Presentation and management of infection in total disc replacement: A review.

Background: Total disc replacement (TDR) is widely used in the treatment of cervical and lumbar spine pathologies. Although TDR infection, particularly delayed infection, is uncommon, the results can be devastating, and consensus on clinical management remains elusive. In this review of the literature, we asked: (1) What are the reported rates of TDR infection; (2) What are the clinical characteristics of TDR infection; and (3) How has infection been managed for TDR patients? Methods: We performed a search of the literature using PubMed and Embase to identify studies that reported TDR infection rates, the identification and management of TDR infection, or TDR failures with positive cultures. Twenty database studies (17 focusing on the cervical spine and 3 on the lumbar spine) and 10 case reports representing 15 patients were reviewed along with device Summary of Safety and Effectiveness Data reports. Results: We found a lack of clarity regarding how infection was diagnosed, indicating a variation in clinical approach and highlighting the need for a standard definition of TDR infection. Furthermore, while reported infection rates were low, the absence of a clear definition prevented robust data analysis and may contribute to underreporting in the literature. We found that treatment strategy and success rely on several factors including patient symptoms and time to onset, microorganism type, and implant positioning/stability. Conclusions: Although treatment strategies varied throughout the extant literature, common practices in eliminating infection and reconstructing the spine emerged. The results will inform future work on the creation of a more robust definition of TDR infection and as well as recommendations for management.

Lateral decubitus anterior exposure of the L4-5 disc maintains safety compared with supine positioning.

Background: Anterior retroperitoneal lumbar spinal exposure has traditionally been performed in the supine position (SUP) to access the L4-L5 and L5-S1 disc spaces where lateral approaches may be unsafe. However, advancements in lateral single position surgery have resulted in advocacy for anterior L4-5 disc access in the lateral decubitus position (LAT). While L5-S1 access in the lateral position is well-described, no series of L4-5 anterior access in the lateral position has been published. The study aims to evaluate the safety of anterior lumbar exposure at the L4-5 disc level in the LAT compared to the SUP. Methods: A multi-center retrospective study of patients who underwent anterior retroperitoneal lumbar exposure involving the L4-5 disc level were classified according to patient positioning: (I) LAT or (II) SUP. Results: One hundred and forty patients were included, of which 65 LAT and 75 SUP patients. Two hundred and thirty-eight anterior levels were exposed, including 113 levels performed in lateral and 125 levels in supine. Mean anterior levels fused was similar (1.74 vs. 1.67 levels, P=0.37). Significantly more LAT patients underwent additional lateral lumbar interbody fusion (LLIF) (21.50% vs. 0.00%, P<0.001). A larger proportion of LAT patients underwent surgery for spinal deformity (21.50% vs. 6.70%, P=0.01) and planned staged procedures (21.50% vs. 6.70%, P=0.01). Intraoperative complication rates were similar (3.10% vs. 4.00%, P=0.77), including similar vascular injury rates (1.50% vs. 0.00%, P=0.28) and no visceral injury. Postoperative complications (15.40% vs. 38.70%, P=0.002) were significantly lower in the LAT group, however major complications (6.20% vs. 13.30%, P=0.16) were similar between groups. Fewer LAT patients experienced postoperative ileus (0.00% vs. 6.70%, P=0.03). The rate of reoperation within 30 days (3.10% vs. 6.70%, P=0.33) and 90 days (3.10% vs. 10.70%, P=0.09) were similar between groups. Conclusions: Anterior lumbar spinal exposure of the L4-5 disc in the LAT is safe compared to supine exposure, despite higher case complexity in the lateral position.

Prosthesis design and likelihood of achieving physiological range of motion after cervical disc arthroplasty: analysis of range of motion data from 1,173 patients from 7 IDE clinical trials.

BACKGROUND CONTEXT: The functional goals of cervical disc arthroplasty (CDA) are to restore enough range of motion (ROM) to reduce the risk of accelerated adjacent segment degeneration but limit excessive motion to maintain a biomechanically stable index segment. This motion-range is termed the "Physiological mobility range." Clinical studies report postoperative ROM averaged over all study subjects but they do not report what proportion of reconstructed segments yield ROM in the Physiological mobility range following CDA surgery. PURPOSE: To calculate the proportion of reconstructed segments that yield flexion-extension ROM (FE-ROM) in the Physiological mobility range (defined as 5°-16°) by analyzing the 24-month postoperative data reported by clinical trials of various cervical disc prostheses. STUDY DESIGN/SETTING: Analysis of 24-month postoperative FE-ROM data from clinical trials. PATIENT SAMPLE: Data from 1,173 patients from single-level disc replacement clinical trials of 7 cervical disc prostheses. OUTCOME MEASURES: 24-month postoperative index-level FE-ROM. METHODS: The FE-ROM histograms reported in Food and Drug Administration-Investigational Device Exemption (FDA-IDE) submissions and available for this analysis were used to calculate the frequencies of implanted levels with postoperative FE-ROM in the following motion-ranges: Hypomobile (0°-4°), Physiological (5°-16°), and Hypermobile (≥17°). The ROM histograms also allowed calculation of the average ROM of implanted segments in each of the 3 motion-ranges. RESULTS: Only 762 of 1,173 patients (implanted levels) yielded 24-month postCDA FE-ROM in the physiological mobility range (5°-16°). The proportions ranged from 60% to 79% across the 7 disc-prostheses, with an average of 65.0%±6.2%. Three-hundred and two (302) of 1,173 implanted levels yielded ROM in the 0°-4° range. The proportions ranged from 15% to 38% with an average of 25.7%±8.9%. One-hundred and nine (109) of 1,173 implanted levels yielded ROM of ≥17° with a range of 2%-21% and an average proportion of 9.3%±7.9%. The prosthesis with built-in stiffness due to its nucleus-annulus design yielded the highest proportion (103/131, 79%) of implanted segments in the physiological mobility range, compared to the cohort average of 65% (p<.01). Sixty-five of the 350 (18.6%) discs implanted with the 2 mobile-core designs in this cohort yielded ROM≥17° as compared to the cohort average of 9.3% (109/1,173) (p<.05). At 2-year postCDA, the "hypomobile" segments moved on average 2.4±1.2°, those in the "physiological-mobility" group moved 9.4±3.2°, and the hypermobile segments moved 19.6±2.6°. CONCLUSIONS: Prosthesis design significantly influenced the likelihood of achieving FE-ROM in the physiological mobility range, while avoiding hypomobility or hypermobility (p<.01). Postoperative ROM averaged over all study subjects provides incomplete information about the prosthesis performance - it does not tell us how many implanted segments achieve physiological mobility and how many end up with hypomobility or hypermobility. We conclude that the proportion of index levels achieving postCDA motions in the physiological mobility range (5°-16°) is a more useful outcome measure for future clinical trials.

Long-term outcomes following lumbar total disc replacement with M6-L.

Background: The motion preserving benefits of lumbar total disc replacement (LTDR) are well established. There is a paucity of long-term follow-up data on the M6-L prosthesis. The aim was to evaluate the clinical and radiographic outcomes of patients undergoing LTDR with M6-L and make comment about its effectiveness and durability. Methods: A retrospective single center chart review was performed of all patients who underwent LTDR with M6-L between January 1, 2011, and January 1, 2021, either as standalone device or combined with a caudal anterior lumbar interbody fusion (ALIF) (hybrid procedure). Preoperative, postoperative, and final follow-up patient reported outcome measures (PROMs) (VAS back, VAS leg, ODI, and SF-12) and patient satisfaction were recorded prospectively. Device range of motion (ROM), adjacent segment degeneration/disease and heterotopic ossification (HO) were obtained from flexion and extension lumbar radiographs at most recent follow-up. Results: Sixty patients underwent LTDR with the M6-L device. Mean age was 41 [16-71] years and 38 (63%) were male. Sixteen (26.7%) underwent standalone LTDR, 42 (70.0%) a hybrid procedure, and 2 (3.3%) a 3-level procedure. Twenty-three (38.3%) patients were lost to follow-up. Thirty-seven (61.7%) were followed for a mean of 4.3 [1-10] years with 36/37 reviewed at a minimum of 2-years and 13/37 followed for over 5-years. Only one patient with osteopenia needed index level revision LTDR surgery for subsidence requiring supplemental posterior instrumentation. There were no osteolysis induced device related failures. Thirty patients obtained long-term follow-up radiographic data. Six patients had adjacent segment degeneration; none required surgery for adjacent segment disease (ASD). Three patients presented with clinically significant HO (2 with McAfee class III, 1 with class IV). The average M6-L ROM was 8.6 degrees. Mean preoperative baseline PROMs demonstrated statistically significant improvements postoperatively and were sustained at last follow-up (P<0.05). Conclusions: Total disc replacement (TDR) with M6-L showed clinically significant improvement in PROMs that were sustained at long-term follow-up. There were no osteolysis induced device related failures. The device ROM was maintained and showed a downward trend over the 10-year study follow-up period. This paper demonstrated that the M6-L was an effective and durable arthroplasty device in this series.

A Retrospective Comparative Study of Long-Term Outcomes Following Cervical Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion.

Introduction The traditional treatment for patients with radiculopathy and myelopathy caused by degenerative disc disease was anterior cervical discectomy and fusion (ACDF). However, a documented complication of ACDF is adjacent segment degeneration (ASD). An alternative that was developed was total disc replacement (TDR). The aim of this study was to determine and compare the short- and medium-to-long-term outcomes after a TDR or ACDF. Methods A retrospective review of 154 patients who had single and two-level ACDFs and 90 TDRs performed by a single surgeon between 2011 and 2017 was conducted. Parameters for comparisons include both radiological evaluation and patient-reported outcome measures (PROMS) at six weeks, one year, and two years postoperatively. The Neck Disability Index (NDI) and the visual analogue scale (VAS) for neck and arm pain are used to evaluate pain, function, patient satisfaction, and overall clinical success. Results TDR and ACDF showed significant improvement in NDI and VAS when compared to pre- and post-operatively at both six weeks (p<0.05 & P=0.032, respectively) and two years (p<0.05 & 0=0.026, respectively). TDR vs. ACDF showed no significant difference (p<0.05). VAS scores after ACDF showed improvement from 13.41 to 3.94 at two years (p<0.001). TDR showed similar scores of 12.5 to 3.55 (p<0.001). The radiological fusion rate at 12 or 24 months showed no significant difference between the two groups. There were two cases that required re-operation after ACDF (1.2%), and two that required TDR (2.2%). Conclusion Both TDR and ACDF lead to clinically significant improvements in pain and function scores. We did not find a statistically significant difference in NDI and VAS in the neck and arm. The results are in agreement with others' assessments of these two treatment modalities. Our conclusions supplement the literature about these operative options for degenerative disc disease of the cervical spine and are a useful addition to the armamentarium in the assessment of patients with degenerative pathology of the c-spine.

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

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. ETHICAL COMMITTEE NUMBER: 174/2019 (Oulu University Hospital Ethics Committee).

Cervical disc arthroplasty (CDA)/total disc replacement (TDR) vs. anterior cervical diskectomy/fusion (ACDF): A review.

Background: We performed a focused review to determine the "non-inferiority", potential superiority, and relative safety/efficacy for performing cervical disc arthroplasty (CDA)/total disc replacement (TDR) in carefully selected patients vs. anterior cervical diskectomy/fusion (ACDF). Notably, CDA/TDR were devised to preserve adjacent level range of motion (ROM), reduce the incidence of adjacent segment degeneration (ASD), and the need for secondary ASD surgery. Methods: We compared the incidence of ASD, reoperations for ASD, safety/efficacy, and outcomes for cervical CDA/TDR vs. ACDF. Indications, based upon the North American Spine Society (NASS) Coverage Policy Recommendations (Cervical Artificial Disc Replacement Revised 11/2015 and other studies) included the presence of radiculopathy or myelopathy/myeloradiculopathy at 1-2 levels between C3-C7 with/without neck pain. Contraindications for CDA/TDR procedures as quoted from the NASS Recommendations (i.e. cited above) included the presence of; "Infection…", "Osteoporosis and Osteopenia", "Instability…", "Sensitivity or Allergy to Implant Materials", "Severe Spondylosis…", "Severe Facet Joint Arthropathy…", "Ankylosing Spondylitis" (AS), "Rheumatoid Arthritis (RA), Previous Fracture…", "Ossification of the Posterior Longitudinal Ligament (OPLL)", and "Malignancy…". Other sources also included spinal stenosis and scoliosis. Results: Cervical CDA/TDR studies in the appropriately selected patient population showed no inferiority/ occasionally superiority, reduced the incidence of ASD/need for secondary ASD surgery, and demonstrated comparable safety/efficacy vs. ACDF. Conclusion: Cervical CDA/TDR studies performed in appropriately selected patients showed a "lack of inferiority", occasional superiority, a reduction in the incidence of ASD, and ASD reoperation rates, plus comparable safety/efficacy vs. ACDF.

Preliminary Clinical Outcome of One-level Mobi-C Total Disc Replacement in Japanese Population.

INTRODUCTION: In 2018, the first Mobi-CⓇ total disk replacement (TDR) case was performed in Japan. In this study, we examined the preliminary clinical outcome of Mobi-CⓇ for degenerative cervical spine disease. METHODS: We examined 24 consecutive patients who underwent 1-level TDR after 2018 and followed up for more than 6 months after surgery. The evaluation criteria included age, gender, diagnosis, follow-up period, surgical level, implant size, surgery time, intraoperative bleeding volume, complications, revision surgery, imaging findings, JOA score, and various questionnaires. RESULTS: The mean age was 52.7 years, 13 males and 11 females. There were 15 cases of cervical disk herniation and 9 cases of cervical spondylosis. The mean follow-up period was 17.4 months. Surgical levels were C3/4 in 4 cases, C4/5 in 2 cases, C5/6 in 16 cases, and C6/7 in 2 cases. The mean operation time was 138.5 minutes, the amount of intraoperative bleeding was 32.1 ml, and there were no serious intraoperative complications. The range of motion of the affected level increased significantly, from 6.6 degrees preoperatively to 12.2 degrees at final follow-up. No patients required revision surgery at final follow-up, and there were no cases of heterotopic ossification or adjacent segment disease. One patient exhibited radiculopathy due to mild subsidence 1 year after surgery, and 1 had asymptomatic contact of device plates. Preoperative and final JOA scores improved from 11.7 to 15.8 points, and NRS improved from 4.3 to 1.3 points for neck pain and 4.3 to 1.7 points for arm pain. Preoperative and final NDI improved from 39.7% to 14.0%, and EQ-5D improved from 0.602 to 0.801. CONCLUSIONS: The short-term treatment outcomes of Mobi-CⓇ TDR were generally favorable. Spine surgeons should comply with guidelines when introducing this procedure and strive to adopt this new technology in Japan.

Finite element analysis of a ball-and-socket artificial disc design to suppress excessive loading on facet joints: A comparative study with ProDisc.

Facet arthrosis at surgical level was identified as major complication after total disc replacement (TDR). One of the reasons for facet arthrosis after TDR has been speculated to be the hypermobility of artificial discs. Accordingly, the artificial disc that can constrain the hypermobility of ball-and-socket type artificial discs and reduce loading on facet joints is demanded. The proposed artificial disc, which is named as NewPro, was constructed based on the FDA-approved ProDisc but contained an interlocking system consisting of additional bars and grooves to control the range of motion (ROM) of lumbar spine in all anatomical planes. The three-dimensional finite element model of L1 to L5 was developed first, and the biomechanical effects were compared between ProDisc and NewPro. The ROM and facet contact force of NewPro were significantly decreased by 42.7% and 14% in bending and by 45.6% and 34.4% in torsion, respectively, compared with the values of ProDisc, thanks to the interlocking system. In addition, the ROM and facet contact force could be selectively constrained by modifying the location of the bars. The proposed artificial disc with the interlocking system was able to constrain the intersegmental rotation effectively and reduce excessive loading on facet joints, although wear and strength tests would be needed prior to clinical applications.

Disc herniation caused by a viscoelastic nucleus after total lumbar disc replacement-a case report.

Degenerative disc disease (DDD) is highly prevalent. If conservative treatment fails, spinal fusion procedures are commonly performed. Total disc replacement (TDR) might be a surgical option for a distinct subset of patients with DDD. Several prostheses have been or are still available. Despite some promising initial clinical results, there is still limited experience with hardware-related adverse events. This report highlights an unreported complication after TDR with a viscoelastic device. Literature about long-term outcome and safety of this particular TDR is scarce. Hence, there exists limited experience with TDR-related complications with such a failure mode. We report a 34-year-old male presented to us with an acute S1 radiculopathy on the right. His past medical history was significant for prior TDR at the level L5/S1 at another hospital 2 years prior to this acute episode. Imaging studies revealed an intraspinal mass compromising the right S1 nerve root. This mass mimicked a disc herniation and sequestrectomy was performed. Intraoperatively, the prolapsed sequester turned out to be part of the viscoelastic nucleus of the disc prosthesis. Interbody fusion combined with posterior instrumentation was ultimately performed. The patient did well afterwards, but is currently (2 years later) developing adjacent segment disease with facet syndromes. Since TDR might be beneficial for certain patients, spine surgeons should be aware of potential device-related complications.

Clinical experience and two-year follow-up with a one-piece viscoelastic cervical total disc replacement.

BACKGROUND: The purpose of this study is to present clinical outcome data from a 2-year post-market study of a viscoelastic one-piece cervical total disc replacement (TDR) in Europe. METHODS: Thirty-nine patients were implanted at five surgical sites in an European post-market clinical study. Clinical outcomes included improvement of neck disability index (NDI) and visual analog scale scores for neck and arm pain from baseline to 2-year follow-up, neurological examinations, patients view on the success of surgery, complications, and subsequent surgical interventions. RESULTS: Thirty patients had the Freedom® Cervical Disc (FCD) implanted at a single level, and nine patients were implanted at two adjacent levels. The population had a similar distribution of male [20] and female [19] subjects, with a mean age of 45 years. All self-administered outcome measures showed significant clinically important improvements from baseline to the 2-year follow-up. Mean preoperative NDI score improved from 48% to 20%, 13%, 8%, 6% and 4% at 6 weeks, 3, 6, 12, and 24 months, respectively. Average preoperative visual analog scale (VAS) scores of the neck, right and left arm pain intensity and frequency showed significant improvement. All neurological outcome measurements showed immediate improvement from preoperative values and continued improvement throughout 2 years follow-up. From pre-op to 24 months, neurological deficits declined in the population from 21% to 6% for reflex function, 62% to 17% for sensory function, and 38% to 3% for motor function. No patients experienced a deterioration in any measured outcomes compared with the preoperative situation. Patient satisfaction increased over 2 years post-op, with 83% of patients responding that they would "definitely" choose to have the same treatment for their neck/arm condition and another 11% responding that they would "probably" choose to have the same treatment. CONCLUSIONS: The FCD performs as expected in patients with single-level and two-level degenerative disc disease.

Intraoperative navigation for accurate midline placement of anterior lumbar interbody fusion and total disc replacement prosthesis.

Anterior lumbar approach techniques for the management of discogenic back pain and placement of spinal instrumentation such as fusion and disc replacement prosthesis is becoming increasingly popular. To date, no studies have reported the clinical usage of spinal navigation with anterior lumber interbody fusion (ALIF) and total disk replacement (TDR). We describe a surgical procedure of a 35-year-old patient presenting with discogenic lower back pain treated with an anterior lumbar interbody fusion and total disc replacement procedure to highlight the clinical advantages of intraoperative CT spinal navigation for accurate implant placement, therefore optimising peri- and post-operative outcomes.