Loading applied on osseointegrated implant by transtibial bone-anchored prostheses during daily activities: Preliminary characterization of prosthetic feet.
Loading applied on osseointegrated implant by transtibial bone-anchored prostheses during daily activities: Preliminary characterization of prosthetic feet.
Project description:The data in this paper are related to the research article entitled "Loading applied on osseointegrated implant by transtibial bone-anchored prostheses during daily activities: Preliminary characterization of prosthetic feet" (Frossard et al., 2019: Accepted). This article contains the individual and grouped loading characteristics applied on transtibial osseointegrated implant generated while walking with bone-anchored prostheses including prosthetic feet with different index of anthropomorphicity. Inter-participant variability was presented for (A) the spatio-temporal characteristics, (B) the loading boundaries and (C) the loading local extremum during walking, ascending and descending ramp and stairs. These initial inter-participant variability benchmark datasets are critical to improve the efficacy and safety of prosthetic components for transtibial prostheses as well as the design of future automated algorithms and clinical trials. Online repository contains the files: https://doi.org/10.17632/vhc6sf7ngy.1.
Project description:The data in this paper are related to the research article entitled "Load applied on osseointegrated implant by transfemoral bone-anchored prostheses fitted with state-of-the-art prosthetic components" (Frossard et al. Clinical Biomechanics, 89 (2021) 105457. DOI: 10.1016/j.clinbiomech.2021.105457). This article contains the overall and individual loading characteristics applied on transfemoral press-fit osseointegrated implant generated by bone-anchored prostheses fitted with state-of-the-art components during daily activities (i.e., microprocessor-controlled Rheo Knee XC knee, energy-storing-and-returning Pro-Flex XC or LP feet (ÖSSUR, Iceland)). Confounders of the loads are presented. The load profiles are characterized by the loading patterns, loading boundaries and loading local extrema of the forces and moments applied during straight-level walking, ascending and descending ramp and stairs at self-selected comfortable pace. The confounders of the loading information as well as new insights into inter-participants variability of loading patterns, loading boundaries and loading local extrema can inform the design of subsequent cross-sectional and longitudinal studies as well as literature reviews and meta-analyzes. The loading datasets are critical to clinicians and engineers designing finite element models of osseointegrated implants (e.g., medullar and percutaneous parts) and prosthetic components, algorithms capable to recognize the loading patterns applied on a residuum during daily activities, as well as clinical trials assessing the effects of particular prosthetic care interventions. Altogether, these datasets provide promoters of prosthetic care innovations with valuable insights informing the prescription of advanced prosthetic components to the growing population of individuals suffering from lower limb loss choosing bionics solutions. Online repository contains the files: https://data.mendeley.com/datasets/gmsyv97cpc/1.
Project description:Percutaneous osseointegrated (OI) implants are increasingly viable as an alternative to socket suspension of prosthetic limbs. Upper extremity prostheses have also become more complex to better replicate hand and arm function and attempt to recreate pre-amputation functional levels. With more functionality comes heavier devices that put more stress on the bone-implant interface, which could be an issue for implant stability. This study quantified transhumeral loading at defined amputation levels using four simulated prosthetic limb-types: (1) body powered hook, (2) myoelectric hook, (3) myoelectric hand, and (4) advanced prosthetic limb. Computational models were constructed to replicate the weight distribution of each prosthesis type, then applied to motion capture data collected during Advanced Activities of Daily Living (AADLs). For activities that did not include a handheld weight, the body powered prosthesis bending moments were 13-33% (range of means for each activity across amputation levels) of the intact arm moments (reference 100%), torsional moments were 12-15%, and axial pullout forces were 30-40% of the intact case (p≤0.001). The myoelectric hook and hand bending moments were 60-99%, torsional moments were 44-97%, and axial pullout forces were 62-101% of the intact case. The advanced prosthesis bending moments were 177-201%, torsional moments were 164-326%, and axial pullout forces were 133-185% of the intact case (p≤0.001). The addition of a handheld weight for briefcase carry and jug lift activities reduced the overall impact of the prosthetic model itself, where the body powered forces and moments were much closer to those of the intact model, and more complex prostheses further increased forces and moments beyond the intact arm levels. These results reveal a ranked order in loading magnitude according to complexity of the prosthetic device, and highlight the importance of considering the patient's desired terminal device when planning post-operative percutaneous OI rehabilitation and training.
Project description:BackgroundDigital amputation is a common upper extremity injury and can cause significant impairment in hand function, as well as psychosocial stigma. Currently, the gold standard for the reconstruction of such injuries involves autologous reconstruction. However, when this or other autologous options are not available, prosthetic reconstruction can provide a functionally and aesthetically viable alternative. This study describes a novel technique, known as a tripod titanium mini-plate, for osseointegrated digit prostheses, and reviews the outcomes in a set of consecutive patients.MethodsA retrospective review of patients who underwent 2-stage prosthetic reconstruction of digit amputations was performed. Demographic information, occupation, mechanism of injury, number of amputated fingers, and level of amputation were reviewed. Functional and aesthetic outcomes were assessed using the quick disabilities of the arm, shoulder, and hand (Q-DASH) scale and a visual analog scale (VAS) score, respectively. In addition, complications during the postoperative period were recorded.ResultsSeven patients were included in this study. Their average age was 29 years. Five patients had single-digit amputations and 2 patients had multiple-digit amputations. Functional and aesthetic outcomes were assessed using the Q-DASH score (average, 10.4) and VAS score (average, 9.1), respectively. One episode of mild cellulitis was seen at 24 months of follow-up. However, it was treated successfully with oral antibiotics. No other complications were reported.ConclusionsWhen autologous reconstruction is not suitable for digit reconstruction, prosthetic osseointegrated reconstruction can provide good aesthetic and functional results. However, larger series with longer-term follow-up are required in order to rule out the possibility of other complications.
Project description:The data in this paper are related to the research article entitled "Development of a government continuous quality improvement procedure for assessing the provision of bone anchored limb prosthesis: A process re-design descriptive study" (Frossard et al., Canadian Prosthetics & Orthotics Journal, 2018. 1(2). p. 1-14). This article contains quality of life data experienced by individuals before and after implantation of a press-fit or screw-type osseointegrated fixation when fitted with conventional socket-suspended and bone-anchored limb prosthesis, respectively. This specifically-designed survey was developed and administered by Queensland Artificial Limb Services (QALS), an Australian State government organization. It was an integrated part of QALS' continuous quality improvement procedure for assessing the provision of bone-anchored prosthesis. A total of 12 out of the 65 consumers completed to the survey, giving a return rate of 18%. This benchmark information can contribute to inform the design of (A) other patients' experience surveys including those built-in governmental continuous quality improvement procedure as well as (B) clinical trials looking at the overall effects of surgical implantation of ossoeintegrated fixation on patients' quality of life. Online repository contains the files: https://data.mendeley.com/datasets/bkbxxmrhfh/1.
Project description:Cadaveric mechanical testing of a percutaneous osseointegration docking system (PODS) for osseointegration (OI) prosthetic limb attachment revealed that translation of the exact system from the humerus to the tibia may not be suitable. The PODS, designed specifically for the humerus achieved 1.4-4.8 times greater mechanical stability in the humerus than in the tibia despite morphology that indicated translational feasibility. To better understand this discrepancy, finite element analyses (FEAs) modeled the implantation of the PODS into the bones. Models from cadaveric humeri (n = 3) and tibia (n = 3) were constructed from CT scans, and virtual implantation preparation of an array of endoprosthesis sizes that made contact with the endosteal surface but did not penetrate the outer cortex was performed. Final impaction of the endoprosthesis was simulated using a displacement ramp function to press the endoprosthesis model into the bone. Impaction force and maximum first principal (circumferential) stress were recorded to estimate stability and assess fracture risk of the system. We hypothesized that the humerus and tibia would have different optimal PODS sizing criteria that maximized impaction force and minimized first principal stress. The optimal sizing for the humerus corresponded to implantation instructions, whereas for the tibia optimal sizing was three times larger than the guidelines indicated. This FEA examination of impaction force and stress distribution lead us to believe that the same endoprosthesis strategy for the humerus is not suitable for the tibia because of thin medial and lateral cortices that compromise implantation.
Project description:Contemporary prosthetic feet are generally optimized for either daily or high-level activities. Prosthesis users, therefore, often require multiple prostheses to participate in activities that span a range of mobility. Crossover feet (XF) are designed to increase the range of activities that can be performed with a single prosthesis. However, little evidence exists to guide clinical prescription of XF relative to traditional energy storing feet (ESF). The objective of this study was to assess the effects of XF and ESF on health outcomes in people with transtibial amputation. A randomized crossover study was conducted to assess changes in laboratory-based (endurance, perceived exertion, walking performance) and community-based (step activity and self-reported mobility, fatigue, balance confidence, activity restrictions, and satisfaction) outcomes. Twenty-seven participants were fit with XF and ESF prostheses with standardized sockets, interfaces, and suspensions. Participants were not blinded to the intervention, and wore each prosthesis for one month while their steps were counted with an activity monitor. After each accommodation period, participants returned for data collection. Endurance and perceived exertion were measured with the Six-Minute Walk Test and Borg-CR100, respectively. Walking performance was measured using an electronic walkway. Self-reported mobility, fatigue, balance confidence, activity restrictions, and satisfaction were measured with survey instruments. Participants also reported foot preferences upon conclusion of the study. Differences between feet were assessed with a crossover analysis. While using XF, users experienced improvements in most community-based outcomes, including mobility (p = .001), fatigue (p = .001), balance confidence (p = .005), activity restrictions (p = .002), and functional satisfaction (p < .001). Participants also exhibited longer sound side steps in XF compared to ESF (p < .001). Most participants (89%) reported an overall preference for XF; others (11%) reported no preference. Results indicate that XF may be a promising alternative to ESF for people with transtibial amputation who engage in a range of mobility activities.Trial registrationClinicalTrials.gov NCT02440711.
Project description:ObjectivesThe aim of this systematic review was to analyze post-loading implant loss for implant-supported prostheses in edentulous jaws, regarding a potential impact of implant location (maxilla vs. mandible), implant number per patient, type of prosthesis (removable vs. fixed), and type of attachment system (screw-retained, ball vs. bar vs. telescopic crown).Material and methodsA systematic literature search for randomized-controlled trials (RCTs) or prospective studies was conducted within PubMed, Cochrane Library, and Embase. Quality assessment of the included studies was carried out, and the review was structured according to PRISMA. Implant loss and corresponding 3- and 5-year survival rates were estimated by means of a Poisson regression model with total exposure time as offset.ResultsAfter title, abstract, and full-text screening, 54 studies were included for qualitative analyses. Estimated 5-year survival rates of implants were 97.9% [95% CI 97.4; 98.4] in the maxilla and 98.9% [95% CI 98.7; 99.1] in the mandible. Corresponding implant loss rates per 100 implant years were significantly higher in the maxilla (0.42 [95% CI 0.33; 0.53] vs. 0.22 [95% CI 0.17; 0.27]; P = 0.0001). Implant loss rates for fixed restorations were significantly lower compared to removable restorations (0.23 [95% CI 0.18; 0.29] vs. 0.35 [95% CI 0.28; 0.44]; P = 0.0148). Four implants and a fixed restoration in the mandible resulted in significantly higher implant loss rates compared to five or more implants with a fixed restoration. The analysis of one implant and a mandibular overdenture also revealed higher implant loss rates than an overdenture on two implants. The same (lower implant number = higher implant loss rate) applied when comparing 2 vs. 4 implants and a mandibular overdenture. Implant loss rates for maxillary overdentures on <4 implants were significantly higher than for four implants (7.22 [95% CI 5.41; 9.64] vs. 2.31 [1.56; 3.42]; P < 0.0001).ConclusionsImplant location, type of restoration, and implant number do have an influence on the estimated implant loss rate. Consistent reporting of clinical studies is necessary and high-quality studies are needed to confirm the present results.
Project description:The prosthetic socket, which transfers load from the residual limb to the prosthesis, is an integral part of the prosthesis. 3D printing has emerged as a potentially viable alternative to traditional fabrication for producing sockets that effectively transfer loads. We conducted a systematic review to better understand the current state of this newer fabrication method, with a focus on the structural integrity of 3D printed sockets and factors that can affect the strength of 3D printed sockets when tested using ISO 10328 standards. Literature searches were carried out in five databases (PubMed, Scopus, CINAHL, Web of Science and Google Scholar). Two reviewers independently performed the literature selection, quality assessment, and data extraction. A total of 1023 unique studies were screened in accordance with inclusion and exclusion criteria. Of 1023 studies, 12 studies met all inclusion criteria, with failure data for 15 3D-printed sockets and 26 standard laminated sockets. Within 3D printed sockets, the addition of composite materials such as carbon fiber particles and distal reinforcement using a compositing infill technique appears to improve socket strength. In light of the considerable amount of heterogeneity between studies in terms of materials and alignment used, the absolute values for failure could not be established for 3DS nor directly compared between 3DS and LCS. However, there is some evidence that the probability of a failure at a given load may be comparable between 3DS and LCS up to the P8 level. For all sockets, whether a laminated composite socket or a 3D printed socket, failure mainly occurred at the distal end of the socket or the pyramid attachment, which is consistent with the ISO testing protocol. Improving the strength of the 3D printed sockets through design modifications at the distal end and implementing emerging printing technologies could help to promote 3D printed sockets as a viable option, particularly when cost or access to care is limited.
Project description:Bone-anchored limb prostheses allow for the direct transfer of external loads from the prosthesis to the skeleton, eliminating the need for a socket and the associated problems of poor fit, discomfort, and limited range of movement. A percutaneous implant system for direct skeletal attachment of an external limb must provide a long-term, mechanically stable interface to the bone, along with an infection barrier to the external environment. In addition, the mechanical integrity of the implant system and bone must be preserved despite constant stresses induced by the limb prosthesis. Three different percutaneous implant systems for direct skeletal attachment of external limb prostheses are currently clinically available and a few others are under investigation in human subjects. These systems employ different strategies and have undergone design changes with a view to fulfilling the aforementioned requirements. This review summarises such strategies and design changes, providing an overview of the biomechanical characteristics of current percutaneous implant systems for direct skeletal attachment of amputation limb prostheses.