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 purpose

Rehabilitation 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.

Methods

51 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.

Results

At 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.

Interpretation

The 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 traditional method of attaching prostheses for patients who have undergone a transfemoral amputation is by means of socket prostheses. Numerous studies have documented the shortcomings of this approach (Hoaglund et al. 1983, Hagberg and Branemark 2001, Hoffman et al. 2002). Skin conditions and volume changes of the stump increase the difficulty in properly attaching and using the prosthesis (Sherman 1999, Collins et al. 2006). In addition, patients experience changes in gait, which reduces hip flexion and extension and increases pelvic tilt (Hagberg et al. 2005, Rabuffetti et al. 2005). There is also a lack of stabilization between the prosthesis and the residual limb.Brånemark introduced the concept of osseointegration in the 1950s (Sullivan 2001). Shortly afterwards, it was applied to human dental implants. Osseointegration was originally defined as “a direct structural and functional connection between ordered living bone and the surface of a load-carrying implant” (Branemark et al. 1977, 2001). This definition has since been modified over the years as follows: “...when there is no progressive relative movement between the implant and the bone with which it has direct contact” (Branemark et al. 2001). Adell et al. (1981) maintained that the fundamental crux and success of osseointegration was threefold: a delicate surgical technique, an adequate recovery period to allow for optimal bony ingrowth, and controlled loading when use of the implant begins. The bone remodeling that occurs around an osseointegrated implant during the carefully controlled rehabilitation permits further integration of the implant into the bone and gives enhanced long-term clinical outcome. The importance of osseointegration for the long-term stability of orthopedic implants has been successfully used in total joint arthroplasty (Engh et al. 2003, Glassman et al. 2006). This approach may provide a stable and functional prosthesis for patients who cannot use a conventional socket prosthesis (Hagberg and Branemark 2009).A number of studies have examined the positive effect of osseointegrated prostheses on the skin around the site and also on joint movement relative to the effect of standard socket prostheses (Hagberg et al. 2005, Lee et al. 2007, Hagberg and Branemark 2009). Increased quality of life, overall well-being, and improved prosthetic usage have been reported (Hagberg et al. 2008).We assessed long-term fixation and stability of the osseointegrated implant using radiostereometric analysis (RSA) and periprosthetic bone remodeling on plain radiographs. Our hypothesis was that there is not substantial micromotion of the implant and that periprosthetic bone remodeling does not have a negative effect on implant stability or performance.     

Joint disease,the hallmark of haemophilia: What issues and challenges remain despite the development of effective therapies?

Although effective therapies for haemophilia have been available for decades, the prevention and treatment of joint disease remain major clinical concerns for all haemophilia patients. Early identification of joint disease is vital to initiate or modify treatment, and prevent arthropathy. However, there remains a need for more sensitive and accurate methods, which may also detect improvement in patient outcome with new therapies or different prophylaxis regimens. These topics were explored at the Ninth Zürich Haemophilia Forum. A summary of our shared views on the limitations of current assessment methods, and the potential advantages of more recently developed tools, is provided. Ultrasonography enables more frequent routine monitoring and the early detection of joint disease. In addition, serological markers may provide suitable biomarkers of early arthropathy. To prevent arthropathy, in our opinion, prophylaxis is key to prevent joint bleeds and subsequent initiation of the ’vicious circle of joint disease’. However, issues remain, including when prophylaxis should be started, stopped, and if it is efficacious for inhibitor patients. Once joint bleeding has occurred, enhanced on-demand treatment should be considered. For more advanced stages of joint disease, the issues regarding the treatment options available are explored. Radiosynovectomy should be performed to treat chronic synovitis, and may prevent the need for elective orthopaedic surgery (EOS). Ultimately, however, EOS can be considered once all other treatment options have been explored. While, bypassing agents have facilitated the use of EOS in inhibitor patients, a multidisciplinary approach and careful surveillance is required for good patient outcome.     

Characteristics and outcome of a first acute myocardial infarction in patients with ankylosing spondylitis

Clinical Rheumatology - To study clinical characteristics, mortality, and secondary prevention, after a first incident acute myocardial infarction (AMI) in patients with ankylosing spondylitis (AS)...     

Self-reported physical activity and aerobic fitness are differently related to mental health

BackgroundA relevant, but overlooked question is if self-reported physical activity and aerobic fitness are differently related to mental health.PurposeTo examine the relation between mental health and level of self-reported physical activity (SRPA) and aerobic fitness (AF), and whether AF mediates the relation between SRPA and mental health.MethodsParticipating in the study were 177 voluntary subjects (49% men, 51% women) with a mean age of 39 years. Symptoms of depression and anxiety were measured through the Hospital Anxiety and Depression (HAD) scale, and the Shirom-Melamed Burnout Questionnaire (SMBQ) was used to evaluate self-reported symptoms of burnout. Leisure time SRPA during the last three months were measured using a single item. AF was measured by using the Åstrand bicycle test.ResultsSelf-reported physical activity, but not AF, was significantly related to self-reported symptoms of depression, anxiety, and burnout. Light to moderate physical activity that is performed regularly seems to be associated with more favorable mental health pattern compared with physical inactivity. No support was found for the mediating effect of AF of the physical activity–mental health relationship.ConclusionsSelf-reported behavior of regular physical activity seems to be more important to monitor than measures of AF when considering the potential preventive effects of physical activity on mental health.     

Efficacy and safety of low-dose fluticasone propionate compared with zafirlukast in patients with persistent asthma

To compare the efficacy and safety of fluticasone propionate and zafirlukast in patients with relatively stable persistent asthma who were previously treated with inhaled corticosteroids and short-acting beta(2)-agonists.A total of 440 patients (> or =12 years of age) previously treated with inhaled corticosteroids (beclomethasone dipropionate or triamcinolone acetonide) and short-acting beta(2)-agonists were included in this randomized double-blind study. After an 8-day run-in period, patients were treated with fluticasone (88 microg) or zafirlukast (20 mg) twice daily for 6 weeks. Outcome measures included pulmonary function (forced expiratory volume in 1 second [FEV(1)], peak expiratory flow [peak flow]), albuterol use, asthma symptoms, withdrawals due to lack of efficacy, and asthma exacerbations.Patients treated with fluticasone (n = 224) experienced greater mean increases in FEV(1) (0.24 L vs. 0.08 L, P <0.001), morning peak flow (30 L/min vs. 6 L/min, P <0.001), and evening peak flow (23 L/min vs. 5 L/min, P <0.001) during the study than did those treated with zafirlukast (n = 216). Fluticasone-treated patients had significantly greater increases in the mean percentages of symptom-free days (22% vs. 8%, P <0.001), rescue-free days (23% vs. 10%, P = 0.002), nights with uninterrupted sleep (<1% vs. -5%, P = 0.006), and fewer asthma exacerbations (1% vs. 6%, P = 0.005). Fewer fluticasone-treated patients were withdrawn due to lack of efficacy (2% vs. 13%, P <0.001).Inhaled fluticasone was more effective than zafirlukast in maintaining or improving asthma control in patients with relatively stable asthma who were switched from low-dose inhaled corticosteroids.     

Prenatal diagnosis of haemophilia in Sweden now more commonly used for psychological preparation than termination of pregnancy

The aims of the study were to define the frequency, outcome and reasons for prenatal diagnosis (PND) in Sweden during a 30‐year period in order to study trends and changes. The study population, from the Swedish nationwide registry of PND of haemophilia, consisted of 54 women, compromising >95% of all, who underwent PND (n = 90) of haemophilia during 1977–2013. PND was performed by amniocentesis (n = 10), chorionic villus sampling (n = 64) or by analysis of foetal blood (n = 16). A total of 27/90 foetuses were found to have haemophilia. Sixteen went to termination and the remaining 11 were born during the end of the study period (2000–2013). Three of 90 pregnancies were terminated due to findings other than haemophilia and 3/90 PNDs led to miscarriage. In the 30 families with known haemophilia, PNDs (n = 55) were used in 27/55 cases for ‘psychological preparation’ and in 23/55 cases with the aim to terminate the pregnancy. A subgroup of women (n = 17) who consecutively underwent PND in the years 1997–2010 were further interviewed. For 11/17, being a carrier had a negative effect on the decision to become pregnant, and in 11 cases PND had influenced their decision to conceive. Our study show that PND of haemophilia is stable over time but increasingly used during the last decade as a psychological preparation for having a child with haemophilia as compared to earlier where more terminations of pregnancies were conducted.     

Peripheral intravenous catheter practices in Australian and New Zealand neonatal units: A cross-sectional survey

Peripheral intravenous catheters (PIVCs) are important tools for the provision of treatment for unwell and premature neonates. This study aimed to explore current PIVC practices (i.e. insertion, product selection, complications and management priorities) within Australian and New Zealand neonatal units, to identify areas for innovation and practice change. The survey was distributed via Australian and New Zealand neonatal nursing associations, with 180 respondents (54% Australia; 46% New Zealand). Respondents reported an average of 2–3 insertion attempts were required per PIVC, with variability in cleansing agents, decontamination techniques, skin barrier films and PIVC dressing products used. The large majority of respondents reported seeing skin complications associated with PIVCs within their practice (94%). Infection prevention was the highest management priority, and skin complication prevention, the lowest priority. High quality research is necessary to inform neonatal PIVC insertion and management practices, to improve patient safety and treatment provision.