Implant loosening and mechanical failure are two major concerns for trans-femoral amputees using osseointegrated fixation. Understanding the true load applied on osseointegrated fixation is one important step in solving the two problems. Conventionally, the load magnitude can be calculated based on the motion of the prosthesis and the ground reaction forces measured by a force plate using inverse dynamics. However, this approach allowed only one or two walking steps to be measured and errors are compounded when involving more than one joint. In this study, we directly measured load acting on the abutment of an osseointegrated prosthesis with a load transducer for twelve trans-femoral amputees. Three-dimensional force and moment patterns at the abutment along a gait cycle were displayed. Step-to-step variability of each subject in various kinetic and temporal parameters as well as subject-to-subject variability in temporal parameters were found low. High subject-to-subject variability in force and moment data was demonstrated

Branemark, Rickard

Frossard, Laurent

Gray, Steven

Hagberg, Kerstin

Haggstrom, Eva

Lee Gow, David

Lee, Winson

English

Queensland University of Technology ePrints Archive

   COVER SHEET   Lee, Winson and Frossard, Laurent and Hagberg, Kerstin and Haggstrom, Eva and Gow, David and Gray, Steven and Branemark, Richard (2006) Direct Measurement of 3D Force and Moment on Lower-Limb Osseointegrated Fixation. In Proceedings Symposium on the 3-D Analysis of Human Movement, Valenciennes, France  Copyright 2006 (please consult author)   Accessed from:  https://eprints.qut.edu.au/secure/00004041/01/Winson-variability_of_load.pdf Direct Measurement of 3D Force and Moment on Lower-Limb Osseointegrated Fixation  W. Lee1,2, L. Frossard1,2, K. Hagberg3, E. Haggstrom4, D. Lee Gow5, S. Gray6 and  R. Branemark3  1School of Engineering Systems, Queensland University of Technology, Brisbane, Australia 2Institute for Health & Biomedical Innovation, Queensland University of Technology, Brisbane, Australia 3Centre of Orthopaedic Osseointegration, Dept. of Orthopaedics, Sahlgrenska University Hospital, Goteborg, Sweden 4Deptartment for Prosthetics and Orthotics, Sahlgrenska University Hospital, Goteborg, Sweden 5Caulfield General Medical Centre, Melbourne, Australia 6Plastic Surgery Unit/Osseointegrated-OPRA Programme, Alfred Hospital Melbourne, Australia  Abstract— Occasional mechanical failures is a concern for transfemoral amputees using osseointegrated fixation. Understanding the true load applied on osseointegrated fixation is one important step in solving this problem. Conventionally, the load magnitude can be calculated based on the motion of the prosthesis and the ground reaction forces measured by a force plate using inverse dynamics. However, this approach allowed only one or two walking steps to be measured and errors are compounded when involving more than one joint above the ankle. In this study, the load applied on the lower-limb osseointegrated fixation was directly measured with a load transducer. Twelve transfemoral amputees fitted with a fixation and their usual prosthesis (knee and foot) were assessed during approximately 51±12 normal walking steps in straight line. Three-dimensional force and moment local extremas and patterns at the fixation along a gait cycle were displayed. Step-to-step variability of each subject was low. This tends to validate gait laboratory-based studies focusing on one or two steps. High subject-to-subject variability was demonstrated. This could be due to the wide variety of components, alignments and anthropometric characteristics within the tested population.    Keywords: Gait, Transducer, Variability, Transfemoral amputation, Osseointegration, Prosthetics.  I.  INTRODUCTION  Conventional socket-type lower limb prosthesis sometimes induces problems of residual limb pain and soft tissue breakdown [1]. A new surgical approach developed by Dr Rickard Brånemark for a direct anchorage into living bone using a titanium implant (osseointegration) may help to alleviate these problems [2]. External prosthesis is attached to an osseointegrated implant. This technique is considered for transfemoral amputees presenting complications while using a socket-type prosthesis [2,3]. So far, there are over 80 amputees were fitted with lower-limb osseointegrated fixation world-wide. The quality of life of the recipients of the fixation was significantly increased through improved comfort, walking and sensory feedback [2,3]. However, some occasional mechanical failures of fixation have been reported. This problem occurred essentially due to a bending of the fixation following a fall of the amputee [3]. This problem must be addressed as it represents a potential hazard for the amputees. Furthermore, there is a need for further improvement of the mechanical design of different prosthetic components for amputees of osseointegrated fixation, such as hydraulic knees, torque protective devices shock absorbers, etc. Knowing the true load applied on the residuum is one important step to the design improvement of the fixation. Conventionally, the load magnitude can be calculated based on the motion of the prosthesis and the ground reaction forces measured by a force plate using inverse dynamics, [4]. The drawbacks, however, are that only one or two steps of walking can be measured, alerted gait can be produced due to force-plate targeting [5], accurate determination of material inertia of limb segments are needed, and errors are compounded when involving more than one joints above the ankle. Recent studies have described the direct measurement of the forces and moments applied on the residuum of transfemoral amputees fitted with conventional socket [6] or osseointegrated fixation [7,8] using a load transducer and recording device (telemoden or data logger). Unfortunately, these studies focused on small size sample. The aim of this study was to measure directly the true load applied on the osseointegrated fixation for twelve transfemoral amputees during normal walking in straight line in the view of analyzing (A) the step-to-step (intra) variability within subjects and (B) the subject-to-subject (inter) variability. Amputees were fitted with their usual prosthesis and alignment in order to assess the true inter variability among different subjects and prostheses set-up.   II. METHOD  Participants A total of twelve transfemoral amputee subjects fitted with osseointegrated fixations, representing approximately 15% global population in 2003, participated in this study. All    Figure1. Example of a typical prosthetic leg setup used to directly measurement the forces and moments applied on the fixation system of transfemoral amputee (left: front view, right: side view). A commercial transducer (A) was mounted to specially designed plates (B) that were positioned between the adaptor (C) connected to the fixation (D) and the knee mechanism (F)  participants (age: 54±12 years, mass: 84.3±16.3 kg, height: 1.78±0.10 m) have used osseointegrated prostheses for over one year. Their body mass had to be below 110 kg to avoid saturation of the load cell. Participants had to be able to walk 200 m without walking aids. Load measurement was taken place in clinical environment in Caulfield General Medical Centre, Melbourne, Australia (N=2), and Sahlgrenska University Hospital, Gothenburg, Sweden (N=10) where the subjects were recruited. The subjects used their current prostheses with the objective to measure the true load during walking for each individual amputee.  Apparatus 3D force and moment applied to the fixation were measured with a six-channel transducer (Model 45E15A; JR3 Inc., Woodland, CA), weighing less than 800g. The transducer can measure up to 1140N with accuracy of 1% of the full scale. A wireless transmitter was used to transmit data from the transducer to a nearly laptop computer. Sampling frequency was set at 200Hz. The transducer was mounted to two customized aluminum plates, which were anchored to the fixation and the prosthetic knee joints. The transducer was aligned in a way that its long axis (L) was coincident with the long axis of the residuum. The other axes referred to the antero-posterior (AP) and medio-lateral (ML) directions were aligned with the anatomical axes of the prosthetic knee. Figure 1 provides an example of the apparatus mounted within the prosthesis.  Protocol Load measurement was first taken in unloaded condition when there was no external force exerted to the transducer for calibration purpose. Subjects were given 15 minutes to get accustomed to the instrumented prostheses before load measurement. They were then required to walk along a level walkway at self-selected comfortable walking speed. The number of walking steps along the walkway depended on the stride length of each subject ranged from 24 to 64 steps (51±12 steps). The cadence ranged from 42.3 to 53.4 strides/min (47.1±3.66 strides/min).    Data reduction The raw data was processed by Matlab software program (Math Works, Inc.). Any offset in the data during the initial unloaded condition was removed. The first and the last strides recorded for each trial were discarded. Force data was normalized by body weight of each subject. Local extrema of each component of forces (FAP, FML, FL) and moments (MAP, MML, ML) were identified for each step on prosthetic limb. Force and moment were averaged for each complete gait cycle across various walking steps of each subject, and were plotted against the percentage of a gait cycle. For each parameter, mean, standard deviation (S.D.) and coefficient of variance (C.V), defined as the standard deviation divided by the mean modulus were produced in two ways: within subject on repeated steps (intra-subject) and across subjects (inter-subjects).  III. RESULTS   Forces The forces on the antero-posterior, medio-lateral and long axes for a complete gait cycle of each subject were plotted in Figure 2. Although there were noticeable differences in the magnitude of forces among different subjects, similar force patterns were shown. Step-to-step variability was low as demonstrated by the small coefficient of variance for each subject. However, high subject-to-subject variability was shown. The mean magnitude and coefficient of variance of the local extremas forces within and across subjects is provided in Table 1.    Figure 2. Normalized (a) FAP, (b) FML and (c) and FL of 12 amputees along a gait cycle. TABLE I.  LOCAL EXTREMA OF FORCE EXPRESSED IN PERCENTAGE OF BODY WEIGHT (%BW)   Moment Lateral rotational moment (MAP) was consistently experienced during stance phase of the gait as presented in Figure 3. Axial rotational moment (ML) was the lowest in magnitude comparing to MAP and MML because of the      Figure 3. Moment about (a) AP axis, (b) ML axis, and (c) L axis of 12 amputees along a gait cycle shorter moment arm. Inconsistent ML patterns were shown among different subjects. The mean, step-to-step and subject-to-subject variability of moment data were provided in Table 2. Similar to the force data, subject-to-subject variability was noticeably higher than step-to-step variability.  TABLE II.  LOCAL EXTREMA OF MOMENT    IV. DISCUSSIONS AND CONCLUSIONS  This study is the first attempt of measuring the variability of the load applied on osseointegrated fixation twelve trans-femoral amputees during normal walking.  Results showed a: • Low step-to-step variability among the twelve subjects. This suggests measuring force in one to two steps of walking may adequately reflect the loading pattern of a subject. This tends to validate gait laboratory-based studies focusing on a limited number of steps.  • High subject-to-subject variability. This could be due to the wide variety of alignments (e.g. walking basis), prosthetic components (e.g. knee, foot, protective device, etc) and anthropometric characteristics (e.g. angle of femur with residuum) within the tested population. This outcome tends to highlight the need for individual-based rather than population-based biomechanical analyses of transfemoral amputees. It is anticipated that this study will provide essential information to Biomechanists facing the challenge of analyzing the locomotion of lower-limb amputees within experimental conditions.   ACKNOWLEDGMENT  The authors would like to express their gratitude to Dr Bill Contoyannis and Dr Andrew Nunn for the participation in the data collection.  This study was partially funded by the ARC Discovery Project (DP0345667), ARC Linkage Grant (LP0455481), a QUT Strategic Link with the Industry and IHBI Advanced Diagnosis in Medical Device Grant.    REFERENCES  [1] Hagberg, K. and R. Brånemark, Consequences of non-vascular trans-femoral amputation: a survey of quality of life, prosthetic use and problems. Prosthetics and Orthotics International, 2001. 25: p. 186-194. [2] Brånemark, R., et al., Osseointegration in skeletal reconstruction and rehabilitation: A review. J Rehabil Res Dev, 2001. 38(2): p. 175-81. [3] Sullivan, J., et al., Rehabilitation of the trans-femoral amputee with an osseointegrated prosthesis: the United Kindom experience. Prosthetics and Orthotics International, 2003. 27: p. 114-120. [4] DiAngelo, D.J., et al., Performance assessment of the Terry Fox jogging prosthesis for above-knee amputees. J. Biomechanics, 1989. 22(6/7): p. 543-548. [5] Wearing, S.C., S.R. Urry, and J.E. Smeathers, Ground reaction forces at discrete sites of the foot derived from pressure plate measurements. Foot Ankle Int, 2001. 22(8): p. 653-61. [6] Frossard, L., Beck, J., Dillon, M., Chappell, M. and Evans, J. H. 2003. Development and Preliminary Testing of a Device for the Direct Measurement of Forces and Moments in the Prosthetic Limb of Transfemoral Amputees During Activities of Daily Living. Journal of Prosthetics and Orthotics 15(4), 135-142.  [7] Frossard, L., et al. Loading applied to the implant of transfemoral amputees fitted with a direct skeletal fixation during walking in a straight line and around a circle. in Proceedings of XIXth Congress of the International Society of Biomechanics. 2003. Dunedin, New Zealand: University of Otago. [9] Frossard, L., et al. Load applied on the abutment of transfemoral amputees fitted with an osseointegrated implant during load bearing exercises using a long pylon. in International Society for Prosthetics and Orthotics. 2004. Melbourne, Australia: La trobe University.     

Direct Measurement Of 3D Force And Moment On Lower-Limb Osseointegrated Fixation

Lee, Winson C.C.

Frossard, Laurent A.

Gow, David A.

Gray, Stephen

Name not available

Direct measurement of 3D force and moment on lower-limb osseointegrated fixation

Direct Measurement Of 3D Force And Moment On Lower-Limb Osseointegrated Fixation

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