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1.
Eur Spine J ; 33(8): 3117-3123, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-39026079

RESUMO

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.


Assuntos
Vértebras Cervicais , Reoperação , Fusão Vertebral , Substituição Total de Disco , Humanos , Feminino , Substituição Total de Disco/métodos , Pessoa de Meia-Idade , Vértebras Cervicais/cirurgia , Estudos Retrospectivos , Adulto , Masculino , Reoperação/métodos , Reoperação/estatística & dados numéricos , Idoso , Fusão Vertebral/métodos , Falha de Tratamento
2.
Eur Spine J ; 33(1): 232-242, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37947890

RESUMO

PURPOSE: To characterize the change of adjacent segment degeneration (ASD) after cervical total disc replacement (CTDR) with more than 12-year follow-up, and identify the risk factors for ASD. METHOD: This process included 75 patients underwent CTDR from February 2004 to December 2012, with the follow-up of 151.9 ± 36.0 (m). The artificial disc included ProDisc-C, Prestige-LP and Mobi-C. ASD was followed up at 1 week, 6 months, 1 year, 2 years, 5 years, 10 years after CTDR and at the endpoint of June 2022. The radiographic measurements were cervical mobility, intervertebral disc height (IDH), cervical lordosis and balance status. The complications were implant migration, subsidence and heterotopic ossification (HO). RESULTS: Cervical mobility in adjacent segments, IDH and lordosis showed no statistical differences between ASD and NASD group. Balance status, subsidence and migration showed no relationship with ASD. Postoperative ASD increased at 6 m and especially between 6 m to 2y. There was no difference between the incidence of upper ASD and lower ASD all the time and few ASD-related reoperation. The majority of adjacent segments were C4/5 (33.6%) and C6/7 (34.2%), and ASD of C5/6 had the highest incidence (61.5%). Cox regression showed ASD was not related to the types of prosthesis or operated numbers. Generalized estimating equations (GEE) analysis showed severe HO had a higher (2.68 times) probability to suffer from ASD. CONCLUSIONS: After over 12-year follow-up of CTDR, the occurrence of ASD and HO had temporal synchronization. ASD was not merely a natural progression but with the pathological process such as HO.


Assuntos
Degeneração do Disco Intervertebral , Disco Intervertebral , Lordose , Ossificação Heterotópica , Substituição Total de Disco , Humanos , Seguimentos , Degeneração do Disco Intervertebral/diagnóstico por imagem , Degeneração do Disco Intervertebral/epidemiologia , Degeneração do Disco Intervertebral/cirurgia , Substituição Total de Disco/efeitos adversos , Lordose/cirurgia , Vértebras Cervicais/diagnóstico por imagem , Vértebras Cervicais/cirurgia , Disco Intervertebral/diagnóstico por imagem , Disco Intervertebral/cirurgia , Ossificação Heterotópica/cirurgia , Resultado do Tratamento , Estudos Retrospectivos
3.
Eur Spine J ; 33(8): 2969-2981, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-39009847

RESUMO

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.


Assuntos
Vértebras Cervicais , Substituição Total de Disco , Humanos , Substituição Total de Disco/métodos , Substituição Total de Disco/efeitos adversos , Vértebras Cervicais/cirurgia , Vértebras Cervicais/diagnóstico por imagem , Reabsorção Óssea/diagnóstico por imagem , Reabsorção Óssea/etiologia , Complicações Pós-Operatórias/etiologia
4.
Eur Spine J ; 33(3): 1292-1299, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38363365

RESUMO

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.


Assuntos
Degeneração do Disco Intervertebral , Ossificação Heterotópica , Osteólise , Substituição Total de Disco , Humanos , Masculino , Feminino , Adulto , Substituição Total de Disco/efeitos adversos , Resultado do Tratamento , Seguimentos , Degeneração do Disco Intervertebral/cirurgia , Estudos Retrospectivos , Osteólise/diagnóstico por imagem , Osteólise/epidemiologia , Osteólise/etiologia , Vértebras Cervicais/diagnóstico por imagem , Vértebras Cervicais/cirurgia , Cervicalgia/etiologia , Ossificação Heterotópica/diagnóstico por imagem , Ossificação Heterotópica/epidemiologia , Ossificação Heterotópica/etiologia
5.
Eur Spine J ; 2024 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-38874639

RESUMO

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

6.
Eur Spine J ; 32(3): 797-802, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36520212

RESUMO

PURPOSE: It is sometimes anticipated that patients with prior spine surgery will have a compromised outcome from future procedures. The purpose of this study was to compare TDR outcomes in patients with prior lumbar spine surgery to those with no previous surgery. METHODS: Post hoc analysis was performed on 5-year follow-up data collected prospectively in the multi-centre FDA-regulated trial for the activL® Artificial Disc which involved 376 patients treated for single-level symptomatic disc degeneration. Clinical outcome measures included the Oswestry Disability Index (ODI), visual analog scales (VAS) assessing back and leg pain, SF-36, adverse events, and re-operations. Radiographic outcomes included flexion/extension range of motion (ROM) and translation of the operated segment. Patients were divided into two groups: Prior Lumbar Surgery (PLS, n = 92) and No Prior Lumbar Surgery (NPLS, n = 284). RESULTS: Baseline demographics were similar in the two groups. ODI, VAS, and SF-36 Physical Component Scale scores improved significantly (p < 0.05) from baseline in both groups with improvements maintained through 5-year post-TDR with no significant differences between groups. There were no statistically significant differences in rates of serious device-related events, procedure-related events, or re-operations. While ROM was significantly less prior to TDR surgery in the PLS group, there was no significant difference in ROM at post-operative points. CONCLUSION: Prior lumbar spine surgery was not associated with compromised outcomes following TDR. These results are in line with reports from earlier studies with shorter follow-up, finding that non-destabilizing prior surgery is not a contra-indication for TDR provided that selection criteria are met. LEVEL OF EVIDENCE I: Diagnostic: individual cross-sectional studies with the consistently applied reference standard and blinding.


Assuntos
Degeneração do Disco Intervertebral , Substituição Total de Disco , Humanos , Estudos Transversais , Seguimentos , Estudos Prospectivos , Degeneração do Disco Intervertebral/diagnóstico por imagem , Degeneração do Disco Intervertebral/cirurgia
7.
Int Orthop ; 47(4): 1071-1077, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36807736

RESUMO

PURPOSE: Microdiscectomy is the current gold standard surgical treatment for primary lumbar disc herniations that fail non-surgical measures. Herniated nucleus pulposus is the manifestation of underlying discopathy that remains unaddressed with microdiscectomy. Therefore, risk remains of recurrent disc herniation, progression of the degenerative cascade, and on-going discogenic pain. Lumbar arthroplasty allows for complete discectomy, complete direct and indirect decompression of neural elements, restoration of alignment, restoration of foraminal height, and preservation of motion. In addition, arthroplasty avoids disruption of posterior elements and musculoligamentous stabilizers. The purpose of this study is to describe the feasibility of the use of lumbar arthroplasty in the treatment of patients with primary or recurrent disc herniations. In addition, we describe the clinical and peri-operative outcomes associated with this technique. METHODS: All patients that underwent lumbar arthroplasty by a single surgeon at a single institution from 2015 to 2020 were reviewed. All patients with radiculopathy and pre-operative imaging demonstrating disc herniation that received lumbar arthroplasty were included in the study. In general, these patients were those with large disc herniations, advanced degenerative disc disease, and a clinical component of axial back pain. Patient-reported outcomes of VAS back, VAS leg, and ODI pre-operatively, at three months, one year, and at last follow-up were collected. Reoperation rate, patient satisfaction, and return to work were documented at last follow-up. RESULTS: Twenty-four patients underwent lumbar arthroplasty during the study period. Twenty-two (91.6%) patients underwent lumbar total disc replacement (LTDR) for a primary disc herniation. Two patients (8.3%) underwent LTDR for a recurrent disc herniation after prior microdiscectomy. The mean age was 40 years. The mean pre-operative VAS leg and back pain were 9.2 and 8.9, respectively. The mean pre-operative ODI was 22.3. Mean VAS back and leg pain was 1.2 and 0.5 at three months post-operative. The mean VAS back and leg pain was 1.3 and 0.6 at one year post-operative. The mean ODI was 3.0 at one year post-operative. One patient (4.2%) underwent re-operation for migrated arthroplasty device which required repositioning. At last follow-up, 92% of patients were satisfied with their outcome and would undergo the same treatment again. The mean time for return-to-work was 4.8 weeks. After returning to work, 89% of patients required no further leave of absence for recurrent back or leg pain at last follow-up. Forty-four percent of patients were pain free at last follow-up. CONCLUSION: Most patients with lumbar disc herniations can avoid surgical intervention altogether. Of those that require surgical treatment, microdiscectomy may be appropriate for certain patients with preserved disc height and extruded fragments. In a subset of patients with lumbar disc herniation that require surgical treatment, lumbar total disc replacement is an effective option by performing complete discectomy, restoring disc height, restoring alignment, and preserving motion. The restoration of physiologic alignment and motion may result in durable outcomes for these patients. Longer follow-up and comparative and prospective trials are needed to determine how the outcomes of microdiscectomy may differ from lumbar total disc replacement in the treatment of primary or recurrent disc herniation.


Assuntos
Deslocamento do Disco Intervertebral , Humanos , Adulto , Deslocamento do Disco Intervertebral/cirurgia , Deslocamento do Disco Intervertebral/etiologia , Estudos Prospectivos , Discotomia/métodos , Dor nas Costas/etiologia , Artroplastia , Vértebras Lombares/cirurgia , Resultado do Tratamento
8.
Eur Spine J ; 31(10): 2607-2611, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-35922636

RESUMO

PURPOSE: The purpose of this study was to investigate reasons and their frequency for why spine surgeons subspecializing in total disc replacement (TDR) performed lumbar fusion rather than TDR. METHODS: The study was based on a consecutive series of 515 patients undergoing lumbar TDR or fusion during a 5-year period by three surgeons specializing in TDR. For each fusion patient, the reason for not performing TDR was recorded. RESULTS: TDR was performed in 65.4% (n = 337) of patients and the remaining 34.6% (n = 178) underwent anterior lumbar interbody fusion (ALIF ± posterior instrumentation). Of the 178 fusion patients, the most common reason for fusion was combined factors related to severe degenerative changes (n = 59, 11.5% of the study population). The second most common reason was > Grade 1 spondylolisthesis (n = 32, 6.2%), followed by insurance non-coverage (n = 24, 4.7%), and osteopenia/osteoporosis (n = 13, 2.5%). Fusion patients were significantly older than TDR patients (52.5 vs. 41.6 years; p < 0.01). There was no significant difference with respect to gender (41.2% female vs. 43.8% female, p > 0.05) or the percentage of patients with single-level surgery (61.2% vs. 56.7%, p > 0.05). CONCLUSION: The most common reason for not performing lumbar TDR was related to anatomic factors that may compromise stability of the operated segment and/or TDR functionality. The older age of fusion patients may be related to these factors. This study found that many patients are appropriate candidates for lumbar TDR. However, even among TDR subspecialists, fusion is preferred when there are factors that cannot be addressed with TDR and/or may compromise implant functionality.


Assuntos
Degeneração do Disco Intervertebral , Fusão Vertebral , Cirurgiões , Substituição Total de Disco , Feminino , Humanos , Degeneração do Disco Intervertebral/cirurgia , Vértebras Lombares/diagnóstico por imagem , Vértebras Lombares/cirurgia , Masculino , Fusão Vertebral/métodos , Substituição Total de Disco/métodos , Resultado do Tratamento
9.
Eur Spine J ; 31(5): 1273-1282, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35020078

RESUMO

BACKGROUND: According to published meta-analyses, cervical total disc replacement (CTDR) seems to be superior to anterior cervical decompression and fusion (ACDF) in most clinical parameters. Despite short-term clinical success of CTDR, there are concerns regarding long-term durability of these prostheses. METHODS: This prospective study involved 382 patients who received standalone CTDR or a hybrid procedure (ACDF/CTDR). A retrospective comparison between different CTDR devices was conducted regarding patient-reported outcome measures (PROMs), failure scenarios, and revision surgeries. The M6-C™ Artificial Cervical Disc (Orthofix, Lewisville, Texas) cohort was compared to the other CTDR devices clinically. Etiological reasons for revision, and the surgical technique of the revision was investigated. RESULTS: Fifty-three patients received M6-C CTDR. Eighteen patients (34%) were revised at an average of 67 months postoperatively for wear-induced osteolysis. There were three additional cases of pending revision. The PROMs of the two groups were similar, indicating that the failure mode (wear-induced osteolysis) is often asymptomatic. The demographics of the two groups were also similar, with more women undergoing revision surgery than men. There were three one-level CTDR, four two-level hybrids, seven three-level hybrids, and three four-level hybrids revised anteriorly. Sixteen patients underwent removal of the prosthesis and were treated according to the extent of osteolysis. There were four vertebrectomies, six revisions to ACDF, and six revisions to another CTDR. One patient underwent supplemental fixation using a posterior approach. The other CTDR cohort had an incidence of 3.3% at the equivalent time, and none of these were due to osteolysis or wear-related events. CONCLUSIONS: There is a concerning midterm failure rate related to ultra-high-molecular-weight-polyethylene wear-induced osteolysis in the M6-C. Patients implanted with the M6-C prosthesis should be contacted, informed, and clinically and radiologically assessed.


Assuntos
Vértebras Cervicais , Osteólise , Polietileno , Substituição Total de Disco , Vértebras Cervicais/cirurgia , Feminino , Humanos , Masculino , Osteólise/etiologia , Polietileno/efeitos adversos , Estudos Prospectivos , Falha de Prótese , Reoperação , Estudos Retrospectivos , Substituição Total de Disco/efeitos adversos , Resultado do Tratamento
10.
Eur Spine J ; 31(5): 1260-1272, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35325298

RESUMO

PURPOSE: Our study aimed to evaluate non-inferiority of ProDisc-C to anterior cervical discectomy and fusion (ACDF) in terms of clinical outcomes and incidence of adjacent segment disease (ASD) at 24-months post-surgery in Asian patients with symptomatic cervical disc disease (SCDD). METHODS: This multicentre, prospective, randomized controlled trial was initiated after ethics committee approval at nine centres (China/Hong Kong/Korea/Singapore/Taiwan). Patients with single-level SCDD involving C3-C7-vertebral segments were randomized (2:1) into: group-A treated with ProDisc-C and group-B with ACDF. Assessments were conducted at baseline, 6-weeks, 3/6/12/18/24-months post-surgery and annually thereafter till 84-months. Primary endpoint was overall success at 24-months, defined as composite of: (1) ≥ 20% improvement in neck disability index (NDI); (2) maintained/improved neurologic parameters; (3) no implant removal/revision/re-operation at index level; and (4) no adverse/severe/life-threatening events. RESULTS: Of 120 patients (80ProDisc-C,40ACDF), 76 and 37 were treated as per protocol (PP). Overall success (PP) was 76.5% in group-A and 81.8% in group-B at 24-months (p = 0.12), indicating no clear non-inferiority of ProDisc-C to ACDF. Secondary outcomes improved for both groups with no significant inter-group differences. Occurrence of ASD was higher in group-B with no significant between-group differences. Range of motion (ROM) was sustained with ProDisc-C but lost with ACDF at 24-months. CONCLUSION: Cervical TDR with ProDisc-C is feasible, safe, and effective for treatment of SCDD in Asians. No clear non-inferiority was demonstrated between ProDisc-C and ACDF. However, patients treated with ProDisc-C demonstrated significant improvement in NDI, neurologic success, pain scores, and 36-item-short-form survey, along with ROM preservation at 24-months. Enrolment difficulties resulted in inability to achieve pre-planned sample size to prove non-inferiority. Future Asian-focused, large-scale studies are needed to establish unbiased efficacy of ProDisc-C to ACDF.


Assuntos
Degeneração do Disco Intervertebral , Fusão Vertebral , Substituição Total de Disco , Povo Asiático , Vértebras Cervicais/cirurgia , Discotomia/métodos , Seguimentos , Humanos , Degeneração do Disco Intervertebral/etiologia , Degeneração do Disco Intervertebral/cirurgia , Deslocamento do Disco Intervertebral , Estudos Prospectivos , Amplitude de Movimento Articular , Fusão Vertebral/métodos , Substituição Total de Disco/métodos , Resultado do Tratamento
11.
Br J Neurosurg ; 36(4): 520-523, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31975616

RESUMO

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.


Assuntos
Compressão da Medula Espinal , Substituição Total de Disco , Vértebras Cervicais/cirurgia , Humanos , Compressão da Medula Espinal/etiologia , Substituição Total de Disco/efeitos adversos
12.
Eur Spine J ; 30(12): 3688-3701, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-33837832

RESUMO

PURPOSE: The purpose of our meta-analyses is to find the most appropriate surgical technique treating lumbar degenerative disc disease (DDD). Spinal fusion is the conventional treatment for lumbar DDD. Total disc replacement (TDR) has been developed to avoid negative effects of fusions by preserving functionality. To our knowledge, there is no evaluation comparing meta-analytically the clinical results of three different surgical techniques with same inclusion and exclusion criteria for treating DDD. METHODS: The surgical techniques TDR, anterior lumbar interbody fusion (ALIF) and circumferential fusion (CFF) are pairwise meta-analytically compared. Primary outcomes are pain measured by the Visual Analogue Scale (VAS) and function measured by the Oswestry Disability Index (ODI). Secondary outcomes are the mean number of complications per case (MNOC) at surgery and follow-up and the overall MNOC. RESULTS: In our systematic search, we found finally six prospective studies with the minimum follow-up of two years: four randomized controlled trials and two cohort studies. In VAS and ODI, TDR is proved to be superior to ALIF and CCF (p < 0.05), whereat ALIF is more effective than CFF without statistical significance. CFF presents the best result in complications with the lowest overall MNOC (0.1), followed by TDR (1.2) and ALIF (1.5). CONCLUSION: According to our meta-analyses, we regard TDR to be the most appropriate surgical technique treating DDD, followed by ALIF. Further studies with a longer follow-up are needed using the same methodical approach to strengthen the VAS and ODI results and to explain the discrepant result to complications.


Assuntos
Degeneração do Disco Intervertebral , Fusão Vertebral , Substituição Total de Disco , Humanos , Degeneração do Disco Intervertebral/cirurgia , Vértebras Lombares/cirurgia , Dor , Estudos Prospectivos , Fusão Vertebral/efeitos adversos , Substituição Total de Disco/efeitos adversos , Resultado do Tratamento
13.
Eur Spine J ; 29(11): 2683-2687, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32277335

RESUMO

INTRODUCTION: One important factor in evaluating the safety of an implant is the rate of subsequent surgery and the reasons for surgery, particularly those that are related to possible problems with the implant. The purpose of this study was to determine the overall re-operation rate (including revisions, removals, device-related, procedure-related, adjacent segment, and others) for a large consecutive series of cervical TDR patients beginning with the first case experience, using a single device at a single institution. METHODS: Surgery records were reviewed to identify cervical TDR patients and those who underwent subsequent surgery. Cervical TDR cases involving ProDisc-C were identified, beginning with the first case performed in 2003 at a multisite spine specialty centre. Only patients who were at least 2 years post-operative were included, producing a consecutive series of 535 patients. There were 115 hybrids in the series (TDR at one level and fusion at an adjacent segment). Data collected included general demographics and level(s) operated. A surgery log through 12-31-18 was reviewed to identify re-operations occurring in the TDR patients. For each re-operation, the reason, duration from index surgery, and procedure were recorded. The mean duration from the index surgery to the search of the surgery log for re-operations was 78.3 months, range 24 to 181 months. RESULTS: Re-operation occurred in 30 patients (5.6%). These included: 3 TDR removals and revision to anterior discectomy and fusion (1 for migration, 1 for subsidence, and 1 for spondylosis), 1 TDR repositioning, 21 secondary surgeries for adjacent segment degeneration (5 of which were adjacent to fusion levels in hybrid procedures), 1 wound infection, 1 hematoma, and 2 received stimulators for pain control. There were no re- operations for device failure. In cases of re-operation for adjacent segment degeneration, the mean duration between the index surgery and re-operation was 47.3 months. CONCLUSION: The re-operation rate was 5.6%. No surgeries were performed for device failure. These results support the safety of the TDR device.


Assuntos
Degeneração do Disco Intervertebral , Substituição Total de Disco , Vértebras Cervicais/cirurgia , Discotomia , Seguimentos , Humanos , Degeneração do Disco Intervertebral/cirurgia , Estudos Prospectivos , Fusão Vertebral , Resultado do Tratamento
14.
Eur Spine J ; 29(11): 2675-2682, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-31286245

RESUMO

PURPOSE: We investigated whether outcomes after cervical total disc replacement (cTDR) are influenced by preoperative neck pain as the chief complaint. METHODS: This was a retrospective study using data in our local spine surgery outcomes database, linked to EUROSPINE Spine Tango Registry. Patients completed questionnaires at baseline enquiring about the "chief complaint" [neck pain (NP), arm/shoulder pain (AP) or neurological deficits (ND)] and including the Core Outcome Measures Index (COMI); these were completed again at 24 months postoperatively, along with a rating of "global treatment outcome" (on a five-point scale, later dichotomized as "good" or "poor"). Differences in outcomes between the groups were examined using ANOVA. Multivariable regression analysis examined the effect of the chief pain location on 24-month outcomes, controlling for age, gender, comorbidity, baseline pain and COMI scores. RESULTS: One hundred and fifty-nine consecutive patients were included, with a chief complaint of NP in 31%, AP in 38% and ND in 31%. The chief complaint groups did not differ in relation to their baseline COMI scores or their reductions in score from before surgery to 24 months after surgery (reduction: NP group, 4.4 ± 2.9 points; AP group, 4.7 ± 2.7; ND group, 4.3 ± 2.9; p = 0.78). Similarly, the percentage of patients reporting a "good global treatment outcome" at 24 months postoperatively did not differ between the groups (NP, 79%; AP, 77%; ND, 85%; p = 0.64). The findings were consistent when controlling for possible confounders in multiple regression. CONCLUSIONS: Having neck pain as opposed to arm pain or neurological deficits as preoperative chief complaint had no significant impact on clinical outcome after cTDR. These slides can be retrieved under Electronic Supplementary Material.


Assuntos
Cervicalgia , Substituição Total de Disco , Vértebras Cervicais/cirurgia , Humanos , Cervicalgia/cirurgia , Estudos Retrospectivos , Inquéritos e Questionários , Resultado do Tratamento
15.
Eur Spine J ; 29(Suppl 1): 57-65, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31916002

RESUMO

INTRODUCTION: Dynamic stabilization of the spine has been performed since the 1990s with the double purpose of restoring spinal segmental stability and allowing residual movement at the operated level. When we take into account the different motion-preserving devices and the spinal areas where they are applied, we can identify three categories of spinal implants: anterior cervical, anterior lumbar, and posterior lumbar. However, as in all prosthetic procedures performed in orthopedic surgery, the life span of a joint replacement device is a central topic of discussion, and this is true also for spinal dynamic devices, being revision surgery a complex procedure in specific cases. MATERIALS AND METHODS: We performed a literature review on the different dynamic spinal implants and the most common causes of failure, providing clinical cases as illustrative options for revision surgery. RESULTS: The review of the literature showed a 11.3% to 22.6% revision rate in posterior lumbar dynamic systems, with a peak of 40.6% in case of adjacent segment disease. In lumbar TDRs, infection and severe dislocations are the most frequent causes of anterior revisions, while posterior pedicle screw fixation could be a suitable option in minimal subsidence or TDR displacement. An algorithm for the planning of revision surgery is proposed. CONCLUSIONS: Surgical revision of spinal dynamic implants could be a demanding surgery especially in anterior approaches. Anterior cervical revision remains globally safe, but careful preoperative evaluation of vessels and ureter are suggested to avoid intraoperative complications in the lumbar spine. In posterior revision, a proper sagittal alignment of the spine should be restored. These slides can be retrieved under Electronic Supplementary Material.


Assuntos
Procedimentos Ortopédicos , Próteses e Implantes , Reoperação , Coluna Vertebral/cirurgia , Algoritmos , Humanos , Procedimentos Ortopédicos/efeitos adversos , Procedimentos Ortopédicos/instrumentação
16.
Eur Spine J ; 29(11): 2665-2669, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-31897732

RESUMO

PURPOSE: The purpose was to investigate reasons and their frequency for why total disc replacement (TDR) specialty surgeons performed anterior cervical discectomy and fusion (ACDF) rather than TDR. METHODS: A consecutive series of 464 patients undergoing cervical spine surgery during a 5-year period by three TDR specialty surgeons was reviewed. For each ACDF, the reason for not performing TDR was recorded. RESULTS: TDR was performed in 76.7% of patients (n = 356) and ACDF in 23.3% (n = 108). The most common reason for ACDF versus TDR was anatomical (conditions that may not be adequately addressed with TDR and/or may interfere with device function), which occurred in 64 of 464 patients (13.79%). The second most common reason was insurance (denial/lack of coverage n = 17, 3.23%), and deformity/kyphosis not addressable with TDR was noted in 13 (2.80%). Pseudoarthrosis repair led to ACDF in three patients (0.65%), two did not receive TDR due to osteoporosis (0.43%), and in two others (0.43%) ACDF was undertaken due to high risk of heterotopic ossification. There was one case (0.22%) each of: nickel allergy, trauma with posterior element fracture, TDR removal, multiple prior cervical spine surgeries, concern about artifact on future imaging studies, benign osteoblastic bone, and limitation to adequate surgical approach for TDR. ACDF patients' mean age was significantly greater than TDR patients' (55.3 vs. 46.7 years; p < 0.01). TDR group had significantly more single-level procedures than ACDF (60.8% vs. 43.5%; p < 0.05). CONCLUSION: The most common reason for ACDF versus TDR was anatomy that may compromise segmental stability and/or TDR functionality. Older age and greater number of operated levels may be related to anatomical factors, primarily significant osteophytes and severely degenerated facets. These factors, as well as deformity/kyphosis, are more common in older patients and require multi-level treatment. This study found that many patients are good cervical TDR candidates; however, even among TDR specialists, ACDF may be preferred where it is prudent to not take undue risks. These slides can be retrieved under Electronic Supplementary Material.


Assuntos
Substituição Total de Disco , Vértebras Cervicais/diagnóstico por imagem , Vértebras Cervicais/cirurgia , Discotomia , Humanos , Degeneração do Disco Intervertebral/diagnóstico por imagem , Degeneração do Disco Intervertebral/cirurgia , Estudos Prospectivos , Fusão Vertebral , Cirurgiões , Resultado do Tratamento
17.
Eur Spine J ; 29(11): 2688-2700, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32279116

RESUMO

PURPOSE: Although cervical total disc replacement (CTDR) is perceived as a safe procedure, no review to date has quantified the complication rates. Of note, heterotopic ossification (HO), one of the complications of CTDR, is hypothesised to cause adjacent segment degeneration (ASDegeneration). This association has not been proven in meta-analysis. Hence, this systematic review and meta-analysis aims to investigate the pooled prevalence of complications following CTDR among studies that concomitantly reported the rate of HO, and the associations between HO and other complications, including ASDegeneration. METHODS: Literatures search was conducted in Embase, MEDLINE, PubMed, and the Cochrane Central Register of Controlled Trials. Complications were stratified into ≥ 1 and < 2 years, ≥ 2 and < 5 years, and ≥ 5 years follow-up. Subgroup and meta-regression analyses were performed. RESULTS: Fifty-three studies were included, composed of 3223 patients in total. The pooled prevalence of post-operative complications following CTDR was low, ranging from 0.8% in vascular adverse events to 4.7% in dysphagia at short-term follow-up. The rate of ASDegeneration was significantly higher at long-term follow-up (pooled prevalence 36.0%, 95% confidence interval [CI] 22.8-49.1%) than that at mid-term follow-up (pooled prevalence 7.3%, 95% CI 2.8-11.8%). Multivariate meta-regression analysis demonstrated that ASDegeneration was independently and inversely correlated with age (p = 0.007) and positively correlated with HO (p = 0.010) at mid-term follow-up. At long-term follow-up, ASDegeneration was still positively correlated with HO (p = 0.011), but not age. Furthermore, dysphagia was inversely associated with HO (p = 0.016), after adjustment for age and length of follow-up. CONCLUSION: In conclusion, HO is associated with ASDegeneration and dysphagia.


Assuntos
Degeneração do Disco Intervertebral , Ossificação Heterotópica , Substituição Total de Disco , Vértebras Cervicais/cirurgia , Humanos , Degeneração do Disco Intervertebral/epidemiologia , Degeneração do Disco Intervertebral/cirurgia , Pescoço , Ossificação Heterotópica/epidemiologia , Ossificação Heterotópica/etiologia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Substituição Total de Disco/efeitos adversos , Resultado do Tratamento
18.
Eur Spine J ; 29(7): 1518-1526, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-31399849

RESUMO

PURPOSE: To report clinical and radiographic outcomes, rate of complications and influence on spinal alignment on long-term follow-up (FU) of patients who underwent lumbar total disc arthroplasty (TDR), bringing some evidence to determine the profile of the most well-suited patients for TDR. METHODS: A retrospective review of patients underwent TDR for low back pain from degenerative disc disease (DDD) resistant to conservative treatment was performed. Demographic features, surgical data, clinical and radiographic outcomes, complications and spinopelvic parameters were evaluated. RESULTS: Thirty patients (32 TDR) were included with a mean FU of 164 ± 36.5 months. The clinical outcomes measured by visual analogue scale and Oswestry Disability Index showed a significant improvement between preoperative and 1-year FU (p < 0.01). No significant temporal variance has been identified between 1-year and long-term follow-up (p > 0.05). The surgical revision rate was 10%. The overall rate of complications was 20%. At final follow-up, the mobility of the prosthesis was preserved in 68.75% of the cases, and 73.3% of the patients were globally well aligned. CONCLUSION: The optimal surgical indication is crucial to achieve excellent clinical and radiological outcomes. According to the literature and to our experience, we underline the importance of a coronal deformity < 15° Cobb angle and a Roussouly type 1 or 2 as the profile of the most well-suited patient for TDR. Our long-term results confirm the existing evidence about efficacy and safety of TDR as a reliable option, in optimal surgery indication, to treat DDD. These slides can be retrieved under Electronic Supplementary Material.


Assuntos
Degeneração do Disco Intervertebral , Disco Intervertebral , Dor Lombar , Vértebras Lombares , Substituição Total de Disco , Adolescente , Adulto , Feminino , Seguimentos , Humanos , Disco Intervertebral/cirurgia , Degeneração do Disco Intervertebral/complicações , Degeneração do Disco Intervertebral/diagnóstico por imagem , Degeneração do Disco Intervertebral/cirurgia , Dor Lombar/diagnóstico , Dor Lombar/etiologia , Dor Lombar/cirurgia , Vértebras Lombares/diagnóstico por imagem , Vértebras Lombares/cirurgia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento , Escala Visual Analógica , Adulto Jovem
19.
Eur Spine J ; 29(11): 2713-2721, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-31309331

RESUMO

INTRODUCTION: We investigated a new metric for assessing the quality of motion of the cervical segments over the arc of extension-to-flexion motion after cervical disc arthroplasty (CDA). We quantified: (1) the amount of motion contributed by individual spinal segments to the total cervical spine motion, termed segmental motion fraction, and its variation throughout the arc of extension-to-flexion motion and (2) how cervical disc arthroplasty using two distinct prosthesis designs may influence the segmental motion contributions. MATERIALS AND METHODS: We tested 16 human C3-T1 spine specimens under physiologic loads; first intact, after CDA at C5-C6, and then at C5-C6 and C6-C7. The M6-C (Orthofix, USA) and Mobi-C (Zimmer, USA) disc prostheses were used in eight specimens each. RESULTS AND CONCLUSIONS: The designs of the cervical disc prostheses tested significantly influenced the variation in segmental motion fraction as the spine underwent motion between the endpoints of extension and flexion. While the mean segmental motion contribution to the total cervical motion was not influenced by prosthesis design, the way the motion took place between the extension and flexion endpoints was significantly influenced. The M6-C artificial disc restored physiologic motion quality such that implanted segments continued to function in harmony with other segments of the cervical spine as measured before arthroplasty. Conversely, the Mobi-C prosthesis, while maintaining average motion contributions similar to the pre-implantation values, demonstrated large deviations in motion contribution over the extension-to-flexion arc motion in ten of 16 implanted segments. Such non-physiologic implant kinematics could cause excessive prosthesis wear and motion and stress shielding at adjacent segments. These slides can be retrieved under Electronic Supplementary Material.


Assuntos
Artroplastia , Disco Intervertebral , Fenômenos Biomecânicos , Vértebras Cervicais/cirurgia , Humanos , Disco Intervertebral/cirurgia , Desenho de Prótese , Amplitude de Movimento Articular
20.
Eur Spine J ; 29(11): 2631-2639, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-31606816

RESUMO

PURPOSE: The purpose of the study is to examine the biomechanical alterations in the index and adjacent levels of the human cervical spine after cervical arthroplasty with Bryan, Prodisc C, or Prestige LP. METHODS: A previously validated C2-T1 osteoligamentous finite element model was used to perform virtual C5-6 arthroplasty using three different FDA-approved artificial cervical discs. Motion-controlled moment loading protocol was used. Moment was varied until Bryan, Prodisc C, and Prestige LP models displayed the same total range of motion across C3-C7 as the intact spine model at 2 Nm of pure moment loading. Range of motion (ROM) and facet force (FF) were recorded at the index level. ROM, FF, and intradiscal pressure (IDP) were recorded at the adjacent levels. RESULTS: Prodisc C and Prestige LP led to supraphysiologic ROM and FF at the index level while decreasing ROM and FF at the adjacent levels. In contrast, Bryan reduced ROM and FF at the index level. Bryan increased ROM and FF at the adjacent levels in flexion, but decreased ROM and FF in the adjacent levels in extension. Prodisc C decreased IDP at the adjacent levels. Bryan reduced IDP in extension only. Prestige LP increased adjacent-level IDP. CONCLUSIONS: The distinct designs and material compositions of the three artificial discs result in varying biomechanical alterations at the index and adjacent levels in the cervical spine after implantation. The findings confirm the design and material influence on the spine biomechanics, as well as the advantages and contraindications of cervical arthroplasty in general. These slides can be retrieved under Electronic Supplementary Material.


Assuntos
Vértebras Cervicais , Disco Intervertebral , Artroplastia , Fenômenos Biomecânicos , Vértebras Cervicais/cirurgia , Análise de Elementos Finitos , Humanos , Disco Intervertebral/cirurgia , Amplitude de Movimento Articular
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