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.

[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.

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.

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.

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.

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.

Clinical and Radiological Outcomes of Cervical Disc Arthroplasty in Patients with Modic Change.

OBJECTIVE: Modic change (MC) is defined as abnormalities observed in the intervertebral disc subchondral and adjacent vertebral endplate subchondral bone changes. Most studies on MC were reported in the lumbar spine and associated with lower back pain. However, MC has been rarely reported in the cervical spine, let alone in those who underwent cervical disc replacement (CDR). This study aimed to focus on MC in the cervical spine and reveal clinical and radiological parameters, especially heterotopic ossification (HO), for patients who underwent CDR. Furthermore, we illustrated the association between MC and HO. METHODS: We retrospectively reviewed patients who underwent CDA from January 2008 to December 2019. The Japanese Orthopaedic Association (JOA), Neck Disability Index (NDI), and Visual Analog Scale (VAS) scores were used to evaluate the clinical outcomes. Radiological evaluations were used to conclude the cervical alignment (CL) and range of motion (ROM) of C2-7, functional spinal unit angle (FSUA), shell angle (SA), FSU height, and HO. Univariate and multivariate logistic regressions were performed to identify the risk factors for HO. The Kaplan-Meier (K-M) method was used to analyze potential risk factors, and multivariate Cox regression was used to identify independent risk factors. RESULTS: A total of 139 patients were evaluated, with a mean follow-up time of 46.53 ± 26.60 months. Forty-nine patients were assigned to the MC group and 90 to the non-MC group. The incidence of MC was 35.3%, with type 2 being the most common. Clinical outcomes (JOA, NDI, VAS) showed no significant difference between the two groups. The differences in C2-7 ROM between the two groups were not significant, while the differences in SA ROM and FSUA ROM were significantly higher in the non-MC than in the MC group (p < 0.05). Besides, FSU height in MC group was significantly lower than that in non-MC group. Parameters concerning CL, including C2-7, FSUA, SA, were not significantly different between the two groups. The incidence of HO and high-grade HO, respectively, in the MC group was 83.7% and 30.6%, while that in the non-MC group was 53.3% and 2.2%, and such differences were significant (p < 0.05). Multivariate logistic regression analyses and Cox regression showed that MC and involved level were significantly associated with HO occurrence (p < 0.05). No implant migration and secondary surgery were observed. CONCLUSION: MC mainly affected the incidence of HO. Preoperative MC was significantly associated with HO formation after CDR and should be identified as a potential risk factor for HO. Rigorous criteria for MC should be taken into consideration when selecting appropriate candidates for CDR.

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.

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.

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.

Structural modification and biomechanical analysis of lumbar disc prosthesis: A finite element study.

BACKGROUND: Most ball-in-socket artificial lumbar disc implanted in the spine result in increased hypermobility of the operative level and overloading of the facet joint. METHODS: A finite element model was established and validated for the lumbar spine (L1-L5). The structure of the Mobidisc prosthesis was modified, resulting in the development of two new intervertebral disc prostheses, Movcore and Mcopro. The prostheses were implanted into the L3/L4 level to simulate total disc replacement, and the biomechanical properties of the lumbar spine model were analyzed after the operation. FINDINGS: Following the implantation of the prostheses, the mobility of operative level, peak stress of lumbar spine models, and peak stress of facet joint increased. The performance of mobility was found to be more similar between Movcore and Mobidisc. The mobility and facet joint peak stress of the Mcopro model decreased progressively with an increase in the Young's modulus of the artificial annulus during flexion, extension, and lateral bending. Among all the models, the Mcopro50 model had the mobility closest to the intact model. It showed a 3% decrease in flexion, equal range of motion in extension, a 9% increase in left lateral bending, a 7% increase in right lateral bending, and a 3% decrease in axial rotation. INTERPRETATION: The feasibility of the new intervertebral disc prostheses, Movcore and Mcopro, has been established. The Mcopro prosthesis, which features an artificial annular structure, offers significant advantages in terms of reduced mobility of the operative level and peak stress of facet joint.

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.

Impact of Preoperative Symptom Duration on Patient-Reported Outcomes Following Cervical Disc Replacement for Cervical Radiculopathy.

STUDY DESIGN: Retrospective review of prospectively collected data. OBJECTIVE: To determine the impact of preoperative symptom duration on postoperative functional outcomes after cervical disc replacement (CDR) for radiculopathy. SUMMARY OF BACKGROUND DATA: CDR has emerged as a reliable and efficacious treatment option for degenerative cervical spine pathologies. The relationship between preoperative symptom duration and outcomes after CDR is not well established. METHODS: Patients with radiculopathy without myelopathy who underwent primary 1- or 2-level CDRs were included and divided into shorter (<6 mo) and prolonged (≥6 mo) cohorts based on preoperative symptom duration. Patient-reported outcome measures (PROMs) included neck disability index (NDI), visual analog scale (VAS) neck and arm. Changes in PROM scores and minimal clinically important difference (MCID) rates were calculated. Analyses were conducted on the early (within 3 mo) and late (6 mo-2 y) postoperative periods. RESULTS: A total of 201 patients (43.6±8.7 y, 33.3% female) were included. In both early and late postoperative periods, the shorter preoperative symptom duration cohort experienced significantly greater change from preoperative PROM scores compared with the prolonged symptom duration cohort for NDI, VAS-Neck, and VAS-Arm. The shorter symptom duration cohort achieved MCID in the early postoperative period at a significantly higher rate for NDI (78.9% vs. 54.9%, P =0.001), VAS-Neck (87.0% vs. 56.0%, P <0.001), and VAS-Arm (90.5% vs. 70.7%, P =0.002). Prolonged preoperative symptom duration (≥6 mo) was identified as an independent risk factor for failure to achieve MCID at the latest timepoint for NDI (OR: 2.9, 95% CI: 1.2-6.9, P =0.016), VAS-Neck (OR: 9.8, 95% CI: 3.7-26.0, P <0.001), and VAS-Arm (OR: 7.5, 95% CI: 2.5-22.5, P <0.001). CONCLUSIONS: Our study demonstrates improved patient-reported outcomes for those with shorter preoperative symptom duration undergoing CDR for radiculopathy, suggesting delayed surgical intervention may result in poorer outcomes and greater postoperative disability. LEVEL OF EVIDENCE: Level III.

Incidence and risk factors of heterotopic ossification after cervical Baguera C disc arthroplasty.

OBJECTIVE: This retrospective study was designed to evaluate the incidence and predisposing factors of heterotopic ossification (HO) after cervical disc arthroplasty (CDA) with a specific implant at 1 and 2 levels, and to investigate the biomechanical effects related to HO. The study goal was to identify ways to reduce the likelihood of HO formation after surgery. METHODS: The study included patients who underwent only 1- or 2-level CDA with the Baguera C disc between November 2014 and December 2021 at a single medical center. All patients were operated on by the same neurosurgeon. The surgical indication included 1-level or 2-level disc herniation between C3 and C7 with radiculopathy, myelopathy, or both, with minimal spondylosis. The various factors were assessed by evaluating plain radiographs and cervical CT scans. The presence of HO was evaluated at different intervals postsurgery, and HO severity was graded using the McAfee classification. RESULTS: Of 107 patients who underwent CDA, 47 (43.9%) had HO at 63 of 171 levels (36.8%). Most cases with HO were grade 1, and no grade 4 was observed. Statistically significant risk factors for HO were the length of endplate coverage ratio and inferior anterior residual exposed endplate (AREE); sex, age, implant height and width, shell angle, and pre- and postoperative functional spinal unit (FSU) angle were not significant. More AREE and greater kyphotic postoperative FSU angle in the flexion position were significant factors differentiating HO grades 0 and 1 from grades 2 and 3. Furthermore, the non-HO group showed a trend of higher range of motion at any postoperative time compared to the HO group, especially at 1 month after surgery. CONCLUSIONS: The HO incidence after CDA was correlated with the residual length of endplate coverage and inferior AREE. Additionally, the AREE and kyphotic postoperative FSU angle in the flexion position were associated with HO grade progression. Patients with HO also showed a trend of lower range of motion at 1 month after surgery. Using an adequately sized implant and encouraging neck motion may help prevent HO development and progression.

Could the different surgical goals of fusion and non-fusion also be achieved in combination within the same patient? Clinical and radiological outcome of hybrid cervical spine surgery.

PURPOSE: Hybrid cervical spine surgery (HS) is a novel surgical strategy wherein an artificial disc replacement is done with a cervical fusion nearby with a stand-alone titanium cage to combine the advantages in both procedures. The aim of this study was to evaluate interactions of these devices within the same patient, and to analyze, if the different goal of each implant is accomplished. METHODS: Thirty-six patients were treated surgically within a non-randomized retrospective study framework with HS. Patients were examined preoperatively followed by clinical and radiological examination at least one year postoperative. Clinical outcome was detected with NDI, VAS arm/neck, pain self-assessment questionnaires and subjective patient satisfaction. Radiological assessments included RoM, segmental lordosis, cervical lordosis of C2-C7, subsidence, ap-migration and heterotopic ossifications (HO) at the cTDR levels. RESULTS: Statistically significant improvement of all clinical scores was observed (NDI 37.5 to 5.76; VASarm 6.41 to 0.69; VASneck 6.78 to 1.48). Adequate RoM was achieved at cTDR levels. RoM in the ACDF levels was reduced statistically significant (p < 0.001), and solid fusion (> 2°) was achieved in all evaluated fusion level. Global lordosis (C2-C7) increased statistically significant (2.4° to 8.1°). Subsidence and HO at the cTDR levels did not occur. CONCLUSIONS: HS results in preservation of the segmental motion in the cTDR and fast and solid fusion in the cage cohort simultaneously. Patient safety was proven. In carefully selected cases, HS is a safe and viable treatment option by choosing the right "philosophy" level per level.

Influence of cervical total disc replacement on motion in the target and adjacent segments.

BACKGROUND CONTEXT: The motion limitation after cervical discectomy and fusion alters the spine´s kinematics. Unphysiological strains may be the result and possible explanation for adjacent segment degeneration. Alterations to cervical kinematics due to cervical total disc replacement (TDR), especially two-level, are still under investigated. PURPOSE: To investigate cervical motion including coupled motions after one-level and two-level TDR in the treated and also the adjacent segments. STUDY DESIGN: An in-vitro study using pure moment loading of human donor spines. METHODS: Seven fresh frozen human cervical spine specimens (C4-T1, median age 46 with range 19-60 years, four female) were included in this study. Specimens were tested in the intact condition first, followed by one-level TDR at C5-6 which was subsequently extended one level further caudal (C5-7). Each specimen was quasistatically loaded with pure moments up to 1.5 Nm in flexion/extension (FE), lateral bending (LB), and axial rotation (AR) in a universal spine tester for 3.5 cycles at 1 °/s. During the tests three dimensional motion tracking was performed for each vertebral body individually. From that, the primary and coupled ROM of each spinal level during the third full cycle of motion were evaluated. Nonparametric statistical analysis was performed using a Friedman-test and post hoc correction with Dunn-Bonferroni-tests (p<.05). Ethics approval was obtained in advance. RESULTS: In FE, one-level TDR (C5-6) moderately increased primary FE in all four segments, but only significantly at the cranial adjacent level C4-5. Additional TDR at C6-7 further increased the ROM at the target segment without much influence on the other levels. Increasing implant height at C6-7 partially counteracted the increased FE. Coupled motions were minimal in all test conditions at all levels. In LB, coupled AR was observed in all test conditions at all levels. One-level TDR decreased primary LB at the target segment C5-6 significantly, without much influence on the other levels. Extending TDR to C6-7 decreased ROM in the target segment but without gaining statistical significance. Increasing implant height at C6-7 further decreased primary LB at the target segment, still without significance. Notably, coupled AR was significantly decreased at the cranial adjacent segment C4-5 compared to the intact condition. In AR, coupled LB was observed in all test conditions at the levels C4-5, C5-6, and C6-7, while the transition level to the thoracic spine C7-T1 showed only little coupled LB. Both one-level and two-level TDR showed little influence on primary AR or coupled motions at any level. Only after increasing implant height at C6-7 was the motion of the caudally adjacent level C7-T1 significantly altered. CONCLUSION: Evaluating primary FE, LB, and AR together with the associated coupled motions revealed widespread influence of cervical TDR not only on the motion of the treated level but also at the adjacent segments. The influence of two-level TDR is more widespread and involves more levels than one-level TDR. CLINICAL SIGNIFICANCE: The prevention of unphysiological strains due to altered kinematics after cervical fusion, which could possibly explain adjacent segment degeneration, were a driving factor in the development of TDR. These experimental findings suggest cervical TDR influences the whole cervical spine, not only the treated segment. The effect becomes more extensive, involving more levels and motion directions, after two-level than after one-level TDR.