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.

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.

Predictive Value of Cervical Degenerative Quantitative Scoring System on Postoperative Disc Height Loss After Cervical Disc Replacement.

STUDY DESIGN: A retrospective study. OBJECTIVE: In this study, a cervical degenerative quantitative scoring system was used to identify the risk factors for disc height loss after cervical disc replacement (CDR) and to verify their accuracy. BACKGROUND: Disc height loss after CDR is drawing much attention. Preoperative cervical degeneration has been proven related to postoperative disc height loss but lacked quantitative verification. PATIENTS AND METHODS: A total of 160 patients who underwent CDR with the Prestige-LP disc at our hospital between January 2011 and December 2016 were retrospectively reviewed. Disc height loss was defined as a reduction of more than 2 mm from postoperative to the final follow-up. A quantitative scoring system was used to evaluate preoperative degeneration on radiographs. Multivariate logistic regression was applied to determine predictive factors and calculate the logistic regression formula. Moreover, receiver operating characteristic curve analysis was conducted to obtain the optimal cutoff value and the area under the receiver operating characteristic curve [areas under the curve (AUC)]. RESULTS: Study subjects had a mean age of 43.51 ± 8.51 years, with a mean follow-up time of 60.14 ± 12.75 months. The overall incidence rate of disc height loss was 65.62%. Multivariate logistic regression analysis showed that endplate sclerosis ( P = 0.000) and low preoperative disc height ( P = 0.000) were independent risk factors for postoperative disc height loss. In addition, the calculated optimal cutoff point was 1 point of endplate sclerosis (AUC = 0.768) and 4.5 mm of preoperative disc height (AUC = 0.795). The regression formula established by multivariate logistic regression analysis was composed of preoperative disc height (odds ratio: 2.995, P = 0.000) and endplate sclerosis (odds ratio: 18.131, P = 0.000), with an AUC of 0.879. CONCLUSIONS: Our findings suggest that a comprehensive preoperative assessment is essential when patients with apparent endplate sclerosis and low preoperative disc height are being considered for CDR.

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

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

Anterior cervical discectomy and fusion versus cervical disc arthroplasty: an epidemiological review of 433,660 surgical patients from 2011 to 2021.

BACKGROUND CONTEXT: Anterior cervical discectomy and fusion (ACDF) and cervical disc arthroplasty (CDA) are commonly performed operations to address cervical radiculopathy and myelopathy. Trends in utilization and revision surgery rates warrant investigation. PURPOSE: To explore the epidemiology, postoperative complications, and reoperation rates of ACDF and CDA. DESIGN: Retrospective cohort study. PATIENT SAMPLE: A total of 433,660 patients who underwent ACDF or CDA between 2011 and 2021 were included in this study. OUTCOME MEASURES: The following data were observed for all cases: patient demographics, complications, and revisions. METHODS: The PearlDiver database was queried to identify patients who underwent ACDF and CDA between 2011 and 2021. Epidemiological analyses were performed to examine trends in cervical procedure utilization by age group and year. After matching by age, sex, Charlson Comorbidity Index (CCI), levels of operation, and reason for surgery, the early postoperative (2-week), short-term (2-year), and long-term (5-year) complications of both cervical procedures were examined. RESULTS: In total, 404,195 ACDF and 29,465 CDA patients were included. ACDF utilization rose by 25.25% between 2011 and 2014 while CDA utilization rose by 654.24% between 2011-2019 followed by relative plateauing in both procedures. Mann-Kendall trend test confirmed a significant but small rise in ACDF and large rise in CDA procedures from 2011 to 2021 (p<.001). After matching, ACDF and CDA had an overall complication rate of 12.20% and 8.77%, respectively, with the most common complications being subsequent anterior revision (4.96% and 3.35%) and dysphagia (3.70% and 2.98%). The ACDF cohort, especially multilevel ACDF patients, generally had more complications and higher revision rates than the CDA cohort (p<.05). CONCLUSIONS: While ACDF utilization has plateaued since 2014, CDA rates have risen by a staggering 654.24% over the past decade. ACDF and CDA complication and revision rates were relatively low in comparison to previously published values, with significantly lower rates in CDA. Although a lack of radiographic data in this study limits its power to recommend either procedure for individual patients with cervical radiculopathy or myelopathy, CDA may be associated with minor improvement in the complication and revision profile.

Impact of Metabolic Syndrome on Early Postoperative Outcomes After Cervical Disk Replacement: A Propensity-matched Analysis.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To compare the demographics, perioperative variables, and complication rates following cervical disk replacement (CDR) among patients with and without metabolic syndrome (MetS). SUMMARY OF BACKGROUND DATA: The prevalence of MetS-involving concurrent obesity, insulin resistance, hypertension, and hyperlipidemia-has increased in the United States over the last 2 decades. Little is known about the impact of MetS on early postoperative outcomes and complications following CDR. METHODS: The 2005-2020 National Surgical Quality Improvement Program was queried for patients who underwent primary 1- or 2-level CDR. Patients with and without MetS were divided into 2 cohorts. MetS was defined, according to other National Surgical Quality Improvement Program studies, as concurrent diabetes mellitus, hypertension requiring medication, and body mass index ≥30 kg/m 2 . Rates of 30-day readmission, reoperation, complications, length of hospital stay, and discharge disposition were compared using χ 2 and Fisher exact tests. One to 2 propensity-matching was performed, matching for demographics, comorbidities, and number of operative levels. RESULTS: A total of 5395 patients were included for unmatched analysis. Two hundred thirty-six had MetS, and 5159 did not. The MetS cohort had greater rates of 30-day readmission (2.5% vs. 0.9%; P =0.023), morbidity (2.5% vs. 0.9%; P =0.032), nonhome discharges (3% vs. 0.6%; P =0.002), and longer hospital stays (1.35±4.04 vs. 1±1.48 days; P =0.029). After propensity-matching, 699 patients were included. All differences reported above lost significance ( P >0.05) except for 30-day morbidity (superficial wound infections), which remained higher for the MetS cohort (2.5% vs. 0.4%, P =0.02). CONCLUSIONS: We identified MetS as an independent predictor of 30-day morbidity in the form of superficial wound infections following single-level CDR. Although MetS patients experienced greater rates of 30-day readmission, nonhome discharge, and longer lengths of stay, MetS did not independently predict these outcomes after controlling for baseline differences in patient characteristics. LEVEL OF EVIDENCE: Level III.

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

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

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

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

Bilateral fracture of L5 pedicles in a patient with total disc replacement of L5-S1: a case report / Fratura bilateral de pedículos L5 em paciente com prótese de disco L5-S1: relato de caso / Fractura bilateral de pedículos L5 en paciente con prótesis de disco L5-S1: reporte de caso

Report of a rare complication - fracture of the pedicles - in a patient with total disc replacement of L5-S1, a surgical resolution, and a biomechanical explanation. To the authors' knowledge, there is only one previous report of bilateral fracture of the pedicles in the literature, as a complication in total disc replacement of the lumbar spine. In this case, no direct repair was made to the fracture site; instead intersomatic fusion was performed by the anterior approach. A 40-year-old male, a martial arts practitioner who had undergone L5-S1 (ProDisc®) disc replacement nine months earlier, with complete resolution of the preoperative symptoms and no complications, sudden pain during physical activity, without neurological symptoms. Computed axial tomography showed a fracture of the L5 pedicles and anterior luxation of the polyethylene insert. Surgery was performed by the posterior approach, with direct repair of the fractures and posterolateral fusion of L5-S1 with transpedicular screws (Schanz) and USS® internal fixator. A follow-up axial CT scan at 6 months after surgery showed complete consolidation of the fractures, and the patient was asymptomatic. Due to the alteration in weight transmission through the anterior part of the spine in the total replacement of the lumbar disc, which preserves the movement but not the absorption of forces, the pedicle becomes more susceptible to fracture. It is important to bear this complication in patients submitted to this procedure.

Relato de uma complicação rara - fratura de pedículos - em paciente com prótese de disco L5-S1, sua resolução cirúrgica e uma explicação biomecânica. Até onde os autores sabem, existe na literatura apenas um relato anterior de fratura bilateral de pedículos como complicação de substituição total de disco lombar; neste caso, não se realizou reparo direto da fratura, e sim, fusão intersomática por acesso anterior. Paciente do sexo masculino, com 40 anos de idade, praticante de artes marciais e com antecedente de prótese de disco L5-S1 (ProDisc®) há nove meses, atinge melhora completa dos sintomas pré-operatórios sem complicações, apresenta dor súbita ao realizar atividade física sem intercorrências neurológicas. Na tomografia axial computadorizada, observa-se fratura de pedículos L5 e luxação anterior do inxerto de polietileno. Realiza-se cirurgia por acesso posterior com reparo direto das fraturas e fusão posterolateral de L5-S1 com parafusos transpediculares tipo Schanz e fixador interno USS®. A TC axial de acompanhamento 6 meses depois da cirurgia mostra consolidação completa das fraturas, e o paciente está assintomático. Devido à alteração da transmissão de cargas através da parte anterior da coluna vertebral na substituição total de disco lombar, que preserva o movimento, mas não a absorção de forças, o pedículo fica mais suscetível à fratura, e é preciso considerar essa complicação em pacientes submetidos a esse procedimento.

Reporte de una rara complicación, fractura de pedículos, en un paciente con prótesis de disco L5-S1, la resolución quirúrgica y una explicación biomecánica. En el conocimiento de los autores, solo existe un reporte previo en la literatura de una fractura bilateral de pedículos como complicación de un reemplazo total de disco lumbar; en dicho caso no se realizó una reparación directa de la fractura, sino una fusión intersomática por vía anterior. Paciente masculino de 40 años de edad, practicante de artes marciales, con antecedente de prótesis de disco L5-S1 L nueve meses atrás, alcanza mejoría total de los síntomas preoperatorios sin complicaciones, presenta dolor súbito al realizar actividad física sin datos neurológicos. En la TAC se observa fractura de pedículos L5 y luxación anterior del inserto de polietileno. Se realiza cirugía por vía posterior con reparación directa de las fracturas y fusión posterolateral L5-S1 mediante tornillos transpediculares tipo Schanz y fijador interno USS®. La TAC de seguimiento a 6 meses de la cirugía muestra una consolidación completa de las fracturas y el paciente se encuentra asintomático. Debido a la alteración en la transmisión de las cargas a través de la porción anterior de la columna vertebral en el reemplazo total de disco lumbar, ya que este preserva el movimiento pero no la absorción de fuerzas, el pedículo es más susceptible a la fractura, es por ello que se debe tener en cuenta esta complicación en pacientes sometidos a dicho procedimiento.