Loading compliance of static load bearing exercises performed by transfemoral amputees fitted with an osseointegrated implant

Background To date bone-anchored prostheses are used to alleviate the concerns caused by socket suspended prostheses and to improve the quality of life of transfemoral amputees (TFA). Currently, two implants are commercially available (i.e., OPRA (Integrum AB, Sweden), ILP (Orthodynamics GmbH, Germany)). [1-17]The success of the OPRA technique is codetermined by the rehabilitation program. TFA fitted with an osseointegrated implant perform progressive mechanical loading (i.e. static load bearing exercises (LBE)) to facilitate bone remodelling around the implant.[18, 19] Aim This study investigated the trustworthiness of monitoring the load prescribed (LP) during experimental static LBEs using the vertical force provided by a mechanical bathroom scale that is considered a surrogate of the actual load applied. Method Eleven unilateral TFAs fitted with an OPRA implant performed five trials in four loading conditions. The forces and moments on the three axes of the implant were measured directly with an instrumented pylon including a six-channel transducer. The “axial” and “vectorial” comparisons corresponding to the difference between the force applied on the long axis of the fixation and LP as well as the resultant of the three components of the load applied and LP, respectively were analysed Results For each loading condition, Wilcoxon One-Sample Signed Rank Tests were used to investigate if significant differences (p<0.05) could be demonstrated between the force applied on the long axis and LP, and between the resultant of the force and LP. The results demonstrated that the raw axial and vectorial differences were significantly different from zero in all conditions (p<0.05), except for the vectorial difference for the 40 kg loading condition (p=0.182). The raw axial difference was negative for all the participants in every loading condition, except for TFA03 in the 10 kg condition (11.17 N). Discussion & Conclusion This study showed a significant lack of axial compliance. The load applied on the long axis was significantly smaller than LP in every loading condition. This led to a systematic underloading of the long axis of the implant during the proposed experimental LBE. Monitoring the vertical force might be only partially reflective of the actual load applied, particularly on the long axis of the implant.

Evaluation framework to assess orthopaedic procedures

Introduction & aims The demand for evidence of efficacy of treatments in general and orthopaedic surgical procedures in particular is ever increasing in Australia and worldwide. The aim of this study is to share the key elements of an evaluation framework recently implemented in Australia to determine the efficacy of bone-anchored prostheses. Method The proposed evaluation framework to determine the benefit and harms of bone-anchored prostheses for individuals with limb loss was extracted from a systematic review of the literature including seminal studies focusing on clinical benefits and safety of procedures involving screw-type implant (e.g., OPRA) and press-fit fixations (e.g., EEFT, ILP, OPL). [1-64] Results The literature review highlighted that a standard and replicable evaluation framework should focus on: • The clinical benefits with a systematic recording of health-related quality of life (e.g., SF-26, Q-TFA), mobility predictor (e.g., AMPRO), ambulation abilities (e.g., TUG, 6MWT), walking abilities (e.g., characteristic spatio-temporal) and actual activity level at baseline and follow-up post Stage 2 surgery, • The potential harms with systematic recording of residuum care, infection, implant stability, implant integrity, injuries (e.g., falls) after Stage 1 surgery. There was a general consensus around the instruments to monitor most of the benefits and harms. The benefits could be assessed using a wide spectrum of complementary assessments ranging from subjective patient self-reporting to objective measurements of physical activity. However, this latter was assessed using a broad range of measurements (e.g., pedometer, load cell, energy consumption). More importantly, the lack of consistent grading of infections was sufficiently noticeable to impede cross-fixation comparisons. Clearly, a more universal grading system is needed. Conclusions Investigators are encouraged to implement an evaluation framework featuring the domains and instruments proposed above using a single database to facilitate robust prospective studies about potential benefits and harms of their procedure. This work is also a milestone in the development of national and international clinical outcome registries.

Osseointegrated total knee replacement connected to a lower limb prosthesis: 4 cases

Background and purpose — Osseointegrated implants are an alternative for prosthetic attachment in individuals with amputation who are unable to wear a socket. However, the load transmitted through the osseointegrated fixation to the residual tibia and knee joint can be unbearable for those with transtibial amputation and knee arthritis. We report on the feasibility of combining total knee replacement (TKR) with an osseointegrated implant for prosthetic attachment. Patients and methods — We retrospectively reviewed all 4 cases (aged 38–77 years) of transtibial amputations managed with osseointegration and TKR in 2012–2014. The below-the-knee prosthesis was connected to the tibial base plate of a TKR, enabling the tibial residuum and knee joint to act as weight-sharing structures. A 2-stage procedure involved connecting a standard hinged TKR to custom-made implants and creation of a skin-implant interface. Clinical outcomes were assessed at baseline and after 1–3 years of follow-up using standard measures of health-related quality of life, ambulation, and activity level including the questionnaire for transfemoral amputees (Q-TFA) and the 6-minute walk test. Results — There were no major complications, and there was 1 case of superficial infection. All patients showed improved clinical outcomes, with a Q-TFA improvement range of 29–52 and a 6-minute walk test improvement range of 37–84 meters. Interpretation — It is possible to combine TKR with osseointegrated implants.

Direct measurement of inner prosthesis loading during activities of daily living: Proposal for classification of functional outcome

Background The purpose of this presentation is to outline the relevance of the categorization of the load regime data to assess the functional output and usage of the prosthesis of lower limb amputees. The objectives are • To highlight the need for categorisation of activities of daily living • To present a categorization of load regime applied on residuum, • To present some descriptors of the four types of activity that could be detected, • To provide an example the results for a case. Methods The load applied on the osseointegrated fixation of one transfemoral amputee was recorded using a portable kinetic system for 5 hours. The load applied on the residuum was divided in four types of activities corresponding to inactivity, stationary loading, localized locomotion and directional locomotion as detailed in previously publications. Results The periods of directional locomotion, localized locomotion, and stationary loading occurred 44%, 34%, and 22% of recording time and each accounted for 51%, 38%, and 12% of the duration of the periods of activity, respectively. The absolute maximum force during directional locomotion, localized locomotion, and stationary loading was 19%, 15%, and 8% of the body weight on the anteroposterior axis, 20%, 19%, and 12% on the mediolateral axis, and 121%, 106%, and 99% on the long axis. A total of 2,783 gait cycles were recorded. Discussion Approximately 10% more gait cycles and 50% more of the total impulse than conventional analyses were identified. The proposed categorization and apparatus have the potential to complement conventional instruments, particularly for difficult cases.

Does gait speed indicate prosthetic walking potential following lower limb amputation?

Background: Gait speed is an indicator of walking ability, morbidity and mortality; and is a reliable, valid and sensitive outcome measure commonly used in the rehabilitation setting. Gait speed is a quick and efficient assessment method; yet, to date, there has been little investigation of its potential use in populations with lower limb amputation.

Lower limb amputation in Northern Netherlands: Unchanged incidence from 1991-1992 to 2003-2004

Background Investigating population changes gives insight into effectiveness and need for prevention and rehabilitation services. Incidence rates of amputation are highly varied, making it difficult to meaningfully compare rates between studies and regions or to compare changes over time. Study Design Historical cohort study of transtibial amputation, knee disarticulation, and transfemoral amputations resulting from vascular disease or infection, with/without diabetes, in 2003-2004, in the three Northern provinces of the Netherlands. Objectives To report the incidence of first transtibial amputation, knee disarticulation, or transfemoral amputation in 2003-2004 and the characteristics of this population, and to compare these outcomes to an earlier reported cohort from 1991 to 1992. Methods Population-based incidence rates were calculated per 100,000 person-years and compared across the two cohorts. Results Incidence of amputation was 8.8 (all age groups) and 23.6 (≥45 years) per 100,000 person-years. This was unchanged from the earlier study of 1991-1992. The relative risk of amputation was 12 times greater for people with diabetes than for people without diabetes. Conclusions Investigation is needed into reasons for the unchanged incidence with respect to the provision of services from a range of disciplines, including vascular surgery, diabetes care, and multidisciplinary foot clinics. Clinical relevance This study shows an unchanged incidence of amputation over time and a high risk of amputation related to diabetes. Given the increased prevalence of diabetes and population aging, both of which present an increase in the population at risk of amputation, finding methods for reducing the rate of amputation is of importance.

The good, the bad and the ugly of bone-anchored prostheses: Guideline to assess true clinical outcomes

The aim of this study is to share the key elements of an evaluation framework to determine the true clinical outcomes of bone-anchored prostheses. Scientists, clinicians and policy makers are encouraged to implement their own evaluations relying on the proposed framework using a single database to facilitate reflective practice and, eventually, robust prospective studies.

Whole of life cycle cost analysis in bridge rehabilitation

The report presents a methodology for whole of life cycle cost analysis of alternative treatment options for bridge structures, which require rehabilitation. The methodology has been developed after a review of current methods and establishing that a life cycle analysis based on a probabilistic risk approach has many advantages including the essential ability to consider variability of input parameters. The input parameters for the analysis are identified as initial cost, maintenance, monitoring and repair cost, user cost and failure cost. The methodology utilizes the advanced simulation technique of Monte Carlo simulation to combine a number of probability distributions to establish the distribution of whole of life cycle cost. In performing the simulation, the need for a powerful software package, which would work with spreadsheet program, has been identified. After exploring several products on the market, @RISK software has been selected for the simulation. In conclusion, the report presents a typical decision making scenario considering two alternative treatment options.

User friendly guide for rehabilitation or strengthening of bridge structures using fiber reinforced polymer composites

A worldwide interest is being generated in the use of fibre reinforced polymer composites (FRP) in rehabilitation of reinforced concrete structures. As a replacement for the traditional steel plates or external post-tensioning in strengthening applications, various types of FRP plates, with their high strength to weight ratio and good resistance to corrosion, represent a class of ideal material in external retrofitting. Within the last ten years, many design guidelines have been published to provide guidance for the selection, design and installation of FRP systems for external strengthening of concrete structures. Use of these guidelines requires understanding of a number of issues pertaining to different properties and structural failure modes specific to these materials. A research initiative funded by the CRC for Construction Innovation was undertaken (primarily at RMIT) to develop a decision support tool and a user friendly guide for use of fibre reinforced polymer composites in rehabilitation of concrete structures. The user guidelines presented in this report were developed after industry consultation and a comprehensive review of the state of the art technology. The scope of the guide was mainly developed based on outcomes of two workshops with Queensland Department of Main Roads (QDMR). The document covers material properties, recommended construction requirements, design philosophy, flexural, shear and torsional strengthening of beams and strengthening of columns. In developing this document, the guidelines published on FIB Bulletin 14 (2002), Task group 9.3, International Federation of Structural Concrete (FIB) and American Concrete Institute Committee 440 report (2002) were consulted in conjunction with provisions of the Austroads Bridge design code (1992) and Australian Concrete Structures code AS3600 (2002). In conclusion, the user guide presents design examples covering typical strengthening scenarios.

Decision support tools for concrete infrastructure rehabilitation (using FRP composites)

This report presents a summary of the research conducted by the research team of the CRC project 2002-005-C, “Decision support tools for concrete infrastructure rehabilitation”. The project scope, objectives, significance and innovation and the research methodology is outlined in the introduction, which is followed by five chapters covering different aspects of the research completed. Major findings of a review of literature conducted covering both use of fibre reinforced polymer composites in rehabilitation of concrete bridge structures and decision support frameworks in civil infrastructure asset management is presented in chapter two. Case study of development of a strengthening scheme for the “Tenthill Creek bridge” is covered in the third chapter, which summarises the capacity assessment, traditional strengthening solution and the innovative solution using FRP composites. The fourth chapter presents the methodology for development of a user guide covering selection of materials, design and application of FRP in strengthening of concrete structures, which were demonstrated using design examples. Fifth chapter presents the methodology developed for evaluating whole of life cycle costing of treatment options for concrete bridge structures. The decision support software tool developed to compare different treatment options based on reliability based whole of life cycle costing will be briefly described in this chapter as well. The report concludes with a summary of findings and recommendations for future research.

Final : report assessing risk and variation in maintenance and rehabilitation costs for road network

This report presents the results of research projects conducted by The Australian Cooperative Research Centre for Construction Innovation, Queensland University of Technology, RMIT University, Queensland Government Department of Main Roads and Queensland Department of Public Works. The research projects aimed at developing a methodology for assessing variation and risk in investment in road network, including the application of the method in assessing road network performance and maintenance and rehabilitation costs for short- and long-term future investment.

Report : review of the literature : maintenance and rehabilitation costs for roads (Risk-based Analysis)

Realistic estimates of short- and long-term (strategic) budgets for maintenance and rehabilitation of road assessment management should consider the stochastic characteristics of asset conditions of the road networks so that the overall variability of road asset data conditions is taken into account. The probability theory has been used for assessing life-cycle costs for bridge infrastructures by Kong and Frangopol (2003), Zayed et.al. (2002), Kong and Frangopol (2003), Liu and Frangopol (2004), Noortwijk and Frangopol (2004), Novick (1993). Salem 2003 cited the importance of the collection and analysis of existing data on total costs for all life-cycle phases of existing infrastructure, including bridges, road etc., and the use of realistic methods for calculating the probable useful life of these infrastructures (Salem et. al. 2003). Zayed et. al. (2002) reported conflicting results in life-cycle cost analysis using deterministic and stochastic methods. Frangopol et. al. 2001 suggested that additional research was required to develop better life-cycle models and tools to quantify risks, and benefits associated with infrastructures. It is evident from the review of the literature that there is very limited information on the methodology that uses the stochastic characteristics of asset condition data for assessing budgets/costs for road maintenance and rehabilitation (Abaza 2002, Salem et. al. 2003, Zhao, et. al. 2004). Due to this limited information in the research literature, this report will describe and summarise the methodologies presented by each publication and also suggest a methodology for the current research project funded under the Cooperative Research Centre for Construction Innovation CRC CI project no 2003-029-C.

Report : development of a methodology for assessing variation in maintenance and rehabilitation costs

In the previous research CRC CI 2001-010-C “Investment Decision Framework for Infrastructure Asset Management”, a method for assessing variation in cost estimates for road maintenance and rehabilitation was developed. The variability of pavement strength collected from a 92km national highway was used in the analysis to demonstrate the concept. Further analysis was conducted to identify critical input parameters that significantly affect the prediction of road deterioration. In addition to pavement strength, rut depth, annual traffic loading and initial roughness were found to be critical input parameters for road deterioration. This report presents a method developed to incorporate other critical parameters in the analysis, such as unit costs, which are suspected to contribute to a certain degree to cost estimate variation. Thus, the variability of unit costs will be incorporated in this analysis. Bruce Highway located in the tropical east coast of Queensland has been identified to be the network for the analysis. This report presents a step by step methodology for assessing variation in road maintenance and rehabilitation cost estimates.

Identification of critical input variables for risk-based cost estimates for road maintenance and rehabilitation

An estimation of costs for maintenance and rehabilitation is subject to variation due to the uncertainties of input parameters. This paper presents the results of an analysis to identify input parameters that affect the prediction of variation in road deterioration. Road data obtained from 1688 km of a national highway located in the tropical northeast of Queensland in Australia were used in the analysis. Data were analysed using a probability-based method, the Monte Carlo simulation technique and HDM-4’s roughness prediction model. The results of the analysis indicated that among the input parameters the variability of pavement strength, rut depth, annual equivalent axle load and initial roughness affected the variability of the predicted roughness. The second part of the paper presents an analysis to assess the variation in cost estimates due to the variability of the overall identified critical input parameters.