Functional outcome of total knee replacement: a study protocol for a prospective, double-blinded, parallel-group randomized, clinical controlled trial of novel, personalized and conventional implants.

BACKGROUND: The development of total knee replacement (TKR) implant designs aims to improve outcome regarding pain, function, joint stiffness, instability, patellar problems, and ultimately wear of the implant. Recently, two major orthopaedic implant manufacturers launched a new generation of TKR implants which, according to the manufacturers, provide improved functional outcome. However, the benefits of these new TKR designs claimed by the manufacturers in terms of improved functional outcome still lack scientific documentation. The present randomized controlled trial has been designed to compare three fixed bearing, cemented cruciate-retaining (CR) designs; one of the new personalized TKR design with two conventional TKR designs with the main emphasis being on functional outcome. METHODS: The present study is a prospective, double-blinded, randomized, single-center intervention trial. A total of 240 patients will be recruited to participate in a parallel-group study at Coxa Hospital for Joint Replacement, Tampere, Finland. We will compare the short-term functional outcome of TKR performed with a novel personalized TKR design (Persona CR, Zimmer, Warsaw, IN, USA) against TKRs performed with two conventional designs (PFC CR, DePuy, Warsaw, IN, USA and Nexgen CR, Zimmer, Warsaw, IN, USA). In total, 80 patients will be randomized in each of the three study arms. The primary outcome in this study is the Oxford Knee Score (OKS), which is a validated patient-reported outcome measure (PROM). Secondary outcome measures include the Forgotten Joint Score, the 15D, the UCLA activity score, and the VAS pain scale. The results will be analyzed after 2-year follow-up. DISCUSSION: This paper presents a prospective, randomized, single-center trial study protocol. It provides details of patient randomization, PROMs, follow-up, methods of analysis of the material, and publication plan. An important aspect that will be considered in the study will be the economic effects of the novel designs as they are substantially more expensive, and the benefits of the added costs remain unknown. In addition, it is especially important to carry out evaluative studies in independent centers that are not biased by the interests of the manufacturers. TRIAL REGISTRATION: Retrospectively registered, November, 2017, ClinicalTrials.gov Identifier: NCT03339557 .

Empirical study on voting power in participatory forest planning.

Multicriteria decision support systems are applied in natural resource management in order to clarify the planning process for the stakeholders, to make all available information usable and all objectives manageable. Especially when the public is involved in planning, the decision support system should be easy to comprehend, transparent and fair. Social choice theory has recently been applied to group decision-making in natural resources management to accomplish these objectives. Although voting forms the basis of democracy, and is usually taken as a fair method, the influence of voters over the outcome may vary. It is also possible to vote strategically to improve the results from each stakeholder's point of view. This study examines the use of social choice theory in revealing stakeholders' preferences in participatory forest planning, and the influence of different voters on the outcome. The positional voting rules examined were approval voting and Borda count, but both rules were slightly modified for the purposes of this study. The third rule examined, cumulative rule, resembles utilitarian voting rules. The voting rules were tested in a real participatory forest planning situation in eastern Lapland, Finland. All voting rules resulted in a different joint order of importance of the criteria. Yet, the preference orders produced had also a lot in common and the criteria could be divided into three quite distinct groups according to their importance. The influence of individual voters varied between the voting rules, and in each case different voter was the most influential.

Histomorphometric analysis of poly-L/D-lactide 96/4 sutures in the gastrocnemius tendon of rabbits.

BACKGROUND: Common Achilles tendon ruptures are not usually fixed by bioabsorbable sutures due to limitations in their strength retention properties. Modern technology has made it possible to develop bioabsorbable sutures with prolonged strength retention. AIMS: To evaluate histologically tissue reactions of poly-L/D-lactide (PLDLA) sutures implanted in Achilles tendon of rabbits. MATERIAL AND METHODS: Fifteen rabbits were evaluated at 2, 6 and 12 weeks postoperatively, with five rabbits in each follow-up group. PLDLA monofilament sutures were implanted into the medial gastrocnemius tendon. Polyglyconate monofilament sutures with similar diameter (Maxon 4-0, Cyanamid of Great Britain Ltd., Gosport, UK) were implanted in the contralateral gastrocnemius tendon. The histology was studied in hard-resin embedded samples. The thickness of the formed fibrous tissue capsule was determined histomorphometrically. RESULTS: PLDLA led to formation of significantly thinner fibrous tissue capsule than Maxon sutures of the same diameter. Median thickness (PLDLA vs. Maxon) at two weeks was 5.26 vs.13.22 microm, at six weeks 11.66 vs. 80.97 microm, and at 12 weeks 10.63 vs. 17.59 microm (p<0.01). CONCLUSIONS: During the 12 week follow-up period, PLDLA sutures implanted intratendineously formed thinner fibrous capsule than Maxon sutures of the same diameter. The suture materials were not totally absorbed by 12 weeks.

Evaluation of exposure to airborne bacterial endotoxins and peptidoglycans in selected work environments.

The aim of this study was to assess workers' exposure to endotoxins and peptidoglycans, as well as associations between workers' reported symptoms and the detected bacterial exposures. From the filter samples, biologically-active endotoxins were analysed with the Limulus amebocyte lysate (LAL) assay. The total amount of endotoxins was analysed as 3-hydroxy (OH) fatty acids with a gas chromatography-mass spectrometry (GC-MS) assay, which was also used to assess peptidoglycans as muramic acid. Biologically-active endotoxins related better to the self-reported symptoms than total endotoxins. Specific 3-OH-14:0 fatty acid in the total endotoxin samples associated better with the symptoms than other 3-OH fatty acids. Half of the surveyed 77 workers reported respiratory symptoms, 27% eye symptoms, and 10% fever or shivering. The proportion of workers with respiratory symptoms was greater when the concentration of endotoxins was over 25 ng/m3. These endotoxin levels were occasionally found in the air of most studied occupational environments. The muramic acid concentrations of peptidoglycans were highest (medians over 100 ng/m3) in the garbage-handling plant and in the grain/vegetable storage houses. The LAL assay for endotoxins, as well as the GC-MS assay analysing muramic acid for peptidoglycans or specific 3-OH fatty acids for endotoxins, seem to be suitable methods for evaluating workers' exposure to airborne bacteria.

Determination of gallic acid in wood dust as an indicator of oak content.

A high-performance liquid chromatography (HPLC) method was developed for the detection of extracted gallic acid in wood dust. Gallic acid is a polyphenol present in carcinogenic oak wood dust, but not in beech, ash, pine or spruce dusts, as confirmed by HPLC analyses. The method involved the extraction of gallic acid from the oak dust, followed by liquid chromatographic analysis. The correlation coefficient for the share of oak dust vs. the gallic acid concentration of wood dust was 0.995. The method was tested with oak wood dust samples collected on polycarbonate membrane filters during an 8 h workshift in a floor board factory, where the dust content of the air samples was determined gravimetrically. The oak dust and the gallic acid concentrations varied from 0.2 to 13.8 mg m-3 and from 0.03 to 3.8 micrograms m-3, respectively. These parameters were linearly correlated with a correlation coefficient of 0.95. The airborne gallic acid determination is a useful technique to confirm occupational exposure to oak wood dust, a recognized human carcinogen.

Mutations induced by 2-amino-1-methyl-6-phenylimidazo [4,5-b]pyridine (PhIP) in cecum and proximal and distal colon of lacI transgenic rats.

2-Amino-1-methyl-6-phenylimidazo[4,5-b]pyridine (PhIP) is a food-borne mutagen and carcinogen that induces tumors of the colon and the prostate gland in male rats and of the mammary gland in female rats. In this study we describe the frequency and specificity of PhIP-induced mutations in the cecum, proximal colon and distal colon of male and female lacI transgenic rats. This is the first report of mutational data from discrete regions of the colon. After 61 days of treatment with 200 p.p.m. PhIP mixed into the diet, PhIP-induced mutant frequencies were elevated 7-fold in the cecum and 14- to 21-fold in the colon of male and female rats compared with untreated controls. PhIP-induced mutant frequencies increased significantly (overall trend, P < 10(-4)) along the length of the colon of both males and females, with cecum < proximal colon < distal colon. A total of 754 PhIP mutants (363 male, 391 female) were sequenced to provide the mutational spectra for each of the three tissue sections from males and females. These mutational spectra consisted predominantly of G:C-->T:A and G:C-->C:G transversions and deletions of G:C base pairs. There were no significant differences between the mutational spectra with respect to sex or position in the colon. Therefore, we surmise that following induction of mutations by PhIP in male and female colons, non-mutagenic factors, possibly hormonal, preferentially influence the formation of tumors in the colon of male rats.

Effect of in situ composting on reducing offensive odors and volatile organic compounds in swineries.

Seven swine farms were studied to find out how the in situ composting system, compared to the slatted floor pit system, influences the concentration and occurrence of malodorous compounds. Ammonia concentrations were measured with diffusion tubes. Small molecular sulfur compounds were analyzed using laminated bags and a gas chromatograph with a FP-detector. All other volatile organic compounds were analyzed by gas chromatography/mass spectrometry with simultaneous sniffing of the eluted compounds. About 400 organic compounds were identified from the air samples, and 94 suspect odorous compounds are listed in the present article. The most intense and unpleasant odors were caused by p-cresol, carboxylic acids (C2-C7), and some ketones such as 3-hydroxy-2-butanone, 2,3-butanedione, and 2-butanone. Terpenes (alpha-pinene, beta-pinene, 3-carene, and limonene), which originate from sawdust, caused the main peaks in the chromatograms of compost swineries. In swine confinement buildings where the composting system was functioning properly, the concentration of sulfur compounds, and especially of carboxylic acids, ketones, and p-cresol, fell effectively. The use of sawdust as composting material caused elevated concentrations of terpenes in the ambient air. There was clearly less airborne ammonia and hydrogen sulfide in the well-functioning compost swineries than in the poorly functioning ones. Elevated hydrogen sulfide levels were measured during turning work, however. In one composting swinery, the hydrogen sulfide level was as high as 15 mg/m3 during turning work. All the other concentrations of odorous compounds did not exceed occupational exposure limit values, but several compounds exceeded the respective threshold odor concentrations.

Comparison of strength properties of poly-L/D-lactide (PLDLA) 96/4 and polyglyconate (Maxon) sutures: in vitro, in the subcutis, and in the achilles tendon of rabbits.

Achilles tendon rupture is a common injury. Absorbable sutures are not commonly used because of their limited strength properties. Recently, sutures with prolonged strength retention properties have been developed. The aim of the study is to test the mechanical properties of recently developed poly-L/D-lactide (PLDLA) sutures in comparison with polyglyconate (Maxon) sutures. PLDLA (0.2 mm thick) and Maxon (4.0) sutures were studied in vitro by immersion in a buffered saline solution (pH 7.4). Tensile strength tests were done on sutures retrieved after 1-26 weeks. In vivo, they were implanted in the subcutis of 32 rabbits. Tensile strength tests were done on sutures retrieved after 1-6 weeks. The sutures were also used to repair the Achilles tendon in rabbits. Maximum force before breaking and percentage elongation of tendons were determined. Although PLDLA had a lower initial tensile strength than Maxon, PLDLA showed more prolonged tensile strength retention than Maxon. Tendons repaired with PLDLA, however, had a lower strength than Maxon-repaired tendons at six weeks (insignificant difference). PLDLA has more prolonged tensile strength properties compared with Maxon. Thus, PLDLA offers an alternative to Maxon in repair of the Achilles tendon.

Extracorporeal liver perfusion using human and pig livers for acute liver failure.

BACKGROUND: Patients with fulminant hepatic failure (FHF) often die awaiting liver transplantation. Extracorporeal liver perfusion (ECLP) has been proposed as a method of "bridging" such patients to transplantation. We report the largest experience to date of ECLP using human and porcine livers in patients with acute liver failure. METHODS: Patients with FHF unlikely to survive without liver transplantation were identified. ECLP was performed with human or porcine livers. Patients underwent continuous perfusion until liver transplantation or withdrawal of support. Two perfusion circuits were used: direct perfusion of patient blood through the extracorporeal liver and indirect perfusion with a plasma filter between the patient and the liver. FINDINGS: Fourteen patients were treated with 16 livers in 18 perfusion circuits. Nine patients were successfully "bridged" to transplantation. ECLP stabilized intracranial pressure (ICP) and cerebral perfusion pressure (CPP). Arterial ammonia levels fell from a median of 146 to 83 micromol/liter within 12 hr and this reduction was maintained at least 48 hr. Pig and human ECLP lowered ammonia levels equally. Serum bilirubin levels also fell from a median of 385 to 198 micromol/liter over the first 12 hr but the response was not sustained as well with porcine livers. There was no immunological benefit to using the the filtered perfusion circuit. INTERPRETATION: These data demonstrate that ECLP is safe and can provide metabolic support for comatose patients with fulminant hepatic failure for up to 5 days. While labor and resource intensive, this technology is available to centers caring for patients with acute liver failure and deserves wider evaluation and application.

Applicability of homogeneous exposure groups for exposure assessment in the chemical industry.

The purpose of the study was to assess occupational exposure to chemicals, by taking the aspects presented in European standard EN 689 into account, especially with respect to homogeneous exposure groups and their suitability as the basis for exposure assessment. In addition, dermal exposure to chemicals was assessed when appropriate. The industries studied included a plywood factory, a paint factory and a sewage treatment plant of an oil refinery. The workers were classified into homogeneous exposure groups by the persons in charge of occupational health issues in the respective workplaces. The concentrations of the contaminants were measured in workplace air by breathing-zone and stationary sampling, and these approaches were compared. Dermal exposure was measured when applicable. The homogeneity of the grouping was tested with analysis of variance whenever possible. The tasks studied in plywood manufacturing fulfilled the criteria of homogeneous exposure groups for both respiratory and dermal exposure. The group of operators in the sewage treatment plant was highly homogeneous. The complicated organization of the tasks made the use of homogeneous exposure groups (HEG) unsuitable at the paint factory. These findings show that reliable exposure assessment cannot be achieved with a formal standard; instead, comprehensive occupational hygiene evaluation is needed. It should also have a great importance when exposure models are developed.

Analysis of oak tannins by liquid chromatography-electrospray ionisation mass spectrometry.

Extractable tannins were analysed by liquid chromatography-electrospray ionisation mass spectrometry in two oak species, North American white oak (Quercus alba) and European red oak (Quercus robur). They mainly included various glucose gallic and ellagic acid esters. The structures were partially determined, and they included grandinin/roburin E, castalagin/vescalagin, gallic acid, valoneic acid bilactone, monogalloyl glucose, digalloyl glucose, trigalloyl glucose, ellagic acid rhamnose, quercitrin and ellagic acid.

Relationship between calf muscle size and strength after achilles rupture repair.

The object was to study the relationships between calf muscle size and strength in 85 patients an average of 3.1 years after repair of achilles tendon rupture. The isokinetic calf muscle strength results were excellent or good for 73% of the patients, whereas calf muscle size was normal in only 30%. The average plantar flexion peak torque per unit muscle cross-sectional area was higher on the injured side than on the uninjured side. The average calf muscle cross-sectional area deficit was 15+/-9% (p<0.001) of that on the unaffected side, while the average plantar flexion peak torque deficit was speed-dependent, being 9+/-18%, 10+/-18 and 2+/-13% of that on the unaffected side at 30, 90, and 240 degrees/sec (p<0.001). The correlation between cross-sectional area and peak torque varied in the range 0.52-0.61 at 30, 90 and 240 degrees/sec (p<0.001).

Comparison of tanker drivers' occupational exposures before and after the installation of a vapour recovery system.

The purpose of this study was to compare tanker drivers' occupational exposure level before and after the installation of vapour recovery facilities at 14 service stations. Road tanker drivers are exposed when handling volatile petrol liquid in bulk in the distribution chain. The drivers' exposure was studied during the unloading operation as the bulk petrol flowed into underground storage tanks, displacing vapours in the tank space and causing emission to the environment and the drivers' work area. The exposures were measured again when the dual point Stage I vapour recovery systems were installed for recycling vapours. Short-term measurements were carried out in the drivers' breathing zones by drawing polluted air through a charcoal tube during unloading. The samples were analysed in the laboratory by gas chromatography for C3-C11 aliphatic hydrocarbons, tert-butyl methyl ether (MTBE), tert-amyl methyl ether (MTAE), benzene, toluene and xylene. The road tanker loads delivered consisted of oxygenated and reformulated petrol (E95 and E98 brands), which contained on average 13% oxygenates. Before the installation of the vapour recovery system, the geometric mean (GM) concentration of aliphatic hydrocarbons was 65 mg m-3 (range 6-645 mg m-3) in the drivers' breathing zones. After the installation at the same service stations, the corresponding exposure level was 8.3 mg m-3 (range < 1-79 mg m-3). The GM of the MTBE concentrations was 8.6 mg m-3 (range 1-67 mg m-3) without vapour recovery and 1.5 mg m-3 (range < 0.1-10 mg m-3) with vapour recovery. The differences between the aliphatic hydrocarbons and the MTBE exposure levels during the unloading of the road tankers without and with vapour recovery were statistically significant (p < 0.05).

Assessment of total exposure to phenol-formaldehyde resin glue in plywood manufacturing.

OBJECTIVE: Respiratory and dermal exposure to phenol-formaldehyde resin-glue components used in plywood manufacturing were assessed. METHODS: Formaldehyde and phenol were monitored in the workplace air. Formaldehyde was measured both in the breathing zones of the workers and at stationary sampling sites. Phenol was used as a marker agent for dermal exposure due to its near-nonvolatility at the temperatures occurring during the present study and to its ready absorption through the skin, causing systemic exposure in addition to local skin rashes. Sampling and analytical methods were developed to measure the dermal exposure to phenol. Sampling was accomplished with whole-body dosimetry using Tyvek coveralls and cotton gloves. In addition, a liquid chromatography method was developed for the analysis of phenol from dermal exposure samples. RESULTS: As expected, formaldehyde was noted to be the major compound causing respiratory exposure. When exposure assessment was done on the basis of air samples collected both at stationary sampling sites and in the breathing zones of the workers the agreement between the results obtained was good. The dermal sampling revealed that the workers were exposed to phenol, but the risk for toxic effects was slight due to the low concentrations of urinary phenol. CONCLUSIONS: We conclude that it is possible to use the stationary sampling method for the assessment of respiratory exposure in a plywood factory instead of the usually more complicated breathing-zone sampling. This study also demonstrates the importance of taking dermal exposure into account, at least due to the ability of the resins to cause skin rashes, in assessment of the exposure to chemicals in plywood manufacturing.

Right heart catheterization in acute lung injury: an observational study.

Right heart catheterization (RHC) is commonly used in the diagnosis and management of acute lung injury (ALI). However, controversy exists regarding RHC. We examined RHC use during the first 3 d of ALI in an observational study of 135 patients defined by American-European Consensus Conference criteria. Study parameters examined for association with RHC included the Acute Physiology and Chronic Health Evaluation (APACHE) III score, lung injury score (LIS), and 20 additional epidemiologic, clinical, and laboratory parameters. RHC was performed in 70 patients (52%) within the first 3 d of ALI. RHC was positively associated (p < 0.05) with a diagnosis of sepsis, APACHE III score, blood urea nitrogen (BUN), creatinine, net fluid balance, and positive end-expiratory pressure. RHC was negatively associated (p < 0.05) with mean arterial pressure (Pa) and PaO2/FIO2. Logistic regression identified four predictors for RHC placement: sepsis, PaO2/FIO2, BUN, and Pa. Initial right atrial and pulmonary artery occlusion pressure measurements demonstrated a moderately strong correlation (r = 0.72). Use of RHC was associated with a change in one or more therapeutic interventions (intravascular fluids, vasopressors, diuretics) in 78% of patients. In summary, patients receiving RHC during the first 3 d of ALI were more severely ill than those who did not receive RHC, and RHC was associated with a change in therapy in most patients.

Validation of computer-mediated open-ended standardized patient assessments.

Quantitative information regarding the development of students' clinical reasoning skills is valuable in assessing third- and fourth-year medical students' clinical knowledge. Standardized patient cases are often used to obtain this quantified information. These cases typically involve a post-patient examination consisting of a series of closed-ended multiple-choice questions. Many medical educators question whether the results from the closed-ended multiple-choice questions truly reflect students' clinical knowledge and reasoning proficiency. Since 1995, the Kirksville College of Osteopathic Medicine (KCOM) has used a computer program, SOAP Note Plus, for standardized patient assessment of students to automate the post-encounter documentation and evaluation. This paper describes the development of the SOAP Note Plus program and a validation study which was conducted to determine the empirical association between the computer-mediated closed-ended and open-ended post-encounter standardized patient assessments. Correlation and GENOVA statistics were used in the analysis of the performance of third-year medical students on the closed-ended and the open-ended assessments following standardized patient encounters and the relationship to their undergraduate GPA, first 2-year medical school GPA and the actual clinical rotation evaluations. The initial results show the positive relationship between the open-ended assessment and the actual clinical rotation evaluations. undergraduate GPA and the first two-years of medical school GPA.

Dissolution of short and long rockwool and glasswool fibers by macrophages in flowthrough cell culture.

Dissolution of MMVF (man-made vitreous fibers) by macrophages has previously been studied utilizing cell cultures in wells. A new, more dynamic method has been developed to explore the effects of macrophages on MMVF dissolution. In this method, the culture medium flows through a membrane on which the macrophages and fibers are placed. The dissolution of short and long rockwool and glasswool fibers was investigated in the present study by macrophages by assessing the dissolution of Si (silicon), Fe (iron), and Al (aluminium) from the fibers. Dissolution of these elements usually increased as a function of time. Generally, the dissolution of elements from the fibers in the flowthrough culture exceeded that observed with the culture in wells system. The dissolution of glasswool fibers was greater in medium than in cell culture, whereas the opposite was true for rockwool fibers. Dissolution of Si was greater from glasswool than from rockwool fibers, while the opposite was true for Fe and Al. Macrophages that had phagocytized fibers in flowthrough culture contained Si, and there were also precipitations with Si in the samples. The fibers in the flowthrough culture also exhibited surface changes such as breakings, pittings, etching, and peeling. The short rockwool fibers tended to fracture more than short glasswool fibers, while long glasswool fibers were more extensively broken than short glasswool fibers. The results with this new, dynamic, flowthrough culture method with macrophages demonstrate that this method provides valuable information on the abilities of macrophages to dissolve MMVF leading to subsequent morphological changes of fibers.