Bone-anchored prostheses for transfemoral amputation: a systematic review of outcomes, complications, patient experiences, and cost-effectiveness.

Introduction: Bone-anchored prostheses (BAP) are an advanced reconstructive surgical approach for individuals who had transfemoral amputation and are unable to use the conventional socket-suspension systems for their prostheses. Access to this technology has been limited in part due to the lag between the start of a new procedure and the availability of evidence that is required before making decisions about widespread provision. This systematic review presents as a single resource up-to-date information on aspects most relevant to decision makers, i.e., clinical efficacy, safety parameters, patient experiences, and health economic outcomes of this technology. Methods: A systematic search of the literature was conducted by an information specialist in PubMed, MEDLINE, Embase, CINAHL, Cochrane Library, the Core Collection of Web of Science, CADTH's Grey Matters, and Google Scholar up until May 31, 2023. Peer-reviewed original research articles on the outcomes of clinical effectiveness (health-related quality of life, mobility, and prosthesis usage), complications and adverse events, patient experiences, and health economic outcomes were included. The quality of the studies was assessed using the Oxford Centre for Evidence-Based Medicine Levels of Evidence and ROBINS-I, as appropriate. Results: Fifty studies met the inclusion criteria, of which 12 were excluded. Thirty-eight studies were finally included in this review, of which 21 reported on clinical outcomes and complications, 9 case series and 1 cohort study focused specifically on complications and adverse events, and 2 and 5 qualitative studies reported on patient experience and health economic assessments, respectively. The most common study design is a single-arm trial (pre-/post-intervention design) with varying lengths of follow-up. Discussion: The clinical efficacy of this technology is evident in selected populations. Overall, patients reported increased health-related quality of life, mobility, and prosthesis usage post-intervention. The most common complication is a superficial or soft-tissue infection, and more serious complications are rare. Patient-reported experiences have generally been positive. Evidence indicates that bone-anchored implants for prosthesis fixation are cost-effective for those individuals who face significant challenges in using socket-suspension systems, although they may offer no additional advantage to those who are functioning well with their socket-suspended prostheses.

A scoring system to evaluate stability of percutaneous osseointegrated implants for transfemoral amputation with validation in the ITAP clinical trial.

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.

Mechanical load applied by Intraosseous Transcutaneous Amputation Prosthesis (ITAP) during walking on level and sloped treadmill: A case study.

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.

Walking ability of individuals fitted with transfemoral bone-anchored prostheses: A comparative study of gait parameters.

OBJECTIVE: This study presents the walking abilities of participants fitted with transfemoral bone-anchored prostheses using a total of 14 gait parameters. DESIGN: Two-centre retrospective cross-sectional comparative study. SETTING: Research facilities equipped with tridimensional motion capture systems. PARTICIPANTS: Two control arms included eight able-bodied participants arm (54 ± 9 years, 1.75 ± 0.07 m, 76 ± 7 kg) and nine participants fitted with transfemoral socket-suspended prostheses arm (59 ± 9 years, 1.73 ± 0.07 m, 80 ± 16 kg). The intervention arm included nine participants fitted with transfemoral bone-anchored prostheses arm (51 ± 13 years, 1.78 ± 0.09 m, 87.3 ± 16.1 kg). INTERVENTION: Fitting of transfemoral bone-anchored prostheses. MAIN MEASURES: Comparisons were performed for two spatio-temporal, three spatial and nine temporal gait parameters. RESULTS: The cadence and speed of walking were 107 ± 6 steps/min and 1.23 ± 0.19 m/s for the able-bodied participants arm, 88 ± 7 steps/min and 0.87 ± 0.17 m/s for the socket-suspended prosthesis arm, and 96 ± 6 steps/min and 1.03 ± 0.17 m/s for bone-anchored prosthesis arm, respectively. Able-bodied participants and bone-anchored prosthesis arms were comparable in age, height, and body mass index as well as cadence and speed of walking, but the able-bodied participant arm showed a swing phase 31% shorter. Bone-anchored and socket-suspended prostheses arms were comparable for age, height, mass, and body mass index as well as cadence and speed of walking, but the bone-anchored prosthesis arm showed a step width and duration of double support in seconds 65% and 41% shorter, respectively. CONCLUSIONS: Bone-anchored and socket-suspended prostheses restored equally well the gait parameters at a self-selected speed. This benchmark data provides new insights into the walking ability of individuals using transfemoral bionics bone-anchored prostheses.

Comparison of conventional socket attachment and bone-anchored prosthesis for persons living with transfemoral amputation - mobility and quality of life.

BACKGROUND: For patients with transfemoral amputation experiencing issues with their sockets, bone-anchored prosthesis systems are an alternative and sometimes the only way to be mobile and independent. The present cross-sectional study aimed to investigate the gait performance and quality of life of a group of patients treated with bone-anchored systems compared to those of participants treated with a conventional socket-suspended prosthesis. METHODS: A total of 17 participants with a socket-suspended and 20 with a bone-anchored prosthesis were included. Gait patterns were examined for symmetry, and performance was assessed using the six-minute walk test and the timed "Up & Go" test. Magnetic resonance imaging was performed to detect signs of osteoarthritis in both hips. Mobility in everyday life and quality of life were assessed using questionnaires. FINDINGS: There were no differences between the groups regarding the quality of life, daily mobility, and gait performance. The step width was significantly higher for the patients using socket-suspended prosthesis. The socket-suspended group showed a significant asymmetry regarding the step length. In the socket-suspended group, the prosthetic leg showed significantly higher cartilage abrasion than the contralateral leg did. INTERPRETATION: Large differences in the measured outcomes in both groups illustrate the very different capabilities of the individual participants, which is apparently not primarily determined by the type of treatment. For patients who are satisfied with the socket treatment and perform well, bone-anchored prosthesis systems may not necessarily improve their functional capabilities and perceived quality of life.

Changes in lower extremity joint moments one-year following osseointegration in individuals with Transfemoral lower-limb amputation: A case series.

BACKGROUND: Dissatisfaction with socket prostheses has led to the development of bone-anchored prostheses through osseointegration for people with transfemoral amputation, eliminating the need for a prosthetic socket. Gait deviations of transfemoral prosthesis users may be linked to increased risk of osteoarthritis, and it remains unknown if gait biomechanics change following osseointegration. The purpose of this case series was to evaluate the longitudinal changes in joint kinetics one year post-osseointegration in patients with transfemoral amputation during walking. METHODS: Knee, hip, and trunk internal moments were evaluated in the prosthetic and intact limbs during walking at a self-selected speed in four participants pre- and one-year post-osseointegration. Longitudinal changes were quantified using the percent change (%∆) in peak joint moments between the two time points and Cohen's d (d) effect size was used to determine the magnitude of effect on joint moments during walking one year following osseointegration. FINDINGS: Participants demonstrated increased peak knee extension moment (224 ± 308%∆, d = -1.31) in the prosthetic limb, while demonstrating reduced peak knee extension moment (-43 ± 34%∆, d = 1.82) in the intact limb post-osseointegration. Participants demonstrated bilateral reduction of peak hip extension moment (prosthetic: -22 ± 37%∆, d = 0.86; intact: -29 ± 10%∆, d = 1.27) and bilateral increase of peak hip abduction moment (prosthetic: 45 ± 40%∆, d = 1.20; intact: 23 ± 44%∆, d = 0.74) post-osseointegration. Participants demonstrated reduced peak trunk moments on both the prosthetic (extension: -31 ± 16%∆, d = 1.51; lateral flexion: -21 ± 20%∆, d = 0.63) and intact side (extension: -7 ± 22%∆, d = 0.38; lateral flexion: -22 ± 18%∆, d = 1.12) post-osseointegration. INTERPRETATION: This case series suggests improved gait symmetry in individuals with transfemoral amputation one year following osseointegration, justifying future investigation.

Daily steps and stepping cadence increase one-year following prosthesis osseointegration in people with lower-limb amputation.

Purpose: People with lower-limb loss participate in less physical activity than able-bodied individuals, which increases the mortality risk and incidence of metabolic syndromes. This study evaluated the effect of lower-limb prosthesis osseointegration on physical activity, including daily steps and stepping cadence.Methods: Free-living walking activity was assessed from 14 patients scheduled to undergo prosthesis osseointegration at two time points (within 2 weeks prior to osseointegration surgery and 12-months following). Daily step count, stepping time, number of walking bouts, average step cadence per bout, maximum step cadence per bout, and time spent in bands of step cadence were compared before and after osseointegration.Results: Twelve months after prosthesis osseointegration, participants increased daily steps, daily stepping time, average step cadence, and maximum cadence per walking bout compared to pre-osseointegration.Conclusions: Participants engaged in more daily steps, higher stepping cadence, and longer bouts at higher cadence one year following osseointegration compared to when using a socket prosthesis. As a novel intervention that is becoming more common, it is important to understand walking activity outcomes as these are critical for long-term health.Implications for RehabilitationPeople with lower-limb loss participate in less physical activity than able-bodied individuals, which increases the mortality risk and incidence of metabolic syndromes.Daily step count, walking bouts, and step cadence during free-living walking activity are promising measures to capture physical functional performance in patients with lower-limb amputation.This study shows that patients with osseointegrated prostheses increase their stepping activity, including daily steps, number of bouts, and stepping cadence compared to when using a socket prosthesis, which has positive implications on overall patient health.As a novel intervention that is becoming more common, it is important for clinicians, patients, and researchers to understand expectations for walking activity outcomes as a critical factor in long-term patient health after prosthesis osseointegration.

Next-generation devices to diagnose residuum health of individuals suffering from limb loss: A narrative review of trends, opportunities, and challenges.

OBJECTIVES: There is a need for diagnostic devices that can assist prosthetic care providers to better assess and maintain residuum health of individuals suffering from neuromusculoskeletal dysfunctions associated with limb loss. This paper outlines the trends, opportunities, and challenges that will facilitate the development of next-generation diagnostic devices. DESIGN: Narrative literature review. METHODS: Information about technologies suitable for integration into next-generation diagnostic devices was extracted from 41 references. We considered the invasiveness, comprehensiveness, and practicality of each technology subjectively. RESULTS: This review highlighted a trend toward future diagnostic devices of neuromusculoskeletal dysfunctions of the residuum capable to support evidence-based patient-specific prosthetic care, patient empowerment, and the development of bionic solutions. This device should positively disrupt the organization healthcare by enabling cost-utility analyses (e.g., fee-for-device business models) and addressing healthcare gaps due to labor shortages. There are opportunities to develop wireless, wearable and noninvasive diagnostic devices integrating wireless biosensors to measure change in mechanical constraints and topography of residuum tissues during real-life conditions as well as computational modeling using medical imaging and finite element analysis (e.g., digital twin). Developing the next-generation diagnostic devices will require to overcome critical barriers associated with the design (e.g., gaps between technology readiness levels of essential parts), clinical roll-out (e.g., identification of primary users), and commercialization (e.g., limited interest from investors). CONCLUSIONS: We anticipate that next-generation diagnostic devices will contribute to prosthetic care innovations that will safely increase mobility, thereby improving the quality of life of the growing global population of individuals suffering from limb loss.

3D-printed PMMA implant for gingival smile treatment through the VISTA technique: A report of a new approach.

BACKGROUND: A gingival display higher than 3 mm is considered a characteristic of a gingival smile (GS). Several etiological factors have been associated to GS and for this reason various treatments have been proposed according to its etiology. The aim of this study is to present a case with an alternative technique to treat GS with minimally invasive vestibular incision subperiosteal tunnel access (VISTA) and polymethyl methacrylate (PMMA) implants for lip repositioning. METHODS AND RESULTS: The patient, a 25-year-old woman diagnosed with excessive gingival exposure, had previously done botulinum toxin (BoNT) injections and did not like the result. She had a major subnasal depression and the upper lip would lodge in there during spontaneous smile. She was informed about all options of treatment and agreed to a lip repositioning installing a customized PMMA implant. CONCLUSION: This is the first study to our knowledge to present a case with use of a PMMA implant associated with the VISTA approach for lip repositioning and gingival smile correction. The results are encouraging, and the patient was satisfied with results accomplished by this technique. KEY POINTS: Why is this case new information? This is a new and innovative surgical approach for gingival smile with PMMA implants through a minimally invasive technique (VISTA). What are the keys to successful management of this case? Well-defined presurgical planning and the presence of the upper lip lodging in the subnasal depression during spontaneous smile. What are the primary limitations to success in this case? Cases with vertical maxillary excess and those in which osteotomy/osteoplasty is indicated. It is a technique-sensitive treatment dependent on the clinician's experience.

Osseointegrated prostheses for the rehabilitation of patients with transfemoral amputations: A prospective ten-year cohort study of patient-reported outcomes and complications.

Background: Osseointegrated implants for patients with transfemoral amputations (TFAs) are a novel treatment under development, and prospective long-term evidence is lacking. The objectives were to determine patient-reported outcomes (PROs) and complications after ten years compared to before treatment and to compare the first five-year period with the later five-year period with regard to the outcomes. Methods: In a nonrandomized, prospective cohort study, patients with TFAs treated between 1999 and 2007 with the Osseointegrated Prosthesis for the Rehabilitation of Amputees (OPRA) system (n â€‹= â€‹51) (28 men/23 women; mean age at amputation: 32 years old; mean age at treatment: 44 years old in a single university hospital were followed for ten years. PROs included the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA, four scores 0-100) and the Short Form 36 Health Survey (SF-36, ten scores 0-100) and were answered before treatment and until the ten-year follow-up after treatment. Analyses of differences in PRO scores were conducted using Wilcoxon's signed rank test. The implant survival and revision-free rates with respect to adverse events (implant revision, mechanical complications, and deep infections) were presented as Kaplan-Meier graphs with 95% confidence intervals (CIs). The incidences of events per ten and five person-years were calculated. Spearman's correlation analysis was used for analyses of associations between adverse events. Results: PROs showed statistically significant mean improvements between baseline and the ten-year follow-up with regard to all Q-TFA scores: the prosthetic use score (+36), prosthetic mobility score (+18), problem score (-28) and global score (+38) (all p â€‹< â€‹0.001), and the SF-36 physical functioning score (+26, p â€‹< â€‹0.001) and physical component score (+6, p â€‹< â€‹0.01). No PROs showed a statistically significant deterioration. Over the ten years, 12 patients were lost (one lost to follow-up, one dropped out of the study, two died, and eight had implants removed (four before five years and four between five and ten years). At ten years, the revision-free survival rates were 83% (CI: 69%-91%), 65% (CI: 49%-77%) and 17% (CI: 7%-29%) for implant revision, deep infection and mechanical complications, respectively. Mechanical complications, 3.9 per 10 person-years (CI: 2.2-5.1) constituted the most common serious adverse event and were more common during the last five years than during the first five years (p â€‹< â€‹0.001). No significant difference in the incidence of deep infections was observed between the earlier and the later five-year periods: 0.3 per 5 person-years (CI: 0.1-0.5) vs. 0.3 per person-years (CI: 0.1-0.5) (p â€‹= â€‹0.740). Correlation analyses between the earlier and later five years revealed a positive association between deep infections and implant removal (0.57, p â€‹< â€‹0.001) and between mechanical complications and adverse events (0.65, p â€‹< â€‹0.001). Conclusion: Improved PROs were demonstrated ten years after the introduction of a novel principle for bone anchorage of amputation prostheses. Nevertheless, an increasing rate of mechanical complications is of concern.

Loading characteristics data applied on osseointegrated implant by transfemoral bone-anchored prostheses fitted with state-of-the-art components during daily activities.

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.

Load applied on osseointegrated implant by transfemoral bone-anchored prostheses fitted with state-of-the-art prosthetic components.

BACKGROUND: This study presented the load profile applied on transfemoral osseointegrated implants by bone-anchored prostheses fitted with state-of-the-art ÖSSUR microprocessor-controlled Rheo Knee XC and energy-storing-and-returning Pro-Flex XC or LP feet during five standardized daily activities. METHODS: This cross-sectional cohort study included 13 participants fitted with a press-fit transfemoral osseointegrated implant. Loading data were directly measured with the tri-axial transducer of an iPecsLab (RTC Electronics, USA) fitted between the implant and knee unit. The loading profile was characterized by spatio-temporal gaits variables, magnitude of loading boundaries as well as onset and magnitude of loading extrema during walking, ascending and descending ramp and stairs. FINDINGS: A total of 2127 steps was analysed. The cadence ranged between 36 ± 7 and 47 ± 6 strides/min. The absolute maximum force and moments applied across all activities was 1322 N, 388 N and 133 N as well as 22 Nm, 52 Nm and 88 Nm on and around the long, anteroposterior and mediolateral axes of the implant, respectively. INTERPRETATION: This study provided new benchmark loading data applied by transfemoral bone-anchored prostheses fitted with selected ÖSSUR state-of-the-art components. Outcomes suggested that such prostheses can generate relevant loads at the interface with the osseointegrated implant to restore ambulation effectively. This study is a worthwhile contribution toward a systematic recording, analysis, and reporting of ecological prosthetic loading profiles as well as closing the evidence gaps between prescription and biomechanical benefits of state-of-the-art components. Hopefully, this will contribute to improve outcomes for growing number of individuals with limb loss opting for bionic solutions.

Preoperative femoral abduction angle correlates with initial postoperative lateral hip pain after transcutaneous osseointegrated prosthetic system (TOPS) in transfemoral amputees.

PURPOSE: To analyse whether a preoperative femoral abduction angle (FAA) correlates with postoperative initial lateral hip pain (LHP) in above-knee amputees (AKA) treated with transcutaneous osseointegrated prosthetic system (TOPS). METHODS: Pre- and postoperative long-leg radiographs of eighteen unilateral AKA (mean age 51.55y ± 12.16) were retrospectively measured. FAA was measured on both sides. Pain intensity of LHP was measured by numeric rating scale (NRS) preoperatively and every week for four weeks from the first day of weight loading. Pearson's r was calculated for correlation. Furthermore, odds ratio for LHP ≥ 5/10 NRS and relative FAA > 13° was calculated. RESULTS: FAA significantly decreased in the postoperative period (pre/post. 15.33° ± 4.22; p < 0.001). Median LHP was 0/10 NRS (min.0, max.3) preoperatively and 4/10 NRS (min.2, max. 7, p < 0.001) postoperatively after first loading. Interestingly, it decreased within four weeks to a median of 0.5/10 NRS (min.0, max. 3) without intervention. A strong correlation was seen on the amputated side between preoperative FAA and LHP after loading (r = 0.835, p < 0.001), as well as the relative FAA to LHP after loading (r = 0.732, p < 0.001) and between the gap of pre- to postoperative FAA and LHP. Odds ratio for LHP ≥ 5/10 and relative FAA > 13° was 6.4 (95%CI = 0.55; 74.89). CONCLUSION: The preoperative FAA strongly correlates with postoperative LHP. Surgeons should be aware of high risk of LHP that can limit prosthetic training. High preoperative FAAs should be realised in the decision meeting of TOPS implantation and pre-rehabilitative reduction of the FAA should be taken into consideration.

A Preliminary Cost-Utility Analysis of the Prosthetic Care Innovations: Basic Framework.

A preliminary cost-utility analysis (CUA) of prosthetic care innovations can provide timely information during the early stage of product development and clinical usage. Concepts of preliminary CUAs are emerging. However, several obstacles must be overcome before these analyses are performed routinely. Disparities of methods and high uncertainty make the outcomes of usual preliminary CUAs challenging to interpret, appraise and share. These shortcomings create opportunities for a basic framework of preliminary CUAs. First, I introduced a basic framework of a preliminary CUA built around a series of constructs and hands-on recommendations. Then, I appraised this framework considering the strengths and weaknesses, barriers and facilitators, and return on investment. The design of the basic framework was determined through the review of health economic and prosthetic-specific literature. A preliminary CUA comparing the costs and utilities between usual intervention and an innovation could be achieved through a 15-step iterative process focusing on feasibility, constructs, analysis, and interpretation of outcomes. This CUA provides sufficient evidence to identify knowledge gaps and improvement areas, educate about the design of subsequent full CUAs, and obtain fast-track approval from governing bodies. Like previous CUAs, the main limitations were inherent to the constructs (e.g., narrow perspective, plausible scenarios, mid-term time horizon, substantial assumptions, data mismatch, high uncertainty). Key facilitators potentially transferable across preliminary CUAs of prosthetic care innovations included choosing abided constructs, capitalizing on prior schedules of expenses, and benchmarking baseline or incremental utilities. This new approach with preliminary CUA can simplify the selection of methods, standardize outcomes, ease comparisons between innovations, and streamline pathways for adoption. Further collegial efforts toward validating standard preliminary CUAs will facilitate access to economic prosthetic care innovations, improving the lives of individuals suffering from limb loss worldwide.

Health Service Delivery and Economic Evaluation of Limb Lower Bone-Anchored Prostheses: A Summary of the Queensland Artificial Limb Service's Experience.

The emergence of skeletal prosthetic attachments leaves governmental organizations facing the challenge of implementing equitable policies that support the provision of bone-anchored prostheses (BAPs). In 2013, the Queensland Artificial Limb Service (QALS) started a five-year research project focusing on health service delivery and economic evaluation of BAPs. This paper reflects on the QALS experience, particularly the lessons learned. QALS' jurisdiction and drivers are presented first, followed by the impact of outcomes, barriers, and facilitators, as well as future developments of this work. The 21 publications produced during this project (e.g., reimbursement policy, role of prosthetists, continuous improvement procedure, quality of life, preliminary cost-utilities) were summarized. Literature on past, current, and upcoming developments of BAP was reviewed to discuss the practical implications of this work. A primary outcome of this project was a policy developed by QALS supporting up to 22 h of labor for the provision of BAP care. The indicative incremental cost-utility ratio for transfemoral and transtibial BAPs was approximately AUD$17,000 and AUD$12,000, respectively, per quality-adjusted life-year compared to socket prostheses. This project was challenged by 17 barriers (e.g., limited resources, inconsistency of care pathways, design of preliminary cost-utility analyses) but eased by 18 facilitators (e.g., action research plan, customized database, use of free repositories). In conclusion, we concluded that lower limb BAP might be an acceptable alternative to socket prostheses from an Australian government prosthetic care perspective. Hopefully, this work will inform promoters of prosthetic innovations committed to making bionic solutions widely accessible to a growing population of individuals suffering from limb loss worldwide.

Trends and Opportunities in Health Economic Evaluations of Prosthetic Care Innovations.

Overcoming obstacles to prosthetic fittings requires frequent tryouts of sockets and components. Repetitions of interventions are upsetting for users and place substantial economic burden on healthcare systems. Encouraging prosthetic care innovations capable of alleviating clinical and financial shortcomings of socket-based solutions is essential. Nonetheless, evidence of socio-economic benefits of an innovation are required to facilitate access to markets. Unfortunately, complex decisions must be made when allocating resources toward the most relevant health economic evaluation (HEE) at a given stage of development of an innovation. This paper first, aimed to show the importance and challenges of HEEs of intervention facilitating prosthetic fittings. Next, the main trends in HEEs at various phases of product development and clinical acceptance of prosthetic care innovations were outlined. Then, opportunities for a basic framework of a preliminary cost-utility analysis (CUA) during the mid-stage of development of prosthetic care innovations were highlighted. To do this, fundamental and applied health economic literature and prosthetic-specific publications were reviewed to extract and analyse the trends in HEEs of new medical and prosthetic technologies, respectively. The findings show there is consensus around the weaknesses of full CUAs (e.g., lack of timeliness, resource-intensive) and strengths of preliminary CUAs (e.g., identify evidence gaps, educate design of full CUA, fast-track approval). However, several obstacles must be overcome before preliminary CUA of prosthetic care innovations will be routinely carried out. Disparities of methods and constructs of usual preliminary CUA are barriers that could be alleviated by a more standardized framework. The paper concludes by identifying that there are opportunities for the development of a basic framework of preliminary CUA of prosthetic care innovations. Ultimately, the collaborative design of a framework could simplify selection of the methods, standardise outcomes, ease comparisons between innovations and streamline pathways for adoption. This might facilitate access to economical solutions that could improve the life of individuals suffering from limb loss.

A Preliminary Cost-Utility Analysis of the Prosthetic Care Innovations: Case of the Keep Walking Implant.

Several obstacles must be overcome before preliminary cost-utility analyses (CUA) of prosthetic care innovations can be routinely performed. The basic framework of preliminary CUAs and hands- on recommendations suggested previously might contribute to wider adoption. However, a practical application for an emerging intervention is needed to showcase the capacity of this proposed preliminary CUA framework. This study presented the outcomes of preliminary CUA of the distal weight bearing Keep Walking Implant (KWI), an emerging prosthetic care innovation that may reduce socket fittings for individuals with transfemoral amputation. The preliminary CUAs compared the provision of prosthetic care without (usual intervention) and with the KWI (new intervention) using a 15-step iterative process focused on feasibility, constructs, analysis, and interpretations of outcomes from an Australia government prosthetic care perspective over a six-year time horizon. Baseline and incremental costs were extracted from schedules of allowable expenses. Baseline utilities were extracted from a study and converted into quality-adjusted life-year (QALY). Incremental utilities were calculated based on sensible gains of QALY from baselines. The provision of the prosthetic care with the KWI could generate an indicative incremental cost-utility ratio (ICUR) of -$36,890 per QALY, which was $76,890 per QALY below willingness-to-pay threshold, provided that the KWI reduces costs by $17,910 while increasing utility by 0.485 QALY compared to usual interventions. This preliminary CUA provided administrators of healthcare organizations in Australia and elsewhere with prerequisite evidence justifying further access to market and clinical introduction of the KWI. Altogether, this work suggests that the basic framework of the preliminary CUA of a prosthetic care innovation proposed previously is feasible and informative when a series of assumptions are carefully considered. This study further confirms that preliminary CUAs prosthetic care interventions might be a relevant alternative to full CUA for other medical treatments.

Piezoelectric bone conduction hearing implant Osia® - audiological and quality of life benefits.

<b>Introduction:</b> Nowadays, there are many options to treat hearing-impaired patients: tympanoplastic surgery, hearing aids and a wide range of implantable devices.</br></br> <b>Aim:</b> The aim of this study is to present the mid-term audiological and quality of life benefits after the implantation of Osia®, an active piezoelectric bone conduction hearing implant. </br></br> <b>Material and methods:</b> The state of the tissues in the implanted area, as well as audiological and quality of life results were analyzed at six, nine and twelve months after implantation in a group of four adult patients with bilateral mixed hearing loss (1 after bilateral canal-wall-down mastoidectomy, 2 with chronic simple otitis media and after myringoplasty in the opposite ear, 1 with bilateral otosclerosis and after stapedotomy in the opposite ear). </br></br> <b>Results:</b> No postoperative complications were found in any of the cases. One year after surgery the mean audiological gain in FF PTA4 (pure tone average for 0.5, 1, 2, and 4 kHz) was 52.2 ± 3.5 dB in comparison to the unaided situation, the mean speech understanding with Osia® in quiet was 90 ± 8.2% for 50 dB SPL, 98.8 ± 2.5% for 65 dB SPL and 100 ± 0% for 80 dB SPL, and the mean speech understanding with Osia® in noise was 37.5% ± 23.6 for 50 dB SPL, 93.8 ± 4.8% for 65 dB SPL and 98.8 ± 2.5% for 80 dB SPL. There was also an evident improvement in the quality of hearing as well as in the quality of life, measured by APHAB (Abbreviated Profile of Hearing Aid Benefit) and SSQ (Speech, Spatial and Qualities of Hearing Scale). </br></br> <b>Conclusions:</b> The Osia® is an effective treatment option for patients with bilateral mixed hearing loss. The mid-term audiological and quality of life results are excellent, but further observations including bigger groups of patients and a longer follow- -up are required.

Longitudinal economic analysis of Bonebridge 601 versus percutaneous bone-anchored hearing devices over a 5-year follow-up period.

OBJECTIVES: Percutaneous bone-anchored hearing devices (pBAHDs) are the most commonly used bone conduction implants (BCI). Concerns surround the long-term complications, notably skin-related, in patients with percutaneous abutments. The active transcutaneous BCI Bonebridge system can help avoid some of these pitfalls but is often considered a second-line option due to various factors including perceived increased overall costs. DESIGN: Longitudinal economic analysis of Bonebridge BCI 601 versus pBAHD over a 5-year follow-up period. SETTING: A specialist hearing implant centre. PARTICIPANTS: Adult patients (≥16 years) with conductive hearing loss, mixed hearing loss or single-sided deafness, who received a Bonebridge or pBAHD implant between 1/7/2013 and 1/12/2018 with a minimum 12-month follow-up. MAIN OUTCOME MEASURES: We compared the mean costs per implanted patient for both implants at 1, 3 and 5 years postoperative time points. Clinical effectiveness was evaluated using objective and patient-reported outcome measures. RESULTS: The mean total cost per patient of Bonebridge was significantly higher than pBAHD at 1-year post-implantation (£8512 standard deviation [SD] £715 vs £5590 SD £1394, P < .001); however, by 5-years post-implantation this difference was no longer statistically significant (£12 453 SD £2159 vs £12 575 SD £3854, P > .05). The overall cost convergence was mainly accounted for by the increased long-term complications, revision surgery rates and higher cost of the pBAHD external processor compared to Bonebridge. CONCLUSIONS: Long-term costs of Bonebridge to healthcare providers are comparable to pBAHDs, whilst offering lower complication rates, comparable audiological benefit and patient satisfaction. Bonebridge should be considered as a first-line BCI option in appropriate cases.

Lower limb prosthetic interfaces: Clinical and technological advancement and potential future direction.

The human-prosthesis interface is one of the most complicated challenges facing the field of prosthetics, despite substantive investments in research and development by researchers and clinicians around the world. The journal of the International Society for Prosthetics and Orthotics, Prosthetics and Orthotics International, has contributed substantively to the growing body of knowledge on this topic. In celebrating the 50th anniversary of the International Society for Prosthetics and Orthotics, this narrative review aims to explore how human-prosthesis interfaces have changed over the last five decades; how research has contributed to an understanding of interface mechanics; how clinical practice has been informed as a result; and what might be potential future directions. Studies reporting on comparison, design, manufacturing and evaluation of lower limb prosthetic sockets, and osseointegration were considered. This review demonstrates that, over the last 50 years, clinical research has improved our understanding of socket designs and their effects; however, high-quality research is still needed. In particular, there have been advances in the development of volume and thermal control mechanisms with a few designs having the potential for clinical application. Similarly, advances in sensing technology, soft tissue quantification techniques, computing technology, and additive manufacturing are moving towards enabling automated, data-driven manufacturing of sockets. In people who are unable to use a prosthetic socket, osseointegration provides a functional solution not available 50 years ago. Furthermore, osseointegration has the potential to facilitate neuromuscular integration. Despite these advances, further improvement in mechanical features of implants, and infection control and prevention are needed.