Heterotopic Ossification after Cervical Arthroplasty with ProDisc-C: Time Course Radiographic Follow-up over 3 years

Object Cervical arthroplasty has been accepted as a viable option for surgical management of cervical spondylosis or degenerative disc disease (DDD). The best candidates for cervical arthroplasty are young patients who have radiculopathy caused by herniated disc with competent facet joints. However, it remains uncertain whether arthroplasty is equally effective for patients who have cervical myelopathy caused by DDD. The aim of this study was to compare the outcomes of arthroplasty for patients with cervical spondylotic myelopathy (CSM) and patients with radiculopathy without CSM. Methods A total of 151 consecutive cases involving patients with CSM or radiculopathy caused by DDD and who underwent one- or two-level cervical arthroplasty were included in this study. Clinical outcome evaluations and radiographic studies were reviewed. Clinical outcome measurements included the Visual Analog Scale (VAS) of neck and arm pain, Japanese Orthopaedic Association (JOA) scores, and the Neck Disability Index (NDI) in every patient. For patients with CSM, Nurick scores were recorded for evaluation of cervical myelopathy. Radiographic studies included lateral dynamic radiographs and CT for detection of the formation of heterotopic ossification . Results Of the 151 consecutive patients with cervical DDD, 125 (82.8%; 72 patients in the myelopathy group and 53 in the radiculopathy group) had at least 24 months of clinical and radiographic follow-up. The mean duration of follow-up in these patients was 36.4 months (range 24–56 months). There was no difference in sex distribution between the 2 groups. However, the mean age of the patients in the myelopathy group was approximately 6 years greater than that of the radiculopathy group (53.1 vs 47.2 years, p < 0.001). The mean operation time, mean estimated blood loss, and the percentage of patients prescribed perioperative analgesic agents were similar in both groups (p = 0.754, 0.652, and 0.113, respectively). There were significant improvements in VAS neck and arm pain, JOA scores, and NDI in both groups. Nurick scores in the myelopathy group also improved significantly after surgery. In radiographic evaluations, 92.5% of patients in the radiculopathy group and 95.8% of those in the radiculopathy group retained spinal motion (no significant difference). Evaluation of CT scans showed heterotopic ossification in 34 patients (47.2%) in the myelopathy group and 25 patients (47.1%) in the radiculopathy group (p = 0.995). At a mean of over 3 years postoperatively, no secondary surgery was reported in either group. Conclusions The severity of myelopathy improves after cervical arthroplasty in patients with CSM caused by DDD. At 3-year follow-up, the clinical and radiographic outcomes of cervical arthroplasty in DDD patients with CSM are similar to those patients who have only cervical radiculopathy. Therefore, cervical arthroplasty is a viable option for patients with CSM caused by DDD who require anterior surgery. However, comparison with the standard surgical treatment of anterior cervical discectomy and fusion is necessary to corroborate the outcomes of arthroplasty for CSM.

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Differences between soft-disc herniation and spondylosis in cervical arthroplasty: CT-documented heterotopic ossification with minimum 2 years of follow-up

Journal of Neurosurgery Spine ◽

10.3171/2011.10.spine11497 ◽

2012 ◽

Vol 16 (2) ◽

pp. 163-171 ◽

Cited By ~ 41

Author(s):

Jau-Ching Wu ◽

Wen-Cheng Huang ◽

Tsung-Hsi Tu ◽

Hsiao-Wen Tsai ◽

Chin-Chu Ko ◽

...

Keyword(s):

Heterotopic Ossification ◽

Clinical Outcomes ◽

Disc Herniation ◽

Cervical Disc ◽

Artificial Disc ◽

Cervical Arthroplasty ◽

Single Level ◽

Arm Pain ◽

Estimated Blood Loss

Object Cervical arthroplasty is a valid option for patients with single-level symptomatic cervical disc diseases causing neural tissue compression, but postoperative heterotopic ossification (HO) can limit the mobility of an artificial disc. In the present study the authors used CT scanning to assess HO formation, and they investigated differences in radiological and clinical outcomes in patients with either a soft-disc herniation or spondylosis who underwent cervical arthroplasty. Methods Medical records, radiographs, and clinical evaluations of consecutive patients who underwent single-level cervical arthroplasty were reviewed. Arthroplasty was performed using the Bryan disc. The patients were divided into a soft-disc herniation group and a spondylosis group. Clinical outcomes were measured using the visual analog scale (VAS) for neck and arm pain and the Neck Disability Index (NDI), whereas HO grading was determined by studying CT scans. Radiological and clinical outcomes were analyzed, and the minimum follow-up duration was 24 months. Results Forty-seven consecutive patients underwent a single-level cervical arthroplasty. Forty patients (85.1%) had complete radiological evaluations and clinical follow-up of more than 2 years. Patients were divided into 1 of 2 groups: soft-disc herniation (16 cases) and the spondylosis group (24 cases). Their mean age was 45.51 ± 11.12 years. Sixteen patients (40%) were female. Patients in the soft-disc herniation group were younger than those in the spondylosis group, but the difference was not statistically significant (42.88 vs 47.26, p = 0.227). The mean follow-up duration was 38.83 ± 9.74 months. Sex, estimated blood loss, implant size, and perioperative NSAID prescription were not significantly different between the groups (p = 0.792, 0.267, 0.581, and 1.000, respectively). The soft-disc herniation group had significantly less HO formation than the spondylosis group (1 HO [6.25%] vs 14 Hos [58.33%], p = 0.001). Almost all artificial discs in both groups remained mobile (100% and 95.8%, p = 0.408). The clinical outcomes were not significantly different between the groups at all postoperative time points of evaluation, and clinical improvements were also similar. Conclusions Clinical outcomes of single-level cervical arthroplasty for soft-disc herniation and spondylosis were similar 3 years after surgery. There was a significantly higher rate of HO formation in patients with spondylosis than in those with a soft-disc herniation. The mobility of the artificial disc is maintained, but the long-term effects of HO and its higher frequency in spondylotic cases warrant further investigation.

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The effects of carpentry on heterotopic ossification and mobility in cervical arthroplasty: determination by computed tomography with a minimum 2-year follow-up

Journal of Neurosurgery Spine ◽

10.3171/2012.3.spine11436 ◽

2012 ◽

Vol 16 (6) ◽

pp. 601-609 ◽

Cited By ~ 46

Author(s):

Tsung-Hsi Tu ◽

Jau-Ching Wu ◽

Wen-Cheng Huang ◽

Ching-Lan Wu ◽

Chin-Chu Ko ◽

...

Keyword(s):

Heterotopic Ossification ◽

Clinical Outcomes ◽

Neck Disability Index ◽

Ct Scanning ◽

Segmental Motion ◽

Artificial Disc ◽

Analog Scale ◽

Cervical Arthroplasty ◽

Neck Disability

Object Heterotopic ossification (HO) after cervical arthroplasty can limit the mobility of an artificial disc. In this study the authors used CT scanning to assess the formation of HO with the goal of investigating the correlation between the carpentry of arthroplasty, formation of HO, mobility, and clinical outcomes. Methods A retrospective review of medical records, radiological studies, and clinical evaluations was conducted for consecutive patients who underwent 1- or 2-level cervical arthroplasty with the Bryan disc. The patients underwent follow-up for more than 24 months. The formation of HO was assessed using CT scanning as the final determination. The perfectness of carpentry for each arthroplasty level was scrutinized using criteria composed of 2 parameters (postoperative shell kyphosis and inadequate endplate coverage). Levels were divided into the optimal carpentry group and the suboptimal carpentry group. Radiographic and clinical outcomes, including the visual analog scale and neck disability index, were compared between the groups. Results A total of 107 levels of Bryan discs were placed in 75 patients (mean age 46.71 ± 9.94 years) and were analyzed. There was a male predominance of 68.0% (51 men), and the mean follow-up duration was 38.56 ± 9.66 months. Heterotopic ossification was identified in 60 levels (56.1%) by CT scanning. Most cases of HO were low grade and did not correlate with the limitation in the segmental motion of the arthroplasty device. There were no significant differences in terms of age, sex, and number of arthroplasty levels between the optimal and the suboptimal carpentry groups. However, the suboptimal carpentry group had significantly more high-grade HO (≥ Grade 2) than the optimal carpentry group (13 levels [12.1%] vs 7 levels [6.5%], p = 0.027). There were also more immobile (range of motion < 3°) artificial discs in the suboptimal carpentry group than the optimal carpentry group (11 levels [10.3%] vs 4 levels [3.7%], p = 0.010). The clinical outcomes (neck and arm visual analog scale scores and Neck Disability Index) in both groups were similarly good. Conclusions Shell kyphosis and inadequate endplate coverage have adverse effects on the formation of HO and segmental mobility after cervical arthroplasty with the Bryan artificial disc. Appropriate carpentry is the more important factor in determining the maintenance of segmental motion. Although the midterm clinical outcome remained similarly good regardless of HO, the carpentry of cervical arthroplasty should not be overlooked. Further studies are needed to clarify the etiology of HO.

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Postoperative nonsteroidal antiinflammatory drugs and the prevention of heterotopic ossification after cervical arthroplasty: analysis using CT and a minimum 2-year follow-up

Journal of Neurosurgery Spine ◽

10.3171/2014.10.spine14333 ◽

2015 ◽

Vol 22 (5) ◽

pp. 447-453 ◽

Cited By ~ 20

Author(s):

Tsung-Hsi Tu ◽

Jau-Ching Wu ◽

Wen-Cheng Huang ◽

Hsuan-Kan Chang ◽

Chin-Chu Ko ◽

...

Keyword(s):

Heterotopic Ossification ◽

Clinical Outcomes ◽

Nonsteroidal Antiinflammatory Drugs ◽

Antiinflammatory Drugs ◽

Cervical Arthroplasty ◽

Arm Pain ◽

Nsaid Group ◽

Number Of Patients ◽

Cox 2

OBJECT Heterotopic ossification (HO) after cervical arthroplasty is not uncommon and may cause immobility of the disc. To prevent HO formation, study protocols of clinical trials for cervical arthroplasty undertaken by the US FDA included perioperative use of nonsteroidal antiinflammatory drugs (NSAIDs). However, there are few data supporting the use of NSAIDs to prevent HO after cervical arthroplasty. Therefore, this study aimed to evaluate the efficacy of NSAIDs in HO formation and clinical outcomes. METHODS Consecutive patients who underwent 1- or 2-level cervical arthroplasty with a minimum follow-up of 24 months were retrospectively reviewed. All patients were grouped into 1 of 2 groups, an NSAID group (those patients who had used NSAIDs postoperatively) and a non-NSAID group (those patients who had not used NSAIDs postoperatively). The formation of HO was detected and classified using CT in every patient. The incidence of HO formation, disc mobility, and clinical outcomes, including visual analog scale (VAS) scores of neck and arm pain, neck disability index (NDI) scores, and complications were compared between the two groups. Furthermore, a subgroup analysis of the patients in the NSAID group, comparing the selective cyclooxygenase (COX)-2 to nonselective COX-2 NSAID users, was also conducted for each of the above-mentioned parameters. RESULTS A total of 75 patients (mean age [± SD] 46.71 ± 9.94 years) with 107 operated levels were analyzed. The mean follow-up duration was 38.71 ± 9.55 months. There were no significant differences in age, sex, and levels of arthroplasty between the NSAID and non-NSAID groups. There was a nonsignificantly lower rate of HO formation in the NSAID group than the non-NSAID group (47.2% vs. 68.2%, respectively; p = 0.129). During follow-up, most of the arthroplasty levels remained mobile, with similar rates of immobile discs in the NSAID and non-NSAID groups (13.2% and 22.7%, respectively; p = 0.318). Furthermore, there was a nonsignificantly lower rate of HO formation in the selective COX-2 group than the nonselective COX-2 group (30.8% vs 52.5%, respectively; p = 0.213). The clinical outcomes, including VAS neck, VAS arm, and NDI scores at 24 months postoperatively, were all similar in the NSAID and non-NSAID groups, as well as the selective and nonselective COX-2 groups (all p > 0.05). CONCLUSIONS In this study there was a trend toward less HO formation and fewer immobile discs in patients who used postoperative NSAIDs after cervical arthroplasty than those who did not, but this trend did not reach statistical significance. Patients who used selective COX-2 NSAIDs had nonsignificantly less HO than those who used nonselective COX-2 NSAIDs. The clinical outcomes were not affected by the use of NSAIDs or the kinds of NSAIDs used (selective vs nonselective COX-2). However, the study was limited by the number of patients included, and the efficacy of NSAIDs in the prevention of HO after cervical arthroplasty may need further investigation to confirm these results.

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Differences between 1- and 2-level cervical arthroplasty: more heterotopic ossification in 2-level disc replacement

Journal of Neurosurgery Spine ◽

10.3171/2012.2.spine111066 ◽

2012 ◽

Vol 16 (6) ◽

pp. 594-600 ◽

Cited By ~ 38

Author(s):

Jau-Ching Wu ◽

Wen-Cheng Huang ◽

Hsiao-Wen Tsai ◽

Chin-Chu Ko ◽

Li-Yu Fay ◽

...

Keyword(s):

Heterotopic Ossification ◽

Clinical Outcomes ◽

Neck Disability Index ◽

Long Term Effects ◽

Antiinflammatory Drugs ◽

Cervical Arthroplasty ◽

Arm Pain ◽

Bryan Disc ◽

Level Group

Object The most currently accepted indication for cervical arthroplasty is 1- or 2-level degenerative disc disease (DDD) refractory to medical treatment. However, the randomized and controlled clinical trials by the US FDA investigational device exemption studies only compared cervical arthroplasty with anterior cervical discectomy and fusion for 1-level disease. Theoretically, 2-level cervical spondylosis usually implicates more advanced degeneration, whereas the 1-level DDD can be caused by merely a soft-disc herniation. This study aimed to investigate the differences between 1- and 2-level cervical arthroplasty. Methods The authors analyzed data obtained in 87 consecutive patients who underwent 1- or 2-level cervical arthroplasty with Bryan disc. The patients were divided into the 1-level and the 2-level treatment groups. Clinical outcomes were measured using the visual analog scale (VAS) for the neck and arm pain and the Neck Disability Index (NDI), with a minimum follow-up of 30 months. Radiographic outcomes were evaluated on both radiographs and CT scans. Results The study analyzed 98 levels of Bryan cervical arthroplasty in 70 patients (80.5%) who completed the evaluations in a mean follow-up period of 46.21 ± 9.85 months. There were 22 females (31.4%) and 48 males (68.6%), whose mean age was 46.57 ± 10.07 years at the time of surgery. The 1-level group had 42 patients (60.0%), while the 2-level group had 28 patients (40.0%). Patients in the 1-level group were younger than those in the 2-level group (mean 45.00 vs 48.93 years, p = 0.111 [not significant]). Proportional sex compositions and perioperative prescription of nonsteroidal antiinflammatory drugs were also similar in both groups (p = 0.227 and p = 1.000). The 2-level group had significantly greater EBL during surgery than the 1-level group (220.80 vs 111.89 ml, p = 0.024). Heterotopic ossification was identified more frequently in the 2-level group than the 1-level group (75.0% vs 40.5%, p = 0.009). Although most of the artificial discs remained mobile during the follow up, the 2-level group had fewer mobile discs (100% and 85.7%, p = 0.022) than the 1-level group. However, in both groups, the clinical outcomes measured by VAS for neck pain, VAS for arm pain, and NDI all significantly improved after surgery compared with that preoperatively, and there were no significant differences between the groups at any point of evaluation (that is, at 3, 6, 12, and 24 months after surgery). Conclusions Clinical outcomes of 1- and 2-level cervical arthroplasty were similar at 46 months after surgery, and patients in both groups had significantly improved compared with preoperative status. However, there was a significantly higher rate of heterotopic ossification formation and less mobility of the Bryan disc in patients who underwent 2-level arthroplasty. Although mobility to date has been maintained in the vast majority (94.3%) of patients, the long-term effects of heterotopic ossification warrant further investigation.

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BioMime – A Sirolimus-eluting Coronary Stent System for the Treatment of Patients with De Novo Coronary Lesions – meriT-1 Report

Interventional Cardiology Review ◽

10.15420/icr.2011.6.1.39 ◽

2011 ◽

Vol 6 (1) ◽

pp. 39

Author(s):

Keyword(s):

Stent Thrombosis ◽

Time Course ◽

De Novo ◽

Drug Eluting Stent ◽

Cobalt Chromium ◽

Cardiac Events ◽

End Points ◽

Safety And Efficacy ◽

Binary Restenosis

Background:Since the first reported use of percutaneous transluminal coronary angioplasty, advances in the interventional cardiology arena have been fast paced. Developers and clinicians are adapting from the learning curve awarded by the time-course of drug-eluting stent (DES) evolution. BioMime™ sirolimus-eluting stent (SES) is a step towards biomimicry. The stent is built on a strut of ultra-low thickness (65μm), a cobalt–chromium platform using an intelligent hybrid of closed and open cells allowing for morphology-mediated expansion. It employs a well-known antiproliferative – sirolimus – that elutes from a known biodegradable copolymer formulation within 30 days. The resultant stent demonstrates almost 100% endothelialisation at 30 days in preclinical models.Methods:The meriT-1 was a prospective, single-arm, single-centre trial to evaluate the safety and efficacy of BioMime SES in 30 patients with a single de novo lesion in native coronary arteries. The primary safety and efficacy end-points were major adverse cardiac events (MACE) at 30 days and in-stent late lumen loss at eight months, as measured using quantitative coronary angiographic (QCA) method. Secondary safety and efficacy end-points included MACE at one and two years and angiographic binary restenosis at eight-month angiographic follow-up. Other end-points included the occurrence of stent thrombosis at acute, subacute, late and very late periods and the percentage of diameter stenosis by QCA.Results:No MACE were observed and the median in-stent late luminal loss in 20 (67%) subjects studied by QCA was 0.15mm, with 0% binary restenosis at eight-month follow-up. No stent thrombosis was observed up to one-year follow-up.Conclusions:In comparison to currently available DES, BioMime SES appears to have a considerable scientific basis for prevention of neointimal proliferation, restenosis and associated clinical events.

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Serial computed tomography findings of Coronavirus disease 2019 (COVID-19) pneumonia treated with favipiravir and steroid therapy: report of 11 cases

Bulletin of the National Research Centre ◽

10.1186/s42269-021-00553-7 ◽

2021 ◽

Vol 45 (1) ◽

Author(s):

Naoki Irizato ◽

Hiroshi Matsuura ◽

Atsuya Okada ◽

Ken Ueda ◽

Hitoshi Yamamura

Keyword(s):

Computed Tomography ◽

Mechanical Ventilation ◽

Steroid Therapy ◽

Time Course ◽

Ground Glass ◽

Time Points ◽

Ct Findings ◽

Mixed Pattern ◽

Bronchial Dilatation

Abstract Background This study evaluated the time course of computed tomography (CT) findings of patients with COVID-19 pneumonia who required mechanical ventilation and were treated with favipiravir and steroid therapy. Results Eleven patients with severe COVID-19 pneumonia were included. CT findings assessed at the three time points showed that all patients had ground-glass opacities (GGO) and consolidation and mixed pattern at intubation. Consolidation and mixed pattern disappeared in most of the patients whereas GGO persisted in all patients at 1-month follow-up. In addition to GGO, a subpleural line and bronchus distortion and bronchial dilatation were frequent findings. The degree of resolution of GGO varied depending on each patient. The GGO score correlated significantly with the time from symptoms onset to initiation of steroid therapy (ρ = 0.707, p = 0.015). Conclusions At 1-month follow-up after discharge, non-GGO lesions were absorbed almost completely, and GGO were a predominant CT manifestation. Starting steroid therapy earlier after onset of symptoms in severe COVID-19 pneumonia may reduce the extent of GGO at 1-month follow-up.

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The long-term course of fatigue following breast cancer diagnosis

Journal of Patient-Reported Outcomes ◽

10.1186/s41687-020-00187-9 ◽

2020 ◽

Vol 4 (1) ◽

Cited By ~ 1

Author(s):

Karin Biering ◽

Morten Frydenberg ◽

Helle Pappot ◽

Niels Henrik Hjollund

Keyword(s):

Breast Cancer ◽

Time Course ◽

Breast Cancer Diagnosis ◽

Patient Characteristics ◽

Repeated Measurements ◽

Diagnosis And Treatment ◽

Persistent Problem ◽

Treatment Regimens ◽

Long Time

Abstract Purpose Fatigue following breast cancer is a well-known problem, with both high and persistent prevalence. Previous studies suffer from lack of repeated measurements, late recruitment and short periods of follow-up. The course of fatigue from diagnosis and treatment to the long-time outcome status is unknown as well as differences in the level of fatigue between treatment regimens. The purpose of this study was to describe the long-time course of fatigue from the time of clinical suspicion of breast cancer, its dependence of patient characteristics and treatment regimens and the comparison with the course of fatigue among women with the same suspicion, but not diagnosed with breast cancer. Methods Three hundred thirty-two women referred to acute or subacute mammography was followed with questionnaires from before the mammography and up to 1500 days. Fatigue was measured by the Multidimensional Fatigue Inventory (MFI-20). The women reported their initial level of fatigue before the mammography and thus without knowledge of whether they had cancer or not. Both women with and without cancer were followed. Women with cancer were identified in the clinical database established by Danish Breast Cancer Cooperative Group (DBCG) to collect information on treatment regimen. Results Compared to fatigue scores before diagnosis, women with breast cancer reported a large increase of fatigue, especially in the first 6 months, followed by a slow decrease over time. Despite the long follow-up period, the women with breast cancer did not return to their level of fatigue at time of the mammography. Women without breast cancer, experienced a rapid decrease of fatigue after disproval of diagnosis followed by a steadier period. Conclusions Fatigue is a persistent problem in women diagnosed with breast cancer, even several years following diagnosis and treatment. The women with breast cancer were most affected by fatigue in the first 6 months after diagnosis.

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Regression of cephalic index following endoscopic repair of sagittal synostosis

Journal of Neurosurgery Pediatrics ◽

10.3171/2018.7.peds18195 ◽

2019 ◽

Vol 23 (1) ◽

pp. 54-60

Author(s):

Nicholas A. Pickersgill ◽

Gary B. Skolnick ◽

Sybill D. Naidoo ◽

Matthew D. Smyth ◽

Kamlesh B. Patel

Keyword(s):

Time Course ◽

Strong Positive Correlation ◽

Cephalic Index ◽

Sagittal Synostosis ◽

Endoscopic Repair ◽

Future Studies ◽

Helmet Therapy ◽

Significant Regression ◽

Strip Craniectomy

OBJECTIVEMetrics used to quantify preoperative severity and postoperative outcomes for patients with sagittal synostosis include cephalic index (CI), the well-known standard, and the recently described adjusted cephalic index (aCI), which accounts for altered euryon location. This study tracks the time course of these measures following endoscopic repair with orthotic helmet therapy. The authors hypothesize that CI and aCI show significant regression following endoscope-assisted repair.METHODSCT scans or 3D photographs of patients with nonsyndromic sagittal synostosis treated before 6 months of age by endoscope-assisted strip craniectomy and postoperative helmet therapy (n = 41) were reviewed retrospectively at three time points (preoperatively, 0–2 months after helmeting, and > 24 months postoperatively). The CI and aCI were measured at each time point.RESULTSMean CI and aCI increased from 71.8 to 78.2 and 62.7 to 72.4, respectively, during helmet treatment (p < 0.001). At final follow-up, mean CI and aCI had regressed significantly from 78.2 to 76.5 and 72.4 to 69.7, respectively (p < 0.001). The CI regressed in 33 of 41 cases (80%) and aCI in 39 of 41 cases (95%). The authors observed a mean loss of 31% of improvement in aCI achieved through treatment. A strong, positive correlation existed between CI and aCI (R = 0.88).CONCLUSIONSRegression following endoscope-assisted strip craniectomy with postoperative helmet therapy commonly occurs in patients with sagittal synostosis. Future studies are required to determine whether duration of helmet therapy or modifications in helmet design affect regression.

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