Ceramic Wear Particles: Can They Be Retrieved In Vivo and Duplicated In Vitro?

BACKGROUND: Little is known about retrieved zirconia platelet toughened alumina (ZPTA) wear particles from ceramic-on-ceramic (COC) total hip arthroplasty. Our objectives were to evaluate clinically retrieved wear particles from explanted periprosthetic hip tissues and to analyze the characteristics of in vitro-generated ZPTA wear particles. METHODS: Periprosthetic tissue and explants were received for 3 patients who underwent a total hip replacement of ZPTA COC head and liner. Wear particles were isolated and characterized via scanning electron microscopy and energy dispersive spectroscopy. The ZPTA and control (highly cross-linked polyethylene and cobalt chromium alloy) were then generated in vitro using a hip simulator and pin-on-disc testing, respectively. Particles were assessed in accordance with American Society for Testing and Materials F1877. RESULTS: Minimal ceramic particles were identified in the retrieved tissue, consistent with the retrieved components demonstrating minimal abrasive wear with material transfer. Average particle diameter from in vitro studies was 292 nm for ZPTA, 190 nm for highly cross-linked polyethylene, and 201 nm for cobalt chromium alloy. CONCLUSION: The minimal number of in vivo ZPTA wear particles observed is consistent with the successful tribological history of COC total hip arthroplasties. Due to the relatively few ceramic particles located in the retrieved tissue, in part due to implantation times of 3 to 6 years, a statistical comparison was unable to be made between the in vivo particles and the in vitro-generated ZPTA particles. However, the study provided further insight into the size and morphological characteristics of ZPTA particles generated from clinically relevant in vitro test setups.

Effects of Different Hemoglobin Levels on Near-Infrared Spectroscopy-Derived Cerebral Oxygen Saturation in Elderly Patients Undergoing Noncardiac Surgery.

Background: Near-infrared spectroscopy (NIRS) is a commonly used technique to evaluate tissue oxygenation and prevent harmful cerebral desaturation in the perioperative setting. The aims of the present study were to assess whether surgery-related anemia can be detected via NIRS of cerebral oxygen saturation and to investigate the effects of different perioperative transfusion strategies on cerebral oxygenation, potentially affecting transfusion decision-making. Study Design and Methods: Data from the ongoing multicenter LIBERAL-Trial (liberal transfusion strategy to prevent mortality and anemia-associated ischemic events in elderly noncardiac surgical patients, LIBERAL) were used. In this single-center sub-study, regional cerebral oxygenation saturation (rSO2) was evaluated by NIRS at baseline, pre-, and post-RBC transfusion. The obtained values were correlated with blood gas analysis-measured Hb concentrations. Results: rSO2 correlated with Hb decline during surgery (r = 0.35, p < 0.0001). Different RBC transfusion strategies impacted rSO2 such that higher Hb values resulted in higher rSO2. Cerebral desaturation occurred at lower Hb values more often. Discussion: Cerebral oxygenation monitoring using NIRS provides noninvasive rapid and continuous information regarding perioperative alterations in Hb concentration without the utilization of patients' blood for blood sampling. Further investigations are required to demonstrate if cerebral rSO2 may be included in future individualized transfusion decision strategies.

Femoral defects in revision hip arthroplasty: a therapy-oriented classification.

INTRODUCTION: The complex field of femoral defects in revision hip arthroplasty displays a lack of standardized, intuitive pre- and intraoperative assessment. To address this issue, the femoral defect classification (FDC) is introduced to offer a reliable, reproducible and an intuitive classification system with a clear therapeutic guideline. MATERIALS AND METHODS: The FDC is based on the integrity of the main femoral segments which determine function and structural support. It focuses on the femoral neck, the metaphysis consisting of the greater and lesser trochanter, and the femoral diaphysis. The four main categories determine the location of the defect while subcategories a, b and c are being used to classify the extent of damage in each location. In total, 218 preoperative radiographs were retrospectively graded according to FDC and compared to intraoperatively encountered bone defects. To account for inter-rater and intra-rater agreement, 5 different observers evaluated 80 randomized cases at different points in time. RESULTS: A Cohens kappa of 0.832 ± 0.028 could be evaluated, accounting for excellent agreement between preoperative radiographs and intraoperative findings. To account for inter-rater reliability, 80 patients have been evaluated by 5 different observers. Testing for inter-rater reliability, a Fleiss Kappa of 0.688 could be evaluated falling into the good agreement range. When testing for intra-rater reliability, Cohens Kappa of each of the 5 raters has been analyzed and the mean was evaluated at 0.856 accounting for excellent agreement. CONCLUSION: The FDC is a reliable and reproducible classification system. It combines intuitive use and structured design and allows for consistent preoperative planning and intraoperative guidance. A therapeutic algorithm has been created according to current literature and expert opinion. Due to the combination of the FDC with the recently introduced Acetabular Defect Classification (ADC) a structured approach to the entire field of hip revision arthroplasty is now available.

Increased rate of enteric bacteria as cause of periprosthetic joint infections in patients with liver cirrhosis.

INTRODUCTION: Periprosthetic joint infections (PJI) are a major complication in joint-arthroplasty. Rifampicin is often used as an additional agent to treat PJI, because it penetrates bacterial biofilms. However, rifaximin, belonging to the same antibiotic class as rifampicin, is frequently used to prevent episodes of hepatic encephalopathy in patients with cirrhosis and may induce resistance to rifampicin. The aim of this study was to examine the microbial pattern of periprosthetic joint infections in cirrhotic patients and to test the hypothesis that intake of rifaximin increases the rate of resistance to rifampicin in periprosthetic joint infections. METHODS: A cohort of cirrhotic patients and PJI (n = 25) was analysed on the characteristics of bacterial isolates from sonication and tissue analysis. In a second step a subgroup analysis on the development of rifampicin resistant bacterial specimens, depending on the intake of rifaximin (8 rifaximin intake patients vs. 13 non rifaximin intake patients) was performed. RESULTS: Intestinal bacteria were found in 50% of the specimens, which was significantly more frequent than in a control cohort. By comparison of the single bacterial isolates, rifampicin resistance was detected in 69.2% (9/13) of the rifaximin-intake samples. In contrast, the non-rifaximin-intake isolates only were resistant to rifampicin in 22.2% (4/18) of the cases (p = 0.01). The odds ratio for developing a rifampicin-resistance through rifaximin intake was calculated as OR = 13.5. CONCLUSION: Periprosthetic joint infections have a high incidence of being caused by enteric bacteria in cirrhotic patients. Due to this change in microbial pattern and the innate resistance to rifampicin of most of gram-negative bacteria, the therapy with rifampicin should be carefully considered. The association between the use of rifaximin and developed resistance to rifampicin has a major impact on the treatment of PJI.

Safety and Suitability of the SmartPill® after Abdominal Surgery: Results of the Prospective, Two-Armed, Open-Label PIDuSA Trial.

INTRODUCTION: Postoperative ileus (POI) is a common complication after abdominal surgery. Until today, an evidence-based treatment of prolonged POI is still lacking, which can be attributed to the poor quality of clinical trials. Various different surrogate markers used to define POI severity are considered to be the cause of low-quality trials making it impossible to derive treatment recommendation. The SmartPill®, which is able to record pH values, temperature and pressure after ingestion, could be an ideal tool to measure transit times and peristalsis and therefore analyze POI severity. Unfortunately, the device has no approval for postoperative use due to safety concerns. The primary objective of the study is to determine safety of the SmartPill® in patients undergoing surgery. Secondary objectives were the quality of the recorded data and the suitability of the SmartPill® for analyzing intestinal motility after different surgical procedures. METHODS: The PIDuSA Study is a prospective, 2-arm, open-label trial. At the end of surgery, the SmartPill® was applied to 49 patients undergoing abdominal surgery having a high risk for impaired intestinal motility and 15 patients undergoing extra-abdominal surgery. Patients were visited daily to access safety data of the SmartPill® on the basis of adverse and serious adverse events (AEs/SAEs). Suitability and data quality were investigated by analyzing data completeness and feasibility to determine transit times and peristalsis for all sections of the gastrointestinal tract. RESULTS: In total, 179 AEs and 8 SAEs were recorded throughout the study affecting 42 patients in the abdominal (158 AEs) and 9 patients in the extra-abdominal surgery group (21 AEs, p = 0.061); none of them were device related. Primary capsule failure was observed in 5 patients, ultimately resulting in an impossibility of data analysis in only 3 patients (4.4%). 9% of the recorded data were incomplete due to the patient's incompliance in keeping the receiver close to the body. In 3 patients (4.4%), isolated small bowel transit could not be determined due to pH alterations as a result of prolonged POI. DISCUSSION: Our study demonstrates that the use of the SmartPill® is safe after surgery but requires a reasonable patient compliance to deliver meaningful data. An objective analysis of transit times and peristalsis was possible irrespective of type and site of surgery in over 95% indicating that the SmartPill® has the potential to deliver objective parameters for POI severity in future clinical trials. However, in some patients with prolonged POI, analysis of small bowel transit could be challenging.

Quantitative sensory phenotyping in chronic neuropathic pain patients treated with unilateral L4-dorsal root ganglion stimulation.

BACKGROUND: In a previous study, we reported that selective dorsal root ganglion stimulation (DRGSTIM) at DRG level L4 promoted a favorable outcome for complex regional pain syndrome (CRPS) patients along with DRGSTIM-related changes of inflammatory biomarkers in blood and saliva. The impact on somatosensation is largely unknown. Herein, we assessed the quantitative sensory profile to quantify L4-DRGSTIM effects in CRPS patients. METHODS: Twelve refractory CRPS patients (4 female; 8 male; mean age 69 ± 9 years) received standardized quantitative sensory testing (QST) protocol at baseline and after 3 months of unilateral L4-DRGSTIM assessing nociceptive and non-nociceptive thermal and mechanical sensitivity of the knee affected by CRPS and the contralateral non-painful knee area. RESULTS: At baseline, CRPS subjects showed significantly increased thresholds for warmth, tactile and vibration detection (WDT, MDT and VDT) and exaggerated pain summation (WUR). After 3 months of unilateral L4-DRGSTIM all pain parameters exhibited trends towards normalization of sensitivity accumulating to a significant overall normalization for pain sensitivity (effect size: 0.91, p < 0.01), while with the one exception of WDT all non-nociceptive QST parameters remained unchanged. Overall change of non-nociceptive detection was negligible (effect size: 0.25, p > 0.40). Notably, reduction of pain summation (WUR) correlated significantly with pain reduction after 3 months of L4-DRGSTIM. CONCLUSIONS: Selective L4-DRGSTIM lowered ongoing pain in CRPS patients and evoked significant normalization in the pain domain of the somatosensory profile. Thermoreception and mechanoreception remained unchanged. However, larger randomized, sham-controlled trials are highly warranted to shed more light on effects and mechanisms of dorsal root ganglion stimulation on quantitative sensory characteristics. The study protocol was registered at the 15.11.2016 on German Register for Clinical Trials (DRKS ID 00011267). https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00011267.

Immunofluorescence analysis of sensory nerve endings in the interosseous membrane of the forearm.

The human interosseous membrane (IOM) is a fundamental stabilizer during forearm rotation. To investigate the dynamic aspects of forearm stability, we analyzed sensory nerve endings in the IOM. The distal oblique bundle (DOB), the distal accessory band (DAB), the central band (CB), the proximal accessory band (PAB), the dorsal oblique accessory cord (DOAC) and the proximal oblique cord (POC) were dissected from 11 human cadaver forearms. Sensory nerve endings were analyzed at two levels per specimen as total cell amount/mm2 after immunofluorescence staining with low-affinity neurotrophin receptor p75, protein gene product 9.5, S-100 protein and 4',6-diamidino-2-phenylindole on an Apotome microscope, according to Freeman and Wyke's classification. Sensory nerve endings were significantly more commonly found to be equally distributed throughout the structures, rather than being epifascicular, interstitial, or close to the insertion into bone (P ≤ 0.001, respectively). Free nerve endings were the predominant mechanoreceptor in all six structures, with highest density in the DOB, followed by the POC (P ≤ 0.0001, respectively). The DOB had the highest density of Pacini corpuscles. The DOAC and CB had the lowest amounts of sensory innervation. The high density of sensory corpuscles in the DOB, PAB and POC indicate that proprioceptive control of the compressive and directional muscular forces acting on the distal and proximal radioulnar joints is monitored by the DOB, PAB and POC, respectively, due to their closed proximity to both joints, whereas the central parts of the IOM act as structures of passive restraint.

Monoflanged Custom-Made Acetabular Components Promote Biomechanical Restoration of Severe Acetabular Bone Defects by Metallic Defect Reconstruction.

BACKGROUND: Custom-made acetabular components (CMAC) are one established method to address severe acetabular bone defects. Monoflanged CMAC may represent an advantageous alternative to establish triflanged CMAC as they promote better primary stability through metallic defect reconstruction and thus anatomic restoration of the center of rotation (COR). METHODS: Fifty-eight consecutive (21 triflanged and 37 monoflanged) CMAC were evaluated for overall survival, reasons for revision, radiological restoration of COR, and clinical outcome parameters. RESULTS: There were no significant differences between both design types regarding overall survival, revision rates, Harris Hip Score, or visual analog scale (pain) score at latest follow-up (mean, 56.3 ± 28.7 months). Triflanged CMAC showed a significant lateralization (P ≤ .001) and cranialization (P = .003) of the COR compared to the contralateral side. Monoflanged CMAC restored the anatomic COR. Reasons for revision surgery and explantation were periprosthetic joint infection (n = 12) and aseptic loosening (n = 2) without significant differences between both groups. CONCLUSION: Monoflanged CMAC demonstrate similar clinical outcome parameters and survival rates as triflanged CMAC but superior biomechanical features and represent therefore a solid alternative treatment option and implant design.

The Influence of Iodine-Impregnated Incision Drapes on the Bacterial Contamination of Scalpel Blades in Joint Arthroplasty.

BACKGROUND: Prosthetic joint infections (PJI) are a disastrous and feared complication in arthroplasty. Over the past decades, surgeons have tried to lower infection rates through all sorts of improvements. At present, it is impossible to reduce the risk to zero. As the contamination of surgical instruments and the surgical field has been identified as a remaining gap prone for infection, scalpel blades among others have become a focal point of several studies. This study is the first to compare the effect of adhesive incision drapes on contamination rates of scalpel blades in primary arthroplasty of the hip and knee. METHODS: A total of 344 microbiologic blade culture results from 2 study groups with and without drape usage and 1 group with known PJI were analyzed and compared to histopathologic and microbiologic tissue results. RESULTS: In 78% of all positive cultures, the bacteria were part of the local skin flora. The contamination rate for the skin blades with a drape was 3.81% vs 12.19% without drape usage. A significant difference was determined between positive skin blade culture results incision drape usage (P = .031). The different pathogens likely responsible for the PJI correlated with the deep blade cultures (P ≤ .01). The overall contamination rate of surgical blades (1.37%) is comparatively low to the results obtained from other surgical equipment in literature. None of those blade-positive patients developed a surgical site infection during 12-month follow-up. CONCLUSION: Iodine-impregnated incision drapes are able to reduce surgical skin blade contamination. Further studies may be needed to assess the relationship between blade contamination and surgical site infections.

Vertebral Bone Marrow-Derived Mesenchymal Stromal Cells from Osteoporotic and Healthy Patients Possess Similar Differentiation Properties In Vitro.

Osteoporosis is a disease characterized by low bone mass and an increased risk of fractures. Although several cellular players leading to osteoporosis have been identified, the role of mesenchymal stromal cells (MSC) is still not fully elaborated. The aim of this study was, therefore, to isolate and characterize MSCs from vertebral body of healthy non-osteoporotic and osteoporotic patients, with a particular focus on their osteogenic differentiation potential. Isolated MSCs were characterized by their osteogenic, adipogenic, and chondrogenic differentiation, as well as surface marker expression, proliferation behavior, and immunomodulatory capacity. The mineralization process was confirmed using Alizarin Red S and alkaline phosphatase (ALP) stains and further evaluated by determining ALP activity, mineral deposition, and free phosphate ion release. MSCs from both healthy and osteoporotic patients showed common fibroblast-like morphology and similar proliferation behavior. They expressed the typical MSC surface markers and possessed immunomodulatory capacity. Both groups demonstrated solid trilineage differentiation potential; osteogenic differentiation was further confirmed by increased ALP activity, deposition of inorganic crystals, phosphate ion release, and expression of osteoblast marker genes. Overall, MSCs from osteoporotic and non-osteoporotic patients showed neither a difference in general MSC features nor in the detailed analysis regarding osteogenic differentiation. These data suggest that vertebral body MSCs from osteoporotic patients were not impaired; rather, they possessed full osteogenic potential compared to MSCs from non-osteoporotic patients.

Characterization and Comparison of Human and Ovine Mesenchymal Stromal Cells from Three Corresponding Sources.

Currently, there is an increasing focus on mesenchymal stromal cells (MSC) as therapeutic option in bone pathologies as well as in general regenerative medicine. Although human MSCs have been extensively characterized and standardized, ovine MSCs are poorly understood. This limitation hampers clinical progress, as sheep are an excellent large animal model for orthopedic studies. Our report describes a direct comparison of human and ovine MSCs from three corresponding sources under the same conditions. All MSCs presented solid growth behavior and potent immunomodulatory capacities. Additionally, we were able to identify common positive (CD29, CD44, CD73, CD90, CD105, CD166) and negative (CD14, CD34, CD45, HLA-DR) surface markers. Although both human and ovine MSCs showed strong osteogenic potential, direct comparison revealed a slower mineralization process in ovine MSCs. Regarding gene expression level, both human and ovine MSCs presented a comparable up-regulation of Runx2 and a trend toward down-regulation of Col1A during osteogenic differentiation. In summary, this side by side comparison defined phenotypic similarities and differences of human and ovine MSCs from three different sources, thereby contributing to a better characterization and standardization of ovine MSCs. The key findings shown in this report demonstrate the utility of ovine MSCs in preclinical studies for MSC-based therapies.

Molecular and Functional Phenotypes of Human Bone Marrow-Derived Mesenchymal Stromal Cells Depend on Harvesting Techniques.

Mesenchymal stromal cells (MSC) harvested in different tissues from the same donor exhibit different phenotypes. Each phenotype is not only characterized by a certain pattern of cell surface markers, but also different cellular functionalities. Only recently were different harvesting and processing techniques found to contribute to this phenomenon as well. This study was therefore set up to investigate proteomic and functional properties of human bone marrow-derived MSCs (hBM-MSC). These were taken from the same tissue and donor site but harvested either as aspirate or bone chip cultures. Both MSC populations were profiled for MSC markers defined by the International Society for Cellular Therapy (ISCT), MSC markers currently under discussion and markers of particular interest. While classic ISCT MSC markers did not show any significant difference between aspirate and outgrowth hBM-MSCs, our additional characterization panel revealed distinct patterns of differentially expressed markers. Furthermore, hBM-MSCs from aspirate cultures demonstrated a significantly higher osteogenic differentiation potential than outgrowth MSCs, which could be confirmed using a transcriptional approach. Our comparison of MSC phenotypes obtained by different harvesting techniques suggests the need of future standardized harvesting, processing and phenotyping procedures in order to gain better comparability in the MSC field.

Acetabular defects in revision hip arthroplasty: a therapy-oriented classification.

INTRODUCTION: The treatment of severe acetabular bone loss remains a difficult challenge. No classification system is available that combines intuitive use, structured design and offers a therapeutic recommendation according to the current literature and modern state of the art treatment options. The goal of this study is to introduce an intuitive, reproducible and reliable guideline for the evaluation and treatment of acetabular defects. METHODS: The proposed Acetabular Defect Classification (ADC) is based on the integrity of the acetabular rim and supporting structures. It consists of 4 main types of defects ascending in severity and subdivisions narrowing down-defect location. Type 1 presents an intact acetabular rim, type 2 includes a noncontained defect of the acetabular rim ≤ 10 mm, in type 3 the rim defect exceeds 10 mm and type 4 includes different kinds of pelvic discontinuity. A collective of 207 preoperative radiographs were graded according to ADC and correlated with intraoperative findings. Additionally, a randomized sample of 80 patients was graded according to ADC by 5 observers to account for inter- and intra-rater reliability. RESULTS: We evaluated the agreement of preoperative, radiographic grading and intraoperative findings presenting with a k value of 0.74. Interobserver agreement presented with a k value of 0.62 and intraobserver at a k value of 0.78. CONCLUSION: The ADC offers an intuitive, reliable and reproducible classification system. It guides the surgeon pre- and intraoperatively through a complex field of practice.

Unilateral L4-dorsal root ganglion stimulation evokes pain relief in chronic neuropathic postsurgical knee pain and changes of inflammatory markers: part II whole transcriptome profiling.

BACKGROUND: In our recent clinical trial, increased peripheral concentrations of pro-inflammatory molecular mediators were determined in complex regional pain syndrome (CRPS) patients. After 3 months adjunctive unilateral, selective L4 dorsal root ganglion stimulation (L4-DRGSTIM), significantly decreased serum IL-10 and increased saliva oxytocin levels were assessed along with an improved pain and functional state. The current study extended molecular profiling towards gene expression analysis of genes known to be involved in the gonadotropin releasing hormone receptor and neuroinflammatory (cytokines/chemokines) signaling pathways. METHODS: Blood samples were collected from 12 CRPS patients for whole-transcriptome profiling in order to assay 18,845 inflammation-associated genes from frozen blood at baseline and after 3 months L4-DRGSTIM using PANTHER™ pathway enrichment analysis tool. RESULTS: Pathway enrichment analyses tools (GOrilla™ and PANTHER™) showed predominant involvement of inflammation mediated by chemokines/cytokines and gonadotropin releasing hormone receptor pathways. Further, screening of differentially regulated genes showed changes in innate immune response related genes. Transcriptomic analysis showed that 21 genes (predominantly immunoinflammatory) were significantly changed after L4-DRGSTIM. Seven genes including TLR1, FFAR2, IL1RAP, ILRN, C5, PKB and IL18 were down regulated and fourteen genes including CXCL2, CCL11, IL36G, CRP, SCGB1A1, IL-17F, TNFRSF4, PLA2G2A, CREB3L3, ADAMTS12, IL1F10, NOX1, CHIA and BDKRB1 were upregulated. CONCLUSIONS: In our sub-group analysis of L4-DRGSTIM treated CRPS patients, we found either upregulated or downregulated genes involved in immunoinflammatory circuits relevant for the pathophysiology of CRPS indicating a possible relation. However, large biobank-based approaches are recommended to establish genetic phenotyping as a quantitative outcome measure in CRPS patients. Trial registration The study protocol was registered at the 15.11.2016 on German Register for Clinical Trials (DRKS ID 00011267). https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00011267.

Effect of transcutaneous vagus nerve stimulation on muscle activity in the gastrointestinal tract (transVaGa): a prospective clinical trial.

PURPOSE: Postoperative ileus (POI) is a common complication after abdominal surgery. Invasive stimulation of the cervical vagus nerve is known to reduce inflammatory response and ameliorated POI after surgery in a mouse model. However, the transcutaneous vagus nerve stimulation (tVNS) is a possible non-invasive approach. In this clinical study, we aimed to investigate the effect of tVNS on the activation of the stomach muscle in humans. METHODS: Patients requiring open laparotomy were screened for this prospective proof of concept clinical study. After open laparotomy, muscle activity of the stomach was measured by a free running electromyography (EMG) before and during tVNS on the ear. Frequency and amplitude of compound gastric action potentials were the electrophysiological parameters we assessed to reveal the changes in electro motor gastric activity. Gastrin levels as a surrogate marker for vagus nerve activation was analyzed before, 1 and 3 h after tVNS. RESULTS: Fourteen patients were included, no severe adverse events and no medical device related adverse events occurred. tVNS led to significant reduction of action potential frequency and significant elevation of action potential amplitude in the stomach compared to control. Gastrin levels were significantly elevated 3 h after tVNS compared to levels before tVNS. CONCLUSION: Application of tVNS is a safe and feasible procedure during surgical intervention. Our results provide evidence that tVNS activates efferent visceral vagal fibers. Therefore, this low risk and easy to perform method could be useful to prevent postoperative ileus. CLINICAL TRIAL REGISTER NUMBER: DRKS00013340.

Outcome evaluation of new calcium titanate schanz-screws for external fixators. First clinical results and cadaver studies.

OBJECTIVE: External fixators are important for correcting length discrepancies and axis deformities in pediatric or trauma orthopedic surgery. Pin loosening is a common pitfall during therapy that can lead to pain, infection, and necessary revisions. This study aims to present clinical data using calcium titanate (CaTiO3) Schanz screws and to measure the fixation strength. PATIENTS AND METHODS: 22 titanate screws were used for external fixators in 4 pediatric patients. Therapy was initiated to lengthen or correct axial deformities after congenital abnormalities. The maximum tightening torque was measured during implantation, and the loosening torque was measured during explantation. In addition, screws of the same type were used in a cadaver study and compared with stainless steel and hydroxyapatite-coated screws. 12 screws of each type were inserted in four tibias, and the loosening and tightening torque was documented. RESULTS: The fixation index in the in vivo measurement showed a significant increase between screw insertion and extraction in three of the four patients. The pins were in situ for 91 to 150 days, and the torque increased significantly (P = 0.0004) from insertion to extraction. The cadaveric study showed lower extraction torques than insertion torques, as expected in this setting. The calculated fixation index was significantly higher in the CaTiO3 group than in the other groups (P = 0.0208 vs. HA and P < 0.0001 vs. steel) and in the HA group vs. plain steel group (P = 0.0448). CONCLUSION: The calcium titanate screws showed favorable fixation strength compared to HA and stainless steel screws and should be considered in long-term therapy of external fixation.

Postoperative Medical Complications and Intermediate Care Unit/Intensive Care Unit Admission in Joint Replacement Surgery: A Prospective Risk Model.

BACKGROUND: Postoperative complications are the main consumers of technical, medical, and human resources. Especially in the field of elective joint replacement surgery, a specialized, easy-to-obtain, and cost-efficient preoperative stratification and risk-estimation model is missing. METHODS: With preoperatively surveyed patient parameters, we identified the most relevant parameters to predict postoperative medical complications. We devised a prospective risk model, measuring the individual probability for intermediate care unit (IMC) or intensive care unit (ICU) admission. The study includes all patients (n = 649) treated with primary or revision total knee arthroplasty in our clinic from 2008 to 2012. RESULTS: The association between general comorbidity scores and mortality risk is well known. Among different comorbidity scores, the Charlson Comorbidity Index is not only relevant for overall postoperative complications (odds ratios [OR] = 2.20) but also predictive of specific complications such as the postoperative need for blood transfusion (OR = 1.94) and unexpected adverse events (OR = 1.74). Considering adverse events, c-reactive protein and leukocyte levels are also highly relevant. Upon predicting a necessary postoperative transfer to an IMC or ICU, the preoperative hemoglobin level, the Charlson Comorbidity Index, and the Index of Coexistent Disease stood out. The latter indicates an increased rate for an IMC/ICU stay by 341% per point. Condensing the most influential predictors, the probability for postoperative IMC/ICU transfer can be calculated for each individual patient. Using the routinely assessed patient's variables, no steadier prediction is possible. CONCLUSION: The introduced risk-estimation model offers a specialized preoperative resource-stratification method in knee joint replacement surgery. It condenses the most influential, individual risk factors to avoid clinical test redundancy and improve resource efficiency and presurgical care planning. A prospective follow-up study could help validating the risk model in clinical routine.

Selective L4 Dorsal Root Ganglion Stimulation Evokes Pain Relief and Changes of Inflammatory Markers: Part I Profiling of Saliva and Serum Molecular Patterns.

OBJECTIVES: Complex regional pain syndrome (CRPS) and associated comorbidities have been linked to a pro-inflammatory state driven by different mediators. Targeted dorsal root ganglion stimulation (DRGSTIM ) suppressed pain levels and improved functional capacity in intractable CRPS. However, clinical trials assessing the impact of DRG stimulation on the neuroimmune axis are lacking. METHODS: This study enrolled 24 subjects (12 refractory CRPS patients plus suitably matched healthy controls) and performed immunoassays of inflammatory mediators in saliva and serum along with score-based assessments of pain, mood, and sleep quality at baseline and after three months of selective L4-DRGSTIM . RESULTS: After three-month L4-DRGSTIM CRPS associated pain significantly decreased. In addition, disturbed sleep and mood improved post-DRGSTIM , although statistically not significant. Significantly increased serum values of pro-inflammatory markers were detected pre- and post L4-DRGSTIM for high-mobility group box 1, tumor-necrosis factor α, interleukin (IL) 6, and leptin. IL-1ß was significantly elevated pre-L4 DRGSTIM , but not posttreatment. Elevated anti-inflammatory IL-10 significantly decreased after three months in serum, while saliva oxytocin concentrations increased in CRPS subjects after L4-DRGSTIM (p = 0.65). No severe implantation and stimulation associated adverse events were recorded. CONCLUSIONS: Selective L4-DRGSTIM improved neuropathic pain and functional impairment in CRPS as previously reported. CRPS patients displayed a pro-inflammatory molecular pattern in serum. Serum anti-inflammatory IL-10 significantly declined, while saliva oxytocin nonsignificantly increased after L4-DRGSTIM . An evidence-based relational interpretation of our study is limited due to the uncontrolled study design. However, molecular profiling of biofluids (saliva, serum) represents a novel and experimental field in applied neuromodulation, which warrant further investigations to unveil mechanisms of neuroimmune modulation.

A case series of cementless revision total knee arthroplasty in patients with benzoyl peroxide allergy.

PURPOSE: The contact allergens nickel, cobalt, and chromium are often discussed as possible triggers of allergic reactions to orthopedic implants. Additionally, acrylates and polymerization additives in bone cement (e.g., benzoyl peroxide (BPO)) have been implicated as triggers of eczema, wound healing disorders, and aseptic implant loosening. We report about six patients with aseptic loosening after total knee arthroplasty (TKA), who underwent revision surgery after testing positive for BPO hypersensitivity. METHODS: After clarification of possible other causes of implant failure, epicutaneous testing had been performed and the implants were replaced in a two-stage procedure with cementless, diaphyseal anchoring, hypoallergenic (TiNb-coated) revision endoprostheses. RESULTS: Epicutaneous testing revealed a BPO allergy in all six patients and an additional nickel allergy in three of the six patients. There was no histopathological or microbiological evidence for a periprosthetic infection. The clinical follow-up showed a low level of pain with good function, a stable knee joint, and proper implant position. The Knee Society Score (KSS) with its subscales Knee Score and Functional Score improved post-operatively from 43 to 70 points and from 47.5 to 68.3 points, respectively. Two implant-specific complications occurred: femoral stress shielding two years post-operatively with no further need for action and aseptic loosening of the tibial stem with the need of revision three years post-operatively. CONCLUSIONS: The regression of complaints after replacement with cementless and nickel-free revision implants suggests allergic implant intolerance. Implantation of a cementless, hypoallergenic endoprosthesis might, therefore, be a surgical treatment strategy in patients with evidence of allergies.

Pre-operative intra-articular deep tissue sampling with novel retrograde forceps improves the diagnostics in periprosthetic joint infection.

BACKGROUND: Histopathological tissue analysis is a key parameter within the diagnostic algorithm for suspected periprosthetic joint infections (PJIs), conventionally acquired in open surgery. In 2014, Hügle and co-workers introduced novel retrograde forceps for retrograde synovial biopsy with simultaneous fluid aspiration of the knee joint. We hypothesised that tissue samples acquired by retrograde synovial biopsy are equal to intra-operatively acquired deep representative tissue samples regarding bacterial detection and differentiation of periprosthetic infectious membranes. METHOD: Thirty patients (male n = 15, 50%; female n = 15, 50%) with 30 suspected PJIs in painful total hip arthroplasties (THAs) were included in this prospective, controlled, non-blinded trial. The results were compared with intra-operatively obtained representative deep tissue samples. RESULTS: In summary, 27 out of 30 patients were diagnosed correctly as infected (17/17) or non-infected (10/13). The sensitivity to predict a PJI using the Retroforce® sampling forceps in addition to standard diagnostics was 85%, the specificity 100%. CONCLUSIONS: Retrograde synovial biopsy is a new and rapid diagnostic procedure under local anaesthesia in patients with painful THAs with similar histological results compared to deep tissue sampling.