Ultrasound melted polymer sleeve for improved screw anchorage in trabecular bone--A novel screw augmentation technique.

BACKGROUND: Screw anchorage in osteoporotic bone is still limited and makes treatment of osteoporotic fractures challenging for surgeons. Conventional screws fail in poor bone quality due to loosening at the screw-bone interface. A new technology should help to improve this interface. In a novel constant amelioration process technique, a polymer sleeve is melted by ultrasound in the predrilled screw hole prior to screw insertion. The purpose of this study was to investigate in vitro the effect of the constant amelioration process platform technology on primary screw anchorage. METHODS: Fresh frozen femoral heads (n=6) and vertebrae (n=6) were used to measure the maximum screw insertion torque of reference and constant amelioration process augmented screws. Specimens were cut in cranio-caudal direction, and the screws (reference and constant amelioration process) were implanted in predrilled holes in the trabecular structure on both sides of the cross section. This allowed the pairwise comparison of insertion torque for constant amelioration process and reference screws (femoral heads n=18, vertebrae n=12). Prior to screw insertion, a micro-CT scan was made to ensure comparable bone quality at the screw placement location. FINDINGS: The mean insertion torque for the constant amelioration process augmented screws in both, the femoral heads (44.2 Ncm, SD 14.7) and the vertebral bodies (13.5 Ncm, SD 6.3) was significantly higher than for the reference screws of the femoral heads (31.7 Ncm, SD 9.6, p<0.001) and the vertebral bodies (7.1 Ncm, SD 4.5, p<0.001). INTERPRETATION: The interconnection of the melted polymer sleeve with the surrounding trabecular bone in the constant amelioration process technique resulted in a higher screw insertion torque and can improve screw anchorage in osteoporotic trabecular bone.

Patient-important outcome for the assessment of fracture repair.

Current evidence indicates that fracture healing assessment is limited to the use of one or two domains (such as pain, range of motion or mobility) in any single study. Functional outcome measures, which include physician-rated or observer-based impairment ratings and patient self-reported or observer-based activity limitation measures, better position the effectiveness of a given intervention towards patient-important outcomes. Health status measures, for example, cover a wide-range of physical, emotional, and social health dimensions. In this paper, we will examine the utility of metrics to assess fracture healing that are important to both the patient and provider, with selected examples from the recent literature. We recommend outcome measures with established and verified reliability and validity. Policy-makers and other stakeholders need to have an accurate assessment of treatment outcome that includes changes in function over time-adequate measures, should be re-applied at periodic intervals.

Identifying a standard set of outcome parameters for the evaluation of orthogeriatric co-management for hip fractures.

BACKGROUND AND PURPOSE: Osteoporotic fractures are an increasing problem in the world due to the ageing of the population. Different models of orthogeriatric co-management are currently in use worldwide. These models differ for instance by the health-care professional who has the responsibility for care in the acute and early rehabilitation phases. There is no international consensus regarding the best model of care and which outcome parameters should be used to evaluate these models. The goal of this project was to identify which outcome parameters and assessment tools should be used to measure and compare outcome changes that can be made by the implementation of orthogeriatric co-management models and to develop recommendations about how and when these outcome parameters should be measured. It was not the purpose of this study to describe items that might have an impact on the outcome but cannot be influenced such as age, co-morbidities and cognitive impairment at admission. METHODS: Based on a review of the literature on existing orthogeriatric co-management evaluation studies, 14 outcome parameters were evaluated and discussed in a 2-day meeting with panellists. These panellists were selected based on research and/or clinical expertise in hip fracture management and a common interest in measuring outcome in hip fracture care. RESULTS: We defined 12 objective and subjective outcome parameters and how they should be measured: mortality, length of stay, time to surgery, complications, re-admission rate, mobility, quality of life, pain, activities of daily living, medication use, place of residence and costs. We could not recommend an appropriate tool to measure patients' satisfaction and falls. We defined the time points at which these outcome parameters should be collected to be at admission and discharge, 30 days, 90 days and 1 year after admission. CONCLUSION: Twelve objective and patient-reported outcome parameters were selected to form a standard set for the measurement of influenceable outcome of patients treated in different models of orthogeriatric co-managed care.

Outcome measures and their measurement properties for trapeziometacarpal osteoarthritis: a systematic literature review.

The objective was to identify all outcome measures used in studies on trapeziometacarpal osteoarthritis (TMC OA) and evaluate their measurement properties. In a two-step systematic literature review, we first identified studies including TMC OA patients and extracted all outcome measures. They were categorized according to the Outcome Measures in Rheumatology (OMERACT) core set for OA including five dimensions: pain, physical function, global assessment, imaging, and quality of life (QoL). Secondly, we retrieved articles on the measurement properties of the identified outcome measures for TMC OA patients. First, 316 articles including 101 different outcome measures were identified, addressing the OMERACT pain and function domains most frequently but under-representing QoL. Second, 12 articles investigating measurement properties of 12 outcome measures were identified. The methodological quality of these studies was poor to fair, implying that based on the literature no recommendations to use any of the outcome measures can yet be made.

A functional outcome study comparing total ankle arthroplasty (TAA) subjects with pain to subjects with absent level of pain by means of videofluoroscopy.

BACKGROUND: Total ankle arthroplasty (TAA) subjects often suffer pain on the anteromedial side of their ankle joint. Whether this prevalent pain is caused by a changed motion pattern of the TAA is unclear. Therefore, this study assessed the kinematic differences in the motion of the TAA components during gait, comparing TAA subjects with elevated versus absent levels of pain. METHODS: Eleven TAA subjects (5 with pain vs. 6 without pain), all with unilateral Mobility™ TAA and at least two years post-operation, were recruited and stratified based on standard clinical assessed patient data. The 3D motion of the TAA was assessed by means of videofluoroscopy during level, uphill and downhill walking. RESULTS: The hypothesis that the pain group shows a different kinematic motion pattern than the no pain group could not be confirmed. CONCLUSIONS: The same kinematic motion pattern causes pain in some patients, but not in others. Further investigation concerning ligament stresses is needed.

Implications for fracture healing of current and new osteoporosis treatments: an ESCEO consensus paper.

Osteoporotic fracture healing is critical to clinical outcome in terms of functional recovery, morbidity, and quality of life. Osteoporosis treatments may affect bone repair, so insights into their impact on fracture healing are important. We reviewed the current evidence for an impact of osteoporosis treatments on bone repair. Treatment with bisphosphonate in experimental models is associated with increased callus size and mineralization, reduced callus remodeling, and improved mechanical strength. Local and systemic bisphosphonate treatment may improve implant fixation. No negative impact on fracture healing has been observed, even after major surgery or when administered immediately after fracture. Experimental data for denosumab and raloxifene suggest no negative implications for bone repair. The extensive experimental results for teriparatide indicate increased callus formation, improved biomechanical strength, and greater external callus volume and total bone mineral content and density. Case reports and a randomized trial have produced mixed results but are consistent with a positive impact of teriparatide on clinical fracture healing. Studies with strontium ranelate in models of fracture healing indicate that it is associated with improved bone microstructure, callus volume, and biomechanical properties. Finally, there is experimental evidence for a beneficial effect of some of the agents currently being developed for osteoporosis, notably sclerostin antibody and DKK1 antibody. There is currently no evidence that osteoporosis treatments are detrimental for bone repair and some promising experimental evidence for positive effects on healing, notably for agents with a bone-forming mode of action, which may translate into therapeutic applications.

Development of a score set to measure function and quality of life in patients suffering from elbow pathology.

INTRODUCTION: Daily function plays an important role in the quality of life for patients suffering from pathology of the upper extremity. The recovery of functions of daily living determines the success or failure of the treatment for the patient. The goal of this study was to establish and validate a score set measuring quality of life, and objective and subjective function in general elbow pathologies. METHODS: A literature review was performed, in order to find a patient-based elbow specific questionnaire. The score set was tested and validated in a cross-sectional setting. RESULTS: The patient-rated elbow evaluation (PREE) was chosen as the patient-based elbow specific questionnaire. For measuring general health and subjective arm function, the short form-36 mental health (SF-36 MH) and the shortened disabilities of the arm, shoulder and hand questionnaire (quick DASH) were chosen, respectively. To measure objective function, several clinical tests were implemented. The score set was tested in 66 patients, of which 56.1% had function restrictions due to pain. The correlation between the PREE-function and quick DASH was found to be the highest (r = 0.74*). Between the PREE and quick DASH, the correlation was good (r = 0.70*) and between the PREE-pain and quick DASH, the correlation was moderate (r = 0.58*). The lowest correlation (r = 0.18) was found between the PREE and SF-36 MH (*p < 0.01). CONCLUSION: General health, subjective and objective function can be measured in elbow pathology patients using a score set containing the SF-36 MH, quick DASH, PREE, and several clinical tests. Further testing of the score set needs to be executed in a prospective study.

Survivorship of second-generation metal-on-metal primary total hip replacement.

BACKGROUND: Second generation metal-on-metal total hip replacements (THR) were introduced in the late 1980s and various studies reported conflicting data on their outcome. METHODS: Implant survival of 1,270 second-generation 28 mm metal-on-metal primary THR in 1,121 patients followed prospectively at a mean of 6.8 years postoperatively was evaluated retrospectively. The probability of survival at 10 years was estimated using the method of Kaplan and Meier, and relative risk factors including age, gender, BMI, type of implant fixation and component size were calculated using the Cox proportional-hazards model. RESULTS: Sixty-three (5%) THRs were revised, these being 28 hips for aseptic loosening and 35 for reasons other than aseptic loosening. The probability of survival at 10 years, with revision for any reason as the endpoint, was 0.90 (95% confidence interval (CI) 0.86-0.94) for the THR as a whole, 0.91 (95% CI 0.87-0.95) for the cup, and 0.96 (95% CI 0.94-0.98) for the stem. No demographic factors or covariates were found to significantly affect the implant survivorship. DISCUSSION: As there was no superior probability of survival, and there have been concerns on putative local and systemic toxicity of metal debris, the use of second-generation metal-on-metal articulations for primary THR remains moot.

A combination of shear and dynamic compression leads to mechanically induced chondrogenesis of human mesenchymal stem cells.

There is great interest in how bone marrow derived stem cells make fate decisions. Numerous studies have investigated the role of individual growth factors on mesenchymal stem cell differentiation, leading to protocols for cartilage, bone and adipose tissue. However, these protocols overlook the role of biomechanics on stem cell differentiation. There have been various studies that have applied mechanical stimulation to constructs containing mesenchymal stem cells, with varying degrees of success. One critical fate decision is that between cartilage and bone. Articular motion is a combination of compressive, tensile and shear deformations; therefore, one can presume that compression alone is unlikely to be a sufficient mechanical signal to generate a cartilage-like tissue in vitro. Within this study, we aimed to determine the role of shear on the fate of stem cell differentiation. Specifically, we investigated the potential enhancing effect of surface shear, superimposed on cyclic axial compression, on chondrogenic differentiation of human bone marrow-derived stem cells. Using a custom built loading device we applied compression, shear or a combination of both stimuli onto fibrin/polyurethane composites in which human mesenchymal stem cells were embedded, while no exogenous growth-factors were added to the culture medium. Both compression or shear alone was insufficient for the chondrogenic induction of human mesenchymal stem cells. However, the application of shear superimposed upon dynamic compression led to significant increases in chondrogenic gene expression. Histological analysis detected sulphated glycosaminoglycan and collagen II only in the compression and shear group. The results obtained may provide insight into post-operative care after cell therapy involving mesenchymal stromal cells.

Balloon kyphoplasty and vertebroplasty in the management of vertebral compression fractures.

Vertebral compression fractures (VCFs) are the most prevalent fractures in osteoporotic patients. The classical conservative management of these fractures is through rest, pain medication, bracing and muscle relaxants. The aim of this paper is to review prospective controlled studies comparing the efficacy and safety of minimally invasive techniques for vertebral augmentation, vertebroplasty (VP) and balloon kyphoplasty (BKP), versus non-surgical management (NSM). The Fracture Working Group of the International Osteoporosis Foundation conducted a literature search and developed a review paper on VP and BKP. The results presented for the direct management of osteoporotic VCFs focused on clinical outcomes of these three different procedures, including reduction in pain, improvement of function and mobility, vertebral height restoration and decrease in spinal curvature (kyphosis). Overall, VP and BKP are generally safe procedures that provide quicker pain relief, mobility recovery and in some cases vertebral height restoration than conventional conservative medical treatment, at least in the short term. However, the long-term benefits and safety in terms of risk of subsequent vertebral fractures have not been clearly demonstrated and further prospective randomized studies are needed with standards for reporting. Referral physicians should be aware of VP/BKP and their potential to reduce the health impairment of patients with VCFs. However, VP and BKP are not substitutes for appropriate evaluation and treatment of osteoporosis to reduce the risk of future fractures.

[Western Ontario shoulder instability index (WOSI): translation and cross-cultural adaptation for use by German speakers]. / "Western Ontario Shoulder Instability Index" (WOSI) : Ubersetzung und transkulturelle Anpassung für den deutschsprachigen Gebrauch.

BACKGROUND: Outcome assessment after orthopaedic interventions is becoming more and more important. However, there are no disease-specific instruments for patient self-assessment of shoulder instability. The goal of our study was to translate and test the Western Ontario Shoulder Instability Index (WOSI) using a standardised approach. The guidelines of the American Association of Orthopedic Surgeons were used for the translation and cross-cultural adaptation process. MATERIAL AND METHOD: Understanding was tested in 20 healthy subjects, and reliability and validity were quantified in 30 patients with shoulder instability. The quality of the translated version was described using the criteria of homogeneity, reliability, and construct validity. RESULTS: The test-retest reliability of the total score [intraclass correlation coefficient (ICC), 0.87] and of the subscores with the ICC (sports, leisure, and work 0.73; sensitivity 0.81; physical symptoms 0.82; and behaviour 0.90) was high. The internal consistency of the total scale was also high (Cronbach's alpha 0.89). CONCLUSIONS: The WOSI covers a broad range of symptoms and impaired functioning in patients with shoulder instability. The German translation shows good results regarding understanding, homogeneity, reliability, and validity. Therefore, it is a useful instrument for self-assessment in patients with shoulder instability.

Evidence for anti-osteoporosis therapy in acute fracture situations--recommendations of a multidisciplinary workshop of the International Society for Fracture Repair.

The International Society for Fracture Repair convened a multidisciplinary workshop to assess the current evidence around the interaction between anti-osteoporosis drugs and the healing of incident fractures, with a view to making recommendations for clinical practice. The consensus was that there is no evidence-based reason to withhold anti-resorptive therapy while a fracture heals, whether or not the patient was taking such therapy when the fracture occurred. The workshop also considered existing models of service provision for secondary prevention and concluded that the essential ingredient for reliable delivery is the inclusion of a dedicated coordinator role. Several unresolved issues were defined as subjects for further research, including the question of whether continuous long-term administration of anti-resorptives may impair bone quality. The rapidly changing area requires re-assessment of drugs and their interaction with fracture healing in the near future.

[Current application of osteoporosis guidelines--expert recommendations of the German Society of Orthopaedic Surgery and Traumatology]. / Umsetzung der Osteoporoseleitlinien in Orthopädie und Unfallchirurgie--Ergebnisse eines Expertenworkshops der DGOU.

AIM: As an increasing number of patients suffer from osteoporosis-related disorders worldwide, the medical as well as the socioeconomic impact of this problem is significant. Although evidence-based guidelines for diagnosis and treatment are available, their application in daily practice is insufficient. The aim of our initiative was to develop a strategy for supporting this transfer. METHODS: An expert group of the German Society of Orthopaedics and Traumatology (DGOU) has analysed the current scientific as well as health-care data bases regarding diagnosis and treatment of osteoporosis. Then a set of recommendations has been developed in order to improve this situation. RESULTS: The identified support strategy will focus on better identification of patients with osteoporosis and frailty, enhanced interdisciplinary approaches and increased activity to disseminate available guidelines. Additionally, more research activities are necessary in order to highlight the socioeconomic burden of the disease and to continuously improve surgical treatment strategies in the future. CONCLUSION: To ensure a successful application of the recommendations, continuous support of involved health professionals as well as political institutions, national health insurance systems, scientific societies and patient organisations is necessary.

Complication reporting in orthopaedic trials. A systematic review of randomized controlled trials.

BACKGROUND: The nature and frequency of complications during or after orthopaedic interventions represent critical clinical information for safety evaluations, which are required for the development or improvement of orthopaedic care. The goal of this systematic review was to check whether essential data regarding the assessment of the prevalence, severity, and characteristics of complications related to orthopaedic interventions are consistently provided by the authors of papers on randomized controlled trials. METHODS: Five major peer-reviewed orthopaedic journals were screened for randomized controlled trials published between January 2006 and July 2007. All relevant papers were obtained, anonymized, and evaluated by two external reviewers. A checklist consisting of three main parts (definition, evaluation, and reporting) was developed and applied for the assessment of complication reporting. The results were stratified into surgical and nonsurgical categories. RESULTS: One hundred and twelve randomized controlled trials were identified. Although complications were included as trial outcomes in two-thirds of the studies, clear definitions of anticipated complications were provided in only eight trials. In 83% of the trials, the person or group assessing the complications was not identified. No trial involved a data safety review board for assessment and classification of complications. CONCLUSIONS: The lack of homogeneity among the published studies that we reviewed indicates that improvement in the reporting of complications in orthopaedic clinical trials is necessary. A standardized protocol for assessing and reporting complications should be developed and endorsed by professional organizations and, most importantly, by clinical investigators.

Age- and gender-specific normative data of grip and pinch strength in a healthy adult Swiss population.

Assessment of hand strength is used in a wide range of clinical settings especially during treatment of diseases affecting the function of the hand. This investigation aimed to determine age- and gender-specific reference values for grip and pinch strength in a normal Swiss population with special regard to old and very old subjects as well as to different levels of occupational demand. Hand strength data were collected using a Jamar dynamometer and a pinch gauge with standard testing position, protocol and instructions. Analysis of the data from 1023 tested subjects between 18 and 96 years revealed a curvilinear relationship of grip and pinch strength to age, a correlation to height, weight and significant differences between occupational groups. Hand strength values differed significantly from those of other populations, confirming the thesis that applying normative data internationally is questionable. Age- and gender-specific reference values for grip and pinch strength are presented.

A sheep model for fracture treatment in osteoporosis: benefits of the model versus animal welfare.

Animal models are necessary to evaluate new options for the treatment of fractures in osteoporotic bone. They permit both the biological response of a living system and the influence of the pathological processes to be taken into account. A sheep model for osteoporosis was established by combining oestrogen deficiency, calcium and vitamin D-deficient diet with steroid medication. Bone mineral density (BMD) was reduced by >30% after 12 weeks of combined treatment. Osteoporosis similar to the human situation with corresponding changes in the micro-architecture and mechanical properties of bone was observed. This publication focuses on the impressive results obtained with the model and contrasts them with considerations of animal welfare. Considerable side-effects associated with steroid medication became manifest. Animals in the treatment groups showed signs of infection of various degrees due to the immunosuppressive effect of the medication. The infections were mostly caused by Corynebacterium pseudotuberculosis. Antibody testing revealed a 100% prevalence of infection in this breed of sheep. A modification of the steroid treatment, i.e. less-frequent injections, reduced the incidence of side-effects. This sheep model shows a significant and reproducible reduction in cancellous BMD of >30%, including relevant changes in biomechanical properties and increased fracture risk. However, the severity of the side-effects cannot be overlooked. The model must be improved if it is to be used in the future. Options to reduce the side-effects are discussed.

Trabecular bone structures in the edentulous diastema of osteoporotic sheep.

The edentulous ovine diastema represents a suitable region for implantological research. Due to distinctive embryonic origin and mechanical loading, the edentulous diastema may respond differently to osteoporosis than tooth-bearing areas. To test this assumption, we subjected geriatric sheep to ovariectomy, calcium-/vitamin-D-restricted diet, and methylprednisolone administration. Adult control sheep remained untreated. Structural parameters and bone mineral density were determined by microcomputed tomography and conventional computed tomography, respectively. We report that the trabecular microstructure in the diastema was preserved from catabolic changes. In contrast, the premolar maxillary region of osteoporotic sheep had diminished trabecular bone mineral density, with the corresponding structural deteriorations. These results suggest that maxillary trabecular bone of the edentulous diastema does not respond to catabolic changes which occur in the tooth-bearing area in osteoporosis. Our findings imply that regional anatomic domains must be considered in the planning of pre-clinical studies, taking osteoporotic changes into account.

Influence of osteoporosis on fracture fixation--a systematic literature review.

UNLABELLED: The goal of our systematic literature search was to prove whether the experimentally shown influence of osteoporosis on fracture fixation could be confirmed in clinical studies. Despite significant effects in several studies, this is not supported by pooled data due to lack of accurate osteoporosis assessment and complication definitions. INTRODUCTION: The fact that osteoporosis causes fractures is well-known; the assumption that it aggravates their orthopaedic treatment has not been proven. The goal of our systematic literature search was to find out whether the experimentally proven influence of osteoporosis on fracture fixation could be confirmed in clinical studies. METHODS: A systematic electronic database search was performed identifying articles that evaluated complications after fracture fixation among patients suspected of having osteoporosis as measured by BMD or surrogates including Singh index or risk factors. To determine complications risks (relative risk within 95% confidence interval) data were pooled across studies, weighted by sample size and stratified by treatment type. RESULTS: Ten studies out of 77 randomized controlled trials (51 hip, 23 distal radius and three proximal humerus studies) and three systematic reviews finally met eligibility criteria. Despite significant differences of the relative complication risk between osteoporotic and non-osteoporotic patients in several studies, this could not be proven in the pooled data. CONCLUSIONS: In contrast to biomechanical evidence that local osteoporosis affects anchorage of implants, this could not be reproduced in clinical studies, due to the lack of accurate osteoporosis assessment, missing complication definitions and heterogeneous inclusion criteria in these studies. Prospective studies are required that address specifically the correlation between local bone status and the risk of fixation failure.

Development of a predictive model for estimating the probability of treatment success one year after total shoulder replacement - cohort study.

OBJECTIVE: To Estimate the probability of treatment success 1 year after a total shoulder arthroplasty by developing a model based on preoperative clinical factors. METHOD: Between June 2003 and December 2006, 140 patients undergoing shoulder operations were assessed for age, gender, current rheumatoid arthritis, Short Form (SF) 36 physical and mental sum scores, previous shoulder operations, the Disabilities of Arm, Shoulder and Hand (DASH) symptom and function scores, the Shoulder Pain and Disability Index (SPADI), and insurance status. One year after the operation a Constant score of 80 or more out of 100 indicated successful treatment. Patient variables were analyzed with a logistic regression model augmented in a stepwise manner and bootstrapped 100 times. Variables selected at least 33 times were incorporated into a final model and the Area under the Receiver Operating Characteristics Curve (aROC) was calculated. RESULTS: There were 47/140 (33.6%) successful treatments. The probability of success was reduced in patients with previous shoulder operations (Odds Ratio [O.R.] 0.17, 95% Confidence Interval (95%CI) 0.04-0.85; P=0.03) and older than 75 years (O.R. 0.21, 95%CI 0.05-0.77; P=0.02). The probability of success increased in patients with a higher SF 36 mental sum score (O.R. 1.03, 95%CI 0.96-1.09, P=0.42) and a higher DASH function score (O.R. 1.05, 95%CI 1.02-1.07, P=0.001). The aROC was 0.79 (0.70-0.88) indicating that the model has a high predictive capacity. CONCLUSION: Once validated this model based on four preoperative clinical factors offers a prediction of whether a patient will respond to treatment 1 year after total shoulder arthroplasty.