RESUMO
OBJECTIVE: Evaluate the safety and efficacy of a novel press-fit bone-anchored prosthesis in an FDA approved study. DESIGN: Single-center, prospective 1-year follow-up cohort study of a percutaneous bone anchored prosthesis. SETTING: Veterans Health Administration Hospital. PARTICIPANTS: Ten male Veterans with unilateral transfemoral amputation that occurred at least 6 months prior to enrollment and was not the result of dysvascular disease (N=10). INTERVENTIONS: All participants received the novel press-fit Percutaneous Osseointegrated Prosthesis (POP) and a minimum of 10 days supervised rehabilitation therapy. OUTCOME MEASURES: Adverse events and radiographs were collected to assess device safety. Temporal assessments of bone density, stomal skin, prosthetic don/doff, functional ambulation, and patient-reported outcome compared our POP to a socket suspension system. RESULTS: Ten male participants mean age 48.8±12.1 years (range, 32-68 y) with mean time since amputation of 9.4± years (range 1-18 y) completed a two-staged implantation protocol and progressed to ambulation with an assistive device by post-operative day 14. Eight of 10 completed all study procedures. One implant loosened at 5 weeks, requiring removal. A second was removed after periprosthetic fracture from a non-device-related fall at 28 weeks. One patient required oral antibiotics for superficial infection. There were significant (P<.05) increases in bone density in the lumbar spine and adjacent to the distal porous coating with no radiographic evidence of bone resorption. Compared to the socket system, the use of POP significantly (P<.05) reduced prosthetic don and doff times and patient-reported prosthetic problem scores. Significant improvements (P<.05) in mean mobility, global health, and walking test scores were also observed. CONCLUSIONS: Improvements in bone density, function, and patient reported outcomes were observed with the POP device when compared to a socket suspension system. This Early Feasibility Study established initial safety and effectiveness of the POP device, supporting expanded investigation as an alternative to socket prostheses.
Assuntos
Amputados , Membros Artificiais , Prótese Ancorada no Osso , Masculino , Humanos , Lactente , Amputados/reabilitação , Prótese Ancorada no Osso/efeitos adversos , Seguimentos , Estudos Prospectivos , Estudos de Viabilidade , Membros Artificiais/efeitos adversos , Osseointegração , Amputação Cirúrgica/reabilitação , Implantação de Prótese/efeitos adversos , Implantação de Prótese/métodos , Desenho de PróteseRESUMO
Hand loss profoundly impacts daily functioning. Reversal of amputation through hand replantation or transplantation offers an alternative to prosthetics for some. Whether recipients exhibit more extensive and natural limb use during everyday life than prosthesis users is, however, unknown.We asked unilateral, below-elbow amputees (N = 22), hand graft recipients (transplants N = 4; replants N = 2), and healthy matched controls (N = 20) to wear wireless accelerometers distally on their forearms/prostheses and proximally on their upper arms. These units captured limb activity over 3 days within participants' natural environments.Graft recipients exhibited heavier reliance on their affected hands compared to amputees' reliance on their prostheses, P < .001. Likewise, reliance on the injured side upper arm was also greater for hand graft recipients than amputees, regardless of whether they were wearing their prostheses, P < .05 in both cases. Hand graft recipients, like healthy controls, also relied more on forearm vs upper arm movements when controlling their limbs, P < .001.Compared with conventional prosthesis users, graft recipients exhibited more extensive and natural functioning of the upper limbs during everyday activities. This information is an important addition to other considerations when evaluating risk-benefit of these treatment alternatives.
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Amputados , Membros Artificiais , Braço , Mãos , Humanos , Extremidade SuperiorRESUMO
AIM: Some patients with intestinal failure requiring home parenteral support (HPS) may be weaned. This study considered all abdominal surgery in a cohort of HPS patients over a 25-year period. Our aim was to identify how many patients can be weaned from HPS and by what means, and to identify what makes weaning more likely. METHOD: A prospectively collected database of HPS patients to December 2018 was analysed for outcomes of care. RESULTS: At 5 years 56% of 205 patients remained on HPS. Fifty eight patients (28%), who had 68 operations, stopped HPS after surgery. Patients stopping HPS had a longer median final small bowel length (155 cm, range 45-350 cm) and were more likely to have colon in circuit (84%) than patients who had reconstructive surgery but did not stop HPS (median small bowel length 50 cm, range 15-135 cm; 50% colon in circuit). The median period between HPS discharge and reconstructive surgery was 238 days. There were no deaths, but 18 Clavien-Dindo grade 3-4 complications occurred within 30 days. Ninety per cent of patients who stopped HPS survived for 5 years from the start of HPS in comparison with 53% of those who remained on HPS. CONCLUSIONS: No previous study has examined surgery in an entire cohort of HPS patients. More than a quarter of HPS patients can be weaned after reconstructive surgery. The length of bowel available for recruitment at surgery is the main determinant of the ability to stop HPS. The possibility of reconstruction should be considered, since patients who stop HPS appear to have a survival advantage.
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Nutrição Parenteral , Síndrome do Intestino Curto , Estudos de Coortes , Humanos , Intestino Delgado , Intestinos , Alta do Paciente , Estudos RetrospectivosRESUMO
OBJECTIVES: To determine which demographic, amputation, and health-related factors were associated with health-related quality of life (HR-QoL) in people living with partial foot amputation (PFA) or transtibial amputation (TTA). DESIGN: Cross-sectional survey. SETTING: Community. PARTICIPANTS: Adults (N=123) with unilateral PFA (n=42) or TTA (n=81). INTERVENTION: Not applicable. MAIN OUTCOME MEASURE: Medical Outcome Short Form (SF-36) version 2. RESULTS: Variation in the SF-36 Physical or Mental Component Summary scores were associated with complex interactions between factors, including: time since amputation, fatigue, anxiety, depression, pain interference, and physical function. Level of amputation (ie, PFA or TTA) did not explain a significant part of the variation in either the SF-36 Physical or Mental Component Summary scores. CONCLUSIONS: Given the complex interactions between factors associated with the physical and mental health components of HR-QoL, there are opportunities to consider the long-term holistic care required by people living in the community with PFA or TTA.
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Amputação Cirúrgica/psicologia , Nível de Saúde , Saúde Mental , Qualidade de Vida/psicologia , Adulto , Fatores Etários , Idoso , Comorbidade , Estudos Transversais , Complicações do Diabetes/epidemiologia , Feminino , Pé/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Desempenho Físico Funcional , Fatores Socioeconômicos , Tíbia/cirurgia , Fatores de TempoRESUMO
OBJECTIVES: Acquired resistance mutations to anaplastic lymphoma kinase (ALK) inhibitors such as crizotinib and alectinib have been documented in non-small cell lung cancer (NSCLC) patients harboring ALK rearrangement (ALK+). Of note I1171T/N/S mutations in the ALK kinase domain have recently been described by several groups to confer resistance to alectinib, a second-generation ALK inhibitor. Additionally one of these reports demonstrated one ALK+ NSCLC patient harboring an I1171T acquired mutation has responded to ceritinib, another second-generation ALK inhibitor. MATERIALS AND METHODS: We reported the presence of an ALK I1171N resistance mutation from comprehensive genomic profiling from a liver biopsy of a progressing metastatic lesion in an ALK+ patient on alectinib after an initial partial response. The patient then responded to ceritinib 750 mg orally once daily but required dose reduction to 600 mg once daily. She initially had grade 3 elevation of liver enzymes from crizotinib necessitating the original switch to alectinib but experienced no transaminase elevations with alectinib or ceritinib. CONCLUSIONS: This is the fifth patient case to date demonstrating that ALK I1171 mutation confers resistance to alectinib and the second reported case of ALK I1171 mutation being sensitivity to ceritinib. Substitutions of isoleucine at amino acid 1171 in the ALK kinase domain may distinguish which second generation ALK inhibitor will be effective after crizotinib failure. This case also provides evidence that transaminase elevations is likely a unique adverse event associated with crizotinib and unlikely a "class" effect involving all ALK inhibitors.
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Carbazóis/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Resistencia a Medicamentos Antineoplásicos/genética , Neoplasias Pulmonares/tratamento farmacológico , Mutação de Sentido Incorreto/genética , Piperidinas/uso terapêutico , Pirimidinas/uso terapêutico , Receptores Proteína Tirosina Quinases/genética , Sulfonas/uso terapêutico , Quinase do Linfoma Anaplásico , Carcinoma Pulmonar de Células não Pequenas/genética , Carcinoma Pulmonar de Células não Pequenas/patologia , Feminino , Humanos , Neoplasias Pulmonares/genética , Neoplasias Pulmonares/patologia , Pessoa de Meia-IdadeRESUMO
An international multidisciplinary group of healthcare professionals and researchers participated in a consensus conference on the management of cerebral palsy, convened by the International Society for Prosthetics and Orthotics. Participants reviewed the evidence and considered contemporary thinking on a range of treatment options including physical and occupational therapy, and medical, surgical and orthotic interventions. The quality of many of the reviewed papers was compromised by inadequate reporting and lack of transparency, in particular regarding the types of patients and the design of the interventions being evaluated. Substantial evidence suggests that ankle-foot orthoses (AFOs) that control the foot and ankle in stance and swing phases can improve gait efficiency in ambulant children (GMFCS levels I-III). By contrast, little high quality evidence exists to support the use of orthoses for the hip, spine or upper limb. Where the evidence for orthosis use was not compelling consensus was reached on recommendations for orthotic intervention. Subsequent group discussions identified recommendations for future research. The evidence to support using orthoses is generally limited by the brevity of follow-up periods in research studies; hence the extent to which orthoses may prevent deformities developing over time remains unclear. The full report of the conference can be accessed free of charge at www.ispoint.org.