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OBJECTIVE: To examine the short-term efficacy and imaging results of using the Mobi-C in cervical hybrid surgery on 2-level cervical spondylolisthesis. To observe post-operative changes in the flexion-extension centre of rotation (FE-COR) and anterior bone loss (ABL) of the anterior cervical disc replacement (ACDR) segment. METHODS: Forty-two patients (20 males and 22 females, aged 42â67 years) who underwent cervical hybrid surgery were retrospectively analysed. Their ACDR segment used Mobi-C, and the fusion segment used ROI-C, with a follow-up of 25â42 months (31.1 ± 4.8 months). The modified Japanese Orthopaedic Association (mJOA) score, Neck Disability Index (NDI), and visual analogue scale (VAS) were used to assess clinical outcomes. Pre-operative, 6-month post-operative, and final follow-up radiographs were collected to compare total cervical spine curvature (C2-C7), curvature of the operated segments, range of motion (ROM) in the total cervical spine, operated segmental ROM, ACDR segmental ROM, and operated adjacent segmental ROM. The height of the superior articular process (HSAP), the orientation of zygapophyseal joint spaces (OZJS), and the length of the superior articular surface (LSAS) were measured. The FE-COR of the ACDR segment was measured using the mid-plumb line method. The translation distance of the Mobi-C was measured. The degree of disc degeneration in the adjacent segment, bony fusion of the ACDF segment, and ABL of the upper and lower vertebra of the ACDR segment were observed. RESULTS: In our group, all patients have shown improvements in their postoperative mJOA, NDI, and VAS scores. Overall cervical ROM and surgical segmental ROM decreased (P < 0.05). However, there was no significant decrease in ACDR segmental ROM and upper or lower adjacent segmental ROM compared with pre-operatively (P > 0.05). For FE-COR-X, only the last follow-up compared with pre-surgery showed statistical significance (46.74 ± 7.71% vs. 50.74 ± 6.92%, P < 0.05). For FE-COR-Y, the change was statistically significant at both 6 months post-operation and the final follow-up compared to pre-operation (45.37% ± 21.11% vs. 33.82% ± 10.87%, 45. 37% ± 21.11% vs. 27.48% ± 13.58%, P < 0.05). No significant difference in the Mobi-C translation distance was observed (P > 0.05). Moreover, the difference in HSAP was not statistically significant at each node (P > 0.05). The OZJS and LSAS were significantly different at the final follow-up compared to the pre-operative period (P < 0.05). All the ACDF segments were observed in a stable condition at the final follow-up. Furthermore, 9 of the adjacent segments showed imaging ASD (9/82, 10.98%), and all were present at the last follow-up, of which 6 were mild, and 3 were moderate. Twenty of the 42 Mobi-C segments had no significant ABL (grade 0) 6 months post-operatively (47.62%). Sixteen cases (38.10%) showed mild ABL (grade 1), and 6 cases (14.28%) showed moderate ABL (grade 2). No severe ABL occurred. CONCLUSION: The cervical hybrid surgery using Mobi-C artificial cervical discs can achieve satisfactory results. The Mobi-C segmental FE-COR-X shows a slow forward shift trend, and FE-COR-Y drops noticeably within 6 months post-surgery before stabilizing. It's common to see mild to moderate ABL after cervical hybrid surgery using Mobi-C, and significant progression is unlikely in the short term. Furthermore, changes in the FE-COR after hybrid surgery in the Mobi-C segment might not affect clinical outcomes.
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Degeneração do Disco Intervertebral , Fusão Vertebral , Substituição Total de Disco , Feminino , Humanos , Masculino , Vértebras Cervicais/diagnóstico por imagem , Vértebras Cervicais/cirurgia , Seguimentos , Degeneração do Disco Intervertebral/diagnóstico por imagem , Degeneração do Disco Intervertebral/cirurgia , Amplitude de Movimento Articular , Estudos Retrospectivos , Rotação , Fusão Vertebral/métodos , Resultado do Tratamento , Corpo Vertebral/cirurgia , Adulto , Pessoa de Meia-Idade , IdosoRESUMO
Cervical disc replacement is an alternative option to an anterior cervical discectomy and fusion for cervical spine degenerative disease. We present the first reported case of a progressively worsening symptomatic spinal cord compression secondary to migration of the nucleus from a Mobi-C total disc replacement.
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Compressão da Medula Espinal , Substituição Total de Disco , Vértebras Cervicais/cirurgia , Humanos , Compressão da Medula Espinal/etiologia , Substituição Total de Disco/efeitos adversosRESUMO
BACKGROUND: Cervical total disc replacement was developed to avoid known complications of cervical fusion. The purpose of this paper was to provide 5-year follow-up results of an ongoing prospective study after implantation of cervical disc prosthesis. METHODS: Three hundred and eighty-four patients were treated using Mobi-C cervical disc (Zimmer Biomet, Troyes, France) and included in a prospective multicentre study. Routine clinical and radiological examinations were reported preoperatively and postoperatively with up to 5-year follow-up. Complications and revision surgeries were also explored. RESULTS: Results at 5 years showed significant improvement in all clinical outcomes (NDI, VAS for arm and neck pain, SF-36 PCS and MCS). Motion at index level increased significantly from 6.0° preoperatively to 8.0°, and 72.1% of the implanted segments were still mobile (referring to threshold of ROM > 3°). Proximal and distal adjacent discs showed no significant change in average motion 5 years after surgery compared to baseline. Ossification resulting in complete fusion was observed in 16.4% of the implanted segments. Distal and proximal adjacent disc degeneration occurred in 42.2% and 39.1% of patients, respectively. Complications rate was 8.9%, and 1.5% of the patients had reoperation at the index level. Surgery rate of adjacent discs was 2.9%. An increased percentage of working patients and a decrease in medication consumption were observed. At 5 years, 93.3% patients were satisfied regarding the overall outcome. CONCLUSIONS: In this study, favourable 5-year follow-up clinical and radiological outcomes were observed with a low rate of adjacent level surgery. These slides can be retrieved under Electronic Supplementary Material.
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Artroplastia , Vértebras Cervicais , Complicações Pós-Operatórias , Substituição Total de Disco , Artroplastia/efeitos adversos , Artroplastia/estatística & dados numéricos , Vértebras Cervicais/diagnóstico por imagem , Vértebras Cervicais/cirurgia , Seguimentos , Humanos , Ossificação Heterotópica/diagnóstico por imagem , Ossificação Heterotópica/epidemiologia , Complicações Pós-Operatórias/diagnóstico por imagem , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Fusão Vertebral , Substituição Total de Disco/efeitos adversos , Substituição Total de Disco/estatística & dados numéricosRESUMO
This paper is a response to Dr. Kathleen Raviele's recent article on her critical analysis of the use of levonorgestrel given to women postsexual assault and her suggestion that the use of Meloxicam may be an ethical alternative.
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Cadmium sulfide and zinc oxide nanoparticles were prepared, characterized and used as electrode modifiers for the sensing of two non-steroidal anti-inflammatory drugs (NSAIDs): naproxen and mobic. The structural and morphological characterization of the synthesized nanoparticles was carried out by XRD, UV-Vis spectroscopy, FTIR and scanning electron microscopy. The electrode's enhanced surface area facilitated the signal amplification of the selected NSAIDs. The CdS-modified glassy carbon electrode (GCE) enhanced the electro-oxidation signals of naproxen to four times that of the bare GCE, while the ZnO-modified GCE led to a two-fold enhancement in the electro-oxidation signals of mobic. The oxidation of both NSAIDs occurred in a pH-dependent manner, suggesting the involvement of protons in their electron transfer reactions. The experimental conditions for the sensing of naproxen and mobic were optimized and, under optimized conditions, the modified electrode surface demonstrated the qualities of sensitivity and selectivity, and a fast responsiveness to the target NSAIDs.
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In recent years, artificial cervical discs have been used in intervertebral disc replacement surgery and hybrid surgery (HS). The advantages and disadvantages of different artificial cervical discs in artificial cervical disc replacement surgery have been compared. However, few scholars have studied the biomechanical effects of various artificial disc prostheses on the human cervical spine in HS which include the Anterior Cervical Discectomy and Fusion (ACDF) and Cervical Disc Arthroplasty (CDA). This study compared the biomechanical behavior of Mobi-C and Prestige LP in the operative and adjacent segments during two-level hybrid surgery. A three-dimensional finite element model of C2-C7 was first established and validated. Subsequently, clinical surgery was then simulated to establish a surgical model of anterior cervical fusion at the C4-C5 level. Mobi-C and Prestige-LP artificial disc prostheses were implanted at the C5-C6 level to create two hybrid models. All finite element models were fixed on the lower endplate of the C7 vertebra and subjected to a load of 73.6 N and different directions of 1 Nm torque on the odontoid process of the C2 vertebra to simulate human flexion, extension, lateral bending, and axial rotation. This paper compares the ROM, intervertebral pressure, and facet joint force after hybrid surgery with the intact model. The results show that compared with Prestige LP, Mobi-C can improve ROM of the replacement segment and compensate for the intervertebral pressure of the adjacent segment more effectively, but the facet joint pressure of the replacement segment may be higher.
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Membros Artificiais , Disco Intervertebral , Fusão Vertebral , Substituição Total de Disco , Humanos , Fenômenos Biomecânicos , Vértebras Cervicais/cirurgia , Discotomia/métodos , Análise de Elementos Finitos , Disco Intervertebral/cirurgia , Amplitude de Movimento Articular , Fusão Vertebral/métodosRESUMO
OBJECTIVE: To study the effect of intra-articular injection of meloxicam (Mobic) on the development of osteoarthritis (OA) in rats and examine concomitant changes in nociceptive behavior and the expression of mitogen-activated protein kinases (MAPKs) in articular cartilage chondrocytes. METHODS: OA was induced in Wistar rats by right anterior cruciate ligament transection (ACLT); the left knee was not treated. The OA + meloxicam (1.0 mg) group was injected intra-articularly in the ACLT knee with 1.0 mg of meloxicam once a week for 5 consecutive weeks starting 5 weeks after ACLT. The OA + meloxicam (0.25 mg) group was treated similarly with 0.25 mg meloxicam. The sham group underwent arthrotomy only and received vehicle of 0.1 mL sterile 0.9% saline injections, whereas the naive rats in meloxicam-only groups were treated similarly with 1.0- and 0.25-mg meloxicam. Nociception was measured as secondary mechanical allodynia and hind paw weight-bearing distribution at before (pre-) and 5, 10, 15, and 20 weeks post-ACLT. Histopathology of the cartilage and synovia was examined 20 weeks after ACLT. Immunohistochemical analysis was performed to examine the effect of meloxicam on MAPKs (p38, c-Jun N-terminal kinase (JNK), and extracellular signal-regulated kinase (ERK)) expression in the articular cartilage chondrocytes. RESULTS: OA rats receiving intra-articular meloxicam treatment showed significantly less cartilage degeneration and synovitis than saline-treated controls. Nociception were improved in the OA + meloxicam groups compared with the OA group. Moreover, meloxicam attenuated p38 and JNK but enhanced ERK expression in OA-affected cartilage. CONCLUSIONS: Intra-articular injection of meloxicam (1) attenuates the development of OA, (2) concomitantly reduces nociception, and (3) modulates chondrocyte metabolism, possibly through inhibition of cellular p38 and JNK, but enhances ERK expression.
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Artrite Experimental/enzimologia , Cartilagem Articular/efeitos dos fármacos , Condrócitos/efeitos dos fármacos , Inibidores de Ciclo-Oxigenase 2/farmacologia , Proteínas Quinases Ativadas por Mitógeno/efeitos dos fármacos , Nociceptividade/efeitos dos fármacos , Osteoartrite do Joelho/enzimologia , Tiazinas/farmacologia , Tiazóis/farmacologia , Animais , Lesões do Ligamento Cruzado Anterior , Artrite Experimental/tratamento farmacológico , Artrite Experimental/patologia , Cartilagem Articular/citologia , Cartilagem Articular/patologia , Condrócitos/enzimologia , Inibidores de Ciclo-Oxigenase 2/uso terapêutico , MAP Quinases Reguladas por Sinal Extracelular/efeitos dos fármacos , MAP Quinases Reguladas por Sinal Extracelular/metabolismo , Injeções Intra-Articulares , Proteínas Quinases JNK Ativadas por Mitógeno/efeitos dos fármacos , Proteínas Quinases JNK Ativadas por Mitógeno/metabolismo , Meloxicam , Proteínas Quinases Ativadas por Mitógeno/metabolismo , Osteoartrite do Joelho/tratamento farmacológico , Osteoartrite do Joelho/patologia , Ratos , Ratos Wistar , Membrana Sinovial/patologia , Tiazinas/uso terapêutico , Tiazóis/uso terapêutico , Proteínas Quinases p38 Ativadas por Mitógeno/efeitos dos fármacos , Proteínas Quinases p38 Ativadas por Mitógeno/metabolismoRESUMO
Recently, many different types of artificial discs have been introduced to persevere the biomechanical behavior of the cervical spine. This study compares the biomechanical behavior of single- and double-level cervical disc arthroplasty, that is "Prestige LP and Mobi-C" on the index and adjacent segment. A three-dimension finite element model of C2-C7 was developed and validated. In single-level prostheses, the Prestige LP or Mobi-C was implanted in the segment C5-C6, while the double-level arthroplasty was integrated at both segments C4-C5 and C5-C6 in the FE model. The intact FE and prosthesis-modified models were constrained from the inferior endplate of the vertebra C7 and applied a compressive load of 73.6 N with a moment load of 1 Nm on the odontoid process of the vertebra C2 to produce flexion/extension, lateral bending, and axial rotation. The prosthesis-modified model's range of motion and intradiscal pressure were determined and compared to the intact model. Also examined the impact of the prostheses on the stress at the bone-implant interface. The range of motion of the implanted segments in both single- and double-levels arthroplasty was increased while that of the adjacent segment of implanted segments decreased. The intradiscal pressure in both levels of arthroplasty was greater than in the intact model. In conclusion, Mobi-C's cervical prostheses could better preserve the normal range of motion and maintain intradiscal pressure than the Prestige LP.
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Membros Artificiais , Disco Intervertebral , Análise de Elementos Finitos , Artroplastia/métodos , Vértebras Cervicais/cirurgia , Rotação , Amplitude de Movimento Articular , Fenômenos BiomecânicosRESUMO
BACKGROUND: Over the past 20 years, multiple randomized controlled trials have shown cervical disc arthroplasty (CDA) to be safe and effective for treating 1- and 2-level degenerative disc disease (DDD). The purpose of this postmarket study is to compare 10-year outcomes between CDA and anterior cervical discectomy and fusion (ACDF) from a randomized study at 3 centers. METHODS: This study was a continuation of a randomized, prospective, multicenter clinical trial comparing CDA with the Mobi-C cervical disc (Zimmer Biomet) vs ACDF. Following completion of the 7-year US Food and Drug Administration study, 10-year follow-up was obtained from consenting patients at 3 high-enrolling centers. The clinical and radiographic endpoints collected at 10 years included composite success, Neck Disability Index, neck and arm pain, short form-12, patient satisfaction, adjacent-segment pathology, major complications, and subsequent surgery. RESULTS: A total of 155 patients were enrolled (105 CDA; 50 ACDF). Follow-up was obtained from 78.1% of patients eligible after 7 years. At 10 years, CDA demonstrated superiority to ACDF. Composite success was 62.4% in CDA and 22.2% in ACDF (P < 0.0001). The cumulative risk of subsequent surgery at 10 years was 7.2% vs 25.5% (P = .001), and the risk of adjacent-level surgery was 3.1% vs 20.5% (P = .0005) in CDA vs ACDF, respectively. The progression to radiographically significant adjacent-segment pathology at 10 years was lower in CDA vs ACDF (12.9% vs 39.3%; P = 0.006). At 10 years, patient-reported outcomes and change from baseline were generally better in CDA patients. A higher percentage of CDA patients reported they were "very satisfied" at 10 years (98.7% vs 88.9%; P = 0.05). CONCLUSIONS: In this postmarket study, CDA was superior to ACDF for treating symptomatic cervical DDD. CDA was statistically superior to ACDF for clinical success, subsequent surgery, and neurologic success. Results through 10 years demonstrate that CDA continues to be a safe and effective surgical alternative to fusion. CLINICAL RELEVANCE: The results of this study support the long-term safety and effectiveness of cervical disc arthroplasty with the Mobi-C.
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Introduction: Cervical total disc replacement (CTDR) is an alternative to anterior cervical discectomy and fusion for select patients that may preserve range of motion and reduce adjacent segment disease. Various CTDR prostheses are available; however, comparative data are limited. This study aimed to compare the short-term kinematic and radiological parameters of the M6-C, Mobi-C, and the CP-ESP prostheses. Methods: This retrospective cohort study included patients treated with CTDR between March 2005 and October 2020 at a single institution. Patients were included if their follow-up assessment included lateral erect and flexion/extension radiographs. The primary outcome assessed at 3-months postoperatively was range of motion, measured by the difference in functional spinal unit angle between flexion and extension. Results: A total of 131 CTDR levels (120 patients, 46.2 ± 10.1 years, 57% male) were included. Prostheses implanted included the M6-C (n = 52), Mobi-C (n = 54), and CP-ESP (n = 25). Range of motion varied significantly (8.2° ± 4.4° vs. 10.9° ± 4.7° vs. 6.1° ± 2.7°, P < 0.001). On post hoc analysis, the Mobi-C prosthesis demonstrated a significantly greater range of motion than either the M6-C prosthesis (P = 0.003) or CP-ESP (P < 0.001). Conclusion: Although the optimal range of motion for CTDR has not been established, short-term differences in the range of motion may guide the selection of CTDR prosthesis. Further studies with longer follow-up and consideration of clinical outcome measures are necessary.
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OBJECTIVE: Total disc arthroplasty (TDA) has been shown to be an effective and safe treatment for cervical degenerative disc disease at short- and midterm follow-up. However, there remains a paucity of literature reporting the differences between individual prosthesis designs with regard to device performance. In this study, the authors evaluated the long-term maintenance of segmental range of motion (ROM) at the operative cervical level across a diverse range of TDA devices. METHODS: In this study, the authors retrospectively evaluated all consecutive patients who underwent 1- or 2-level cervical TDA between 2005 and 2020 at a single institution. Patients with a minimum of 6 months of follow-up and lateral flexion/extension radiographs preoperatively, 2 months postoperatively, and at final follow-up were included. Radiographic measurements included static segmental lordosis, segmental range of motion (ROM) on flexion/extension, global cervical (C2-7) ROM on flexion/extension, and disc space height. The paired t-test was used to evaluate improvement in radiographic parameters. Subanalysis between devices was performed using one-way ANCOVA. Significance was determined at p < 0.05. RESULTS: A total of 85 patients (100 discs) were included, with a mean patient age of 46.01 ± 8.82 years and follow-up of 43.56 ± 39.36 months. Implantations included 22 (22.00%) M6-C, 51 (51.00%) Mobi-C, 14 (14.00%) PCM, and 13 (13.00%) ProDisc-C devices. There were no differences in baseline radiographic parameters between groups. At 2 months postoperatively, PCM provided significantly less segmental lordosis (p = 0.037) and segmental ROM (p = 0.039). At final follow-up, segmental ROM with both the PCM and ProDisc-C devices was significantly less than that with the M6-C and Mobi-C devices (p = 0.015). From preoperatively to 2 months postoperatively, PCM implantation led to a significant loss of lordosis (p < 0.001) and segmental ROM (p = 0.005) relative to the other devices. Moreover, a significantly greater decline in segmental ROM from 2 months postoperatively to final follow-up was seen with ProDisc-C, while segmental ROM increased significantly over time with Mobi-C (p = 0.049). CONCLUSIONS: Analysis by TDA device brand demonstrated that motion preservation differs depending on disc design. Certain devices, including M6-C and Mobi-C, improve ROM on flexion/extension from preoperatively to postoperatively and continue to increase slightly at final follow-up. On the other hand, devices such as PCM and ProDisc-C contributed to greater segmental stiffness, with a gradual decline in ROM seen with ProDisc-C. Further studies are needed to understand how much segmental ROM is ideal after TDA for preservation of physiological cervical kinematics.
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OBJECTIVE: To investigate the range of motion (ROM) index of a two-level cervical arthroplasty. METHODS: Seven human cadaveric spines were biomechanically examined from C2 level to T1 level under intact status and the following conditions: 2-level arthroplasty (C4-C6) employing Mobi-C devices (MM group), 2-level anterior cervical discectomy and fusions (2-ACDFs) (FF group), and both as a hybrid surgery (HS) (MF group and FM group). Multidirectional flexibility examination was conducted according to the Panjabi hybrid testing protocol. Unconstrained intact moments of ±1.5 NM were performed for axial rotation (AR) flexion/extension (FE), and lateral bending (LB). RESULTS: No statistical differences were found between the intact spine and MM group at the operative- and adjacent-level kinematics in the three loading conditions, except that C4-C5 ROM significantly increased in the axial rotation loading (P<0.05). Compared with the intact spine, MF group led to a significant decrease at the arthrodesis segment ROM C5-C6 in the three loading (P<0.05), with corresponding significantly increased at C4-C5 in FE and AR (P<0.05). FM group resulted in a significant decrease in ROM C4-C5 (P<0.05) with corresponding significantly increased at C5-C6 in FE, AR and LB (P<0.05). There was not any difference for non-operative level kinematics between MF group and FM group and intact spine. Compared with the intact spine, FF group led to a significant decrease at the arthrodesis-levels (P<0.05) and marked increase at the non-operative level kinematics. CONCLUSION: A two-level Mobi-C and Hybrid construct generated better biomechanical conditions. This study suggested that two-level cervical total disc replacement or HS could become an alternative approach for therapy of two-level consecutive cervical spondylosis.
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BACKGROUND: Short- and mid-term studies have shown the effectiveness of cervical disc arthroplasty (CDA) to treat cervical disc degeneration. OBJECTIVE: To report the 10-yr outcomes of a multicenter experience with cervical arthroplasty for 1- and 2-level pathology. METHODS: This was a prospective study of patients treated with CDA at 1 or 2 contiguous levels using the Mobi-C® Cervical Disc (Zimmer Biomet). Following completion of the 7-yr Food and Drug Administration postapproval study, follow-up continued to 10 yr for consenting patients at 9 high-enrolling centers. Clinical and radiographic endpoints were collected out to 10 yr. RESULTS: At 10 yr, patients continued to have significant improvement over baseline Neck Disability Index (NDI), neck and arm pain, neurologic function, and segmental range of motion (ROM). NDI and pain outcomes at 10 yr were significantly improved from 7 yr. Segmental and global ROM and sagittal alignment also were maintained from 7 to 10 yr. Clinically relevant adjacent segment pathology was not significantly different between 7 and 10 yr. The incidence of motion restricting heterotopic ossification at 10 yr was not significantly different from 7 yr for 1-level (30.7% vs 29.6%) or 2-level (41.7% vs 39.2%) patients. Only 2 subsequent surgeries were reported after 7 yr. CONCLUSION: Our results through 10 yr were comparable to 7-yr outcomes, demonstrating that CDA with Mobi-C continues to be a safe and effective surgical treatment for patients with 1- or 2-level cervical degenerative disc disease.
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Artroplastia/tendências , Vértebras Cervicais/diagnóstico por imagem , Vértebras Cervicais/cirurgia , Degeneração do Disco Intervertebral/diagnóstico por imagem , Degeneração do Disco Intervertebral/cirurgia , Adulto , Artroplastia/métodos , Feminino , Seguimentos , Humanos , Disco Intervertebral/diagnóstico por imagem , Disco Intervertebral/cirurgia , Masculino , Pessoa de Meia-Idade , Cervicalgia/diagnóstico por imagem , Cervicalgia/cirurgia , Estudos Prospectivos , Amplitude de Movimento Articular/fisiologia , Fatores de Tempo , Substituição Total de Disco/métodos , Substituição Total de Disco/tendências , Resultado do TratamentoRESUMO
BACKGROUND: Cervical disc herniation is a common condition usually treated with anterior cervical discectomy and fusion (ACDF) or, more recently, with cervical disc arthroplasty (CDA). Both treatments offer similar clinical results. However, CDA has been found to offer fewer medium- to long-term complications as well as potential reduction of long-term adjacent disc degeneration. OBSERVATIONS: A 40-year-old man was treated with cervical discectomy and arthroplasty due to a C6-C7 disc herniation with left C7 radiculopathy. After the treatment, his postoperative follow-up appointments were uneventful for 9 months. However, after 9 months, he reported cervical pain and a right C7 radiculopathy after neck extension. Imaging confirmed a posterior intraprosthetic dislocation, the first case reported to date. The patient was received emergency surgery under neuromonitoring, and the prosthesis was replaced by an ACDF and anterior plate. The insert presented a rupture of the anterior horn. The patient presented no preoperative or postoperative neurological deficit, and his follow-up review revealed no issues. LESSONS: Posterior intraprosthetic dislocation is an extremely rare complication. It may occur with Mobi-C cervical arthroplasty in the case of rupture and oxidation of the polyethylene insert. Spine surgeons should be aware of this potential major complication.
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BACKGROUND: Radiculopathy and myelopathy resulting from degenerative disc disease are currently treated with anterior cervical discectomy and fusion (ACDF), but there is a high incidence of adjacent segment disease after treatment. METHODS: With recent advances in cervical disc arthroplasty (CDA), we performed a review of published articles, examining the latest clinical data on the efficacy, safety, and complications of the current cervical disc devices on the market. We focused on the long-term follow up data of single-level, multi-level, and hybrid CDA as compared to ACDF, paying close attention to the newest cervical disc devices. A search was performed utilizing PubMed, Google Scholar, and Clinical Key to identify articles on 1-level, 2-level, and hybrid approaches to CDA. The articles were reviewed by two authors for relevance and power with higher emphasis placed on FDA IDE trials. RESULTS: The results conclude that CDA has an equivalent or improved clinical outcome when compared with ACDF with improved patient reported neck disability indexes and VAS neck pain scale. CDA also has lower rates of dysphagia, adjacent segment disease, and lower rates of reoperation when compared to ACDF. The data suggest there is no increased rate of reoperation in patients treated with multilevel CDA when compared to ACDF. In addition, the data from the limited clinical trials suggest that hybrid CDA and ACDF is safe and decreases risk of ASD. CONCLUSION: CDA has been shown to be effective and safe with low complication rates. However, the data are of low quality, and more hybrid studies must be performed in the future to confirm these findings. CLINICAL RELEVANCE: The reduction in overall postsurgical complications including ASD and in the need for additional surgery in the CDA group. LEVEL OF EVIDENCE: 3.
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BACKGROUND: Cervical disc replacement (CDR) has emerged as an alternative to anterior cervical discectomy and fusion for the surgical treatment of degenerative cervical disc disease. Although comparison of the 2 techniques has been studied in the literature, a thorough assessment of all artificial discs between each has not been performed. The objective of the present study was to examine the long-term outcomes of 5 artificial discs. METHODS: An electronic literature search was conducted for studies of CDR devices for all years available. Only articles in English were included. Heterotopic ossification, adjacent segment disease, and reoperation comprised the primary outcomes of interest. Pooled descriptive statistics with effect size (ES) and 95% confidence interval were used to synthesize the outcomes for each device. RESULTS: Sixty-five studies (n = 5785) were included in the analysis. Comparison of the incidence of grade III/IV heterotopic ossification showed a significant variability between the 5 devices (P < 0.001) with ProDisc-C (ES, 38%; 95% confidence interval [CI], 24%-54%) having the highest incidence rate. Overall rate of adjacent segment disease was 14% (95% CI, 7%-23%) with significant associated heterogeneity (P < 0.001). Regarding 2-year reoperation risk, the overall incidence rate was 2% (95% CI, 1%-3%), with nonsignificant variability between devices (P = 0.63). The highest rate was observed in the Discover group (ES, 4%; 95% CI, 0%-13%). CONCLUSIONS: The results of the present meta-analysis indicate that surgical and clinical outcomes may differ among different CDR devices. These findings may assist surgeons in tailoring their decision making to specific patient profiles. Future multicenter efforts are needed to validate associations found in this study.
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Vértebras Cervicais/cirurgia , Degeneração do Disco Intervertebral/cirurgia , Disco Intervertebral/cirurgia , Substituição Total de Disco , Adulto , Discotomia/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reimplante/métodos , Tempo , Substituição Total de Disco/métodosRESUMO
Cervical spondylosis is one of the most commonly treated conditions in neurosurgery. Increasingly, cervical disc replacement (CDR) has become an alternative to traditional arthrodesis, particularly when treating younger patients. Thus, surgeons continue to gain a greater understanding of short- and long-term complications of arthroplasty. Here, the authors present a series of 4 patients initially treated with Mobi-C artificial disc implants who developed postoperative neck pain. Dynamic imaging revealed segmental kyphosis at the level of the implant. All implants were locked in the flexion position, and all patients required reoperation. This is the first reported case series of symptomatic segmental kyphosis after CDR.
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INTRODUCTION: Cervical disc arthroplasty (CDA) has become an acceptable alternative for anterior cervical discectomy and fusion (ACDF) for a significant patient population with cervical radiculopathy and/or myelopathy secondary to degenerative changes in the cervical spine. There are sufficient mid- and long-term data supporting performance and safety of one-level CDA. With the success of single-level cervical CDA, considerable interest exists about CDA use for multilevel cervical degenerative disc disease (DDD). This review analyzes the safety and efficacy of two-level CDA for treatment of symptomatic cervical DDD with focus on the Mobi-C® Cervical Disc. AREAS COVERED: This review summarizes previously published articles in a literature search using keywords: 'two-level-anterior cervical arthrodesis; two-level anterior cervical decompression and fusion (ACDF); two-level cervical disc arthroplasty (CDA); two-level cervical total disc replacement; two-level symptomatic degenerative disc disease (DDD); Mobi-C® disc'. EXPERT OPINION: Two-level CDA with the Mobi-C® device demonstrated equivalent, and in certain aspects, favorable outcomes compared to ACDF for treatment of symptomatic cervical 2-level degenerative disc disease (DDD) indicating a satisfactory safety and efficacy profile.
Assuntos
Vértebras Cervicais/cirurgia , Substituição Total de Disco/efeitos adversos , Substituição Total de Disco/instrumentação , Artroplastia , Análise Custo-Benefício , Seguimentos , Humanos , Substituição Total de Disco/economia , Resultado do TratamentoRESUMO
BACKGROUND: Heterotopic ossification (HO) is a known risk following cervical total disc replacement (CTDR) surgery, but the cause and effect of HO are not well understood. Reported HO rates vary, and few studies are specifically designed to report HO. The effects on outcomes, and the risk factors for the development of HO have been hypothesized and reported in small-population, retrospective analyses, using univariate statistics. METHODS: Posthoc, multiple-phase analysis of radiographic, clinical, and demographic data for CTDR as it relates to HO was performed. HO was radiographically graded for 164 one-level and 225 two-level CTDR patients using the McAfee and Mehren system. Analysis was performed to correlate HO grades to clinical outcomes and to evaluate potential risk factors for the development of HO using demographics and baseline clinical measures. RESULTS: At 7 years, 1-level clinically relevant HO grades were 17.6% grade 3 and 11.1% grade 4. Two-level clinically relevant HO grades, evaluated using the highest patient grade, were 26.6% grade 3 and 10.8% grade 4. Interaction between HO and time revealed significance for neck disability index (NDI; P = .04) and Visual Analog Scale (VAS) neck pain (P = .02). When analyzed at each time point NDI was significant at 48-84 months and VAS neck at 60 months. For predictors 2 analyses were run; odds ratios indicated follow-up visit, male sex, and preoperative VAS neck pain are related to HO development, whereas hazard ratios indicated male sex, obesity, endplate coverage, levels treated, and preoperative VAS neck pain. CONCLUSIONS: This is the largest study to report HO rates, and related outcomes and risk factors. To develop an accurate predictive model, further large-scale analyses need to be performed. Based on the results reported here, clinically relevant HO should be more accurately described as motion-restricting HO until a definitive link to outcomes has been established.
RESUMO
OBJECTIVE: Cervical spondylosis affects a huge proportion of the middle-aged population. Degenerative changes can occur in multiple regions of the cervical spine typically affecting the joints, intervertebral discs and endplates. These changes lead to compression of adjacent nervous structures, which results in radiculopathic and myelopathic pain. Various treatment modalities are currently available with non-surgical approaches the initial go to if there is no symptomatic cord compression. Anterior cervical discectomy and fusion, or arthroplasty are the two common surgical approaches if non-surgical treatments fail to relieve symptoms of the patients or there are signs of central cord compression. However, studies have shown that there is an increased risk of adjacent segment disease related to fusion. Cervical disc arthroplasty aims to restore normal range of motion (ROM) in patients with pain and disability due to degenerative disc disease resistant to conservative care. Two common disc prostheses used include M6-C and Mobi-C. Both prostheses comprise a mobile polymer segment sandwiched between two metal endplates with mechanisms resembling an actual intervertebral disc. This study aims to compare the kinematics associated with these prostheses, against the normal range of motion in the non-degenerative population. METHOD: Patients who underwent M6-C or Mobi-C disc replacements by the senior author from 2012 to 2015 were identified at a single tertiary institution. Routine 3-month postoperative lateral radiographs were analyzed for flexion and extension ROM angles at the involved vertebral level by two independent authors. Data was compared to previous published studies investigating cervical spine ROM of asymptomatic patients. RESULTS: There was no statistical significance in the difference of overall flexion range between M6-C and Mobi-C prostheses. However, overall range of extension of Mobi-C was greater compared to M6-C (P = 0.028). At C5-6 , the range of flexion for both implants were similar but lesser compared to asymptomatic patients (P < 0.001). Range of extension was greater in the Mobi-C group (14.2° ± 5.1°) compared to the M6-C (7.3° ± 4.6°) (P = 0.0009). At C6-7 , there were no statistical differences in both range of flexion and extension between the two prostheses and asymptomatic patients (P > 0.05). CONCLUSION: The early results regarding restoration of ROM following cervical arthroplasty using either M6-C or Mobi-C prosthesis are encouraging. Long-term follow-up studies are necessary to observe the change in ROM over time with physiological loading and wear patterns.