Magnitude and variability of loading on the osseointegrated implant of transfemoral amputees during walking

This study directly measured the load acting on the abutment of the osseointegrated implant system of transfemoral amputees during level walking, and studied the variability of the load within and among amputees. Twelve active transfemoral amputees (age: 54±12 years, mass:84.3±16.3 kg, height: 17.8±0.10 m) fitted with an osseointegrated implant for over 1 year participated in the study. The load applied on the abutment was measured during unimpeded, level walking in a straight line using a commercial six-channel transducer mounted between the abutment and the prosthetic knee. The pattern and the magnitude of the three-dimensional forces and moments were revealed. Results showed a low step-to-step variability of each subject, but a high subject-to-subject variability in local extrema of body-weight normalized forces and moments and impulse data. The high subject-to-subject variability suggests that the mechanical design of the implant system should be customized for each individual, or that a fit-all design should take into consideration the highest values of load within a broad range of amputees. It also suggests specific loading regime in rehabilitation training are necessary for a given subject. Thus the loading magnitude and variability demonstrated should be useful in designing an osseointegrated implant system better able to resist mechanical failure and in refining the rehabilitation protocol.

Repeatability of static load bearing exercises during rehabilitation of individuals with transfemoral amputation fitted with osseointegrated implant

Bone-anchored prostheses, relying on implants to attach the prosthesis directly to the residual skeleton, are the ultimate resort for patients with transfemoral amputations (TFA) experiencing severe socket discomfort. The first patient receiving a bone-anchored prosthesis underwent the surgery in 1990 in the Sahlgrenska University Hospital (Sweden). To date, there are two commercially available implants: OPRA (Integrum, Sweden) and ILP (Orthodynamics, Germany). The key to success to this technique is a firm bone-implant bonding, depending on increasing mechanical stress applied daily during load bearing exercises (LBE). The loading data could be analysed through different biomechanical variables. The intra-tester reliability of these exercises will be presented here. Moreover the effect of increase of loading, axes of application of the load and body weight as well as the difference between force and moment variables will be discussed.

Static load bearing exercises during rehabilitation of individuals with transfemoral amputation fitted with osseointegrated implant: Load compliance

Osseointegration has been introduced in the orthopaedic surgery in the 1990’s in Gothenburg (Sweden). To date, there are two frequently used commercially available human implants: the OPRA (Integrum, Sweden) and ILP (Orthodynamics, Germany) systems. The rehabilitation program with both systems include some form of static load bearing exercises. These latter involved following a load progression that is monitored by the bathroom scale, providing only the load applied on the vertical axis. The loading data could be analysed through different biomechanical variables. For instance, the load compliance, corresponding to the difference between the load recommended (LR) and the load actually applied on the implant, will be presented here.

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].

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.

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 of Bone Insertion Level of Support Teeth in Class I Mandibular Removable Partial Denture Associated With an Osseointegrated Implant: A Study Using Finite Element Analysis

Purpose: This study evaluated the influence of distal extension removable partial denture associated with implant in cases of different bone level of abutment tooth, using 2D finite element analysis.Materials and Methods: Eight hemiarch models were simulated: model A-presenting tooth 33 and distal extension removable partial denture replacing others teeth, using distal rest connection and no bone lost; model B-similar to model A but presenting distal guide plate connection; model C-similar to model A but presenting osseointegrated implant with ERA retention system associated under prosthetic base; model D-similar to model B but presenting osseointegrated implant as described in model C; models E, F, G, and H were similar to models A, B, C, and D but presenting reduced periodontal support around tooth 33. Using ANSYS 9.0 software, the models were loaded vertically with 50 N on each cusp tip. For results, von Mises Stress Maps were plotted.Results: Maximum stress value was encountered in model G (201.023 MPa). Stress distribution was concentrated on implant and retention system. The implant/removable partial denture association decreases stress levels on alveolar mucosa for all models.Conclusions: Use of implant and ERA system decreased stress concentrations on supporting structures in all models. Use of distal guide plate decreased stress levels on abutment tooth and cortical and trabecular bone. Tooth apex of models with reduced periodontal support presented increased stress when using distal rest. (Implant Dent 2011;20:192-201)

Evaluation of Different Retention Systems on a Distal Extension Removable Partial Denture Associated With an Osseointegrated Implant

The aim of this study was to evaluate the biomechanical behavior of a mandibular distal extension removable partial denture (DERPD) associated with an implant and different retention system, by bidimensional finite element method. Five hemimandible models with a canine and external hexagon implant at second molar region associated with DERPD were simulated: model A, hemimandible with a canine and a DERPD; model B, hemimandible with a canine and implant with a healing abutment associated to a DERPD; model C, hemimandible with a canine and implant with an ERA attachment associated to a DERPD; model D, hemimandible with a canine and implant with an O'ring attachment associated to a DERPD; and model E, hemimandible with a canine and implant-supported prosthesis associated to a DERPD. Cusp tips were loaded with 50 N of axial or oblique force (45 degrees). Finite element analysis was performed in ANSYS 9.0. model E showed the higher displacement and overload in the supporting tissues; the patterns of stress distribution around the dental apex of models B, C, and D were similar. The association between a DERPD and an osseointegrated implant using the ERA or O'ring systems shows lower stress values. Oblique forces showed higher stress values and displacement. Oblique forces increased the displacement and stress levels in all models; model C displayed the best stress distribution in the supporting structures; healing abutment, ERA, and O'ring systems were viable with RPD, but DERPD association with a single implant-supported prosthesis was nonviable.

Osseointegrated Implant Fracture: Causes and Treatment

Despite its high success rate, therapy with osseointegrated dental implants is not free of complications. Among the problems that may occur is fracture of implants, which, albeit a rare phenomenon, may lead to unpleasant clinical outcomes for the patient, as well as for the clinician. Thus, it is paramount to know the factors related to the biological processes involved in maintenance of osseointegration and biomechanics applied to dental implants to prevent such complications, as well as treatment options available to deal with the problem. Therefore, the objectives of this work were to investigate the literature to identify causative factors that may lead to fracture of dental implants and to discuss available procedures.

Zygomatic bone: Anatomic bases for osseointegrated implant anchorage

Purpose: The aim of the present study was to evaluate zygomatic bone thickness considering a possible relationship between this parameter and cephalic index (Cl) for better use of Cl in the implant placement technique. Materials and Methods: Cl was calculated for 60 dry Brazilian skulls. The zygo matic bones of the skulls were divided into 13 standardized sections for measurement. Bilateral measurements of zygomatic bone thickness were made on dry skulls. Results: Sections 5, 6, 8, and 9 were appropriate for implant anchorage in terms of location. The mean thicknesses of these sections were 6.05 mm for section 5, 3.15 mm for section 6, 6.13 mm for section 8, and 4.75 mm for section 9. In only 1 section, section 8, did mean thickness on 1 side of of the skull differ significantly from mean thickness on the other side (P <.001). Discussion: For the relationship between quadrant thick ness and Cl, sections 6 and 8 varied independently of Cl. Section 5 associated with brachycephaly, and section 9 associated with subbrachycephaly, presented variations in the corresponding thickness. Conclusion: Based on the results, implants should be placed in sections 5 and 8, since they presented the greatest thickness, except in brachycephalic subjects, where thickness was greatest in section 5, and in subbrachycephalic subjects, where thickness was greatest in section 9. Cl did not prove to be an appropriate parameter for evaluating zygomatic bone thickness for this sampling.

Apparatus for monitoring load bearing rehabilitation exercises of a transfemoral amputee fitted with an osseointegrated fixation : a proof-of-concept study

The purpose of this proof-of-concept study was to determine the relevance of direct measurements to monitor the load applied on the osseointegrated fixation of transfemoral amputees during static load bearing exercises. The objectives were (A) to introduce an apparatus using a three-dimensional load transducer, (B) to present a range of derived information relevant to clinicians, (C) to report on the outcomes of a pilot study and (D) to compare the measurements from the transducer with those from the current method using a weighing scale. One transfemoral amputee fitted with an osseointegrated implant was asked to apply 10 kg, 20 kg, 40 kg and 80 kg on the fixation, using self-monitoring with the weighing scale. The loading was directly measured with a portable kinetic system including a six-channel transducer, external interface circuitry and a laptop. As the load prescribed increased from 10 kg to 80 kg, the forces and moments applied on and around the antero-posterior axis increased by 4 fold anteriorly and 14 fold medially, respectively. The forces and moments applied on and around the medio-lateral axis increased by 9 fold laterally and 16 fold from anterior to posterior, respectively. The long axis of the fixation was overloaded and underloaded in 17 % and 83 % of the trials, respectively, by up to ±10 %. This proof-of-concept study presents an apparatus that can be used by clinicians facing the challenge of improving basic knowledge on osseointegration, for the design of equipment for load bearing exercises and for rehabilitation programs.

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.

Evaluation of the influence of location of osseointegrated implants associated with mandibular removable partial dentures

Purpose: The aim of this research was to assess, by means of, the bi-dimensional finite element method, the best implant location in the alveolar edge, through stress distribution and support structure displacement of a distal extension removable partial denture associated with an osseointegrated implant of 10.0 x .75 mm, acting as abutment for the denture base.Methods and Materials: Five models in sagittal cut were used to represent: model A-hemi arch containing natural tooth 33 and the distal alveolar edge; model B-similar to model A, but with a conventional removable partial denture to replace the absent teeth; model C (MC)-similar to the previous one, with an implant in the distal region of the edge under the denture base; model D-similar to MC, with the implant in the central region of the edge; model E-similar to MC, with an implant in the mesial region of the edge. With the aid of the finite element program ANSYS 8.0, the models were loaded with strictly vertical forces of 50 N on each cusp tip. Displacement and von Mises Maps were plotted for visualization of results.Results: The introduction of implant diminished the tendency of intrusion of the removable partial denture in all situations. The maximum stress was observed on implant in all situations. Approximating implant in direction of support teeth was benefit for stress distribution.Conclusion: Model D presented the lowest value for maximum tendency to displacement when compared with those found in the other models; model E demonstrated better relief with regard to demand from the abutment tooth; locating the implant near of the abutment tooth influenced positively the distribution of stresses on the analyzed structures.