The past, present, and the future of disc nucleus replacement. A systematic review of a large diversity of ideas and experiences.

Disc nucleus replacement (NR) is a challenging surgical technique used as a medical treatment for early-stage disc herniation to restore disc height and the biomechanical function of a motion segment, which may reduce low back pain. The surgical procedure involves the removal and replacement of the degenerated nucleus pulposus with a substitute by accessing the annulus fibrosos via a created hole. Over the decades, nucleus replacement has been an important issue, leading to the development of different substitute alternatives. The first ideas are dated to the 1950s and since then, more than a hundred nucleus replacement concepts can be identified. There were numerous attempts and several clinical trials; however, after more than 70 years of research, no gold standard for nucleus pulposus replacement has been identified. This review aims to collect the different nucleus replacements reported in the literature, thus understanding what failed, what could be improved and what are the opportunities for the future. A systematic review of the literature was performed using a keyword-based search on PubMed, Web of Science, and Scopus databases to detect all nucleus replacements presented in the past by clinicians and engineers. Several studies were extracted from which the main nucleus replacements over the years were investigated, including the ones that received CE mark, FDA approval, or IDE approval and, also those involved in clinical trials. A total of 116 studies were included in this review. The extracted data concern the nucleus replacements proposed over the years to create a historical background as complete as possible, including their mechanical and biomechanical characterization and the clinical trials conducted over the years. Nucleus disc arthroplasty has been explored for many years. Unfortunately, even today there is still nothing safe and definitive in this surgical practice. This review provides an overview of the nucleus replacement history. A breakthrough could be the improvements in technologies for the annulus fibrous closing or sealing and the tissue engineering and medical regenerative techniques which could certainly ensure a higher NR implantation success rate in the future of this clinical treatment. It is not yet clear what is the future of this clinical practice. Only scientific research can answer the question: is the nucleus replacement still a possible clinical solution?

The footprint mismatch of cervical disc arthroplasty comes from degenerative factor besides ethnic factor.

A mismatch in footprints of cervical total disc arthroplasty (CTDA) implants occasionally occurred in Asian population and it had been attributed solely to ethnic factor. Yet, cervical degeneration process may play a role. Our purpose was to compare the cervical vertebra morphometric data with and without degeneration. The study included patients with CT scans of cervical spine from our hospital between January, 2019, and September, 2021. The total cervical degenerative index (TCDI) of each patient were collected by adding CDI score for 5 disc-levels. Patients were categorized into normal (TCDI 0-5) and degeneration groups (TCDI 6-60). Various measurements of the C3-C7 vertebral body and endplate were taken. Forty-nine patients in the normal group and 55 in the degeneration group were included. No significant difference was noted in gender, BH, BW, or BMI except age and TCDI (p < .001). During degeneration, disproportional endplate size changes were observed, with an increment ratio of 12-20% in the anteroposterior and 5-17% in the mediolateral plane throughout C3-C7, while vertebral body height remained constant. In conclusion, degeneration process, besides ethnic factor, causes the endplate size and shape mismatch. This information can help spine surgeon choose appropriate implants in CTDA surgery.

The Impact of Endplate Coverage on Heterotopic Ossification Following Cervical Disc Replacement: A Systematic Review and Meta Analysis.

STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVE: Describe the impact of endplate coverage on HO in cervical disc replacement (CDR). SUMMARY OF BACKGROUND DATA: CDR is a motion-sparing alternative to anterior cervical discectomy and fusion. However, the high prevalence of heterotopic ossification threatens to diminish range of motion and limit this benefit associated with CDR. MATERIALS AND METHODS: A systematic review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. EMBASE and PubMed databases were queried. Results were deduplicated and screened. Relevant studies were included. All metrics that were reported in ≥3 studies were aggregated for analysis. SPSS was used to perform the meta-analysis. RESULTS: A total of 10 studies were included in the systematic review. Endplate coverage was assessed using a wide variety of measurements, including anteroposterior implant depth (ID), endplate depth (ED), exposed endplate depth (EED), implant depth to endplate depth ratio (ID:ED), EED to ED ratio (EED:ED), implant width (IW) to endplate width (EW) ratio (IW:EW), and the implant area (IA) to endplate area (EA) ratio (IA:EA). No evidence has linked ID (three studies) to HO. Mixed evidence has linked ID:ED (3/5) and IW:ED (1/2) to HO. All available evidence has linked ED (2), EED (4), EED:ED (2), and IA:EA (1) to HO. In our meta-analysis, ID was not found to be a significant risk factor for HO. However, EED and ID:ED were found to be significant risk factors for HO formation. CONCLUSIONS: Exposed endplate, especially as assessed by EED and ID:ED, is a significant risk factor for HO. Surgeons should focus on preoperative planning and intraoperative implant selection to maximize endplate coverage. While optimizing technique and implant selection is crucial, improved implant design may also be necessary to ensure that appropriate implant-endplate footprint matching is possible across the anatomic spectrum.

[Expert consensus on clinical application of cervical artificial disc replacement].

Cervical artificial disc replacement preserves the range of motion after the decompression, and this technology has achieved good clinical results. The indications, surgical procedures, and perioperative management of cervical disc arthroplasty are different from traditional anterior cervical decompression and fusion. The Health Management and Enhanced Recovery of Cervical Spine Disorders Committee, Chinese Research Hospital Association has established an expert group to draw up this expert consensus through literature analysis and professional discussions. The purpose of this consensus is to standardize the surgical indications and patient selection of cervical artificial disc replacement, to guide surgical procedures and perioperative management, and to improve the clinical outcomes of cervical artificial disc replacement.

Clinical management of bone loss in cervical total disc arthroplasty: literature review and treatment recommendations.

PURPOSE: Cervical total disc replacement (cTDR) has been established as an alternative treatment for degenerative cervical radiculopathy and myelopathy. While the rate of complications for cTDR is reasonably low, recent studies have focused on bone loss after cTDR. The purpose of this work is to develop a clinical management plan for cTDR patients with evidence of bone loss. To guide our recommendations, we undertook a review of the literature and aimed to determine: (1) how bone loss was identified/imaged, (2) whether pre- or intraoperative assessments of infection or histology were performed, and (3) what decision-making and revision strategies were employed. METHODS: We performed a search of the literature according to PRISMA guidelines. Included studies reported the clinical performance of cTDR and identified instances of cervical bone loss. RESULTS: Eleven case studies and 20 cohort studies were reviewed, representing 2073 patients with 821 reported cases of bone loss. Bone loss was typically identified on radiographs during routine follow-up or by computed tomography (CT) for patients presenting with symptoms. Assessments of infection as well as histological and/or explant assessment were sporadically reported. Across all reviewed studies, multiple mechanisms of bone loss were suspected, and severity and progression varied greatly. Many patients were reportedly asymptomatic, but others experienced symptoms like progressive pain and paresthesia. CONCLUSION: Our findings demonstrate a critical gap in the literature regarding the optimal management of patients with bone loss following cTDR, and treatment recommendations based on our review are impractical given the limited amount and quality evidence available. However, based on the authors' extensive clinical experience, close follow-up of specific radiographic observations and serial radiographs to assess the progression/severity of bone loss and implant changes are recommended. CT findings can be used for clinical decision-making and further follow-up care. The pattern and rate of progression of bone loss, in concert with patient symptomatology, should determine whether non-operative or surgical intervention is indicated. Future studies involving implant retrieval, histopathological, and microbiological analysis for patients undergoing cTDR revision for bone loss are needed.

Treatment of failed cervical total disc replacements in a series of 53 cases and description of a management strategy.

PURPOSE: To describe modes of failure of cervical TDR, their related treatment strategies, and to describe a management strategy for the treatment of failed cervical TDR. METHODS: This retrospective study was based on a consecutive series of 53 cervical TDR patients who underwent removal or revision surgery. Chart review was conducted to collect general descriptive data, reasons for TDR removal/revision, duration from index implantation to re-operation, and the subsequent procedure performed. RESULTS: Among 53 patients, 36 underwent TDR removal and fusion, 16 underwent TDR removal and replacement with another TDR, and one patient's TDR was revised by repositioning. The mean duration from index surgery to removal/revision was 40.1 months (range: 3 days-222 months). In all cases, removal/revision surgery was completed without complication. The most common reason for removal was severe osteolysis, often involving C. acnes infection, and was primarily associated with one implant type. TDR removal and fusion were performed for subsidence, device migration, treatment of symptoms arising from posterior anatomy (facet joints, etc.), approach-related complications and pain. TDR replacement was feasible for hypermobility, metal allergy, implant locked in kyphosis, and oversized implant use. In one case of TDR malpositioning, the device was successfully revised into appropriate position. CONCLUSION: After cervical TDR failure, replacing a TDR with another implant can be feasible. Reasons for revision or removal after cervical TDR surgery include biomechanical failure, implant migration, surgeon or technical error, or biological reasons. The type of failure can help the surgeon create a strategy to address these complications.

Predictors of Nonhome Discharge After Cervical Disc Replacement.

STUDY DESIGN: Retrospective review of a national database. OBJECTIVE: The aim of this study was to identify the factors that increase the risk of nonhome discharge after CDR. SUMMARY OF BACKGROUND DATA: As spine surgeons continue to balance increasing surgical volume, identifying variables associated with patient discharge destination can help expedite postoperative placement and reduce unnecessary length of stay. However, no prior study has identified the variables predictive of nonhome patient discharge after cervical disc replacement (CDR). METHODS: The American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database was queried for patients who underwent primary 1-level or 2-level CDR between 2011 and 2020. Multivariable Poisson regression with robust error variance was employed to identify the predictors for nonhome discharge destination following surgery. RESULTS: A total of 7276 patients were included in this study, of which 94 (1.3%) patients were discharged to a nonhome destination. Multivariable regression revealed older age (OR: 1.076, P <0.001), Hispanic ethnicity (OR: 4.222, P =0.001), BMI (OR: 1.062, P =0.001), ASA class ≥3 (OR: 2.562, P =0.002), length of hospital stay (OR: 1.289, P <0.001), and prolonged operation time (OR: 1.007, P <0.001) as predictors of nonhome discharge after CDR. Outpatient surgery setting was found to be protective against nonhome discharge after CDR (OR: 0.243, P <0.001). CONCLUSIONS: Age, Hispanic ethnicity, BMI, ASA class, prolonged hospital stay, and prolonged operation time are independent predictors of nonhome discharge after CDR. Outpatient surgery setting is protective against nonhome discharge. These findings can be utilized to preoperatively risk stratify expected discharge destination, anticipate patient discharge needs postoperatively, and expedite discharge in these patients to reduce health care costs associated with prolonged length of hospital stay. LEVEL OF EVIDENCE: IV.

Prosthesis optimization and mechanical analysis of artificial lumbar disc replacement.

BACKGROUND: Artificial lumbar disc replacement is an effective method for the treatment of lumbosacral degenerative diseases. An appropriate artificial intervertebral disc device is of great significance for the maintenance of spinal stability and activity. METHODS: Two finite element models of ProDisc-L prosthesis replacement and improved prosthesis replacement were constructed by using the finite element model of complete lumbar L1-L5 segment established by CT image data. The mechanical properties of the surgical models before and after improvement were analyzed and evaluated. RESULTS: The ProDisc-L group and the improved group showed similar lumbar's ROM and maintained a similar ROM with the normal lumbar spine. There was no significant change in the intervertebral disc's pressure between the adjacent segments of the two prosthesis groups compared with the normal group, but the stress value of the improved prosthesis group was slightly lower than that of the ProDisc-L group. In addition, the improved prosthesis replacement has more reasonable stress distribution. CONCLUSIONS: Compared with the ProDisc-L prosthesis, the improved prosthesis can reduce the pressure in the intervertebral disc of the adjacent segment, the contact stress of the facet joint and the artificial prosthesis, which provides reference for the subsequent design of the prosthesis structure.

Clinical Outcomes and Complication Rates for Noncontiguous Anterior Cervical Discectomy and Fusion, Cervical Disc Arthroplasty, and Hybrid Cervical Surgery: A Systematic Review.

OBJECTIVE: This study examined clinical outcomes associated with 3 types of noncontiguous cervical surgeries - anterior cervical discectomy and fusion (ACDF), cervical disc arthroplasty (CDA), and hybrid cervical surgery (HCS) - to improve surgeon decision-making. METHODS: A systematic review was performed using PubMed, CINAHL, MEDLINE, and Web of Science from database inception until June 6th, 2023. Inclusion criteria were studies that reported any type of clinical outcome, examined noncontiguous ACDF, noncontiguous CDA, and/or noncontiguous HCS. RESULTS: Ten articles out of 523 articles initially retrieved were included. Patients (n = 388) had a mean age of 52 ± 5.1 years and a mean follow up time of 33 ± 6.0 months. Overall, 119 patients underwent non-contiguous HCS, 65 underwent non-contiguous CDA, and 204 underwent non-contiguous ACDF. There appears to be no clinically meaningful difference in Neck Disability Index (NDI) score, Japanese Orthopedic Association (JOA) score, and improvement in pain based on surgery type. There was a total of 83 complications (21% of cases) with non-contiguous ACDF having a higher absolute rate of dysphagia (20%) as compared to non-contiguous HCS (6.7%) or non-contiguous CDA (6.2%). Non-contiguous ACDF had a higher absolute rate of adjacent segment degeneration (ASD) as a reported complication (6.4%) as compared to non-contiguous HCS (1.7%) and non-contiguous CDA (0.0%). CONCLUSIONS: There may be no clinically meaningful difference in many clinical outcomes for different non-contiguous surgical interventions for non-contiguous cervical degenerative disc disease (CDDD). However, complication rates, such as dysphagia and ASD, appear higher for non-contiguous ACDF as compared to non-contiguous CDA or HCS.

Cervical Alignment and Range of Motion Change after Anterior 3-Level Hybrid Surgery Compared with Cervical Laminoplasty: A Matched Cohort Study.

OBJECTIVES: Cervical alignment and range of motion (ROM) changes after cervical spine surgery are related to cervical biomechanical and functions. Few studies compared these parameters between posterior laminoplasty and anterior 3-level hybrid surgery incorporating anterior cervical discectomy and fusion (ACDF) with cervical disc replacement (CDR). This study is aimed to detect the differences of cervical alignment and ROM changes of the two surgeries in a matched-cohort study. METHODS: From January 2018 and May 2020, 51 patients who underwent 3-level hybrid surgery incorporating ACDF with ACDR were included. A 1:1 match of the patients who underwent cervical laminoplasty based on age, gender, duration of symptoms, body mass index, and cervical alignment type was utilized as control group. General data (operative time, blood loss, etc.), Japanese Orthopaedic Association (JOA) score, VAS (Visual Analog Score), NDI (The Neck Disability Index), cervical sagittal alignment, and cervical range of motion (ROM) were recorded and compared. RESULTS: Both groups gained significant improvement in JOA, VAS, NDI scores postoperatively (p < 0.05). Cervical alignment significantly increased in hybrid group and decreased in control group after surgeries (p < 0.001). ROM decrease was similar in two groups. For cervical lordosis, though cervical alignment angle in control group decreased, the final follow-up cervical alignment and cervical alignment changes were not significantly different between hybrid and control groups. For cervical non-lordosis, cervical alignment decreased in control group while increased in hybrid group. At final follow-up, cervical alignment and the changes between the two groups were significantly different. Both control group and hybrid group had similar ROM decrease after the surgery no matter whether there was cervical lordosis or non-lordosis. Hybrid surgery showed cervical alignments significantly improved and similar ROM preservation compared with control group at final follow-up both for 1-level and 2-level disc replacement subgroups. CONCLUSIONS: The hybrid surgery demonstrated advantages of preserving cervical alignment and gaining similar cervical ROM preservation compared with cervical laminoplasty, especially for cervical non-lordosis. Given the importance of restoring lordotic cervical alignment, hybrid surgery may be preferred over laminoplasty to treat multilevel cervical disc herniation.

Biomechanical analysis of single and multi-level artificial disc replacement (ADR) in cervical spine using multi-scale loadings: A finite element study.

Artificial disc replacement (ADR) is a clinical procedure used to diagnose cervical degenerative disc disease, preserving range of motion (ROM) at the fixation level and preventing adjacent segment degeneration (ASD). This study analyzed the biomechanics of ADR by examining range of motion (ROM), stress levels in bone and implants, and strain in the bone-implant interface using multi-scale loadings. The study focused on single- and double-level patients across various loading scales during physiological motions within the cervical spine. Results showed increased ROM in single-level and double-level fixations during physiological loadings, while ROM decreased at the adjacent level of fixation with the intact cervical spine model. The Prodisc-Implant metal endplate experienced a maximum von Mises stress of 432 MPa during axial rotation, confirming the long durability and biomechanical performance of the bone-implant interface.

Long-term results and surgical strategy development for degenerative disease treatment in athletes: a retrospective single-center study.

PURPOSE: To analyze of the results of spine surgical treatment of athletes with lumbar degenerative disease and development of a surgical strategy based on the preoperative symptoms and radiological changes in the lumbar spine. METHODS: For 114 athletes with lumbar degenerative disease were included in the present study. Four independent groups were studied: (1) microsurgical/endoscopic discectomy (n = 35); (2) PRP therapy in facet joints (n = 41); (3) total disc replacement (n = 11); (4) lumbar interbody fusion (n = 27). We evaluated postoperative clinical outcomes and preoperative radiological results. The average postoperative follow-up was 5 (3;6), 3.5 (3;5), 3 (2;4) and 4 (3;5) years, respectively. The analysis included an assessment of clinical outcomes (initial clinical symptoms, chronic pain syndrome level according to the VAS, quality of life according to the SF-36 questionnaire, degree of tolerance to physical activity according to the subjective Borg Rating of Perceived Exertion Scale) and radiological data (Dynamic Slip, Dynamic Segmental Angle, degenerative changes in the facet joint according to the Fujiwara classification and disc according to the Pfirrmann classification; changes in the diffusion coefficient using diffusion-weighted MRI). RESULTS: The median and 25-75% quartiles timing of return to sports were 12.6 (10.2;14.1), 2.8 (2.4;3.7), 9 (6;12), and 14 (9;17) weeks, respectively. We examined the type of surgical treatment utilized, as well as the preoperative clinical symptoms, severity of degenerative changes in the intervertebral disc and facet joint, the timing of return to sports, the level of pain syndrome, the quality of life according to SF-36, and the degree of tolerance to physical activity. We then developed a surgical strategy based on individual preoperative neurological function and lumbar morphological changes. CONCLUSIONS: In this retrospective study, we report clinical results of four treatment options of lumbar spine degenerative disease in athletes. The use of developed patient selection criteria for the analyzed surgical techniques is aimed at minimizing return-to-play times.

Biomechanical Effects on the Prostheses and Vertebrae of Three-Level Hybrid Surgery: A Finite Element Study.

PURPOSE: Three-level hybrid surgery (HS) consisting of cervical disc arthroplasty (CDA) and anterior cervical discectomy and fusion (ACDF) has been partly used for the treatment of multi-level cervical degenerative disc disease (CDDD). The complications related to the implants and the collapse of the surgical vertebral bodies had been reported in multi-level anterior cervical spine surgery. Thus, this study aimed to explore the biomechanical effects on the prostheses and vertebrae in three-level HS. METHODS: A FE model of cervical spine (C0-T1) was constructed. Five surgical models were developed. They were FAF model (ACDF-CDA-ACDF), AFA model (CDA-ACDF-CDA), FFF model (three-level ACDF), SF model (single-level ACDF), and SA model (single-level CDA). A 75-N follower load and 1.0-N·m moment was applied to produce flexion, extension, lateral bending, and axial rotation. RESULTS: Compared with the intact model, the range of motion (ROM) of total cervical spine in FAF model decreased by 34.54%, 54.48%, 31.76%, and 27.14%, respectively, in flexion, extension, lateral bending, and axial rotation, which were lower than those in FFF model and higher than those in AFA model. The ROMs of CDA segments in FAF and AFA models were similar to the intact model and SA model. Compared with the intact model, the ROMs at C3/4 segment in FFF model increased from 5.71% to 7.85%, and increased from 5.31% to 6.81% at C7/T1 segment, following by FAF model, then the FAF model. The maximum interface pressures of the Prestige-LP in FAF model were similar to SA model, however the corresponding values were increased in AFA model. The maximum interface pressures of the Zero-P were increased in FAF and AFA model compared with those in SF and FFF models. The stress was mainly distributed on the screws. In AFA model, the maximum pressures of the ball and trough articulation in superior and inferior Prestige-LP were all increased compared with those in SA and FAF model. In FFF model, the maximum pressures of the vertebrae were higher than those in other models. The stress was mainly distributed on the anterior area of the vertebral bodies. CONCLUSIONS: HS seemed to be more suitable than ACDF for the surgical treatment of three-level CDDD in consideration of the biomechanical effects, especially for the two-level CDA and one-level ACDF construct. But a more appropriate CDA prosthesis should be explored in the future.

Effect of device constraint: a comparative network meta-analysis of ACDF and cervical disc arthroplasty.

BACKGROUND CONTEXT: Clinical trials have demonstrated that cervical disc arthroplasty (CDA) is an effective and safe alternative treatment to anterior cervical discectomy and fusion (ACDF) for cervical degenerative disc disease in the appropriately indicated patient population. Various devices for CDA exist, differing in the level of device constraint. PURPOSE: To investigate outcomes following Anterior Cervical Discectomy and Fusion (ACDF) versus CDA stratified based on the level of device constraint: Constrained, Semiconstrained, and Unconstrained. STUDY DESIGN: Systematic review and network meta-analysis. PATIENT SAMPLE: A total of 2,932 CDA patients (979 Constrained, 1,214 Semiconstrained, 739 Unconstrained) and 2,601 ACDF patients from 41 studies that compared outcomes of patients undergoing CDA or ACDF at a single level at a minimum of 2 years follow-up. OUTCOME MEASURES: Outcomes of interest included the development of adjacent segment degeneration (ASD), index and adjacent segment reoperation rates, range of motion (ROM), high-grade heterotopic ossification (HO, McAfee Grades 3/4), and patient-reported outcomes (NDI/VAS). METHODS: CDA devices were grouped based on the degrees of freedom (DoF) allowed by the device, as either Constrained (3 DoF), Semiconstrained (4 or 5 DoF), or Unconstrained (6 DoF). A random effects network meta-analysis was conducted using standardized mean differences (SMD) and log relative risk (RR) were used to analyze continuous and categorical data, respectively. RESULTS: Semiconstrained (p=.03) and Unconstrained CDA (p=.01) demonstrated a significantly lower risk for ASD than ACDF. All levels of CDA constraint demonstrated a significantly lower risk for subsequent adjacent segment surgery than ACDF (p<.001). Semiconstrained CDA also demonstrated a significantly lower risk for index level reoperation than both ACDF and Constrained CDA (p<.001). Unconstrained devices retained significantly greater ROM than both Constrained and Semiconstrained CDA (p<.001). As expected, all levels of device constraint retained significantly greater ROM than ACDF (p<.001). Constrained and Unconstrained devices both demonstrated significantly lower levels of disability on NDI than ACDF (p=.02). All levels of device constraint demonstrated significantly less neck pain than ACDF (p<.05), while Unconstrained CDA had significantly less arm pain than ACDF (p=.02) at final follow-up greater than 2 years. CONCLUSION: CDA, particularly the unconstrained and semiconstrained designs, appears to be more effective than ACDF in reducing the risk of adjacent segment degeneration and the need for further surgeries, while also allowing for greater range of motion and better patient-reported outcomes. Less constrained CDA conferred a lower risk for index level reoperation, while also retaining more range of motion than more constrained devices.

Practical Answers to Frequently Asked Questions in Anterior Cervical Spine Surgery for Degenerative Conditions.

INTRODUCTION: Surgical counseling enables shared decision making and optimal outcomes by improving patients' understanding about their pathologies, surgical options, and expected outcomes. Here, we aimed to provide practical answers to frequently asked questions (FAQs) from patients undergoing an anterior cervical diskectomy and fusion (ACDF) or cervical disk replacement (CDR) for the treatment of degenerative conditions. METHODS: Patients who underwent primary one-level or two-level ACDF or CDR for the treatment of degenerative conditions with a minimum of 1-year follow-up were included. Data were used to answer 10 FAQs that were generated from author's experience of commonly asked questions in clinic before ACDF or CDR. RESULTS: A total of 395 patients (181 ACDF, 214 CDR) were included. (1, 2, and 3) Will my neck/arm pain and physical function improve? Patients report notable improvement in all patient-reported outcome measures. (4) Is there a chance I will get worse? 13% (ACDF) and 5% (CDR) reported worsening. (5) Will I receive a significant amount of radiation? Patients on average received a 3.7 (ACDF) and 5.5 mGy (CDR) dose during. (6) How long will I stay in the hospital? Most patients get discharged on postoperative day one. (7) What is the likelihood that I will have a complication? 13% (8% minor and 5% major) experienced in-hospital complications (ACDF) and 5% (all minor) did (CDR). (8) Will I need another surgery? 2.2% (ACDF) and 2.3% (CDR) of patients required a revision surgery. (9 & 10) When will I be able to return to work/driving? Most patients return to working (median of 16 [ACDF] and 14 days [CDR]) and driving (median of 16 [ACDF] and 12 days [CDR]). CONCLUSIONS: The answers to the FAQs can assist surgeons in evidence-based patient counseling.

Removals and Revisions of Cervical Total Disc Replacement Devices in a Consecutive Series of 1626 Patients Beginning With the First Case Experience in 2003.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: The purpose of this study was to investigate the rate of cervical total disc replacement (TDR) device removal or revision. BACKGROUND: Cervical TDR has gained acceptance as an alternative to anterior cervical discectomy and fusion in appropriately selected patients. There have been concerns over device safety, one measure of which is subsequent surgery related to device problems. PATIENTS AND METHODS: A consecutive series of 1626 patients undergoing cervical TDR from 2003 to June 2021 were included, consisting of TDRs up to 3 levels and hybrids (TDR and fusion). TDR removal or revision surgeries and reasons for these surgeries, procedures performed, and duration from index procedure were recorded. Data were analyzed to determine the removal/revision rate and factors possibly related to these events. RESULTS: There were 24 removals/revisions (1.48%) in the 1626 patients. Removal was performed in 23 cases (1.41%) and revision in 1 (0.06%). Among removal cases, anterior cervical discectomy and fusion was performed in 18 and TDR was replaced with another TDR in 5. Removals with fusion included 5 cases of osteolysis with/without Cutibacterium acnes , 4 device displacement/migration, 4 posterior spinal pathology, and one for each of the following: metal allergy, approach-related complications, malpositioning, subsidence, and hypermobility. The revision involved TDR repositioning 3 days after index surgery. There were 66 patients for whom a minimum of 10-year follow-up was confirmed, and none had removal/revision surgery 10 or more years after index surgery. There was no relationship between the occurrence of removal/revision and age, sex, body mass index, or physician experience (learning curve). The removal/revision rate was significantly higher in FDA trials versus postapproval (4.1% vs . 1.3%, P < 0.05). CONCLUSION: In this large consecutive series of patients, 1.48% of cervical TDRs were removed/revised. The low rate of removals/revisions over a long period of time provides support for the devices' safety. LEVEL OF EVIDENCE: Level IV.

The Fragility of Statistical Findings in Cervical Disc Arthroplasty: a Systematic Review of Randomized Controlled Trials.

PURPOSE: This study employs both the fragility index (FI) and fragility quotient (FQ) to assess the level of robustness in the cervical disc arthroplasty (CDA) literature. We hypothesize that dichotomous outcomes involving CDA would exhibit statistical vulnerability. METHODS: A PubMed search was conducted to evaluate dichotomous data for randomized controlled trials (RCTs) in CDA literature from 2000 to 2023. The FI of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The FQ was calculated by dividing each fragility index by the study sample size. The interquartile range (IQR) was also calculated for the FI and FQ. RESULTS: Of the 1561 articles screened, 111 met the search criteria, with 35 RCTs evaluating CDA included for analysis. Six hundred and ninety-three outcome events with 130 significant (P < 0.05) outcomes and 563 nonsignificant (P ≥ 0.05) outcomes were identified. The overall FI and FQ for all 693 outcomes were 5 (IQR 3-7) and 0.019 (IQR 0.011-0.043). Fragility analysis of statistically significant outcomes and nonsignificant outcomes both revealed an FI of 5. All of the studies reported loss to follow-up (LTF) data where 65.7% (23) did not report or reported an LTF greater or equal to 5. CONCLUSIONS: The literature regarding CDA RCTs lacks statistical robustness and may misrepresent the conclusions with the sole use of the P value. By implementing the FI and FQ along with the P value, we believe the interpretation and contextualization of the clinical data surrounding CDA will be better understood.

Reasons for Revision Surgery After Cervical Disk Arthroplasty Based on Medical Device Reports Maintained by the US Food and Drug Administration.

STUDY DESIGN: Retrospective database review. OBJECTIVE: The aim of this study was to analyze revisions of CDAs reported to the MAUDE database. SUMMARY OF BACKGROUND DATA: Cervical disk arthroplasty (CDA) has emerged as a motion-preserving alternative to anterior cervical discectomy and fusion (ACDF) for degenerative cervical disease, demonstrating comparable outcomes. Despite the availability of variable CDA designs, there is limited data on the specific complications of individual CDAs. The Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database has been used to systematically report complications associated with CDAs. However, data on specific reasons for CDA revision remains scarce. The purpose of this study is to compare common complications associated with revision for different CDAs. METHODS: The MAUDE database was queried from January 2005 to September 2023, including all nine FDA-approved CDAs. The full-text reports of each complication were categorized based on whether revision surgery was performed, the complications and the type of CDA collected and compared. RESULTS: A total of 678 revisions for nine CDAs were reported: Mobi-C (239), M6 (167), Prodisc-C (88), Prestige (60), PCM (44), Bryan (35), Secure (23), Simplify (21), and Discover (1). The top three complications associated with revision were migration (23.5%), neck pain (15.5%), and heterotopic ossification (6.6%). The most common complications per device were migration for Mobi-C (26.4%), Prodisc-C (21.3%), Prestige (24.6%), PCM (84.1%), Bryan (48.6%), Secure (30.4%), and Discover (100%). For M6, the most common complications associated with revision surgery were osteolysis (18.6%) and neck pain (18.6%), while neck pain (23.8%) was the most common for the Simplify. CONCLUSIONS: The MAUDE database highlights complications related to CDA revision in which the primary complications consistently include implant migration, neck pain, and heterotopic ossification, varying in their rerelvance depending on the CDA. LEVEL OF EVIDENCE: Level II.

Comparison of the Outcomes of Anterior Cervical Discectomy and Fusion and Cervical Disc Replacement for Cervical Disc Disease.

OBJECTIVE: To compare the radiological outcome and development of heterotopic ossification (HO) following single-segment anterior cervical discectomy and fusion (ACDF) and cervical disc replacement (CDR) for cervical disc herniation and evaluate their impact on surgical success. STUDY DESIGN: Descriptive comparative study. Place and Duration of the Study: Neurosurgery Department at Bozyaka Education and Research Hospital, Izmir, Turkiye, between January 2020 and June 2022. METHODOLOGY: Patients aged 18-70 years with radicular neck pain unresponsive to conventional medical treatment and an MRI-confirmed diagnosis were included. Patients with osteoporosis (OP) were excluded. Patients were randomised into two treatment groups (ACDF and CDR) and stratified by age and symptom severity. Radiographic assessments and HO classification according to McAfee were performed. RESULTS: Among the included patients, 56 underwent ACDF and 45 underwent CDR. The mean patient age was 48.29 ± 9.530 and 41.84 ± 7.239 years in the ACDF and CDR groups, respectively (p <0.001). The postoperative disc height increased in both groups. The T1 slope was significantly higher preoperatively and in the early postoperative period in the CDR group than in the ACDF group (p = 0.001). HO was graded as 1, 2, 3, and 4 in 28 (27.7%), 6 (5.9%), 7 (6.9%), and 4 (3%) patients, respectively. CONCLUSION: ACDF and CDR provided similar improvements in radiological measurements and pain relief. Although both procedures significantly enhanced the patient's quality of life and disability scores, HO was more prevalent following CDR during long-term follow-up. KEY WORDS: Cervical disc replacement, Anterior cervical discectomy and fusion, Spinal surgery techniques, Heterotopic ossification.

Cervical Disk Replacement Versus Anterior Cervical Diskectomy and Fusion: Effect of Procedural Variant on Patients With a Prolonged Preoperative Duration of Symptoms From Disk Herniation.

INTRODUCTION: Patients with a prolonged preoperative symptom duration (PSD) in the setting of cervical disk herniation (DH) may suffer inferior outcomes after surgical intervention. Comparison between anterior cervical diskectomy and fusion (ACDF) versus cervical disk arthroplasty (CDA) in this at-risk population has not yet been conducted. METHODS: Patients undergoing ACDF or CDA for DH with a PSD > 180 days were selected. Six-week (6W) and final follow-up (FF) patient-reported outcome measures (PROMs) as well as magnitude of postoperative improvements (∆PROM) were compared between cohorts using multivariable linear regression. Intercohort achievement rates of minimal clinically important difference (MCID) in each PROM were compared. RESULTS: Seventy-seven of 190 patients were in the CDA cohort. 6W Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) was superior in the CDA cohort. The ACDF cohort demonstrated notable improvements in the 6W Neck Disability Index (NDI), visual analog scale-neck pain (VAS-N), visual analog scale-arm pain (VAS-A), and 9-item Patient Health Questionnaire (PHQ-9). The CDA cohort demonstrated notable improvements in 6W PROMIS-PF, NDI, VAS-N, and VAS-A. FF VAS-A was better in the CDA cohort. The ACDF cohort demonstrated notable improvements in FF PROMIS-PF, NDI, VAS-N, and VAS-A. The CDA cohort demonstrated notable improvements in all FF PROMs. ∆PROM-6W in PROMIS-PF was greater in the CDA cohort. CONCLUSION: Patients with prolonged PSD due to cervical DH demonstrated notable improvements in physical function, disability, pain, and mental health regardless of fusion versus arthroplasty techniques. Accounting for demographic variations, patients undergoing CDA demonstrated a greater magnitude of improvement and superior scores in physical function at the first postoperative follow-up. Rates of clinically tangible improvements in PROMs did not markedly vary by surgical procedure. Patients undergoing CDA may perceive greater early improvements to physical function compared with patients undergoing ACDF for prolonged PSD due to DH.