Osseointegrated prostheses for rehabilitation following amputation : The pioneering Swedish model.

The direct attachment of osseointegrated (OI) prostheses to the skeleton avoids the inherent problems of socket suspension. It also provides physiological weight bearing, improved range of motion in the proximal joint, as well as osseoperceptive sensory feedback, enabling better control of the artificial limbs by amputees. The present article briefly reviews the pioneering efforts on extremity osseointegration surgeries in Sweden and the development of the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) program. The standard implant design of the OPRA system and surgical techniques are described as well as the special rehabilitation protocols based on surgical sites. The results of long-term follow-up for transradial, transhumeral, and thumb amputee operations are briefly reported including the prospective study of transfemoral amputees according to OPRA protocol. The importance of refinement on implant designs and surgical techniques based on the biomechanical analysis and early clinical trials is emphasized. Future aspects on osseointegration surgery are briefly described, including novel treatment options using implanted electrodes

Effect on signal-to-noise ratio of splitting the continuous contacts of cuff electrodes into smaller recording areas.

BackgroundCuff electrodes have been widely used chronically in different clinical applications. This neural interface has been dominantly used for nerve stimulation while interfering noise is the major issue when employed for recording purposes. Advancements have been made in rejecting extra-neural interference by using continuous ring contacts in tripolar topologies. Ring contacts provide an average of the neural activity, and thus reduce the information retrieved. Splitting these contacts into smaller recording areas could potentially increase the information content. In this study, we investigate the impact of such discretization on the Signal-to-Noise Ratio (SNR). The effect of contacts positioning and an additional short circuited pair of electrodes were also addressed.MethodsDifferent recording configurations using ring, dot, and a mixed of both contacts were studied in vitro in a frog model. An interfering signal was induced in the medium to simulate myoelectric noise. The experimental setup was design in such a way that the only difference between recordings was the configuration used. The inter-session experimental differences were taken care of by a common configuration that allowed normalization between electrode designs.ResultsIt was found that splitting all contacts into small recording areas had negative effects on noise rejection. However, if this is only applied to the central contact creating a mixed tripole configuration, a considerable and statistically significant improvement was observed. Moreover, the signal to noise ratio was equal or larger than what can be achieved with the best known configuration, namely the short circuited tripole. This suggests that for recording purposes, any tripole topology would benefit from splitting the central contact into one or more discrete contacts.ConclusionsOur results showed that a mixed tripole configuration performs better than the configuration including only ring contacts. Therefore, splitting the central ring contact of a cuff electrode into a number of dot contacts not only provides additional information but also an improved SNR. In addition, the effect of an additional pair of short circuited electrodes and the "end effect" observed with the presented method are in line with previous findings by other authors

Stable fixation of an osseointegated implant system for above-the-knee amputees: titel RSA and radiographic evaluation of migration and bone remodeling in 55 cases.

Background and purposeRehabilitation of patients with transfemoral amputations is particularly difficult due to problems in using standard socket prostheses. We wanted to assess long-term fixation of the osseointegrated implant system (OPRA) using radiostereometric analysis (RSA) and periprosthetic bone remodeling.Methods51 patients with transfemoral amputations (55 implants) were enrolled in an RSA study. RSA and plain radiographs were scheduled at 6 months and at 1, 2, 5, 7, and 10 years after surgery. RSA films were analyzed using UmRSA software. Plain radiographs were graded for bone resorption, cancellization, cortical thinning, and trabecular streaming or buttressing in specifically defined zones around the implant.ResultsAt 5 years, the median (SE) migration of the implant was -0.02 (0.06) mm distally. The rotational movement was 0.42 (0.32) degrees around the longitudinal axis. There was no statistically significant difference in median rotation or migration at any follow-up time. Cancellization of the cortex (plain radiographic grading) appeared in at least 1 zone in over half of the patients at 2 years. However, the prevalence of cancellization had decreased by the 5-year follow-up.InterpretationThe RSA analysis for the OPRA system indicated stable fixation of the implant. The periprosthetic bone remodeling showed similarities with changes seen around uncemented hip stems. The OPRA system is a new and promising approach for addressing the challenges faced by patients with transfemoral amputations

The clinical, radiological, microbiological, and molecular profile of the skin-penetration site of transfemoral amputees treated with bone-anchored prostheses.

The breach of the skin barrier is a critical issue associated with the treatment of individuals with transfemoral amputation (TFA) using osseointegrated, percutaneous titanium implants. Thirty TFA patients scheduled for abutment exchange or removal were consecutively enrolled. The aims were to determine the macroscopic skin signs, the presence of bacteria and the gene expression in abutment-adherent cells and to conduct correlative and comparative analyses between the different parameters. Redness and a granulation ring were present in 47% of the patients. Bacteria were detected in 27/30 patients, commonly in the bone canal. Staphylococcus aureus, coagulase-negative staphylococci, streptococci, and Enterococcus faecalis were the most common. A positive correlation was found between TNF-α expression and the detection of S. aureus. Staphylococcus aureus together with other bacterial species revealed a positive relationship with MMP-8 expression. A negative correlation was demonstrated between the length of the residual femur bone and the detection of a granulation ring and E. faecalis. A positive correlation was revealed between fixture loosening and pain and the radiological detection of endosteal bone resorption. Fixture loosening was also correlated with the reduced expression of interleukin-10 and osteocalcin. It is concluded that several relationships exist between clinical, radiological, microbiological, and molecular assessments of the percutaneous area of TFAs. Further long term studies on larger patient cohorts are required to determine the precise cause-effect relationships and unravel the role of host-bacteria interactions in the skin, bone canal and on the abutment for the longevity of percutaneous implants as treatment of TFA. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 105A: 578-589, 2017

Osseointegrated Titanium Implants for Limb Prostheses Attachments: Infectious Complications

Femoral amputation is a devastating event. Percutaneous, bone anchored prosthetic systems reduce problems associated with socket suspended prostheses, but the design is inherently vulnerable to infection. The aims of this thesis were to determine the risk of implant-associated infection, bacterial biofilm properties and the functional impact using this implant treatment regime. Definition of implant related osteomyelitis was based on clinical signs, radiography and positive tissue cultures. In 3-year prospective study 39 patients were evaluated twice for infectious frequency, clinical presentation, and its relation to bacterial flora at the skin-implant interface (Paper 1). The frequency of implant infection was 5% at inclusion and 18% at follow-up. The most common bacteria in superficial, and deep cultures were Staphylococcus aureus and coagulase-negative staphylococci. Despite frequent colonization by potentially virulent bacteria, limited disability, and only one implant removal was found. Phenotypical and genotypical biofilm formation was determined in 13 (7 staphylococcal, 6 enterococcal) osteomyelitis strains (Paper II). Antimicrobial resistance was tested with a novel combination of the Calgary biofilm MBEC device, and a custom-made susceptibility MIC plate. The majority of the strains produced biofilm with increased antimicrobial resistance, compared to their planktonic counterparts. Slime producing strains tolerated higher antimicrobial concentrations compared to non-producers. All staphylococcal strains carried ica genes. The long-term risk of implant-associated infection, and its relation to patient and method specific factors was determined in a 20-year retrospective analysis of the first 96 femoral implant patients (102 implants) (Paper III). A 10-year cumulative risk of 20% for developing osteomyelitis (16 patients), and a 10-year cumulative risk of 9 % for implant extraction due to osteomyelitis (10 patients) was found. Antibiotic treatment (median 3.5 months) and selective minor debridement, with retained implants, cured 7 out of 18 patients at the 24- month follow-up (Paper IV). Six patients were cured after implant extraction, and 5 had chronic low-grade infections with stable implants, but variable use of the external prosthetic leg. The most common pathogens were S. aureus and E. faecalis. C-reactive protein serum levels were significantly higher in patients with osteomyelitis caused by S. aureus than other pathogens. It is concluded that the finding of an increased risk of osteomyelitis with time using this implant system calls for; i) careful patient selection and information of long term risks, ii) further studies on infection control, iii) consideration of biofilm in treatment, and iv) improved diagnostics, and antibiotic delivery

Treatment of phantom limb pain (PLP) based on augmented reality and gaming controlled by myoelectric pattern recognition: a case study of a chronic PLP patient

A variety of treatments have been historically used to alleviate phantom limb pain (PLP) with varying efficacy. Recently, virtual reality (VR) has been employed as a more sophisticated mirror therapy. Despite the advantages of VR over a conventional mirror, this approach has retained the use of the contralateral limb and is therefore restricted to unilateral amputees. Moreover, this strategy disregards the actual effort made by the patient to produce phantom motions. In this work, we investigate a treatment in which the virtual limb responds directly to myoelectric activity at the stump, while the illusion of a restored limb is enhanced through augmented reality (AR). Further, phantom motions are facilitated and encouraged through gaming. The proposed set of technologies was administered to a chronic PLP patient who has shown resistance to a variety of treatments (including mirror therapy) for 48 years. Individual and simultaneous phantom movements were predicted using myoelectric pattern recognition and were then used as input for VR and AR environments, as well as for a racing game. The sustained level of pain reported by the patient was gradually reduced to complete pain-free periods. The phantom posture initially reported as a strongly closed fist was gradually relaxed, interestingly resembling the neutral posture displayed by the virtual limb. The patient acquired the ability to freely move his phantom limb, and a telescopic effect was observed where the position of the phantom hand was restored to the anatomically correct distance. More importantly, the effect of the interventions was positively and noticeably perceived by the patient and his relatives. Despite the limitation of a single case study, the successful results of the proposed system in a patient for whom other medical and non-medical treatments have been ineffective justifies and motivates further investigation in a wider study