Spatio-temporal characteristics of locomotion and functional outcomes of individuals with transfemoral amputation fitted with OPRA fixation

The conventional method of attachment of prosthesis involves a socket. A new method relying on osseointegrated fixation has emerged in the last decades. It has significant prosthetic benefits. Only a few studies demonstrated the biomechanical benefits. The ultimate aim of this study was to characterise the functional outcome of individuals with lower limb amputation fitted with osseointegrated fixation, which can be assess through temporal and spatial gait characteristics. The specific objective of this study was to present the key temporal and spatial gait characteristics of individuals with transfemoral amputation (TFA).

Biomechanics of transfemoral amputees fitted with osseointegrated fixation: Loading data for evidence-based practice

This presentation will provide an overview of the load applied on the residuum of transfemoral amputees fitted with an osseointegrated fixation during (A) rehabilitation, including static and dynamic load bearing exercises (e.g., rowing, adduction, abduction, squat, cycling, walking with aids), and (B) activities of daily living including standardized activities (e.g., level walking in straight line and around a circle, ascending and descending slopes and stairs) and activities in real world environments.

Temporal and spatial gait characteristics of transfemoral amputees fitted with osseointegrated fixation: preliminary data

The conventional method of attachment of prosthesis involves on a socket. A new method relying on osseointegrated fixation is emerging. It has significant prosthetic benefits. Only a few studies demonstrated the biomechanical benefits. The ultimate aim of this study was to characterise the functional outcome of transfemoral amputees fitted with osseointegrated fixation, which can be assess through temporal and spatial gait characteristics. The specific objective of this preliminary study was to present the key temporal and spatial gait characteristics.

Hip joint stabilization vs. propulsion and resistance in individuals with transfemoral amputation

Joint moments and joint powers are widely used to determine the effects of rehabilitation programs and prosthetic components (e.g., alignments). A complementary analysis of the 3D angle between joint moment and joint angular velocity has been proposed to assess whether the joints are predominantly driven or stabilized.

Static load bearing exercises during rehabilitation of individuals with transfemoral amputation fitted with osseointegrated implant: Kinetic analysis

The desire to solve problems caused by socket prostheses in transfemoral amputees and the acquired success of osseointegration in the dental application has led to the introduction of osseointegration in the orthopedic surgery. Since its first introduction in 1990 in Gothenburg Sweden the osseointegrated (OI) orthopedic fixation has proven several benefits[1]. The surgery consists of two surgical procedures followed by a lengthy rehabilitation program. The rehabilitation program after an OI implant includes a specific training period with a short training prosthesis. Since mechanical loading is considered to be one of the key factors that influence bone mass and the osseointegration of bone-anchored implants, the rehabilitation program will also need to include some form of load bearing exercises (LBE). To date there are two frequently used commercially available human implants. We can find proof in the literature that load bearing exercises are performed by patients with both types of OI implants. We refer to two articles, a first one written by Dr. Aschoff and all and published in 2010 in the Journal of Bone and Joint Surgery.[2] The second one presented by Hagberg et al in 2009 gives a very thorough description of the rehabilitation program of TFA fitted with an OPRA implant. The progression of the load however is determined individually according to the residual skeleton’s quality, pain level and body weight of the participant.[1] Patients are using a classical bathroom weighing scale to control the load on the implant during the course of their rehabilitation. The bathroom scale is an affordable and easy-to-use device but it has some important shortcomings. The scale provides instantaneous feedback to the patient only on the magnitude of the vertical component of the applied force. The forces and moments applied along and around the three axes of the implant are unknown. Although there are different ways to assess the load on the implant for instance through inverse dynamics in a motion analysis laboratory [3-6] this assessment is challenging. A recent proof- of-concept study by Frossard et al (2009) showed that the shortcomings of the weighing scale can be overcome by a portable kinetic system based on a commercial transducer[7].

Walking ability of individuals with transfemoral amputation fitted with osseointegrated implant

The prosthetic benefits of osseointegrated fixation for individuals with limb loss, particularly those with transfemoral amputation (TFA), have been clearly demonstrated in the literature. However, very little information is currently available to established how this prosthetic benefits are translated into functional outcomes and, more precisely, walking abilities [1-3]. The ultimate aim of this presentation was to explore how walking abilities of a TFA fitted with an OPRA fixation could be assess through typical temporal and spatial gait characteristics[2].

Classification of activities of daily living of individual with limb loss

The monitoring of the actual activities of daily living of individuals with lower limb amputation is essential for an evidence-based fitting of the prosthesis, more particularly the choice of components (e.g., knees, ankles, feet)[1-4]. The purpose of this presentation was to give an overview of the categorization of the load regime data to assess the functional output and usage of the prosthesis of lower limb amputees has presented in several publications[5, 6]. The objectives were to present a categorization of load regime and to report the results for a case.

Dynamic input to determine hip joint moments, power and work on the prosthetic limb of transfemoral amputees: ground reactions vs knee reactions

Study Design: Comparative analysis Background: Calculations of lower limbs kinetics are limited by floor-mounted force-plates. Objectives: Comparison of hip joint moments, power and mechanical work on the prosthetic limb of a transfemoral amputee calculated by inverse dynamics using either the ground reactions (force-plates) or knee reactions (transducer). Methods: Kinematics, ground reactions and knee reactions were collected using a motion analysis system, two force-plates and a multi-axial transducer mounted below the socket, respectively. Results: The inverse dynamics using ground reactions under-estimated the peaks of hip energy generation and absorption occurring at 63 % and 76 % of the gait cycle (GC) by 28 % and 54 %, respectively. This method over-estimated a phase of negative work at the hip (from 37 %GC to 56 %GC) by 24%. It under-estimated the phases of positive (from 57 %GC to 72 %GC) and negative (from 73 %GC to 98 %GC) work at the hip by 11 % and 58%, respectively. Conclusions: A transducer mounted within the prosthesis has the capacity to provide more realistic kinetics of the prosthetic limb because it enables assessment of multiple consecutive steps and a wide range of activities without issues of foot placement on force-plates. CLINICAL RELEVANCE The hip is the only joint that an amputee controls directly to set in motion the prosthesis. Hip joint kinetics are associated with joint degeneration, low back pain, risks of fall, etc. Therefore, realistic assessment of hip kinetics over multiple gait cycles and a wide range of activities is essential.

Static load bearing exercises of individuals with transfemoral amputation fitted with an osseointegrated implant: Reliability of kinetic data

This study aimed at presenting the intra-tester reliability of the static load bearing exercises (LBEs) performed by individuals with transfemoral amputation (TFA) fitted with an osseointegrated implant to stimulate the bone remodelling process. There is a need for a better understanding of the implementation of these exercises particularly the reliability. The intra-tester reliability is discussed with a particular emphasis on inter-load prescribed, inter-axis and inter-component reliabilities as well as the effect of body weight normalisation. 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. Reliability of loading variables was assessed using intraclass correlation coefficients (ICCs) and percentage standard error of measurement values (%SEMs). The ICCs of all variables were above 0.9 and the %SEM values ranged between 0 and 87%. This study showed a high between-participants’ variance highlighting the lack of loading consistency typical of symptomatic population as well as a high reliability between the loading sessions indicating a plausible correct repetition of the LBE by the participants. However, these outcomes must be understood within the framework of the proposed experimental protocol.

Safety of OPRA procedure for individuals with upper limb amputation

Surgical implantations of osseointegrated fixations for bone-anchored prosthesis are developing at an unprecedented pace worldwide while initial skepticism in the orthopedic community is slowly fading away. Clearly, this option is becoming accessible to a wide range of individuals with limb loss. [1-18] The team led by Dr Rickard Branemark has previously published a number of landmark articles focusing on the benefits and safety of the OPRA fixation mainly for individual with lower limb loss, particularly those with transfemoral amputation. [1-3, 19-32] However, similar information is lacking for those with upper limb amputation. This team is once again taking a leading role by sharing a retrospective study focusing on the implant survival, adverse events, implant stability, and bone remodelling for 18 individuals with transhumeral amputation over a 5-year post-operative period. Therefore, a comprehensive analysis of the safety of the procedure is accessible for the first time. In essence, the results showed an implant survival rate of 83% and 80% at 2 and 5 year follow ups, respectively. The most frequent adverse events were superficial skin infections that occurred for 28% (5) participants while the least frequent was deep bone infection that happened only once. More importantly, 38% of complications due to infections were effectively managed with nonoperative treatments (e.g., revision of skin penetration site, local cleaning, antibiotics, restriction of soft tissue mobility). Implant stability and bone remodelling were satisfactory. Clearly, this study provided better understanding of the safety of the OPRA surgical and rehabilitation procedure for individuals with upper limb amputation while establishing standards and benchmark data for future studies. However, strong evidences of the benefits are yet to be demonstrated. However, increase in health related quality of life and functional outcomes (e.g., range of movement) are likely. Altogether, the team of authors are providing further evidence that bone-anchored attachment is definitely a promising alternative to socket prostheses.

Direct measurement of prosthetic loading for evidence-based practice

The demand for an evidence-based clinical practice involving lower limb amputees is increasing. Some of the critical care decisions are related to the loading applied on the residuum partially responsible for comfort and functional outcome. This loading can be assessed using inverse dynamics equations. Typically, this method requires a gait laboratory (e.g., 3D motion analysis system, force-plates). It is mainly suited for the analysis only few steps of walking while being expensive and labour intensive. However, recent scientific and industrial developments demonstrated that discrete and light portable sensors can be placed within the prosthesis to measure accurately the loading during an unlimited number of steps and activities of daily living. Several studies indicated that method based on direct measurements might provide more realistic results. Furthermore, it is a user-friendly method more accessible to clinicians, such as prosthetists. The purpose of this symposium will be to give an overview of these additional opportunities for clinicians to obtain relevant data for evidence-based practice. The three main aims will be: • To present some of the equipment used for direct measurements, • To propose ways to analyse some key data sets, • To give some practical example of data sets for transtibial and transfemoral amputees.

Customised osteotomy guides and endoprosthetic reconstruction for periacetabular tumours

Purpose We sought to analyse clinical and oncological outcomes of patients after guided resection of periacetabular tumours and endoprosthetic reconstruction of the remaining defect. Methods From 1988 to 2008, we treated 56 consecutive patients (mean age 52.5 years, 41.1 % women). Patients were followed up either until death or February 2011 (mean follow up 5.5 years, range 0.1–22.5, standard deviation ± 5.3). Kaplan–Meier analysis was used to estimate survival rates. Results Disease-specific survival was 59.9 % at five years and 49.7 % at ten and 20 years, respectively. Wide resection margins were achieved in 38 patients, whereas 11 patients underwent marginal and seven intralesional resection. Survival was significantly better in patients with wide or marginal resection than in patients with intralesional resection (p = 0.022). Survival for patients with secondary tumours was significantly worse than for patients with primary tumours (p = 0.003). In 29 patients (51.8 %), at least one reoperation was necessary, resulting in a revision-free survival of 50.5 % at five years, 41.1 % at ten years and 30.6 % at 20 years. Implant survival was 77.0 % at five years, 68.6 % at ten years and 51.8 % at 20 years. A total of 35 patients (62.5 %) experienced one or more complications after surgery. Ten of 56 patients (17.9 %) experienced local recurrence after a mean of 8.9 months. The mean postoperative Musculoskeletal Tumor Society (MSTS) score was 18.1 (60.1 %). Conclusion The surgical approach assessed in this study simplifies the process of tumour resection and prosthesis implantation and leads to acceptable clinical and oncological outcomes.

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.

Errors in the knee joint forces and moments during gait depending on the foot and knee prosthetic components

Background Previously studies showed that inverse dynamics based on motion analysis and force-plate is inaccurate compared to direct measurements for individuals with transfemoral amputation (TFA). Indeed, direct measurements can appropriately take into account the absorption at the prosthetic foot and the resistance at the prosthetic knee. [1-3] However, these studies involved only a passive prosthetic knee. Aim The objective of the present study was to investigate if different types of prosthetic feet and knees can exhibit different levels of error in the knee joint forces and moments. Method Three trials of walking at self-selected speed were analysed for 9 TFAs (7 males and 2 females, 47±9 years old, 1.76±0.1 m 79±17 kg) with a motion analysis system (Qualisys, Goteborg, Sweden), force plates (Kitsler, Winterthur, Switzerland) and a multi-axial transducer (JR3, Woodland, USA) mounted above the prosthetic knee [1-17]. TFAs were all fitted with an osseointegrated implant system. The prostheses included different type of foot (N=5) and knee (N=3) components. The root mean square errors (RMSE) between direct measurements and the knee joint forces and moments estimated by inverse dynamics were computed for stance and swing phases of gait and expressed as a percentage of the measured amplitudes. A one-way Kruskal-Wallis ANOVA was performed (Statgraphics, Levallois-Perret, France) to analyse the effects of the prosthetic components on the RMSEs. Cross-effects and post-hoc tests were not analysed in this study. Results A significant effect (*) was found for the type of prosthetic foot on anterior-posterior force during swing (p=0.016), lateral-medial force during stance (p=0.009), adduction-abduction moment during stance (p=0.038), internal-external rotation moment during stance (p=0.014) and during swing (p=0.006), and flexion-extension moment during stance (p = 0.035). A significant effect (#) was found for the type of prosthetic knee on anterior-posterior force during swing (p=0.018) and adduction-abduction moment during stance (p=0.035). Discussion & Conclusion The RMSEs were larger during swing than during stance. It is because the errors on accelerations (as derived from motion analysis) become substantial with respect to the external loads. Thus, inverse dynamics during swing should be analysed with caution because the mean RMSEs are close to 50%. Conversely, there were fewer effects of the prosthetic components on RMSE during swing than during stance and, accordingly, fewer effects due to knees than feet. Thus, inverse dynamics during stance should be used with caution for comparison of different prosthetic components.

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.