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1.
Otol Neurotol ; 45(8): 913-918, 2024 Sep 01.
Artículo en Inglés | MEDLINE | ID: mdl-39142312

RESUMEN

INTRODUCTION: This study reviews the feasibility of implanting active osseointegrated bone conduction devices in young children, below the prior age for FDA indication (<12 years), which has recently been reduced to 5 years. Outcomes included differences in adverse event rates and operative time between two groups (<12 and 12 years or older). MATERIALS AND METHODS: This study is a retrospective review of children receiving active osseointegrated bone conduction devices at a tertiary referral center academic hospital. One hundred and twenty-four children received 135 active osseointegrated bone conduction devices (May 2018-March 2024). RESULTS: Of 135 devices, 77 (57%) were in children <12 years (mean age (SD) = 7.9 (2.0) years, range = 4.9-11.9 years) and 58 (43%) were in 12 years or older (mean age (SD) = 15.1 (1.7) years, range = 12-18 years). Adverse events were significantly higher in the older group, occurring in 8 (10%) of 77 devices in children <12 years and 15 (26%) of 58 devices in children 12 years and older (26%) (Fisher's exact test = 0.0217 at p < 0.05). Major adverse events occurred in 5/124 (4%) patients, with 2 in patients <12 years (2/73, 3%) and 3 in children 12 and older (3/51, 6%). The proportion of major events between groups was not significantly different (Fisher's exact test = 0.4, p < 0.05). Mean surgical time was significantly less (t = -2.8799, df = 120.26, p = 0.005) in the children <12 years (mean (SD) = 66.5 (22.4) min) compared to those 12 and over (mean (SD) = 78.32 (23.1) min). CONCLUSIONS: Implantation of active osseointegrated bone conduction devices is feasible in children as young as 5 years and demonstrates low rates of complication. Further miniaturization may allow even earlier safe intervention.


Asunto(s)
Conducción Ósea , Estudios de Factibilidad , Oseointegración , Humanos , Niño , Conducción Ósea/fisiología , Estudios Retrospectivos , Masculino , Femenino , Preescolar , Oseointegración/fisiología , Adolescente , Resultado del Tratamiento , Pérdida Auditiva Conductiva/cirugía , Audífonos , Prótesis Anclada al Hueso , Implantación de Prótesis/métodos
2.
J Rehabil Med ; 56: jrm40111, 2024 Aug 22.
Artículo en Inglés | MEDLINE | ID: mdl-39175448

RESUMEN

OBJECTIVE: To explore cognitive load in people with transfemoral amputations fitted with socket or bone-anchored prostheses by describing activity in the left and right dorsolateral prefrontal cortices during single- and dual-task walking. DESIGN: Cross-sectional pilot study. PATIENTS: 8 socket prosthesis users and 8 bone-anchored prosthesis users. All were fitted with microprocessor-controlled prosthetic knees. METHODS: Participants answered self-report questionnaires and performed gait tests during 1 single-task walking condition and 2 dual-task walking conditions. While walking, activity in the dorsolateral prefrontal cortex was measured using functional near-infrared spectroscopy. Cognitive load was investigated for each participant by exploring the relative concentration of oxygenated haemoglobin in the left and right dorsolateral prefrontal cortex. Symmetry of brain activity was investigated by calculating a laterality index. RESULTS: Self-report measures and basic gait variables did not show differences between the groups. No obvious between-group differences were observed in the relative concentration of oxygenated haemoglobin for any walking condition. There was a tendency towards more right-side brain activity for participants using a socket prosthesis during dual-task conditions. CONCLUSIONS: This pilot study did not identify substantial differences in cognitive load or lateralization between socket prosthesis users and bone-anchored prosthesis users.


Asunto(s)
Miembros Artificiales , Cognición , Caminata , Humanos , Proyectos Piloto , Masculino , Persona de Mediana Edad , Estudios Transversales , Femenino , Caminata/fisiología , Cognición/fisiología , Adulto , Anciano , Fémur/cirugía , Amputación Quirúrgica/rehabilitación , Diseño de Prótesis , Prótesis Anclada al Hueso , Corteza Prefrontal/fisiopatología , Amputados/rehabilitación , Amputados/psicología , Espectroscopía Infrarroja Corta , Marcha/fisiología
3.
Otol Neurotol ; 45(7): e541-e546, 2024 Aug 01.
Artículo en Inglés | MEDLINE | ID: mdl-38995722

RESUMEN

HYPOTHESIS: Here, we aim to 1) expand the available evidence for the use of machine learning techniques for soft tissue classification after BCD surgery and 2) discuss the implications of such approaches toward the development of classification applications to aid in tissue monitoring. BACKGROUND: The application of machine learning techniques in the soft tissue literature has become a large field of study. One of the most commonly reported outcomes after percutaneous bone-conduction device (BCD) surgery is soft tissue health. Unfortunately, the classification of tissue around the abutment as healthy versus not healthy is a subjective process, even though such decisions can have implications for treatment (i.e., topical steroid versus surgical revision) and resources (e.g., clinician time). METHODS: We built and tested a convolutional neural network (CNN) model for the classification of tissues that were rated as "green" (i.e., healthy), "yellow" (i.e., unhealthy minor), and "red" (i.e., unhealthy severe). METHODS: Representative image samples were gathered from a regional bone-conduction amplification site (N = 398; 181 samples of green; 144 samples of yellow; 73 samples of red). The image samples were cropped, zoomed, and normalized. Feature extraction was then implemented and used as the input to train an advanced CNN model. RESULTS: Accuracy of image classification for the healthy ("green") versus not healthy ("yellow" and "red") model was approximately 87%. Accuracy of image classification for the unhealthy ("yellow") versus unhealthy ("red") model was approximately 94%. CONCLUSIONS: Monitoring tissue health is an ongoing challenge for BCD users and their clinicians not trained in soft tissue management (e.g., audiologists). If machine learning can aid in the classification of tissue health, this would have significant implications for stakeholders. Here we discuss how machine learning can be applied to tissue classification as a potential technological aid in the coming years.


Asunto(s)
Aprendizaje Automático , Redes Neurales de la Computación , Humanos , Piel , Audífonos , Conducción Ósea/fisiología , Prótesis Anclada al Hueso
4.
J Neuroeng Rehabil ; 21(1): 128, 2024 Jul 31.
Artículo en Inglés | MEDLINE | ID: mdl-39085954

RESUMEN

BACKGROUND: Systems that capture motion under laboratory conditions limit validity in real-world environments. Mobile motion capture solutions such as Inertial Measurement Units (IMUs) can progress our understanding of "real" human movement. IMU data must be validated in each application to interpret with clinical applicability; this is particularly true for diverse populations. Our IMU analysis method builds on the OpenSim IMU Inverse Kinematics toolkit integrating the Versatile Quaternion-based Filter and incorporates realistic constraints to the underlying biomechanical model. We validate our processing method against the reference standard optical motion capture in a case report with participants with transfemoral amputation fitted with a Percutaneous Osseointegrated Implant (POI) and without amputation walking over level ground. We hypothesis that by using this novel pipeline, we can validate IMU motion capture data, to a clinically acceptable degree. RESULTS: Average RMSE (across all joints) between the two systems from the participant with a unilateral transfemoral amputation (TFA) on the amputated and the intact sides were 2.35° (IQR = 1.45°) and 3.59° (IQR = 2.00°) respectively. Equivalent results in the non-amputated participant were 2.26° (IQR = 1.08°). Joint level average RMSE between the two systems from the TFA ranged from 1.66° to 3.82° and from 1.21° to 5.46° in the non-amputated participant. In plane average RMSE between the two systems from the TFA ranged from 2.17° (coronal) to 3.91° (sagittal) and from 1.96° (transverse) to 2.32° (sagittal) in the non-amputated participant. Coefficients of Multiple Correlation (CMC) results between the two systems in the TFA ranged from 0.74 to > 0.99 and from 0.72 to > 0.99 in the non-amputated participant and resulted in 'excellent' similarity in each data set average, in every plane and at all joint levels. Normalized RMSE between the two systems from the TFA ranged from 3.40% (knee level) to 54.54% (pelvis level) and from 2.18% to 36.01% in the non-amputated participant. CONCLUSIONS: We offer a modular processing pipeline that enables the addition of extra layers, facilitates changes to the underlying biomechanical model, and can accept raw IMU data from any vendor. We successfully validate the pipeline using data, for the first time, from a TFA participant using a POI and have proved our hypothesis.


Asunto(s)
Amputación Quirúrgica , Miembros Artificiales , Humanos , Fenómenos Biomecánicos , Amputación Quirúrgica/rehabilitación , Fémur/cirugía , Oseointegración/fisiología , Masculino , Prueba de Estudio Conceptual , Amputados/rehabilitación , Caminata/fisiología , Adulto , Prótesis Anclada al Hueso
5.
J Biomech ; 171: 112208, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38941842

RESUMEN

For some individuals with severe socket-related problems, prosthesis osseointegration directly connects a prosthesis to the residual limb creating a bone-anchored limb (BAL). We compared dynamic gait stability and between-limb stability symmetry, as measured by the Margin of Stability (MoS) and the Normalized Symmetry Index (NSI), for people with unilateral transfemoral amputation before and one-year after BAL implantation. The MoS provides a mechanical construct to assess dynamic gait stability and infer center of mass and limb control by relating the center of mass and velocity to the base of support. Before and one-year after BAL implantation, 19 participants walked overground at self-selected speeds. We quantified dynamic gait stability anteriorly and laterally at foot strike and at the minimum lateral MoS value. After implantation, we observed decreased lateral MoS at foot strike for the amputated (MoS mean(SD) %height; pre: 6.6(2.3), post: 5.9(1.3), d = 0.45) and intact limb (pre: 6.2(1.2), post: 5.8(1.0), d = 0.38) and increased between-limb MoS symmetry at foot strike (NSI mean(SD) %; anterior-pre: 10.3(7.3), post: 8.4(3.6), d = 0.23; lateral-pre: 18.8(12.4), post: 12.4(4.9), d = 0.47) and at minimum lateral stability (pre: 28.1(18.1), post: 19.2(6.8), d = 0.50). Center of mass control using a BAL resulted in dynamic gait stability more similar between limbs and may have reduced the adoption of functional asymmetries. We suggest that improved between-limb MoS symmetry after BAL implantation is likely due to subtle changes in individual limb MoS values at self-selected walking speeds resulting in an overall positive impact on fall risk through improved center of mass and prosthetic limb control.


Asunto(s)
Amputación Quirúrgica , Fémur , Marcha , Humanos , Marcha/fisiología , Masculino , Femenino , Persona de Mediana Edad , Adulto , Fémur/cirugía , Miembros Artificiales , Amputados , Prótesis Anclada al Hueso , Anciano , Caminata/fisiología , Oseointegración , Fenómenos Biomecánicos
6.
Clin Otolaryngol ; 49(5): 670-676, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-38926155

RESUMEN

INTRODUCTION: Although the Baha 5SP has been commercially available for six years, very few studies have been performed on the device's efficacy. The current study aims to evaluate the characteristics and audiological results in patients with severe-to-profound mixed hearing loss fitted with this superpower sound processor. METHODS: This retrospective evaluation was conducted at a tertiary referral centre where a series of 82 adult patients with severe-to-profound mixed hearing loss were implanted with a percutaneous bone-anchored hearing system and fitted with a superpower sound processor between 2016 and 2019. Patients with incomplete or unreliable audiological data (n = 24) were excluded, resulting in 58 data sets for analysis. The main outcome measures were unaided and aided pure-tone thresholds and aided free-field speech perception in quiet. RESULTS: The median unaided air conduction (AC) threshold averaged across 0.5, 1 and 2 kHz (PTA0.5-2kHz) of all patients was 75 dB hearing loss (HL); the median unaided AC averaged across 1, 2 and 4 kHz (PTA1-4kHz) was 84 dB HL. For bone conduction and direct bone conduction, the median PTA0.5-2kHz was 52 and 47 dB HL, respectively. With the superpower device, the median free-field speech reception threshold was 54 dB sound pressure level (SPL), and the median speech perception score at 65 dB SPL was 80%. CONCLUSIONS: At least 75% of the patients reached a maximum phoneme score of 70%. For patients with lower scores, the superpower device still provides a substantial hearing benefit. This makes the superpower device particularly suitable for patients with severe-to-profound mixed hearing loss with a contraindication for conventional hearing aids and/or cochlear implants.


Asunto(s)
Audífonos , Perdida Auditiva Conductiva-Sensorineural Mixta , Percepción del Habla , Humanos , Estudios Retrospectivos , Femenino , Masculino , Persona de Mediana Edad , Adulto , Anciano , Perdida Auditiva Conductiva-Sensorineural Mixta/rehabilitación , Audiometría de Tonos Puros , Prótesis Anclada al Hueso , Conducción Ósea , Diseño de Prótesis , Resultado del Tratamiento , Anciano de 80 o más Años , Anclas para Sutura
7.
Otol Neurotol ; 45(6): 676-683, 2024 Jul 01.
Artículo en Inglés | MEDLINE | ID: mdl-38865727

RESUMEN

HYPOTHESIS: Resonance frequency analysis (RFA) is a reliable, noninvasive method to assess the stability of bone-anchored hearing implants (BAHIs), although surgical-, implant-, and host-related factors can affect its outcome. BACKGROUND: BAHI plays an important role in restoring hearing function. However, implant- and host-related factors contribute to premature implant extrusion. To mitigate this, noninvasive methods to assess implant stability, along with a better understanding of factors contributing to BAHI failure, are needed. METHODS: We evaluated the utility of RFA to quantify implant stability in sawbone (bone mimicking material), 29 human cadaveric samples, and a prospective cohort of 29 pediatric and 27 adult participants, and identified factors associated with implant stability. To validate the use of RFA in BAHI, we compared RFA-derived implant stability quotient (ISQ) estimates to peak loads obtained from mechanical push-out testing. RESULTS: ISQ and peak loads were significantly correlated (Spearman rho = 0.48, p = 0.0088), and ISQ reliably predicted peak load up to 1 kN. We then showed that in cadaveric samples, abutment length, internal table bone volume, and donor age were significantly associated with implant stability. We validated findings in our prospective patient cohort and showed that minimally invasive Ponto surgery (MIPS; versus linear incision), longer implantation durations (>16 wk), older age (>25 yr), and shorter abutment lengths (≤10 mm) were associated with better implant stability. Finally, we characterized the short-term reproducibility of ISQ measurements in sawbone and patient implants. CONCLUSIONS: Together, our findings support the use of ISQ as a measure of implant stability and emphasize important considerations that impact implant stability, including surgical method, implant duration, age, and abutment lengths.


Asunto(s)
Audífonos , Análisis de Frecuencia de Resonancia , Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Niño , Adolescente , Estudios Prospectivos , Prótesis Anclada al Hueso , Adulto Joven , Anciano , Anclas para Sutura , Cadáver
8.
Orthopadie (Heidelb) ; 53(7): 519-526, 2024 Jul.
Artículo en Alemán | MEDLINE | ID: mdl-38829401

RESUMEN

Aseptic implant loosening is the primary cause of revisions in arthroplasty. Various in vitro and in vivo methods are available for assessing implant fixation and stability. The aim of the Musculoskeletal Biomechanics Research Network (MSB-NET) is to continuously improve or develop these methods. In vitro analyses are often conducted using static and dynamic ISO and ASTM standards, while RSA, DXA, and EBRA analyses are established in vivo methods for evaluating implant fixation. Primary stability analyses, as well as acoustical methods, provide additional opportunities to detect loosening early and precisely evaluate implant stability. The cluster serves as a link between basic research, clinical practice, and end users to promote in vitro and in vivo methods to improve implant safety.


Asunto(s)
Falla de Prótesis , Humanos , Prótesis Anclada al Hueso , Análisis de Falla de Equipo/métodos
9.
Otol Neurotol ; 45(5): 556-563, 2024 Jun 01.
Artículo en Inglés | MEDLINE | ID: mdl-38693091

RESUMEN

OBJECTIVE: To investigate the feasibility of early sound processor loading with two separate bone-anchored hearing aid implants 1 to 2 weeks after implantation. Secondary endpoints included registration of any postoperative complications, skin reactions, and any adverse events. STUDY DESIGN: Prospective, nonrandomized, noncontrolled, multicenter clinical trial. SETTING: Tertiary referral center. PATIENTS: Sixty adult patients, eligible for bone-anchored hearing aid surgery, were enrolled. INTERVENTION: Implantation of the bone-anchored hearing aid implants were done using minimally invasive surgery with tissue preservation. MAIN OUTCOME MEASURE: Implant stability quotient (ISQ) values were recorded using resonance frequency analysis. Follow-ups were scheduled 5 to 12 days, 4 to 8 weeks, 6 months, and 12 months postoperatively. Differences between the lowest ISQ values (ISQ low) over time were analyzed by paired-samples t test with a significance level of 0.05. Skin and soft tissue reactions were assessed according to Holger's classification. RESULTS: Loading time of the Ponto Wide implant was 11.6 ± 1.4 days (SD) in average (median, 12 d; range, 7-19 d). Loading of the Ponto BHX implant was done 9.7 ± 3.5 days (SD) postoperatively (median, 9 d; range, 5-19 d). The implant stability increased significantly during the 12-month study period with both implants. One Ponto BHX implant was lost. Skin and soft tissue reactions were few in both groups. Across all planned follow-up visits, no skin and soft tissue reactions were observed in 86% (Ponto BHX implant) and 85% (Ponto Wide implant). CONCLUSION: Very early loading of sound processors after percutaneous bone-anchored hearing system surgery is safe already 1 to 2 weeks postoperatively.


Asunto(s)
Audífonos , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Prótesis Anclada al Hueso , Estudios Prospectivos , Implantación de Prótesis/métodos , Anclas para Sutura , Resultado del Tratamiento
10.
Am J Otolaryngol ; 45(4): 104328, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38733715

RESUMEN

PURPOSE: To evaluate outcomes following explantation of percutaneous or transcutaneous bone conduction implants (pBCIs or tBCIs) and subsequent implantation of transcutaneous active bone conduction hearing devices (BCHDs); to provide guidance regarding staging of surgery and adjunctive procedures. MATERIALS AND METHODS: Retrospective chart review of eight adult subjects (ten ears) with pBCIs or tBCIs who underwent explantation of their device and subsequent implantation with a BCHD [MED-EL BONEBRIDGE™ (n = 7, 70 %) or Cochlear™ Osia® (n = 3, 30 %)]. RESULTS: Reasons for pBCI or tBCI explantation were pain (60 %, 6/10), infection (60 %, 6/10), skin overgrowth (50 %, 5/10), and inability to obtain new processors (20 %, 2/10). Median time between pBCI or tBCI removal and BCHD staged implant was 4.7 (IQR 2.2-8.1) months. Two subjects developed complications following BCHD implantation. One had a persistent wound overlying the osseointegrated screw after removal of the pBCI abutment, requiring removal and temporalis rotational flap. Staged Osia® implantation was performed, but ultimately wound dehiscence developed over the device. The second subject experienced an infection after BONEBRIDGE™ implantation (32 days after pBCI explant), necessitating washout and treatment with intravenous antibiotics. There was subsequent device failure. CONCLUSION: The transition from a pBCI or tBCI to a novel transcutaneous device is nuanced. Staged pBCI or tBCI explantation and novel BCHD implantation with sufficient time for wound healing is vital. Adjunctive procedures to augment soft tissue in cases of prior attenuation may be required to avoid complications with larger internal devices.


Asunto(s)
Conducción Ósea , Remoción de Dispositivos , Audífonos , Humanos , Audífonos/efectos adversos , Estudios Retrospectivos , Masculino , Femenino , Persona de Mediana Edad , Adulto , Resultado del Tratamiento , Anciano , Prótesis Anclada al Hueso , Implantación de Prótesis/métodos , Implantación de Prótesis/efectos adversos , Pérdida Auditiva Conductiva/cirugía , Pérdida Auditiva Conductiva/etiología
11.
Otol Neurotol ; 45(5): e435-e442, 2024 Jun 01.
Artículo en Inglés | MEDLINE | ID: mdl-38728559

RESUMEN

OBJECTIVE: This study evaluates the clinical outcomes of 807 percutaneous wide-diameter bone-anchored hearing implants (BAHIs) in 701 patients. In addition, it compares patient groups and examines bone conduction device (BCD) usage. STUDY DESIGN: Retrospective cohort study. Mean follow-up period of 3.8 years. SETTING: Tertiary referral center. PATIENTS: All patients implanted with a percutaneous wide-diameter BAHI until December 2020 were included. Patients were divided into age groups, "loading-time" groups, and, if applicable, specific subgroups thought to be at risk for complications postsurgery, e.g., intellectual disability and comorbidities. MAIN OUTCOME MEASURES: Soft tissue reaction, implant survival, revision surgery, and BCD usage. RESULTS: In 9.1% of the 5,188 observations of 807 implants, an adverse soft tissue reaction was reported according to the Holgers' scale. Significantly more (adverse) soft tissue reactions were observed in children and intellectually disabled (ID) patients (p < 0.05). Comorbidity subgroups showed no significant differences in soft tissue reactions. Implant loss percentage, including explantations, was 6.2%. Implant survival was significantly worse in patients with ID (14.1%; p = 0.021). Pediatric age, early loading, or comorbidities did not significantly influence implant survival. At least 592 implants (73.4%) were used for bone conduction hearing, of which 65.4% were used daily. CONCLUSION: Both children and ID patients are more prone to (adverse) soft tissue reactions, ID patients only have a higher risk of implant loss. The rate of implant loss in children seemed to be reduced compared to previous studies and thus more comparable to adults since using wide-diameter implants.


Asunto(s)
Conducción Ósea , Prótesis Anclada al Hueso , Audífonos , Humanos , Masculino , Femenino , Estudios Retrospectivos , Adulto , Niño , Persona de Mediana Edad , Adolescente , Adulto Joven , Anciano , Preescolar , Resultado del Tratamiento , Reoperación/estadística & datos numéricos , Estudios de Seguimiento , Anciano de 80 o más Años , Anclas para Sutura , Complicaciones Posoperatorias/epidemiología
12.
J Biomech ; 168: 112098, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38636112

RESUMEN

Individuals with unilateral transtibial amputation (TTA) using socket prostheses demonstrate asymmetric joint biomechanics during walking, which increases the risk of secondary comorbidities (e.g., low back pain (LBP), osteoarthritis (OA)). Bone-anchored limbs are an alternative to socket prostheses, yet it remains unknown how they influence multi-joint loading. Our objective was to determine the influence of bone-anchored limb use on multi-joint biomechanics during walking. Motion capture data (kinematics, ground reaction forces) were collected during overground walking from ten participants with unilateral TTA prior to (using socket prostheses) and 12-months after bone-anchored limb implantation. Within this year, each participant completed a rehabilitation protocol that guided progression of loading based on patient pain response and optimized biomechanics. Musculoskeletal models were developed at each testing timepoint (baseline or 12-months after implantation) and used to calculate joint kinematics, internal joint moments, and joint reaction forces (JRFs). Analyses were performed during three stance periods on each limb. The between-limb normalized symmetry index (NSI) was calculated for joint moments and JRF impulses. Discrete (range of motion (ROM), impulse NSI) dependent variables were compared before and after implantation using paired t-tests with Bonferroni-Holm corrections while continuous (ensemble averages of kinematics, moments, JRFs) were compared using statistical parametric mapping (p < 0.05). When using a bone-anchored limb, frontal plane pelvic (residual: pre = 9.6 ± 3.3°, post = 6.3 ± 2.5°, p = 0.004; intact: pre = 10.2 ± 3.9°, post = 7.9 ± 2.6°, p = 0.006) and lumbar (residual: pre = 15.9 ± 7.0°, post = 10.6 ± 2.5°, p = 0.024, intact: pre = 17.1 ± 7.0°, post = 11.4 ± 2.8°, p = 0.014) ROM was reduced compared to socket prosthesis use. The intact limb hip extension moment impulse increased (pre = -11.0 ± 3.6 Nm*s/kg, post = -16.5 ± 4.4 Nm*s/kg, p = 0.005) and sagittal plane hip moment impulse symmetry improved (flexion: pre = 23.1 ± 16.0 %, post = -3.9 ± 19.5 %, p = 0.004, extension: pre = 29.2 ± 20.3 %, post = 8.7 ± 22.9 %, p = 0.049). Residual limb knee extension moment impulse decreased compared to baseline (pre = 15.7 ± 10.8 Nm*s/kg, post = 7.8 ± 3.9 Nm*s/kg, p = 0.030). These results indicate that bone-anchored limb implantation alters multi-joint biomechanics, which may impact LBP or OA risk factors in the TTA population longitudinally.


Asunto(s)
Tibia , Caminata , Humanos , Masculino , Caminata/fisiología , Fenómenos Biomecánicos , Femenino , Persona de Mediana Edad , Tibia/cirugía , Tibia/fisiología , Adulto , Rango del Movimiento Articular , Miembros Artificiales , Prótesis Anclada al Hueso , Amputación Quirúrgica/rehabilitación , Anciano , Articulación de la Rodilla/fisiología , Articulación de la Rodilla/fisiopatología , Articulación de la Cadera/fisiología , Articulación de la Cadera/cirugía
13.
J Neuroeng Rehabil ; 21(1): 35, 2024 03 07.
Artículo en Inglés | MEDLINE | ID: mdl-38454427

RESUMEN

BACKGROUND: Persons with a transfemoral amputation (TFA) often experience difficulties in daily-life ambulation, including an asymmetrical and less stable gait pattern and a greater cognitive demand of walking. However, it remains unclear whether this is effected by the prosthetic suspension, as eliminating the non-rigid prosthetic connection may influence stability and cortical activity during walking. Spatiotemporal and stability-related gait parameters, as well as cortical activity during walking, were evaluated between highly active individuals (MFC-level K3-4) with a TFA and able-bodied (AB) persons, and between persons with a bone-anchored prosthesis (BAP) and those with a socket-suspended prosthesis (SSP). METHODS: 18 AB persons and 20 persons with a unilateral TFA (10 BAP-users, 10 SSP-users) walked on a treadmill at their preferred speed. Spatiotemporal and margin of stability parameters were extracted from three-dimensional movement recordings. In addition, 126-channel electroencephalogram (EEG) was recorded. Brain-related activity from several cortical areas was isolated using independent component analysis. Source-level data were divided into gait cycles and subjected to time-frequency analysis to determine gait-cycle dependent modulations of cortical activity. RESULTS: Persons with TFA walked with smaller and wider steps and with greater variability in mediolateral foot placement than AB subjects; no significant differences were found between BAP- and SSP-users. The EEG analysis yielded four cortical clusters in frontal, central (both hemispheres), and parietal areas. No statistically significant between-group differences were found in the mean power over the entire gait cycle. The event-related spectral perturbation maps revealed differences in power modulations (theta, alpha, and beta bands) between TFA and AB groups, and between BAP- and SSP-users, with largest differences observed around heel strike of either leg. CONCLUSIONS: The anticipated differences in gait parameters in persons with TFA were confirmed, however no significant effect of the fixed suspension of a BAP was found. The preliminary EEG findings may indicate more active monitoring and control of stability in persons with TFA, which appeared to be timed differently in SSP than in BAP-users. Future studies may focus on walking tasks that challenge stability to further investigate differences related to prosthetic suspension.


Asunto(s)
Amputados , Miembros Artificiales , Prótesis Anclada al Hueso , Humanos , Marcha , Amputación Quirúrgica , Caminata , Fenómenos Biomecánicos , Diseño de Prótesis
14.
Proc Inst Mech Eng H ; 238(4): 412-422, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38415608

RESUMEN

Percutaneous osseointegrated implants for individuals with lower limb amputation can increase mobility, reduce socket related pain, and improve quality of life. It would be useful to have an evaluation method to assess the interface between bone and implant. We assessed outpatient radiographs from the Intraosseous Transcutaneous Amputation Prosthesis clinical trial using an interface scoring system which summed and weighted equally measures of implant collar cortical ongrowth and radiolucency along the implant stem/bone interface. Radiographs from 12 participants with unilateral transfemoral amputations (10 males, 2 females, mean age = 43.2, SD = 7.4 years) in the clinical trial from cohort I (implanted in 2008/09) or cohort II (implanted in 2013/14) were collated (mean image span = 7.2, SD = 2.4 years), scale normalised, zoned, and measured in a repeatable way. Interface scores were calculated and then compared to clinical outcomes. Explanted participants received the lowest interface scores. A higher ratio of stem to residuum and shorter residuum's produced better interface scores and there was an association (weak correlation) between participants with thin cortices and the lowest interface scores. A tapered, cemented, non curved stem may provide advantageous fixation while stem alignment did not appear critical. In summary, the interface score successfully demonstrated a non-invasive evaluation of percutaneous osseointegrated implants interfaces when applied to the Intraosseous Transcutaneous Amputation Prosthesis clinical trial. The clinical significance of this work is to identify events leading to aseptic or septic implant removal and contribute to clinical guidelines for monitoring rehabilitation, design and surgical fixation choices.


Asunto(s)
Amputados , Miembros Artificiales , Prótesis Anclada al Hueso , Masculino , Femenino , Humanos , Adulto , Implantación de Prótesis , Oseointegración , Calidad de Vida , Fémur/cirugía , Amputados/rehabilitación , Amputación Quirúrgica , Diseño de Prótesis , Resultado del Tratamiento
15.
Med Eng Phys ; 124: 104097, 2024 02.
Artículo en Inglés | MEDLINE | ID: mdl-38418026

RESUMEN

This proof of concept study presents a method to collect and analyse kinetic data from one participant with a transfemoral amputation fitted with a percutaneous osseointegrated implant walking on a level and sloped treadmill. We describe the construction of and results from a bespoke wireless six axis load cell built into one participant's prosthetic assembly. The load cell does not clinically compromise the participant in any way and is an initial milestone in the development of a light-weight wireless load cell for use with percutaneous osseointegrated implants. In this case, it is the first time that kinetic data from a participant fitted with an Intraosseous Transcutaneous Amputation Prosthesis has been published. We propose that the data can be used to model the load transfer to the host bone, with several clinically significant applications. The raw dynamic data are made available and quasi-static load cases for each functional phase of gait are presented. Peak forces obtained in the medio-lateral (X), cranio-caudal (Y) and antero-posterior (Z) axes over level ground respectively were -243.8 N (0.24 BW), 1321.5 N (1.31 BW) and -421.8 N (0.42 BW); uphill were -141.0 N (0.14 BW), 1604.2 N (1.59 BW), -498.1 N (0.49 BW); downhill were -206.0 N (0.20 BW), 1103.9 N (1.09 BW), -547.2 N (0.54 BW). The kinetics broadly followed able bodied gait patterns with some gait strategies consistent in participants with other implant designs or prosthetic socket connections, for example offloading the artificial limb downhill.


Asunto(s)
Amputados , Miembros Artificiales , Prótesis Anclada al Hueso , Humanos , Caminata , Marcha , Amputación Quirúrgica , Diseño de Prótesis , Fenómenos Biomecánicos
16.
Med Eng Phys ; 123: 104091, 2024 01.
Artículo en Inglés | MEDLINE | ID: mdl-38365342

RESUMEN

This short communication presents the gait1415+2 musculoskeletal model, that has been developed in OpenSim to describe the lower-extremity of a human subject with transfemoral amputation wearing a generic lower-limb bone-anchored prosthesis. The model has fourteen degrees of freedom, governed by fifteen musculotendon units (placed at the contralateral and residual limbs) and two generic actuators (one placed at the knee joint and one at the ankle joint of the prosthetic leg). Even though the model is a simplified abstraction, it is capable of generating a human-like walking gait and, specifically, it is capable of reproducing both the kinematics and the dynamics of a person with transfemoral amputation wearing a bone-anchored prosthesis during normal level-ground walking. The model is released as support material to this short communication with the final goal of providing the scientific community with a tool for performing forward and inverse dynamics simulations, and for developing computationally-demanding control schemes based on artificial intelligence methods for lower-limb prostheses.


Asunto(s)
Amputados , Miembros Artificiales , Prótesis Anclada al Hueso , Humanos , Inteligencia Artificial , Caminata , Marcha , Fenómenos Biomecánicos , Diseño de Prótesis
17.
Sci Rep ; 14(1): 627, 2024 01 05.
Artículo en Inglés | MEDLINE | ID: mdl-38182598

RESUMEN

This study evaluated the peri-implant tissues under normal conditions and under the influence of experimental peri-implantitis (EPI) in osseointegrated implants installed in the maxillae of rats treated with oncologic dosage of zoledronate. Twenty-eight senescent female rats underwent the extraction of the upper incisor and placement of a titanium dental implant (DI). After eight weeks was installated a transmucosal healing screw on DI. After nine weeks, the following groups were formed: VEH, ZOL, VEH-EPI and ZOL-EPI. From the 9th until the 19th, VEH and VEH-EPI groups received vehicle and ZOL and ZOL-EPI groups received zoledronate. At the 14th week, a cotton ligature was installed around the DI in VEH-EPI and ZOL-EPI groups to induce the EPI. At the 19th week, euthanasia was performed, and the maxillae were processed so that at the implanted sites were analyzed: histological aspects and the percentage of total bone tissue (PTBT) and non-vital bone tissue (PNVBT), along with TNFα, IL-1ß, VEGF, OCN and TRAP immunolabeling. ZOL group presented mild persistent peri-implant inflammation, higher PNVBT and TNFα and IL-1ß immunolabeling, but lower for VEGF, OCN and TRAP in comparison with VEH group. ZOL-EPI group exhibited exuberant peri-implant inflammation, higher PNVBT and TNFα and IL-1ß immunolabeling when compared with ZOL and VEH-EPI groups. Zoledronate disrupted peri-implant environment, causing mild persistent inflammation and increasing the quantity of non-vital bone tissue. Besides, associated with the EPI there were an exacerbated inflammation and even greater increase in the quantity of non-vital bone around the DI, which makes this condition a risk factor for medication-related osteonecrosis of the jaws.


Asunto(s)
Prótesis Anclada al Hueso , Osteonecrosis , Periimplantitis , Femenino , Animales , Ratas , Periimplantitis/etiología , Ácido Zoledrónico/efectos adversos , Factor de Necrosis Tumoral alfa , Factor A de Crecimiento Endotelial Vascular , Inflamación , Interleucina-1beta , Maxilares
18.
Eur J Orthop Surg Traumatol ; 34(2): 885-892, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-37750975

RESUMEN

PURPOSE: To evaluate the implant survival rate, mechanical complications, and reported patient outcomes of bone-anchored prostheses for patients with lower limb amputation in France after 1-15 years of follow-up. METHODS: This retrospective cohort study included patients who underwent surgery at a single center in France between 2007 and 2021. The primary outcomes were the implant survival rate and functional scores assessed by the Questionnaire for Transfemoral Amputees (Q-TFA). Secondary outcomes were adverse events that occurred during follow-up. RESULTS: The cohort consisted of 20 bone-anchored prostheses in 17 patients. The main level of amputation was transfemoral (82%, n = 14). The main reason for amputation was trauma (n = 15). The mean age at amputation was 32 (range 15-54) years, and the mean age at the first stage of osseointegration was 41 (range 21-58) years. The Kaplan-Meier survival curve showed respective survival rates of 90%, 70%, and 60% at 2, 10, and 15 years. All Q-TFA scores were significantly improved at last the follow-up. Eleven patients (65%) experienced mechanical complications. In total, 37 infectious events occurred in 13 patients (76%), mainly comprising stage 1 infections (68%, n = 25). Only two cases of septic loosening occurred (12%), leading to implant removal. CONCLUSION: This is the first French cohort of bone-anchored prostheses and among the series with the longest follow-up periods. The findings indicate that bone-anchored prostheses are safe and reliable for amputee patients who have difficulties with classic prostheses.


Asunto(s)
Miembros Artificiales , Prótesis Anclada al Hueso , Humanos , Adolescente , Adulto Joven , Adulto , Persona de Mediana Edad , Tasa de Supervivencia , Estudios Retrospectivos , Amputación Quirúrgica/efectos adversos , Oseointegración , Miembros Artificiales/efectos adversos , Extremidad Inferior/cirugía , Medición de Resultados Informados por el Paciente , Diseño de Prótesis
19.
Support Care Cancer ; 31(12): 641, 2023 Oct 18.
Artículo en Inglés | MEDLINE | ID: mdl-37851170

RESUMEN

PURPOSE: To investigate the survival rate in implants placement in irradiated and non-irradiated bone in patients undergoing head and neck cancer (HNC) treatment. We focused on the consequences of the main complications, such as osteoradionecrosis and peri-implantitis. METHODS: An electronic search conducted by PRISMA protocol was performed. Full texts were carefully assessed, and data were assimilated into a tabular form for discussion and consensus among the expert panel. The quality assessment and the risk of bias are verified by Joanna Briggs Institute checklist (JBI) and The Newcastle-Ottawa Scale (NOS), and Risk of Bias in Non-Randomized Studies of Interventions (ROBINS-I) assessment tool. RESULTS: A total of 452 records were identified in the based on our PICOs strategy and after screening, 19 articles were included in the descriptive analysis of the review. Totaling 473 implants placed in irradiated and non-irradiated bone, and 31.6% of the patients were over 60 years of age. 57.9%) performed implant placement in a period of 12 months or more after the ending of radiotherapy. Only 5 studies had a follow-up period longer than 5 years after implant placement, of which three were used for the meta-analysis. In the meta-analysis of 5-year survival rate, analysis of implants in irradiated bone was assessed; a random effect model was used and a weighted proportion (PP) of 93.13% (95% CI: 87.20-99.06; p < 0.001), and in the 5-year survival rate, analysis of implants in non-irradiated bone was analysed; a fixed effect model was used and a weighted proportion (PP) of 98.52% survival (95% CI: 97.56-99.48, p < 0.001). CONCLUSIONS: Survival rates of implants placed in irradiated bone are clinically satisfactory after a follow-up of 5 years, with a fewer percentage than in implants placed in non-irradiated bone after metanalyses performed.


Asunto(s)
Prótesis Anclada al Hueso , Neoplasias de Cabeza y Cuello , Humanos , Persona de Mediana Edad , Anciano , Neoplasias de Cabeza y Cuello/radioterapia
20.
Acta Orthop ; 94: 499-504, 2023 10 10.
Artículo en Inglés | MEDLINE | ID: mdl-37830879

RESUMEN

BACKGROUND AND PURPOSE: Little is known about the activities of daily living (ADL) of patients with a bone-anchored prosthesis (BAP). We aimed to objectively measure ADL without and with BAP during standard care of follow-up. Our secondary aim was to measure mobility and walking ability. PATIENTS AND METHODS: Patients aged 18-99 years who underwent surgery for transfemoral or transtibial BAP between September 11, 2017, and February 11, 2021, were eligible for inclusion in this retrospective case series of patients with socket prosthesis. ADL was measured with a continuous recording activity monitor (hours [h]) before surgery, and at 6, 12, and 24 months with BAP. Mobility and walking ability were assessed by the Timed Up and Go test (TUG) (seconds [s]) and 6 Minute Walk Test (6MWT) (meters [m]), respectively. RESULTS: 48 of the 57 eligible patients provided informed consent and were included. Their age was 59 (1st quartile to 3rd quartile 51-63) years. Total daily activity before BAP was 1.6 h (0.82-2.1) and increased to 2.1 h (1.4-2.5) at 6, 2.0 h (1.5-2.7) at 12, and 2.7 h (2.0-3.3) at 24 months with BAP. Daily walking increased from 1.3 h (0.79-1.9) before BAP to 1.8 h (1.6-2.3) at 6, to 1.7 h (1.2-2.4) at 12, and 2.0 h (1.6-2.6) at 24 months. Median TUG decreased from 12 s (9.1-14) before BAP to 8.9 s (7.7-10) at 24 months. Mean 6MWT increased from 272 m (SD 92) before BAP to 348 m (SD 68) at 24 months. CONCLUSION: Objective measurements on ADL positively changed in patients with BAP. This effect was also seen in mobility and walking ability at 24 months.


Asunto(s)
Amputados , Miembros Artificiales , Prótesis Anclada al Hueso , Humanos , Actividades Cotidianas , Estudios de Seguimiento , Estudios Retrospectivos , Equilibrio Postural , Estudios de Tiempo y Movimiento , Extremidad Inferior/cirugía , Caminata
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