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1.
J Voice ; 37(4): 633.e1-633.e6, 2023 Jul.
Article in English | MEDLINE | ID: mdl-34024697

ABSTRACT

OBJECTIVE: In a postlaryngectomy patient, tracheoesophageal (TE) speech is considered to be the most effective and preferred method of communication. Previous research has demonstrated that despite an appropriately sized TE prosthesis placement at the time of puncture, there are a portion of patients that require resizing postoperatively. The purpose of this study was to report on the variability of the tracheoesophageal prosthesis length. STUDY DESIGN: Retrospective chart review. SETTING: Tertiary care academic medical center. METHODS: This was a retrospective chart review of 62 patients who underwent secondary tracheoesophageal puncture (TEP) at a tertiary care academic medical center from January 2008 to November 2019. Patient demographic information, average changes in prosthesis length, number of prosthesis adjustments, and timing of prosthesis exchanges were collected. RESULTS: 62 patients met criteria for study inclusion. Mean age was 61.96 years old with 49 being male (79%) and 13 (21%) females. Overall change in prosthesis length was - 3.85 mm ± 3.58 with time to first prosthesis change at 2.29 months ± 2.73. There was an average of 4.37 changes ± 3.43 before reaching a stable length. Twenty-six patients (41.9%) had increases in their prosthesis length resulting in closure of the tracheoesophageal fistula requiring seven patients (11.3%) to return to the operating room for repuncturing. History of smoking (P = 0.02), Blom-Singer prosthesis type (P = 0.03), and larger diameter (P = 0.01) appeared to be predisposing factors for a fluctuating prosthesis length. CONCLUSION: Tracheoesophageal prosthesis length decreases over time for secondary punctures, requiring adjustments with a speech language pathologist. There are a clinically significant portion that have fluctuations in prosthesis length resulting in an increased risk for requiring re-puncturing.


Subject(s)
Prostheses and Implants , Trachea , Female , Humans , Male , Middle Aged , Laryngectomy/rehabilitation , Retrospective Studies , Trachea/anatomy & histology , Trachea/surgery , Treatment Outcome , Prosthesis Fitting/statistics & numerical data , Tracheoesophageal Fistula/surgery , Adult , Aged , Aged, 80 and over , Prostheses and Implants/statistics & numerical data , Risk Factors
2.
São Paulo; s.n; 2023. 25 p.
Thesis in Portuguese | Coleciona SUS, Sec. Munic. Saúde SP, HSPM-Producao, Sec. Munic. Saúde SP | ID: biblio-1531295

ABSTRACT

Introdução: Com o passar dos anos a técnica de mamoplastia de aumento foi sendo aprimorada. Novos instrumentos para auxílio cirúrgico foram adicionados, incluindo o uso de afastadores luminosos para produção de túneis subcutâneos e descolamento subglandular ou retromuscular. Por essa técnica, em um só estágio, é possível obter o formato, volume e simetria adequada das mamas, assim como correção da flacidez abdominal, com cicatriz localizada apenas no abdome. Objetivo: Demonstrar a experiência do Serviço de Cirurgia Plástica do Hospital do Servidor Público Municipal de São Paulo com a técnica cirúrgica de inclusão dos implantes mamários através da dermolipectomia abdominal. Método: Foram selecionados prontuários de pacientes operadas entre março de 2011 e novembro de 2021 que foram submetidas à inclusão dos implantes mamários através da abdominoplastia. Resultados: A amostra deste estudo foi constituída por 24 pacientes do sexo feminino, com média de idade de 37,6 ± 8,1 anos, e IMC médio de 23,5 ± 2,0 kg/m2, todas submetidas à abdominoplastia concomitantemente ao aumento das mamas. Em média, foram colocadas próteses no volume de 293,5 ± 32,2 ml e o peso dos retalhos uma média de 734,2 ± 320,0 g. A duração média das cirurgias foi de 205,9 ± 34 minutos. Avaliando as complicações relacionadas aos procedimentos, deiscência associada à cicatriz hipertrófica foi observada em 3 pacientes (12,5%), contratura capsular em 3 (12,5%), formação de queloide em 2 (8%), ruptura de prótese em 1 (4%), granuloma na cicatriz em 1 (4%), seroma em 1 (4%), e rippling associado à ptose de grau I em 1 (4%). Conclusão: Este levantamento pontual demonstrou que a inclusão dos implantes mamários através da dermolipectomia abdominal traz excelentes resultados, eliminando as cicatrizes mamárias e com baixa taxa de complicações. Palavras-chave: Cirurgia plástica. Implantes de mama. Mamoplastia. Abdominoplastia. Procedimentos de Cirurgia Plástica.


Subject(s)
Humans , Female , Adult , Middle Aged , Prostheses and Implants/statistics & numerical data , Rupture/surgery , Cicatrix/surgery , Cicatrix, Hypertrophic/surgery , Breast Implants/statistics & numerical data , Contracture/surgery , Plastic Surgery Procedures/methods , Seroma/surgery , Abdominoplasty/methods , Granuloma/surgery , Keloid/surgery
3.
Molecules ; 27(3)2022 Jan 18.
Article in English | MEDLINE | ID: mdl-35163869

ABSTRACT

This prospective clinical study aimed to evaluate the peri-implant hard tissue dimensional change at 6 months of immediate implant placement with bone graft materials in the posterior area using cone-beam computed tomography (CBCT). Twelve dental implants were placed concurrently following tooth extraction in the posterior area and filled with xenograft particles. The CBCT images were taken immediately after surgical procedures and then at 6 months follow-up. To evaluate the hard tissue changes, the vertical and horizontal bone thickness were analyzed and measured using ImageJ software. Paired t-test or Wilcoxon match-pair signed-rank test was done to analyze the changes of hard tissue values at the same level between immediately and 6 months following immediate implant placement. Independent t-test or Mann-Whitney U test was used to analyze the dimensional change in the vertical and horizontal direction in buccal and lingual aspects. The level of significance was set at p value = 0.05. All implants were successfully osseointegrated. At 6 months follow-up, the vertical bone change at the buccal aspect was -0.69 mm and at the lingual aspect -0.39 mm. For horizontal bone thickness, the bone dimensional changes at 0, 1, 5, and 9 mm levels from the implant platform were -0.62 mm, -0.70 mm, -0.24 mm, and -0.22 mm, respectively. A significant bone reduction was observed in all measurement levels during the 6 months after implant placement (p value < 0.05). It was noted that even with bone grafting, a decrease in bone thickness was seen following the immediate implant placement. Therefore, this technique can be an alternative method to place the implant in the posterior area.


Subject(s)
Bone Regeneration , Bone Transplantation/methods , Bone and Bones/cytology , Cone-Beam Computed Tomography/methods , Dental Restoration Repair/methods , Prostheses and Implants/statistics & numerical data , Tooth Attrition/therapy , Adult , Aged , Bone and Bones/diagnostic imaging , Dental Caries/therapy , Humans , Image Processing, Computer-Assisted/methods , Middle Aged , Prospective Studies , Tooth, Nonvital/therapy
4.
BMC Cancer ; 21(1): 986, 2021 Sep 03.
Article in English | MEDLINE | ID: mdl-34479488

ABSTRACT

BACKGROUND: Prosthesis-related complications, after knee reconstruction with endoprosthesis during operation for tumors around the knee, remain an unresolved problem which necessitate a revision or even an amputational surgery. The purpose of the current study was to identify significant risk factors associated with implant failure, and establish a novel model to predict survival of the prosthesis in patients operated with endoprostheses for tumor around knee. METHODS: We retrospectively reviewed the clinical database of our institution for patients who underwent knee reconstruction due to tumors. A total of 203 patients were included, including 123 males (60.6%) and 80 (39.4%) females, ranging in age from 14 to 77 years (mean: 34.3 ± 17.3 years). The cohort was randomly divided into training (n = 156) and validation (n = 47) samples. Univariable COX analysis was used for initially identifying potential independent predictors of prosthesis survival with the training group (p < 0.150). Multivariate COX proportional hazard model was selected to identify final significant prognostic factors. Using these significant predictors, a graphic nomogram, and an online dynamic nomogram were generated for predicting the prosthetic survival. C-index and calibration curve were used for evaluate the discrimination ability and accuracy of the novel model, both in the training and validation groups. RESULTS: The 1-, 5-, and 10-year prosthetic survival rates were 94.0, 90.8, and 83.0% in training sample, and 96.7, 85.8, and 76.9% in validation sample, respectively. Anatomic sites, length of resection and length of prosthetic stem were independently associated with the prosthetic failure according to multivariate COX regression model (p<0.05). Using these three significant predictors, a graphical nomogram and an online dynamic nomogram model were generated. The C-indexes in training and validation groups were 0.717 and 0.726 respectively, demonstrating favourable discrimination ability of the novel model. And the calibration curve at each time point showed favorable consistency between the predicted and actual survival rates in training and validation samples. CONCLUSIONS: The length of resection, anatomical location of tumor, and length of prosthetic stem were significantly associated with prosthetic survival in patients operated for tumor around knee. A user-friendly novel online model model, with favorable discrimination ability and accuracy, was generated to help surgeons predict the survival of the prosthesis.


Subject(s)
Knee Prosthesis/statistics & numerical data , Neoplasms/surgery , Nomograms , Plastic Surgery Procedures/methods , Prostheses and Implants/statistics & numerical data , Prosthesis Failure/trends , Adolescent , Adult , Aged , Female , Follow-Up Studies , Humans , Male , Middle Aged , Neoplasms/pathology , Prognosis , Retrospective Studies , Risk Factors , Young Adult
5.
Proc Natl Acad Sci U S A ; 118(30)2021 07 27.
Article in English | MEDLINE | ID: mdl-34301889

ABSTRACT

Wireless, battery-free, and fully subdermally implantable optogenetic tools are poised to transform neurobiological research in freely moving animals. Current-generation wireless devices are sufficiently small, thin, and light for subdermal implantation, offering some advantages over tethered methods for naturalistic behavior. Yet current devices using wireless power delivery require invasive stimulus delivery, penetrating the skull and disrupting the blood-brain barrier. This can cause tissue displacement, neuronal damage, and scarring. Power delivery constraints also sharply curtail operational arena size. Here, we implement highly miniaturized, capacitive power storage on the platform of wireless subdermal implants. With approaches to digitally manage power delivery to optoelectronic components, we enable two classes of applications: transcranial optogenetic activation millimeters into the brain (validated using motor cortex stimulation to induce turning behaviors) and wireless optogenetics in arenas of more than 1 m2 in size. This methodology allows for previously impossible behavioral experiments leveraging the modern optogenetic toolkit.


Subject(s)
Brain/physiology , Optogenetics , Prostheses and Implants/statistics & numerical data , Transcranial Direct Current Stimulation/instrumentation , Wireless Technology/instrumentation , Animals , Mice , Mice, Inbred C57BL
6.
Sci Rep ; 11(1): 8469, 2021 04 19.
Article in English | MEDLINE | ID: mdl-33875672

ABSTRACT

Palatal defects are rehabilitated by fabricating maxillofacial prostheses called obturators. The treatment incorporates taking deviously unpredictable impressions to facsimile the palatal defects into plaster casts for obturator fabrication in the dental laboratory. The casts are then digitally stored using expensive hardware to prevent physical damage or data loss and, when required, future obturators are digitally designed, and 3D printed. Our objective was to construct and validate an economic in-house smartphone-integrated stereophotogrammetry (SPINS) 3D scanner and to evaluate its accuracy in designing prosthetics using open source/free (OS/F) digital pipeline. Palatal defect models were scanned using SPINS and its accuracy was compared against the standard laser scanner for virtual area and volumetric parameters. SPINS derived 3D models were then used to design obturators by using (OS/F) software. The resultant obturators were virtually compared against standard medical software designs. There were no significant differences in any of the virtual parameters when evaluating the accuracy of both SPINS, as well as OS/F derived obturators. However, limitations in the design process resulted in minimal dissimilarities. With further improvements, SPINS based prosthetic rehabilitation could create a viable, low cost method for rural and developing health services to embrace maxillofacial record keeping and digitised prosthetic rehabilitation.


Subject(s)
Imaging, Three-Dimensional/methods , Mouth Diseases/rehabilitation , Palate/surgery , Photogrammetry/methods , Prostheses and Implants/statistics & numerical data , Smartphone/statistics & numerical data , Computer-Aided Design , Humans , Workflow
7.
Dis Colon Rectum ; 64(4): 466-474, 2021 04 01.
Article in English | MEDLINE | ID: mdl-33399411

ABSTRACT

BACKGROUND: Anal inserts and percutaneous tibial nerve stimulation may be offered to those with fecal incontinence in whom other conservative treatments have failed. OBJECTIVE: We aimed to compare anal inserts and percutaneous tibial nerve stimulation. DESIGN: This was an investigator-blinded randomized pilot study. SETTINGS: The study was conducted at a large tertiary care hospital. PATIENTS: Adult patients with passive or mixed fecal incontinence were recruited. INTERVENTIONS: Patients were randomly assigned to receive either the anal inserts or weekly percutaneous tibial nerve stimulation for a period of 3 months. MAIN OUTCOME MEASURES: The primary end point was a 50% reduction of episodes of fecal incontinence per week as calculated by a prospectively completed 2-week bowel diary. Secondary end points were St Mark's incontinence score, International Consultation on Incontinence Questionnaire-Bowel scores (for bowel pattern, bowel control, and quality of life), use of antidiarrheal agents, estimates of comfort and acceptability. RESULTS: Fifty patients were recruited: 25 were randomly assigned to anal inserts and 25 were randomly assigned to percutaneous tibial nerve stimulation. All completed treatment. A significant improvement of scores in the 2-week bowel diary, the St Mark's scores and the International Consultation on Incontinence Questionnaire-Bowel scores, was seen in both groups after 3 months of treatment. A reduction of ≥50% fecal incontinence episodes was reached by 76% (n = 19/25) by the anal insert group, compared with 48% (n = 12/25) of those in the percutaneous tibial nerve stimulation group (p = 0.04). The St Mark's fecal incontinence scores and the International Consultation on Incontinence Questionnaire-Bowel scores for bowel pattern, bowel control, and quality of life (p = 0.01) suggest similar improvement for each group. LIMITATIONS: A realistic sample size calculation could not be performed because of the paucity of objective prospective studies assessing the effect of the insert device and percutaneous tibial nerve stimulation. CONCLUSIONS: Both anal insert and percutaneous tibial nerve stimulation improved the symptoms of fecal incontinence after 3 months of treatment. The insert device appeared to be more effective than percutaneous tibial nerve stimulation. Larger studies are needed to investigate this further. See Video Abstract at http://links.lww.com/DCR/B460. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov No. NCT04273009. ESTUDIO PILOTO ALEATORIZADO DE INSERCIONES ANALES CONTRA LA ESTIMULACIN PERCUTNEA DEL NERVIO TIBIAL EN PACIENTES CON INCONTINENCIA FECAL: ANTECEDENTES:Las inserciones anales y la estimulación percutánea del nervio tibial (PTNS) se pueden ofrecer a las personas con incontinencia fecal que han fallado en otros tratamientos conservadores.OBJETIVO:Nuestro objetivo fue comparar inserciones anales y estimulación percutánea del nervio tibial.DISEÑO:Este fue un estudio piloto aleatorio ciego para investigadores.AJUSTE:El estudio se realizó en un hospital de atención terciaria.PACIENTES:Se reclutaron pacientes adultos con incontinencia fecal pasiva o mixta.INTERVENCIONES:Los pacientes fueron asignados al azar para recibir inserciones anales o estimulación del nervio tibial percutáneo semanal durante un período de tres meses.PRINCIPALES MEDIDAS DE RESULTADO:El principal resultado fue una reducción del 50% de los episodios de incontinencia fecal por semana, según lo calculado mediante un diario intestinal de dos semanas completado de forma prospectiva. Los criterios de valoración secundarios fueron la puntuación de incontinencia de St Mark, las puntuaciones del ICIQ-B (para patrón intestinal, control intestinal y calidad de vida), uso de agentes antidiarreicos, estimaciones de comodidad y aceptabilidad.RESULTADOS:Se reclutaron 50 pacientes: 25 fueron asignados al azar a inserciones anales y 25 a PTNS. Todo el tratamiento completado. Se observó una mejora significativa de las puntuaciones en el diario intestinal de dos semanas, la puntuación de St Mark y la puntuación del ICIQ-B en ambos grupos después de 3 meses de tratamiento. Se alcanzó una reducción de ≥ 50% de los episodios de incontinencia fecal en un 76% (n = 19/25) en el grupo de inserción anal, en comparación con el 48% (n = 12/25) de los del grupo de estimulación percutánea del nervio tibial (p = 0,04). Las puntuaciones de incontinencia fecal de St Mark, las puntuaciones del ICIQ-B para el patrón intestinal, el control intestinal y la calidad de vida (p = 0,01) sugieren una mejora similar para cada grupo.LIMITACIONES:No se pudo realizar un cálculo realista del tamaño de la muestra debido a la escasez de estudios prospectivos objetivos que evaluaran el efecto del dispositivo de inserción y la estimulación percutánea del nervio tibial.CONCLUSIONES:Tanto la inserción anal como la estimulación percutánea del nervio tibial mejoraron los síntomas de incontinencia fecal después de 3 meses de tratamiento. El dispositivo de inserción parecia ser más efectivo que la estimulación percutánea del nervio tibial. Se necesitan estudios más amplios para investigar esto más a fondo. Consulte Video Resumen en http://links.lww.com/DCR/B460.NÚMERO DE REGISTRO DE PRUEBA:Clinicaltrials.gov No. NCT04273009.


Subject(s)
Fecal Incontinence/prevention & control , Prosthesis Implantation/instrumentation , Tibial Nerve/physiology , Transcutaneous Electric Nerve Stimulation/methods , Adult , Aged , Case-Control Studies , Fecal Incontinence/therapy , Female , Humans , Male , Middle Aged , Pilot Projects , Prostheses and Implants/adverse effects , Prostheses and Implants/statistics & numerical data , Prosthesis Design/trends , Prosthesis Implantation/methods , Prosthesis Implantation/statistics & numerical data , Quality of Life , Silicones/adverse effects , Surveys and Questionnaires , Transcutaneous Electric Nerve Stimulation/statistics & numerical data , Treatment Outcome
8.
BJU Int ; 127(3): 326-331, 2021 03.
Article in English | MEDLINE | ID: mdl-32869902

ABSTRACT

OBJECTIVES: To undertake a prospective multicentre national audit of penile prosthesis practice in the UK over a 3-year period. PATIENTS AND METHODS: Data were submitted by urological surgeons as part of the British Association of Urological Surgeons Penile Prosthesis National Audit. Patients receiving a penile prosthesis (inflatable or malleable) were included as part of a prospective registry over a 3-year period. Data were validated and then analysed using a software package (Tableau). RESULTS: A total of 1071 penile prosthesis procedures were included from 22 centres. The three commonest aetiological factors for erectile dysfunction were diabetes, prostate surgery and Peyronie's disease. Of the recorded data, inflatable penile prostheses were the commonest devices implanted, with 665 devices used (62.1%), whereas malleable prostheses accounted for 14.2% of the implants. Recorded intra-operative complications included urethral injury (0.7%, n = 7), corporal perforation (1.1%, n = 12) and cross-over (0.6%, n = 6). Known postoperative complications were recorded in 9.8% of patients (74/752), with the two most frequently reported being postoperative penile pain (n = 11) and scrotal haematoma (n = 14). CONCLUSION: This baseline analysis is the largest prospective registry of penile prostheses procedures to date. The data show that, over the 3-year collection period in the UK, there are now fewer surgeons performing the procedure, together with a reduction in the number of centres. Peri-operative complications were infrequent, and the rate of implant abortion (e.g. as a result of urethral injury) was very low. Further follow-up data will be required to publish long-term outcomes and patient satisfaction.


Subject(s)
Erectile Dysfunction/surgery , Hematoma/etiology , Prostheses and Implants/statistics & numerical data , Prosthesis Implantation/statistics & numerical data , Scrotum , Adolescent , Adult , Aged , Aged, 80 and over , Anti-Bacterial Agents/therapeutic use , Antibiotic Prophylaxis/statistics & numerical data , Diabetes Complications/complications , Erectile Dysfunction/etiology , Humans , Intraoperative Complications/etiology , Male , Middle Aged , Pain, Postoperative/etiology , Penile Induration/surgery , Prospective Studies , Prostatectomy/adverse effects , Prostheses and Implants/adverse effects , Prosthesis Implantation/adverse effects , Registries , United Kingdom , Urethra/injuries , Urologists/statistics & numerical data , Young Adult
9.
Adv Wound Care (New Rochelle) ; 10(12): 671-684, 2021 12.
Article in English | MEDLINE | ID: mdl-32320367

ABSTRACT

Significance: The intent of this work was to summarize the existing evidence of, and highlight knowledge gaps specific to, prosthetic devices/componentry and training regimes, particularly in the context of the human-device interaction and deleterious musculoskeletal conditions secondary to lower limb loss. Recent Advances: With the recent and evolving technological advancements in prostheses, there are numerous devices available to individuals with lower limb loss. Current literature demonstrates the importance of expanding the knowledge of all prosthetic device-specific factors and the significance of proper prescription, fit, and alignment, along with adequate device-/activity-specific training, to enhance human-device interaction, reduce gait abnormalities and compensatory motions, and as a result, mitigate risk for secondary musculoskeletal conditions. Critical Issues: Inadequate device prescription, fit, alignment, and training are evident owing to the lack of knowledge or awareness of the many device-specific properties and factors, leading to suboptimal use, as well as, biomechanical compensations, which collectively and adversely affect the function, activity level, and overall health of the prosthesis user. Future Directions: To maximize optimal outcomes after lower limb loss, it is essential to better appreciate the factors that affect both prosthesis use and satisfaction, particularly any modifiable factors that might be targeted in rehabilitation interventions such as device prescription, fit/alignment, and training regimes. A better understanding of such device-specific factors will help enhance the human-device interaction and resulting functional performance, thereby reducing secondary musculoskeletal conditions, allowing for the readiness of the fighting force (return-to-duty/redeployment) and/or improved reintegration into civilian society/work, and overall enhancing quality of life after lower limb loss.


Subject(s)
Amputation, Surgical/rehabilitation , Amputees/rehabilitation , Lower Extremity/injuries , Prostheses and Implants/statistics & numerical data , Amputation, Surgical/adverse effects , Humans , Musculoskeletal Diseases/etiology , Musculoskeletal Diseases/rehabilitation , Quality of Life
10.
Surg Oncol ; 36: 56-60, 2021 Mar.
Article in English | MEDLINE | ID: mdl-33310675

ABSTRACT

PURPOSE: While limb-sparing surgery is now possible for more than 80% of patients with bone tumours, wide resection is often required, necessitating bone reconstruction. This paper aims to present a surgical technique that combines the advantages of a hollow, titanium, custom-made prosthesis and the biological aspects of microsurgical flaps and bone graft. PATIENTS AND METHODS: From June 2016 to September 2017 at our institution, six consecutive patients with skeletal tumours underwent one-stage reconstructive surgery with concomitant implantation of a 3D-printed prosthesis. RESULTS: At an average follow-up of 30 months (range: 18-45), no early complications were observed, and no implant removals were needed. One patient experienced a delayed haematogenous deep infection, which healed after surgical debridement. Three patients died of their underlying disease 18, 22, and 23 months after surgery, respectively. All flaps and custom reconstructions were successful, with primary osseointegration at a mean of four months (range: 2-7). Patients' average Musculoskeletal Tumour Society score was 23.2 (range: 18-28). CONCLUSION: A hollow, custom-made, titanium prosthesis filled with bone graft, used in conjunction with a microsurgical flap, may offer good osseointegration in different anatomic locations among a patient population with a high risk of infection, pseudarthrosis, and long-term mechanical complications. The surgical technique's advantages are preliminarily demonstrated. Further studies with longer follow-up periods and larger sample sizes are required to confirm our findings.


Subject(s)
Bone Neoplasms/surgery , Bone Transplantation/methods , Plastic Surgery Procedures/methods , Prostheses and Implants/statistics & numerical data , Surgical Flaps/transplantation , Adolescent , Adult , Bone Neoplasms/pathology , Child , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prognosis , Retrospective Studies , Young Adult
11.
J Pediatr Orthop ; 41(3): e204-e210, 2021 Mar 01.
Article in English | MEDLINE | ID: mdl-33370003

ABSTRACT

BACKGROUND: There are few reports on the surgical management of early-onset scoliosis (EOS) associated with Marfan syndrome (MFS). Affected patients tend to have more rapid curve progression than those with idiopathic EOS, and their course is further complicated by medical comorbidities. As surgical techniques and implants for growing spines become more widely applied, this study seeks to better delineate the safety and efficacy of growth-friendly spinal instrumentation in treating this population. METHODS: A prospective registry of children treated for EOS was queried for MFS patients treated between 1996 and 2016. Forty-two patients underwent rib-based or spine-based growing instrumentation and were assessed on preoperative, surgical, and postoperative clinical and radiographic parameters including complications and reoperations. Subgroup analysis was performed based on spine-based versus rib-based fixation. RESULTS: Patients underwent their index surgery at a mean age of 5.5 years, when the major coronal curve and kyphosis measured 77 and 50 degrees, respectively. Over half were treated with traditional growing rods. Patients underwent 7.2 total surgical procedures-4.7 lengthening and 1.9 revision surgeries not including conversion to fusion-over a follow-up of 6.5 (±4.1) years. Radiographic correction was greatest at index surgery but maintained over time, with a final thoracic height measuring 23.8 cm. Patients experienced a mean of 2.6 complications over the course of the study period; however, a small group of 6 patients experienced ≥6 complications while over half of patients experienced 0 or 1. Implant failures represented 42% of all complications with infection and pulmonary complications following. CONCLUSIONS: This is the largest report on patients with EOS and MFS. All subtypes of growth-friendly constructs reduced curve progression in this cohort, but complications and reoperations were nearly universal; patients were particularly plagued by implant failure and migration. Further collaborations are needed to enhance understanding of optimal timing and fixation constructs for those with MFS and other connective tissue diseases.


Subject(s)
Marfan Syndrome/surgery , Orthopedic Procedures/instrumentation , Prostheses and Implants/statistics & numerical data , Scoliosis/surgery , Thoracic Vertebrae/surgery , Adolescent , Child , Child, Preschool , Disease Progression , Female , Humans , Infant , Kyphosis/etiology , Kyphosis/surgery , Male , Marfan Syndrome/complications , Orthopedic Procedures/statistics & numerical data , Prostheses and Implants/adverse effects , Reoperation , Retrospective Studies , Scoliosis/etiology , Spinal Fusion , Treatment Outcome
12.
Prostate Cancer Prostatic Dis ; 24(2): 349-357, 2021 06.
Article in English | MEDLINE | ID: mdl-33005003

ABSTRACT

BACKGROUND: To report the 3-year results of a prospective, single arm, multicenter, international clinical study with the second generation of the temporary implantable nitinol device (iTIND; Medi-Tate Ltd®, Israel) on men suffering lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO). METHODS: Eighty-one men with symptomatic BPO (IPSS ≥ 10, peak urinary flow <12 ml/s, and prostate volume <75 ml) were enrolled in this study between December 2014 and December 2016. Subjects were washed-out 1 month for alpha-blockers and 6 months for 5-ARIs. The implantation was performed under light sedation and the removal 5-7 days later with topical anesthesia. Perioperative results including OR-time, pain (VAS) postoperative complications (Clavien-Dindo-Grading System), functional results (Qmax, IPSS, PVR) and quality of life (QoL) were assessed at 1, 3, 6 months, 1, 2, and 3 years. Sexual and ejaculatory function were evaluated using two yes/no questions. RESULTS: Thirty-six month functional results were available for 50 patients and demonstrated that iTIND efficacy remained stable through 3 years, with averages IPSS, QOL, Qmax and PVR of 8.55 + 6.38, 1.76 + 1.32, 15.2 + 6.59 ml/s and 9.38 + 17.4 ml, improved from baseline by -58.2, -55.6, +114.7, and -85.4% (all significantly different from their corresponding baseline values, p < 0.0001). Even considering the Intention to Treat analysis (ITT), the 36-month results confirmed significant improvements of the functional outcomes if compared with baselines values (all p < 0.0001). No late post-operative complications were observed between 12 and 36 months. Sexual function was stable through 3 years, with no reports of sexual or ejaculatory dysfunctions. No patients underwent alternative treatments between 24 and 36 months. CONCLUSION: Treatment of BPO-related LUTS with iTIND demonstrated a significant and durable reduction in symptoms and improvement of functional parameters and quality of life at 3 years of follow-up. No late post-operative complications, ejaculatory dysfunction or additional treatment failures were observed between 24 and 36 months.


Subject(s)
Alloys/chemistry , Lower Urinary Tract Symptoms/surgery , Prostatic Hyperplasia/complications , Prostatic Neoplasms/complications , Prostheses and Implants/statistics & numerical data , Quality of Life , Aged , Aged, 80 and over , Follow-Up Studies , Humans , Lower Urinary Tract Symptoms/etiology , Lower Urinary Tract Symptoms/pathology , Male , Middle Aged , Prognosis , Prospective Studies
13.
J Laryngol Otol ; 134(12): 1065-1068, 2020 Dec.
Article in English | MEDLINE | ID: mdl-33336637

ABSTRACT

OBJECTIVE: This study aimed to evaluate surgical and functional outcomes, in a tertiary referral centre, of two different types of semi-implantable transcutaneous bone conduction devices. METHOD: This study involved prospective data collection and review of patients implanted between November 2014 and December 2016. Glasgow Hearing Aid Inventory (Glasgow Hearing Aid Benefit Profile or Glasgow Hearing Aid Difference Profile) and Client Oriented Scale of Improvement were completed where appropriate. Surgical and audiological outcomes were recorded in the surgical notes. RESULTS: Glasgow Hearing Aid Difference Profile and Glasgow Hearing Aid Benefit Profile showed similar mean score in the active and the passive transcutaneous bone conduction devices. Client Oriented Scale of Improvement showed improvements in listening situations. Post-operative speech reception threshold showed better mean threshold in the active transcutaneous bone conduction devices group when compared with the passive transcutaneous bone conduction devices group. No device failures or surgical complications existed in either group, with the surgical time being less in the passive transcutaneous bone conduction devices group. CONCLUSION: Both devices are reliable semi-implantable transcutaneous bone conduction devices with excellent surgical and functional outcomes and patient satisfaction. Overall surgical time was much less in the passive transcutaneous bone conduction devices group with no necessity for pre-planning. This is much easier to remove with the possibility of conversion to other devices in the manufacturer's portfolio and wide-ranging wireless accessories. Further studies are needed to assess the longer-term results in a bigger population.


Subject(s)
Bone Conduction/physiology , Hearing Aids/statistics & numerical data , Hearing Loss, Conductive/surgery , Prostheses and Implants/statistics & numerical data , Hearing Tests/methods , Humans , Middle Aged , Operative Time , Patient Satisfaction , Postoperative Period , Prospective Studies , Prostheses and Implants/trends , Retrospective Studies , Speech Reception Threshold Test/methods , Treatment Outcome
14.
Cir. plást. ibero-latinoam ; 46(4): 411-420, oct.-dic. 2020. tab, graf
Article in Spanish | IBECS | ID: ibc-198724

ABSTRACT

INTRODUCCIÓN Y OBJETIVO: Últimamente ha surgido gran controversia sobre diversos aspectos de los implantes mamarios. De hecho, la posible relación entre la texturación del implante y el linfoma anaplásico de células grandes llevó a la retirada voluntaria del mercado de los implantes con cubierta Biocell(R) de Allergan en julio de 2019. El propósito principal de este estudio fue evaluar las preferencias y prácticas habituales de los miembros de la Asociación Española de Cirugía Plástica Estética (AECEP) con respecto a la cirugía con implantes mamarios. Además, analizamos los cambios en la práctica clínica experimentados desde la encuesta publicada en 2016. MATERIAL Y MÉTODO: Llevamos a cabo una encuesta con 15 preguntas relativas a la selección y diferentes aspectos clínicos relacionados con el aumento mamario, en diciembre del año 2019 entre los miembros de la AECEP. Por otro lado, hacemos un estudio comparativo entre los datos actuales y los obtenidos en la encuesta publicada en el año 2017. RESULTADOS: Los 146 miembros de la AECEP recibieron una invitación a participar en la encuesta, de los cuales respondieron 74 (50.7%). De las respuestas obtenidas, 50 (67.6%) correspondieron a hombres. El 89.2% (n=66) tenían una experiencia profesional superior a 10 años y un 70.2% (n=52) tenían una edad comprendida entre los 46 y los 65 años. Respecto al tipo de implante, un 52.7% (n=39) mostró preferencia por los implantes microtexturizados redondos y un 47.3% (n=35) prefirió los microtexturizados anatómicos. En comparación con la encuesta del 2017, una proporción significativamente mayor de participantes prefirió los implantes microtexturizados redondos y microtexturizados anatómicos (p = 0.0025 y p = 0.0015 respectivamente). Por el contrario, una proporción significativamente menor prefirió el uso de implantes macrotexturizados redondos (p = 0.0018) y macrotexturizados anatómicos (p < 0.0001). El plano submuscular fue de elección para el 44.6% de los participantes (n=33). La contractura capsular grado III/IV fue la principal indicación de capsulectomia total para el 94.5% (n=70). La mayor parte fueron partidarios de una actitud vigilante en pacientes con implantes con cubierta Biocell(R) (n=68, 93.1%). El 85.1% (n=63) recomendó vigilancia con técnicas de imagen y sólo 19 participantes (25.7%) fueron partidarios de prohibir el uso de implantes macrotexturizados. CONCLUSIONES: Los resultados de esta encuesta muestran un cambio significativo en la práctica clínica habitual de los encuestados. Respecto a 2017 se ha producido un incremento significativo en el uso de implantes mamarios lisos/nanotexturizados y microtexturizados, mientras que se ha reducido, de forma significativa, el uso de implantes mamarios macrotexturizados


BACKGROUND AND OBJECTIVE: Over the last several years there has been great controversy about different aspects related to breast implants. In fact, the potential relationship between implant texture and anaplastic large cell lymphoma led to the voluntary recall of Biocell(R) coated implants (Allergan(R)) in July 2019. The main purpose of this study was to evaluate the preferences and daily practice of members of Spanish Association of Aesthetic Plastic Surgery (AECEP) regarding to breast implant surgery. Additionally, we assessed possible changes experienced in clinical practice since our survey published in 2017. METHODS: A 15 questions survey, regarding to the selection and different clinical aspects related to breast augmentation, was carried out between January and March 2019 among AECEP members. In addition, a comparative study between current data and those reported in 2017 survey was conducted. RESULTS: The 146 members of the AECEP received an invitation to participate in the survey, of whom 74 (50.7%) responded to it. Of the responses obtained, 67.6% (n=50) corresponded to men, 89.2% (n=66) had more than 10 years of professional experience and 70.2% (n=52) had an age between 46 and 65 years. Regarding the type of implant, 52.7% (n=39) showed a preference for round microtextured implants and 47.3% (n=35) preferred anatomical microtextured implants. Compared to the 2017 survey, a significantly greater proportion of participants preferred round microtextured and anatomical microtextured implants (p = 0.0025 and p = 0.0015, respectively). In contrast, a significantly lower proportion preferred the use of round macrotextured implants (p = 0.0018) and anatomical macrotextured ones (p <0.0001). The submuscular plane was of choice for 44.6% (n=33). Grade III / IV capsular contracture was the main indication for total capsulectomy for 94.5% (n=70). Most of participants ( 93.1%, n=68) were in favor of a vigilant attitude in patients with Biocell(R)-coated implants. 85.1% (n=63) recommended surveillance with imaging techniques and only 25.7% (n=19) thought that the use of macro-textured implants must be prohibited. CONCLUSIONS: The results of this survey showed a significant change in the current clinical practices among the participants. Comparing with 2017 survey, there has been a significant increase in the use of smooth / nano-textured and microtextured breast implants, while the use of macro-textured breast implants has been significantly reduced


Subject(s)
Humans , Male , Female , Middle Aged , Aged , Breast Implants/classification , Breast Implants/statistics & numerical data , Societies, Medical/statistics & numerical data , Prostheses and Implants/classification , Perception , Surveys and Questionnaires , Cross-Sectional Studies , Confidence Intervals , Prostheses and Implants/statistics & numerical data , Postoperative Complications , Surgeons/statistics & numerical data
15.
Eur J Med Res ; 25(1): 25, 2020 Jun 29.
Article in English | MEDLINE | ID: mdl-32600384

ABSTRACT

BACKGROUND: Detection of atrial fibrillation (AF) after cryptogenic stroke (CS) has therapeutic implications, but the most effective type and optimal duration of monitoring have still to be defined. This study that involved patients with CS or transient ischemic attack (TIA), all of whom carried an implantable cardiac monitor (ICM), sought to assess the incidence of AF and other arrhythmia detected using tele-monitoring or interval-based follow-up by an internal cardiologist at the university medical center of Rostock (UMR) or an external cardiologist. METHODS: The ICM implantation was performed during the inpatient stay in the neurology department, with inclusion and exclusion criteria jointly determined by the neurology and cardiology departments. Cardiologists programmed individual threshold values during ICM implantation, which were designed to instantly trigger an episode being recording and an alarm message being sent out. Outpatient care consisted of tele-monitoring of implants or interval-based follow-up care. RESULTS: The indication for ICM implantation was made for 102 patients, 88 of whom underwent ICM implantation, with full documentation available for these 88 study patients. Within a median observation period of 21.5 months, AF occurred in 19 patients, with a median observation time to the event of 7 months. In all cases, AF detection was followed by immediate medical intervention. Comparing patients with and without AF revealed that the median age of the AF group exceeded by 10 years that of the other patients. Stroke recurrence was recorded in five patients, with a median observation time to the event of 9 months. Comparing patients with and without stroke recurrence revealed that the median age in the stroke recurrence group tended to be higher by 14 years. No statistically significant between-group differences were found with regard to integration into tele-monitoring, nor were there any differences identified between outpatient care at the UMR or in the outpatient sector. CONCLUSIONS: This study confirmed the feasibility of using an interdisciplinary and intersectoral therapeutic approach for monitoring CS patients with implanted ICMs. Further randomized studies are warranted to confirm these encouraging data. An open discussion concerning optimal care forms and opportunities for introducing digitizing care pathways appears warranted.


Subject(s)
Atrial Fibrillation/diagnosis , Electrocardiography, Ambulatory/instrumentation , Ischemic Stroke/complications , Monitoring, Physiologic/instrumentation , Prostheses and Implants/statistics & numerical data , Adult , Aged , Aged, 80 and over , Atrial Fibrillation/epidemiology , Atrial Fibrillation/etiology , Female , Follow-Up Studies , Germany/epidemiology , Humans , Incidence , Male , Middle Aged , Prognosis , Retrospective Studies
16.
Spine (Phila Pa 1976) ; 45(13): 872-876, 2020 Jul 01.
Article in English | MEDLINE | ID: mdl-32539289

ABSTRACT

STUDY DESIGN: Analysis of explanted MAGnetic Expansion Control (MAGEC) growing rods. OBJECTIVE: The aim of this study was to quantify the rate of locking pin breakage in explanted MAGEC rods and compare with the manufacturer's data. SUMMARY OF BACKGROUND DATA: On June 25, 2019, NuVasive released an Urgent Field Safety Notice stating that MAGEC rods manufactured before March 26, 2015 had a higher than expected locking pin breakage rate of 5%. For rods made on or after that date, no pin breakages had occurred. METHODS: From our independent explant database of 139 explanted MAGEC rods supplied from 10 UK spinal centers (Belfast, Bristol, Birmingham, Edinburgh, Exeter, Leeds, Newcastle, Nottingham, Oxford, and Sheffield) and one Danish center (Aarhus), we divided the rods into those manufactured before March 26, 2015, and those manufactured on or after that date. MAGEC rods were cut open to fully assess internal components including locking pins. From each of the two cohorts, 10 locking pins were selected at random and their diameters were measured using a micrometer. RESULTS: One hundred and five explanted MAGEC rods were made before March 26, 2015 and could be disassembled to allow the locking pin to be examined. Fifty-nine percent (62/105) of these locking pins had fractured. For the MAGEC rods manufactured on or after March 26, 2015, 21% (6/29) were found to have fractured locking pins. Locking pins in MAGEC rods made on or after March 26, 2015 were of a stronger material and a larger diameter. CONCLUSION: Fifty-nine percent of the locking pins in MAGEC rods manufactured before March 26, 2015 had fractured, far greater than the 5% stated in the Urgent Field Safety Notice. Locking pin fracture still occurred in MAGEC rods manufactured on or after that date, in 21% of cases. This contrasted with the 0% reported by the manufacturer. LEVEL OF EVIDENCE: 4.


Subject(s)
Orthopedic Fixation Devices/statistics & numerical data , Prostheses and Implants/statistics & numerical data , Prosthesis Failure , Scoliosis/surgery , Adolescent , Child , Child, Preschool , Databases, Factual , Device Removal , Female , Humans , Male , Manufacturing Industry/statistics & numerical data , Orthopedic Fixation Devices/adverse effects , Prostheses and Implants/adverse effects
17.
Medicina (Kaunas) ; 56(6)2020 May 27.
Article in English | MEDLINE | ID: mdl-32471305

ABSTRACT

Background and Objectives: Implant stability in vivo is contingent on multiple factors, such as bone structure, instrument positioning and implant surface modifications, implant diameter, and implant length. Resonance-frequency analysis is considered a non-invasive, reliable, predictable, and objective method by which to evaluate implant stability, due to its correlation with bone-to-implant contact. The purpose of this study was to evaluate the effect of implant length on the primary and secondary stability of single-implant crown rehabilitations, as measured by resonance-frequency analysis at different times. Materials and Methods: Implants of 10 and 11.5 mm were placed, and the resonance frequency was measured at the time of surgery (T0), as well as at 3 (T1), 6 (T2), and 12 (T3) months post-surgery. Results: A total of 559 implants were placed in 195 patients. Significant differences were observed when comparing the implant stability quotient (ISQ) values at T1, with values for 10-mm implants being greater than those for 11.5-mm implants (p = 0.035). These differences were also observed when comparing ISQ values for buccal and lingual areas. At T0, T2, and T3, no significant differences in ISQ values were observed. The use of 10-mm implants in the anterior maxilla yielded significantly greater values at T0 (p = 0.018) and T1 (p = 0.031) when compared with 11.5-mm implants. Significant differences in measurements were observed only for buccal areas (p = 0.005; p = 0.018). When comparing the sample lengths and sex, women with 11.5-mm implants showed significantly lower results than those with 10-mm implants (p < 0.001). Conclusions: There is a direct relationship between implants of a smaller length and greater ISQ values, with this relationship being most evident in the maxilla and in women.


Subject(s)
Dental Implantation, Endosseous/classification , Mandible/surgery , Maxilla/surgery , Prostheses and Implants/standards , Quality of Health Care/standards , Adult , Dental Implantation, Endosseous/methods , Dental Implantation, Endosseous/standards , Female , Follow-Up Studies , Humans , Male , Mandible/abnormalities , Maxilla/abnormalities , Middle Aged , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Prospective Studies , Prostheses and Implants/statistics & numerical data , Quality of Health Care/statistics & numerical data , Resonance Frequency Analysis
18.
Infection ; 48(4): 559-568, 2020 Aug.
Article in English | MEDLINE | ID: mdl-32372396

ABSTRACT

PURPOSE: Biofilm-active antibiotics are suggested to improve the outcome of implant-associated infections; however, their role in infections after spinal instrumentation is unclear. Therefore, we evaluated the outcome of patients with spinal implant-associated infections treated with and without biofilm-active antibiotics. METHODS: The probability of infection-free survival was estimated for treatment of spinal implant-associated infections with and without biofilm-active antibiotics using the Kaplan-Meier method; Cox proportional-hazards regression model was used to identify factors associated with treatment failure. RESULTS: Among 93 included patients, early-onset infection was diagnosed in 61 (66%) and late-onset in 32 infections (34%). Thirty patients (32%) were treated with biofilm-active antibiotic therapy and 63 (68%) without it. The infection-free survival after a median follow-up of 53.7 months (range, 8 days-9.4 years) was 67% (95% confidence interval [CI], 55-82%) after 1 year and 58% (95% CI 43-71%) after 2 years. The infection-free survival after 1 and 2 years was 94% (95% CI 85-99%) and 84% (95% CI 71-93%) for patients treated with biofilm-active antibiotics, respectively, and 57% (95% CI 39-80%) and 49% (95% CI 28-61%) for those treated without biofilm-active antibiotics, respectively (p = 0.009). Treatment with biofilm-active antibiotics (hazard ratio [HR], 0.23, 95% CI 0.07-0.77), infection with Staphylococcus auras (HR, 2.19, 95% CI 1.04-4.62) and polymicrobial infection (HR, 2.44, 95% CI 1.09-6.04) were significantly associated with treatment outcome. Severe pain was observed more often in patients without biofilm-active antibiotic therapy (49% vs. 18%, p = 0.027). CONCLUSION: Treatment with biofilm-active antibiotics was associated with better treatment outcome and less postoperative pain intensity.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Biofilms/drug effects , Postoperative Complications/microbiology , Prostheses and Implants/statistics & numerical data , Prosthesis-Related Infections/drug therapy , Treatment Failure , Adolescent , Adult , Aged , Aged, 80 and over , Child , Cohort Studies , Female , Germany , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Postoperative Complications/drug therapy , Proportional Hazards Models , Prosthesis-Related Infections/microbiology , Spine/surgery , Young Adult
20.
Eur J Orthop Surg Traumatol ; 30(1): 31-35, 2020 Jan.
Article in English | MEDLINE | ID: mdl-31324968

ABSTRACT

PURPOSE: To retrospectively analyze the entire cohort of patients in the Republic of Slovenia diagnosed with bone sarcomas in the long bones or pelvis/sacrum/coccyx from January 1, 2009, to December 31, 2018, with an observational nationwide study, whereby all patients were evaluated by one single tumor board in the country. We evaluated surgical outcomes and tested whether survival of bone sarcoma patients depended on age, gender, histological diagnosis. MATERIALS AND METHODS: Cancer Registry of the Republic of Slovenia was screened for all ICD-10 diagnoses from C40.0 to C40.9 and C41.4 in the designated time frame, and the patients were then clinically followed up until the end of the observation period on June 1, 2019. RESULTS: The cohort of 160 patients was treated surgically in 141 cases, 29 patients required subsequent revision(s) and cumulative endoprosthetic infection rate was 12.5%. In the follow-up, 54 patients died and the 2 patients were missing. Cumulative proportion of survival at 5/10 years was 61%/54%, respectively. After adjustment for age, gender and diagnosis, higher age (odds ratio 1.06 for each additional year), osteosarcoma (odds ratio 4.07) and Ewing sarcoma (odds ratio 11.68) were the significant risk factors of shorter oncological survival. CONCLUSION: This is the first Slovenian nationwide cohort study of bone sarcoma patients, unique in its circumscribed geographic area and evaluation/treatment at a single center by a single tumor board. Although comparable to other countries, results show a grim picture and the lack of improvement in bone sarcoma survival within the last 20 years.


Subject(s)
Bone Neoplasms/pathology , Bone Neoplasms/surgery , Prostheses and Implants/statistics & numerical data , Registries , Sarcoma/pathology , Sarcoma/surgery , Adolescent , Adult , Biopsy, Needle , Bone Neoplasms/diagnostic imaging , Bone Neoplasms/mortality , Child , Cohort Studies , Disease-Free Survival , Female , Humans , Immunohistochemistry , Kaplan-Meier Estimate , Male , Prognosis , Proportional Hazards Models , Retrospective Studies , Risk Assessment , Sarcoma/diagnostic imaging , Sarcoma/mortality , Slovenia , Survival Analysis , Treatment Outcome , Young Adult
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