIONS: After over 12-year follow-up of CTDR, the occurrence of ASD and HO had temporal synchronization. ASD was not merely a natural progression but with the pathological process such as HO.

Prospective, multicenter clinical trial comparing the M6-C compressible cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 5-year results of an FDA investigational device exemption study.

BACKGROUND CONTEXT: Various total disc replacement (TDR) designs have been compared to anterior cervical discectomy and fusion (ACDF) with favorable short and long-term outcomes in FDA-approved investigational device exemption (IDE) trials. The unique design of M6-C, with a compressible viscoelastic nuclear core and an annular structure, has previously demonstrated favorable clinical outcomes through 24 months. PURPOSE: To evaluate the long-term safety and effectiveness of the M6-C compressible artificial cervical disc and compare to ACDF at 5 years. STUDY DESIGN: Prospective, multicenter, concurrently and historically controlled, FDA-approved IDE clinical trial. PATIENT SAMPLE: Subjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and received M6-C (n=160) or ACDF (n=189) treatment as part of the IDE study. Safety outcomes were evaluated at 5 years for all subjects. The primary effectiveness endpoint was available at 5 years for 113 M6-C subjects and 106 ACDF controls. OUTCOME MEASURES: The primary endpoint of this analysis was composite clinical success (CCS) at 60 months. Secondary endpoints were function and pain (neck disability index, VAS), physical quality of life (SF-36, SF-12), safety, neurologic, and radiographic assessments. METHODS: Propensity score subclassification was used to control for selection bias and match baseline covariates of the control group to the M6-C subjects. Sixty-month CCS rates were estimated for each treatment group using a generalized linear model controlling for propensity score. RESULTS: At 5 years postoperatively, the M6-C treatment resulted in 82.3% CCS while the ACDF group showed 67.0% CCS (superiority p=.013). Secondary endpoints indicated that significantly more M6-C subjects achieved VAS neck and arm pain improvements and showed maintained or improved physical functioning on quality-of-life measures compared to baseline assessments. The M6-C group-maintained flexion-extension motion, with significantly greater increases from baseline disc height and disc angle than observed in the control group. The rates of M6-C subsequent surgical interventions (SSI; 3.1%) and definitely device- or procedure-related serious adverse events (SAE failure; 3.1%) were similar to ACDF rates (SSI=5.3%, SAE failure=4.8%; p>.05 for both). CONCLUSIONS: Subjects treated with the M6-C artificial disc demonstrated superior 5-year achievement of clinical success when compared to ACDF controls. In addition, significantly more subjects in the M6-C group showed improved pain and physical functioning scores than observed in ACDF subjects, with no difference in reoperation rates or safety outcomes.

Headache relief 10 years after cervical disc arthroplasty: multicenter randomized clinical trial post hoc analysis.

OBJECTIVE: Headache relief after anterior cervical spine surgery has been reported. No study, however, has followed patients out to 10 years to assess the durability of headache improvement. The authors analyzed a group of patients with a 10-year follow-up after one- or two-level cervical disc arthroplasty (CDA) from an FDA investigational device exemption (IDE) study. METHODS: The authors performed a post hoc analysis of 189 patients treated with CDA from the 9 highest enrolling sites in a prospective multicenter randomized US FDA IDE clinical trial. Patients had one- or two-level CDA at contiguous levels from C3 to C7 using the Mobi-C device. The authors evaluated headache scores from the headache section of the Neck Disability Index (NDI), along with associated demographic variables (age, sex, race, ethnicity, and BMI). Preoperative and 10-year postoperative headache scores were analyzed. Primary analysis was conducted via the Wilcoxon rank-sum test, followed by univariate and multivariable logistic regression. RESULTS: After accounting for age, BMI, race, ethnicity, and sex, there was sustained headache improvement 10 years after CDA (p = 0.04). Preoperatively, the median NDI score was 3.00 (IQR 1.00-4.00) and after 10 years it was 1.00 (IQR 0.00-2.00), with a decrease in the NDI score by 1.00 point (95% CI 0.00-2.00, p = 0.04). For one-level CDA, the median NDI score was 3.00 (IQR 1.00-4.00) preoperatively but 1.00 (IQR 0.00-2.00) at 10 years, with an estimated reduction in the NDI score of 1 point (95% CI 1.00-2.00, p < 0.0001). For two-level CDA, the median NDI score was 3.00 (IQR 1.75-4.00) preoperatively and 1.00 (IQR 0.00-2.00) at 10 years, with an estimated reduction in the NDI score of 1 point (95% CI 1.00-2.00, p < 0.0001). CONCLUSIONS: Headache relief provided by cervical CDA, for symptomatic C3-7 cervical spondylosis, was sustained even 10 years after surgery. There was no difference in headache improvement between the one- and two-level CDA groups, or among BMI, sex, race, and ethnicity strata.

Intervertebral (lumbar) disc replacement:the current state and future perspectives.

PURPOSE: Low back pain is a significant socio-economic problem which is expected to deepen. Degenerative disc disease is considered to be one of its main causes. Unsuccessful conservative treatments usually lead to surgical treatments, including methods providing pain relief by vertebral fusion in the affected segment. However, this leads to changes in biomechanics, which is why approximately 30 years ago total disc replacements appeared. This work aims at determining the current state of treatments with this kind of replacement, comparing the results with those of fusion methods and assessing why fusion continues to dominate. Current treatments of degenerative disc disease by advanced procedures (regenerative and gene therapy, 3D printing) is also examined and evaluated, and future developments are considered. METHODS: A critical review based on available scientific articles from online databases. The main keywords used were "lumbar", "total", "disc" and "replacement", supplemented according to the individual, monitored areas ("follow-up", "fusion", "future" etc.). For the articles found through database search (n = 895), narrower selection was made and the result was 33 articles included in review. REVIEW: Total disc replacements have not yet satisfactorily demonstrated that they are superior to fusion methods in long term follow-up. Advanced methods are in their infancy. CONCLUSIONS: Additional research and development of total disc replacements is still necessary. For implants, the 3D scan - 3D model - 3D printing chain and its related technologies are increasingly important. The development of regenerative procedures using induced pluripotent stem cells and gene therapies is important, but conservative treatments and primary prevention should also be developed because regenerative procedures and gene therapies apparently will not be used routinely until the future.

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

BACKGROUND CONTEXT: Anterior 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. PURPOSE: Our goal was to compare the long-term outcomes of TDR and ACDF procedures. STUDY DESIGN: Retrospective case-control study. PATIENT SAMPLE: All 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 MEASURES: The 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. METHODS: The 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. RESULTS: The 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. CONCLUSIONS: There 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.

Cervical disc arthroplasty with the Baguera C prosthesis: clinical and radiological results of a 10-year follow-up study.

PURPOSE: We evaluated the long-term safety, mobility and complications of cervical total disc arthroplasty with the Baguera®C prosthesis over 10 years. METHODS: We included 91 patients treated by arthroplasty for cervical degenerative disc disease. A total of 113 prostheses were implanted (50 one-level, 44 two-level and 19 hybrid constructs). They were assessed for complications, clinically, with NDI and SF-12 questionnaires and by independent radiologists for ROM, HO, disc height and adjacent level degeneration. RESULTS: No spontaneous migration, loss of fixation, subsidence, vascular complication or dislocation were observed. The reoperation rate was 1%. About 82.7% of the patients were pain free. About 9.9% were taking occasional grade I painkillers. Motricity and sensitivity were preserved in 98.8% and 96.3%. The NDI showed an average functional disability of 17.58%, 26% lower than preoperatively. The SF-12 scores were close to normal health. The average ROM at the treated level was 7.4°. Motion was preserved in 86.6%. Lack of motion was observed in 13.4%. Grades II and III H0 were present in 53.7% and 31.7%, respectively, Grade IV was present in 13.4%. Motion was preserved in 100% of the grades 0-III. The preoperative adjacent level disc height of 4.3 mm remained stable during all the follow-ups at 4.4 mm and 4.2 mm, respectively, at 5 and 10 years. CONCLUSIONS: After 10 years, cervical arthroplasty with the Baguera®C prosthesis presents excellent safety and functional results and low complications. Motion was preserved in 86.6%, with a 7.4° ROM. Although common, HO did not hinder motion. Adjacent disc height preservation confirms some adjacent level degeneration protection.

Incidence of Heterotopic Ossification at 10 years After Cervical Disk Replacement: A Systematic Review and Meta-analysis.

STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVE: This study aimed to assess the incidence of heterotopic ossification (HO) 10 years after cervical disk replacement (CDR). SUMMARY OF BACKGROUND DATA: HO is a common complication after CDR and may limit the range of motion of the artificial disk. As HO usually progresses slowly, a long-term follow-up is required to better understand its incidence. In recent years, the increasing number of original articles reporting 10-year outcomes gives us the opportunity to better understand the long-term incidence of HO. MATERIALS AND METHODS: We searched PubMed, Medline, Embase, and Cochrane Library databases to identify eligible studies. The incidence of HO was pooled, and subgroup analysis was performed. Meta-regression analyses were conducted to identify factors contributing to heterogeneity. RESULTS: Eleven studies with at least 10 years of follow-up comprising 1140 patients who underwent CDR were included. The pooled incidence of overall HO was 70% (95% CI, 60%-81%) at 10 years postoperatively, 60% (95% CI, 44%-75%) at five or six years postoperatively, and 50% (95% CI, 27%-72%) at one or two years postoperatively. The pooled incidence of severe HO (grade 3 or 4) was 37% (95% CI, 29%-45%), and mild HO (grade 1 to 2) was 30% (95% CI, 17%-44%) at 10 years of follow-up. Pooled range of motion decreased from 8.59° before surgery to 7.40° 10 years after surgery. Subgroup analysis showed that HO incidence differed according to the prosthesis type. The earlier publication was associated with a higher pooled incidence of severe HO in the meta-regression analysis. CONCLUSIONS: This is the first meta-analysis providing detailed information on the pooled 10-year incidence of HO after CDR. The incidence of HO seems to increase with the length of follow-up. LEVEL OF EVIDENCE: 3.

Up to 10-year surveillance comparison of survivability in single-level cervical disc replacement versus anterior cervical discectomy and fusion in New York.

OBJECTIVE: Cervical disc replacement (CDR) is an alternative treatment to anterior cervical discectomy and fusion (ACDF), which is the current gold standard, for degenerative cervical diseases such as cervical spondylotic myelopathy and cervical radiculopathy. CDR has several theoretical benefits over ACDF, including preservation of motion, earlier return to unrestricted activity, and potentially a lower risk of adjacent-segment disease. Recent literature has reported positive clinical results for CDR, but few studies have investigated the long-term risk of revision surgery of CDR versus ACDF. The purpose of this study was to identify and analyze the epidemiological, clinical, and operative risk factors that affect revision rates following single-level CDR and ACDF procedures. METHODS: A retrospective cohort was extracted from the Statewide Planning and Research Cooperative System using ICD-9 and CPT codes. Inclusion criteria were adult patients undergoing primary, subaxial (C3-7), single-level ACDF or CDR for cervical radiculopathy and/or cervical spondylotic myelopathy between 2005 and 2013. Survivability was defined as the time between the index procedure and the presence of a subsequent discharge record for cervical spinal fusion or disc replacement. Statistical analyses were performed using chi-square tests, t-tests, Cox proportional hazards models, and a Kaplan-Meier plot. RESULTS: A total of 7450 patients were included in this study (6615 ACDF and 835 CDR). When adjusted for patient demographics, the hazard ratios showed no significant differences in the incidence of revision risk between the two cohorts. The CDR cohort had a higher incidence of postoperative dysphagia (p < 0.05). Patients undergoing ACDF had a longer average hospital stay (2.8 vs 1.9 days, p < 0.001). There was no significant difference in time to revision surgery (p = 0.486). CONCLUSIONS: CDR and ACDF have both been shown to be effective treatments for cervical spine disease. CDR patients had a shorter average inpatient hospital stay compared with ACDF patients but tended to experience dysphagia more frequently. There was a tendency toward increased survivability of CDR; however, this was not found to be statistically significant at any time point. The large size and heterogeneity of each cohort and the availability of > 10 years of surveillance data differentiate this study from other published literature. This investigation has limitations inherent to large data analysis studies, including the implementation and inaccuracy of diagnosis and procedural coding; however, this reflects real-world use of coding by practitioners.

Anterior Bone Loss after Cervical Baguera C Disc versus Bryan Disc Arthroplasty.

Objectives: The objectives of this study were to identify the risk factors and incidence of anterior bone loss (ABL) after Baguera C cervical disc arthroplasty (CDA) and identify whether design differences in artificial discs affect ABL. Methods: In this retrospective radiological review of patients who underwent single-level Baguera C CDA in a medical center, the extent of ABL and the following radiological parameters were recorded: global and segmental alignment angle, lordotic angle (or functional spinal unit angle), shell angle, global range of motion (ROM), and ROM of the index level. ABL at the index level was grade 0-2. Grade 0 was defined as no remodeling, grade 1 as spur disappearance or mild change in body contour, and grade 2 as obvious bone regression with Baguera C Disc exposure. Results: Combining grade 1 and grade 2, ABL was found in 56 upper adjacent vertebrae and 52 lower adjacent vertebrae of the 77 patients. Only 18 patients (23.4%) had no ABL. Shell angle differed significantly between ABL grades of both the upper and lower adjacent level: 0.0° in grade 0 and 1 ABL vs. 2.0° in grade 2 ABL of the upper adjacent level (p < 0.05); and 0.0° in grade 0 and 1 ABL vs. 3.5° in grade 2 ABL of the lower adjacent level (p < 0.05). A female predominance of ABL was found. Hybrid surgery and artificial disc size were also related to ABL. Conclusions: ABL is more common in Baguera C Disc arthroplasty than Bryan Disc arthroplasty. Larger shell angle was related to ABL after CDA with Baguera C Discs, which may indicate that shell angle is pivotal in determining the incidence of ABL after CDA. Females had more ABL with Baguera C Disc arthroplasty; this might be related to shorter endplate lengths as well as a smaller endplate-implant mismatch.

Observational, Multicenter Study of the Efficacy and Safety of Cervical Disk Arthroplasty With Mobi-C in the Treatment of Cervical Degenerative Disk Disease. Results at 10 years Follow-Up.

BACKGROUND: Cervical disk arthroplasty replacement (CDA) was developed to avoid specific disadvantages of cervical fusion. The purpose of this paper is to provide 10-year follow-up results of an ongoing prospective study after CDA. METHODS: Three hundred eighty-four patients treated using the Mobi-C (ZimVie, Troyes, France) were included in a prospective multicenter study. Routine clinical and radiologic examinations were reported preoperatively and postoperatively with up to 10-year follow-up. Complications and revision surgeries were also documented. RESULTS: At 10 years showed significant improvement in all clinical outcomes [Neck Disability Index, visual analog scale (VAS) for arm and neck pain, physical component summary of SF36, and mental component summary of SF36). Motion at the index level increased significantly over baseline (mean range of motion=7.6 vs. 8 degrees at five years and 6.0 degrees preoperatively; P <0.001) and 71.3% of the implanted segments remained mobile (range of motion>3 degrees). Adjacent disks were also mobile at 10 years with the same mobility as preoperatively. At 10 years, 20.9% of the implanted segments demonstrated no heterotopic ossification. Thirty-four patients (8.9%) experienced 41 adverse events, with or without reoperation during the first five years. We found only two additional surgeries after five years. We observed an increased percentage of working patients and a decrease in medication consumption. Regarding the overall outcome, 94% of patients were satisfied. CONCLUSIONS: Our 10-year results showed significant improvement in all clinical outcomes, with low rates of revision or failure. This experience in patients with long-term follow-up after CDA endorses durable, favorable outcomes in properly selected patients.

Trends in use, outcomes, and revision procedures of anterior cervical disc replacement in the United States: a premiere database analysis from 2006-2019.

PURPOSE: We sought to characterize trends in demographics, comorbidities, and postoperative complications among patients undergoing primary and revision cervical disc replacement (pCDR/rCDR) procedures. METHODS: In this retrospective database study, the Premier Healthcare database was queried from 2006 to 2019. Annual proportions or medians were calculated for patient and hospital characteristics, comorbidities, and postoperative complications associated with CDR surgery. Trends were assessed using linear regression analyses with year of service as the sole predictor. RESULTS: A total of 16,178 pCDR and 758 rCDR cases were identified, with a median (IQR) age of 46 (39; 53) and 51 (43; 60) years among patients, respectively. The annual number of both procedures increased between 2006 and 2019, from 135 to 2220 for pCDR (p < 0.001), and from 17 to 49 for rCDR procedures (p < 0.001), with radiculopathy being the main indication for surgery in both groups. Mechanical failure was identified as a major indication for rCDR procedures with an increase over time (p = 0.002). Baseline patient comorbidity burden (p = 0.045) and complication rates (p < 0.001) showed an increase. For both procedures, an increase in outpatient surgeries and procedures performed in rural hospitals was seen (pCDR: p = 0.045; p = 0.006; rCDR: p = 0.028; p = 0.034). CONCLUSION: PCDR and rCDR procedures significantly increased from 2006 to 2019. At the same time, comorbidity burden and complication rates increased, while procedures were more often performed in an outpatient and rural setting. The identification of these trends can help guide future practice and lead to further areas of research.

Cervical Total Disc Replacement and Anterior Cervical Discectomy and Fusion: Comparison of 30-Day Population Comorbidities and Perioperative Complications Using 6 Years of American College of Surgeons National Surgical Quality Improvement Program Participant Use File Data.

OBJECTIVE: American College of Surgeons National Surgical Quality Improvement Program Participant Use File data from 2014 through 2019 were used to compare 1- and 2-level anterior cervical discectomy and fusion (ACDF) and cervical total disc replacement (cTDR) with respect to: patient demographics, comorbidities, adverse events, and 30-day morbidity rates. METHODS: One- and 2-level ACDF and cTDR patients were identified by current procedural terminology codes. Demographics, comorbidities, and adverse events were summarized. Unmatched cohorts were compared using Wilcoxon Rank Sum test for continuous variables, Pearson χ2 test for categorical variables, and 30-day morbidity using inverse probability of treatment weighted log-binomial regression. RESULTS: American College of Surgeons National Surgical Quality Improvement Program 2014 through 2019 Participant Use File datasets represent 4,862,497 unique patients, identifying 13,347 1-level, 6933 2-level ACDF, 3114 1-level, and 862 2-level cTDR patient cohorts. Statistically significant differences between cohorts are extensive: age, sex, race, admission status, patient origin, discharge disposition, emergent surgery, surgical specialty, American Society of Anesthesiologists classification, wound class, operative time, hospital LOS, BMI, functional status, smoking, diabetes, dyspnea, chronic obstructive pulmonary disease, congestive heart failure, hypertension, renal failure, dialysis, cancer, steroid use, anemia, bleeding disorders, systemic sepsis, and number of concurrent comorbid conditions. Inverse probability of treatment weighted log-binomial models, demonstrated increased risk of deep venous thrombosis/thrombophlebitis, pulmonary embolism, deep incisional surgical site infection, pneumonia, and unplanned return to operating room associated with ACDF while increased risk of cerebral vascular accident/stroke with neurological deficit and myocardial infarction associated with cTDR. The composite complications outcome favors cTDR over ACDF for 30-day morbidity. No mortalities occurred within the cTDR cohort. CONCLUSIONS: Adjusting for demographics and comorbidities; ACDF has a higher average risk of adverse event. When ACDF and cTDR are equipoise, consideration for cTDR may be indicated in populations with higher rates of comorbid conditions.

Long-term results of the NECK trial-implanting a disc prosthesis after cervical anterior discectomy cannot prevent adjacent segment disease: five-year clinical follow-up of a double-blinded randomised controlled trial.

BACKGROUND CONTEXT: Motion preserving anterior cervical disc arthroplasty (ACDA) in patients with cervical radiculopathy was introduced to prevent symptomatic adjacent segment disease as compared to anterior cervical discectomy and fusion (ACDF). PURPOSE: To evaluate the long-term outcome in patients with cervical radiculopathy due to a herniated disc undergoing ACDA, ACDF or ACD (no cage, no plate) in terms of clinical outcome measured by the Neck Disability Index (NDI). Likewise, clinically relevant adjacent segment disease is assessed as a long-term result. STUDY DESIGN: Double-blinded randomized controlled trial. PATIENT SAMPLE: A total of 109 patients with one level herniated disc were randomized to one of the following treatments: ACDA, ACDF with intervertebral cage, ACD without cage. OUTCOME MEASURES: Clinical outcome was measured by patients' self-reported NDI, Visual Analogue Scale (VAS) neck pain, VAS arm pain, SF36, EQ-5D, perceived recovery and reoperation rate. Radiological outcome was assessed by radiographic cervical curvature and adjacent segment degeneration (ASD) parameters at baseline and up until five years after surgery. METHODS: To account for the correlation between repeated measurements of the same individual Generalized Estimated Equations (GEE) were used to calculate treatment effects, expressed in difference in marginal mean values for NDI per treatment group. RESULTS: Clinical outcome parameters were comparable in the ACDA and ACDF group, but significantly worse in the ACD group, though not reaching clinical relevance. Annual reoperation rate was 3.6% in the first two years after surgery, declined to 1.9% in the years thereafter. The number of reoperations for ASD was not lower in the ACDA group, while the number of reoperations at the index level was higher after ACD, when compared to ACDF and ACDA. CONCLUSIONS: A persisting absence of clinical superiority was demonstrated for the cervical disc prosthesis five years after surgery. Specifically, clinically relevant adjacent level disease was not prevented by implanting a prosthesis. Single level ACD without implanting an intervertebral device provided worse clinical outcome, which was hypothesized to be caused by delayed fusion. This stresses the need for focusing on timely fusion in future research.

Comparison of clinical outcomes between cervical disc arthroplasty and anterior cervical discectomy and fusion for the treatment of single-level cervical spondylosis: a 10-year follow-up study.

BACKGROUND CONTEXT: The theoretical advantage of cervical disc arthroplasty includes preserved motion at the cervical level, which may reduce degeneration of the adjacent segments. The long-term follow-up results are still controversial. PURPOSE: The present study aimed to retrospectively study the long-term efficacy and complications of cervical disc arthroplasty using a single commercially-available device in a single center. STUDY DESIGN: This was a propensity-score matched cohort study. PATIENT SAMPLE: This study enrolled 148 single-level cervical degenerative disease patients from January 2009 to March 2012. After 1:1 propensity score matching, 39 patients remained in the ACDF or ACDR groups. OUTCOME MEASURES: The outcome measures were neurological functions (Neck Disability Index (NDI) and Japan Orthopedic Association (JOA) scores), radiographic evaluations (cervical curvature, operative segment range of motion, degenerative condition of adjacent segments, heterotopic ossification (HO) of the surgical segment), and complications. METHODS: NDI and JOA scores were used to evaluate patient neurological functions. Cervical curvature (C2-C7 Cobb angle) and operative segment range of motion (ROM) were compared between the two groups. Grading criteria for osteophyte formation were used to evaluate the degenerative condition of adjacent segments. HO after ACDR was graded according to the McAfee grading method. RESULTS: The average follow-up time was 119.3 ±17.2 months. Satisfactory improvements in neurological function were obtained for both the ACDR and ACDF groups. There were no significant differences in VAS or NDI scores between the two groups. In the ACDR group, the ROM of the operative segment increased from 6.7 ±4.3° before the operation to 8.9 ±3.5° on the second day after the operation (p<.001). The ROM of the operative segment was 8.1 ±4.0° at the 1-year follow-up, 7.2 ±3.6° at the 2-year follow-up, 5.7 ±4.5° at the 5-year follow-up and 4.3 ±3.9° at the last follow-up. ASD was more likely to develop in the caudal adjacent segments and progressed with the follow-up time. At the last follow-up, HO was present in 27 patients (69.23%), while high-grade HO (McAfee scores III and IV) was detected in 6 patients (15.38%). CONCLUSIONS: Through nearly 10 years of follow-up, ACDR was as effective as ACDF for treating single-level degenerative cervical disc disease. However, HO and the role of ACDR in the protection of ASD remains to be further observed and followed up.

Safety and Validity of Anterior Cervical Disc Replacement for Single-level Cervical Disc Disease: Initial Two-year Follow-up of the Prospective Observational Post-marketing Surveillance Study for Japanese Patients.

Anterior cervical disc replacement (ACDR) using cervical artificial disc (CAD) has the advantage of maintaining the range of motion (ROM) at the surgical level, subsequently reducing the postoperative risk of adjacent disc disease. Following the approval for the clinical use in Japan, a post-marketing surveillance (PMS) study was conducted for two different types of CAD, namely, Mobi-C (metal-on-plastic design) and Prestige LP (metal-on-metal design). The objective of this prospective observational multicenter study was to analyze the first 2-year surgical results of the PMS study of 1-level ACDR in Japan. A total of 54 patients were registered (Mobi-C, n = 24, MC group; Prestige LP, n = 30, PLP group). Preoperative neurological assessment revealed radiculopathy in 31 patients (57.4%) and myelopathy in 15 patients (27.8%). Preoperative radiological assessment classified the disease category as disc herniation in 15 patients (27.8%), osteophyte in 6 patients (11.1%), and both in 33 patients (61.1%). The postoperative follow-up rates at 6 weeks, 6 months, 1 year, and 2 years after ACDR were 92.6%, 87.0%, 83.3%, and 79.6%, respectively. In both groups, patients' neurological condition improved significantly after surgery. Radiographic assessment revealed loss of mobility at the surgical level in 9.5% of patients in the MC group and in 9.1% of patients in the PLP group. No secondary surgeries at the initial surgical level and no serious adverse events were observed in either group. The present results suggest that 1-level ACDR is safe, although medium- to long-term follow-up is mandatory to further verify the validity of ACDR for Japanese patients.

Impact of heterotopic ossification following lumbar total disk replacement: a systematic review.

BACKGROUND CONTEXT: Lumbar total disc replacement (TDR) is an alternative to lumbar fusion in the treatment of lower back pain and reduces the risk of adjacent segment degeneration. Heterotopic ossification (HO) has been identified as a common complication following lumbar TDR. PURPOSE: This systematic review aims to determine the prevalence, risk factors and clinical and radiological impact of HO following lumbar TDR. STUDY DESIGN: Systematic Review. METHODS: MEDLINE, Scopus, PubMed and Cochrane Central were searched for articles that referred to lumbar TDR and HO. The hits were assessed against inclusion and exclusion criteria. Data from each included study was extracted and analysed with respect to the study aims. RESULTS: Twenty-six studies were included in this review and the pooled prevalence of HO was estimated to be between 13.2% (participants) and 15.3% (vertebral levels). TDR clinical outcomes were not found to be reduced by HO and there was insufficient data to identify a given impact upon radiological outcomes. Age and follow up time were identified as potential risk factors for HO. CONCLUSIONS: This review was hampered by inconsistencies in the reporting of HO across the studies. We therefore recommend that a set of guidelines should be produced to aid future researchers and reduce the risk of bias.

Anterior Bone Loss in Cervical Disc Arthroplasty Correlates with Increased Cervical Lordosis.

OBJECTIVE: Although cervical disc arthroplasty (CDA) has reportedly been associated with similarly low incidences of complications to anterior cervical discectomy and fusion, the phenomenon of anterior bone loss (ABL) is unique to CDA and has only recently gained notice. This study thus aimed to investigate the incidence of ABL and its correlation with cervical alignment post-operation. METHODS: Consecutive patients who received CDA for herniated disc or spondylosis were retrospectively reviewed. The development and extent of ABL was detected by comparison of preoperative and postoperative serial images for the relative position of the anterior vertebral body with the CDA devices and graded into 3 levels: grade 1 (minor bone loss), grade 2 (anterior portion of the vertebral body without exposure of the artificial disc), and grade 3 (anterior portion of the vertebral body with exposure of the device). RESULTS: A total of 41 patients were analyzed with a mean follow-up of 24.1 months. Under serial radiologic examinations during follow-up, all patients (41 of 41 = 100%) had bone loss of various degrees, with grade 3 ABL the most common (30 of 41 = 73.1%). There were 8 and 3 patients who had grades 2 and 1 ABL, respectively. The changes of the Cobb angle (ΔCobb) trended towards higher grades of ABL. CONCLUSIONS: During the mean follow-up of 2 years, ABL was a common radiologic finding. More than half of the patients (26 of 41, 63.4%) in the series gained cervical lordosis (ΔCobb >0) after CDA. These patients with increased cervical lordosis (ΔCobb >0) after CDA had higher grades of ABL.