Understanding the differences in wear testing method standards for total knee replacement.

Preclinical evaluation of the wear of total knee replacements (TKR) is usually undertaken using International Standards Organization (ISO) test methods. Two international standards for the preclinical wear simulation of TKRs have been developed; using either force or displacement control. In addition, based on previously published measured kinematics of healthy subjects, a gait cycle (displacement control) was also developed at the University of Leeds, which pre-dates the ISO displacement control standard. Furthermore, different test methods have adopted different approaches to defining the centres of rotation and polarity (direction of application) of motions. However, the effects of using these different control regimes and input conditions on the kinematics, contact mechanics, and wear of any one TKR have not been fully investigated previously. The current study investigated the kinematics, contact mechanics, and wear performance of a TKR when running under ISO force and displacement control test methods as well as the Leeds gait cycle inputs using experimental and computational simulation methods, with the aim of understanding the mechanical and tribological outcomes predicted by the different test method standard conditions. Three ISO wear testing standards were investigated using a mid-size Sigma curved TKR (DePuy, UK), with moderately cross-linked UHMWPE curved inserts; ISO-14243-3-2004, ISO-14243-3-2014 and ISO-14243-1-2009. In addition, the Leeds displacement control gait cycle was also investigated. According to the computational simulation predictions, reversing the anterior-posterior (AP) displacement and tibial rotation polarities in the displacement control ISO-2014 standard compared to the ISO-2004 standard resulted in high stress, of more than 65 MPa, at the posterior edge of the inserts with more than 10% increase in wear rate for this TKR design. Although Leeds gait input kinematics produced femoral rollback, it did not result in high stress edge loading on the posterior lip of the insert. This was attributed to different test input kinematics and different centres of rotation of the femoral component adopted in the displacement control standard ISO-2014 and Leeds gait test methods. The predicted AP displacement and tibial rotation from the force control ISO-2009 had different polarities and magnitudes to the corresponding displacement control profiles. In addition, the predicted wear rate, from the computational model, under the force control ISO-2009 standard was more than double that predicted under displacement control ISO standards due to the increased AP displacement and tibial rotation motions predicted under the force control standard. These major differences, in the mechanics and wear, between different test methods imply that each standard must therefore be used with its own predicate control results from a device with proven clinical history and results across different standards should never be compared, as the choice of test method standard may well be dependent on the design solution for the knee. Clinically, the kinematics in the population are extremely variable, which results in highly variable wear rates. While a standard method is necessary, on its own it is not adequate and needs to be supported by tests under a portfolio of representative conditions with different kinematic conditions, different soft tissue constraints, as well as with different alignments, so that the variability and range of wear rates expected clinically might be determined. This study enables further progress towards the definition of such a portfolio of representative conditions, by deepening the understanding of the relationships between currently used input conditions and the resulting mechanical and wear outputs.

The influence of a calcium sulphate bone void filler on the third-body damage and polyethylene wear of total knee arthroplasty.

OBJECTIVES: Bone void fillers are increasingly being used for dead space management in arthroplasty revision surgery. The aim of this study was to investigate the influence of calcium sulphate bone void filler (CS-BVF) on the damage and wear of total knee arthroplasty using experimental wear simulation. METHODS: A total of 18 fixed-bearing U2 total knee arthroplasty system implants (United Orthopedic Corp., Hsinchu, Taiwan) were used. Implants challenged with CS-BVF were compared with new implants (negative controls) and those intentionally scratched with a diamond stylus (positive controls) representative of severe surface damage (n = 6 for each experimental group). Three million cycles (MC) of experimental simulation were carried out to simulate a walking gait cycle. Wear of the ultra-high-molecular-weight polyethylene (UHMWPE) tibial inserts was measured gravimetrically, and damage to articulating surfaces was assessed using profilometry. RESULTS: There was no significant difference (p > 0.05) between the wear rate of implants challenged with CS-BVF (3.3 mm3/MC (95% confidence interval (CI) 1.8 to 4.8)) and the wear rate of those not challenged (2.8 mm3/MC (95% CI 1.3 to 4.3)). However, scratching the cobalt-chrome (CoCr) significantly (p < 0.001) increased the wear rate (20.6 mm3/MC (95% CI 15.5 to 25.7)). The mean surface roughness of implants challenged with CS-BVF was equivalent to negative controls both after damage simulation (p = 0.98) and at the conclusion of the study (p = 0.28). CONCLUSION: When used close to articulating surfaces, a low-hardness, high-purity CS-BVF had no influence on wear. When trapped between the articulating surfaces of a total knee arthroplasty, CS-BVF did not scratch the surface of CoCr femoral components, nor did it increase the wear of UHMWPE tibial inserts compared with undamaged negative controls.Cite this article: R. M. Cowie, S. S. Aiken, J. J. Cooper, L. M. Jennings. The influence of a calcium sulphate bone void filler on the third-body damage and polyethylene wear of total knee arthroplasty. Bone Joint Res 2019;8:65-72. DOI: 10.1302/2046-3758.82.BJR-2018-0146.R1.

Development of a preclinical natural porcine knee simulation model for the tribological assessment of osteochondral grafts in vitro.

In order to pre-clinically evaluate the performance and efficacy of novel osteochondral interventions, physiological and clinically relevant whole joint simulation models, capable of reproducing the complex loading and motions experienced in the natural knee environment are required. The aim of this study was to develop a method for the assessment of tribological performance of osteochondral grafts within an in vitro whole natural joint simulation model. The study assessed the effects of osteochondral allograft implantation (existing surgical intervention for the repair of osteochondral defects) on the wear, deformation and damage of the opposing articular surfaces. Tribological performance of osteochondral grafts was compared to the natural joint (negative control), an injury model (focal cartilage defects) and stainless steel pins (positive controls). A recently developed method using an optical profiler (Alicona Infinite Focus G5, Alicona Imaging GmbH, Austria) was used to quantify and characterise the wear, deformation and damage occurring on the opposing articular surfaces. Allografts inserted flush with the cartilage surface had the lowest levels of wear, deformation and damage following the 2 h test; increased levels of wear, deformation and damage were observed when allografts and stainless steel pins were inserted proud of the articular surface. The method developed will be applied in future studies to assess the tribological performance of novel early stage osteochondral interventions prior to in vivo studies, investigate variation in surgical precision and aid in the development of stratified interventions for the patient population.

An in vitro simulation model to assess the severity of edge loading and wear, due to variations in component positioning in hip joint replacements.

The aim of this study was to develop a preclinical in vitro method to predict the occurrence and severity of edge loading condition associated with the dynamic separation of the centres of the head and cup (in the absence of impingement) for variations in surgical positioning of the cup. Specifically, this study investigated the effect of both the variations in the medial-lateral translational mismatch between the centres of the femoral head and acetabular cup and the variations in the cup inclination angles on the occurrence and magnitude of the dynamic separation, the severity of edge loading, and the wear rate of ceramic-on-ceramic hip replacement bearings in a multi-station hip joint simulator during a walking gait cycle. An increased mismatch between the centres of rotation of the femoral head and acetabular cup resulted in an increased level of dynamic separation and an increase in the severity of edge loading condition which led to increased wear rate in ceramic-on-ceramic bearings. Additionally for a given translational mismatch, an increase in the cup inclination angle gave rise to increased dynamic separation, worst edge loading conditions, and increased wear. To reduce the occurrence and severity of edge loading, the relative positions (the mismatch) of the centres of rotation of the head and the cup should be considered alongside the rotational position of the acetabular cup. This study has considered the combination of mechanical and tribological factors for the first time in the medial-lateral axis only, involving one rotational angle (inclination) and one translational mismatch. © 2017 The Authors Journal of Biomedical Materials Research Part B: Applied Biomaterials Published by Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 1897-1906, 2018.

In vitro biomechanical and hydrodynamic characterisation of decellularised human pulmonary and aortic roots.

BACKGROUND AND PURPOSE OF THE STUDY: The use of decellularised biological heart valves in the replacement of damaged heart valves offers a promising solution to reduce the degradation issues associated with existing cryopreserved allografts. The purpose of this study was to assess the effect of low concentration sodium dodecyl sulphate decellularisation on the in vitro biomechanical and hydrodynamic properties of cryopreserved human aortic and pulmonary roots. METHOD: The biomechanical and hydrodynamic properties of cryopreserved decellularised human aortic and pulmonary roots were fully characterised and compared to cellular human aortic and pulmonary roots in an unpaired study. Following review of these results, a further study was performed to investigate the influence of a specific processing step during the decellularisation protocol ('scraping') in a paired comparison, and to improve the method of the closed valve competency test by incorporating a more physiological boundary condition. RESULTS: The majority of the biomechanical and hydrodynamic characteristics of the decellularised aortic and pulmonary roots were similar compared to their cellular counterparts. However, several differences were noted, particularly in the functional biomechanical parameters of the pulmonary roots. However, in the subsequent paired comparison of pulmonary roots with and without decellularisation, and when a more appropriate physiological test model was used, the functional biomechanical parameters for the decellularised pulmonary roots were similar to the cellular roots. CONCLUSION: Overall, the results demonstrated that the decellularised roots would be a potential choice for clinical application in heart valve replacement.

A comprehensive combined experimental and computational framework for pre-clinical wear simulation of total knee replacements.

A more robust pre-clinical wear simulation framework is required in order to simulate wider and higher ranges of activities, observed in different patient populations such as younger more active patients. Such a framework will help to understand and address the reported higher failure rates for younger and more active patients (National_Joint_Registry, 2016). The current study has developed and validated a comprehensive combined experimental and computational framework for pre-clinical wear simulation of total knee replacements (TKR). The input mechanical (elastic modulus and Poisson's ratio) and wear parameters of the moderately cross-linked ultra-high molecular weight polyethylene (UHMWPE) bearing material were independently measured from experimental studies under realistic test conditions, similar to the loading conditions found in the total knee replacements. The wear predictions from the computational wear simulation were validated against the direct experimental wear measurements for size 3 Sigma curved total knee replacements (DePuy, UK) in an independent experimental wear simulation study under three different daily activities; walking, deep squat, and stairs ascending kinematic conditions. The measured compressive mechanical properties of the moderately cross-linked UHMWPE material were more than 20% lower than that reported in the literature under tensile test conditions. The pin-on-plate wear coefficient of moderately cross-linked UHMWPE was significantly dependant of the contact stress and the degree of cross-shear at the articulating surfaces. The computational wear predictions for the TKR from the current framework were consistent and in a good agreement with the independent full TKR experimental wear simulation measurements, with 0.94 coefficient of determination of the framework. In addition, the comprehensive combined experimental and computational framework was able to explain the complex experimental wear trends from the three different daily activities investigated. Therefore, such a framework can be adopted as a pre-clinical simulation approach to optimise different designs, materials, as well as patient's specific total knee replacements for a range of activities.

Development and characterisation of a large diameter decellularised vascular allograft.

The aims of this study were to develop a biological large diameter vascular graft by decellularisation of native human aorta to remove the immunogenic cells whilst retaining the essential biomechanical, and biochemical properties for the ultimate benefit of patients with infected synthetic grafts. Donor aortas (n = 6) were subjected to an adaptation of a propriety decellularisation process to remove the cells and acellularity assessed by histological analysis and extraction and quantification of total DNA. The biocompatibility of the acellular aortas was determined using standard contact cytotoxicity tests. Collagen and denatured collagen content of aortas was determined and immunohistochemistry was used to determine the presence of specific extracellular matrix proteins. Donor aortas (n = 6) were divided into two, with one half subject to decellularisation and the other half retained as native tissue. The native and decellularised aorta sections were then subject to uniaxial tensile testing to failure [axial and circumferential directions] and suture retention testing. The data was compared using a paired t-test. Histological evaluation showed an absence of cells in the treated aortas and retention of histoarchitecture including elastin content. The decellularised aortas had less than 15 ng mg-1 total DNA per dry weight (mean 94% reduction) and were biocompatible as determined by in vitro contact cytotoxicity tests. There were no gross changes in the histoarchitecture [elastin and collagen matrix] of the acellular aortas compared to native controls. The decellularisation process also reduced calcium deposits within the tissue. The uniaxial tensile and suture retention testing revealed no significant differences in the material properties (p > 0.05) of decellularised aorta. The decellularisation procedure resulted in minimal changes to the biological and biomechanical properties of the donor aortas. Acellular donor aorta has excellent potential for use as a large diameter vascular graft.

Influence of contact pressure, cross-shear and counterface material on the wear of PEEK and CFR-PEEK for orthopaedic applications.

Total joint replacement is a successful surgical intervention for the treatment of the degeneration of many joints, particularly the hip and knee. As the demand for joint replacement grows, and the life expectancy of the population increases, the performance requirements of these implants also changes. New materials, to improve longevity and enhance performance have been explored including PEEK and CFR-PEEK. This study investigated whether CFR-PEEK and PEEK were appropriate materials for total joint replacement by examining wear performance in simple configuration studies articulating against cobalt chrome under a range of cross-shear and contact pressure conditions. Simple geometry pin on plate studies were conducted for one million cycles for each test condition, with the contact pressure and cross-shear conditions representing a range in which the material may need to operate in-vivo. The wear factor for PEEK was significantly higher than CFR-PEEK and conventional polyethylene under all test conditions. Both PEEK and CFR-PEEK wear were influenced by contact pressure, with the highest wear factors for both materials measured at the highest pressure conditions. PEEK appeared to have a cross-shear dependent wear response, but this was not observed for the CFR-PEEK material. This study has further characterised the wear performance of two materials that are gaining interest for total joint replacement. The wear performance of the PEEK material showed poorer wear performance compared to polyethylene when articulating with a metal counterface, but the performance of the CFR-PEEK material suggested it may provide a suitable alternative to polyethylene in some applications. The wear performance of CFR-PEEK was poorer than polyethylene when it was used as the plate, when there was translation of the contact zone over the surface of the CFR-PEEK plate. This has implications for applications in low conforming contacts, such as lower conformity knee replacement.

The wear of fixed and mobile bearing unicompartmental knee replacements.

Unicompartmental knee replacements (UKR) are an option for surgical intervention for the treatment of single-compartment osteoarthritis. The aim of this study was to compare the wear of a low-conformity fixed-bearing UKR with a conforming mobile bearing UKR under two kinematic conditions, to investigate the effect of implant design and kinematics on wear performance in a physiological knee wear simulator. Under both sets of kinematic conditions, the relatively low-conforming fixed UKR showed lower wear, compared with the more conforming anterior-posterior sliding mobile bearing. However, it should be noted that differences in materials between the two designs also contribute to the relative wear performance of the bearings. The combined wear of the medial and lateral bearings of the fixed-bearing UKR as a 'total knee' were significantly reduced compared with a fixed-bearing total knee replacement studied under the same kinematic conditions.

Wear and creep of highly crosslinked polyethylene against cobalt chrome and ceramic femoral heads.

The wear and creep characteristics of highly crosslinked ultrahigh-molecular-weight polyethylene (UHMWPE) articulating against large-diameter (36mm) ceramic and cobalt chrome femoral heads have been investigated in a physiological anatomical hip joint simulator for 10 million cycles. The crosslinked UHMWPE/ceramic combination showed higher volume deformation due to creep plus wear during the first 2 million cycles, and a steady-state wear rate 40 per cent lower than that of the crosslinked UHMWPE/cobalt chrome combination. Wear particles were isolated and characterized from the hip simulator lubricants. The wear particles were similar in size and morphology for both head materials. The particle isolation methodology used could not detect a statistically significant difference between the particles produced by the cobalt chrome and alumina ceramic femoral heads.

The influence of tibial tray design on the wear of fixed-bearing total knee replacements.

Debris-induced osteolysis due to surface wear is a potential long-term problem in total knee replacements (TKRs). Wear between the tibial tray and ultra-high molecular weight polyethylene insert is thought to contribute to the wear. This study investigated the influence of tibial tray design on the wear of fixed-bearing TKRs. Specifically, this study investigated the influence of the material's surface finish and design characteristics of the locking mechanism of the tibial tray on the wear in fixed-bearing knees for both cruciate-retaining (CR) and posterior-stabilized designs. A new fixed-bearing tibial tray design using Co-Cr and with an improved locking mechanism significantly reduced polyethylene wear from 22.8 +/- 6.0 mm3 per 10(6) cycles to 15.9 +/- 2.9 mm3 per 10(6) cycles compared with a previous titanium alloy tray with a CR design. The wear rates were similar to those of a fixed-bearing insert clamped into a tibial tray, suggesting that the decrease in wear was due to a reduction in backside wear. There was no significant difference between the wear rates of a cruciate-retaining design and a posterior-stabilized design under the two kinematic conditions tested.

The influence of femoral condylar lift-off on the wear of artificial knee joints.

In vivo fluoroscopic studies of patients with total knee replacements (TKRs) have shown lift-off of the femoral condyles from the tibial insert. This study investigated the influence of femoral condylar lift-off on the ultra-high molecular weight polyethylene (UHMWPE) wear of fixed bearing (FB) and rotating platform mobile bearing (RP MB) total knee replacements, using a physiological knee joint simulator. In the absence of lift-off, the RP MB knees exhibited a lower wear rate of 5.2 +/- 2.2 mm3 per million cycles (mm3/MC) compared with 8.8 +/- 4.8 mm3/MC for the FB knees. The presence of femoral condylar lift-off was found to accelerate the wear of the FB and RP MB knees tested in this study to 16.4 +/- 2.9 and 16.9 +/- 2.9 mm3/MC respectively. For the RP MB knees the increase in wear rate was more marked, resulting in a similar wear rate for both designs of knee under lift-off conditions. In both cases the medial condyle displayed more wear damage. This study has shown that a small amount of abduction/adduction lift-off and medial-lateral shift increases wear and that the increase in wear is design dependent. In this simulator test, lift-off was simulated on every cycle, whereas the amount of wear and effect of lift-off clinically would depend on the frequency of occurrence of lift-off in vivo.

Wear and biological activity of highly crosslinked polyethylene in the hip under low serum protein concentrations.

Crosslinked ultra-high molecular weight polyethylene (UHMWPE) has been developed and introduced into clinical practice in order to reduce wear in the hip. Zero wear of highly crosslinked UHMWPE in vitro has been reported by some groups using lubricants with high concentrations of serum proteins in hip simulators. In contrast, some clinical studies have reported finite wear rates. The aim of this study was to compare the wear rates, wear surfaces, and wear debris produced by UHMWPE with different levels of crosslinking in a hip joint simulator, with lower, more physiologically relevant concentrations of protein in the lubricant. The UHMWPEs were tested in the Leeds ProSim hip joint simulator against cobalt-chromium (CoCr) femoral heads. The wear particles were isolated and imaged using a field emission gun scanning electron microscope (FEGSEM) at high resolution. The highly crosslinked UHMWPEs had significantly lower wear volumes than the non-crosslinked UHMWPEs. No significant difference was found in the percentage number and percentage volume of the particles in different size ranges from any of the materials. They had similar values of specific biological activity. The functional biological activity (FBA), which takes into account the wear volume and specific biological activity, showed that the highly crosslinked UHMWPEs had lower FBAs due to their lower wear volume.

Effects of a peracetic acid disinfection protocol on the biocompatibility and biomechanical properties of human patellar tendon allografts.

Patellar tendon allografts, retrieved from cadaveric human donors, are widely used for replacement of damaged cruciate ligaments. In common with other tissue allografts originating from cadaveric donors, there are concerns regarding the potential for disease transmission from the donor to the recipient. Additionally, retrieval and subsequent processing protocols expose the graft to the risk of environmental contamination. For these reasons, disinfection or sterilisation protocols are necessary for these grafts before they are used clinically. A high-level disinfection protocol, utilising peracetic acid (PAA), has been developed and investigated for its effects on the biocompatibility and biomechanics of the patellar tendon allografts. PAA disinfection did not render the grafts either cytotoxic or liable to provoke an inflammatory response as assessed in vitro . However, the protocol was shown to increase the size of gaps between the tendon fibres in the matrix and render the grafts more susceptible to digestion with collagenase. Biomechanical studies of the tendons showed that PAA treatment had no effect on the ultimate tensile stress or Young's modulus of the tendons, and that ultimate strain was significantly higher in PAA treated tendons.

The influence of ventricular input impedance on the hydrodynamic performance of bioprosthetic aortic roots in vitro.

BACKGROUND AND AIM OF THE STUDY: Hydrodynamic function testing using pulsatile flow simulators provides a valuable means of comparative assessment of heart valves in vitro. The majority of pulsatile flow simulators consist of modular rigid chambers and a positive displacement pump with an infinite input impedance, in which the inertia of the test fluid results in pressure oscillations when the valves under test are opening and closing. For mechanical and stented bioprosthetic valves these pressure oscillations decay quickly. However, due to the highly compliant nature of tissue roots, the resulting pressure and flow oscillations are extreme and extend throughout systole. With increasing interest in the use of free-sewn roots and valves it is most desirable to improve this hydrodynamic model. The aim of this study was to investigate the influence in changes in ventricular input impedance on the hydrodynamic characteristics of free-sewn aortic roots and stented valves. METHODS: The Leeds pulsatile flow simulator was modified to incorporate additional compliance chambers in the form of a viscoelastic impedance adaptor (VIA) at the pump/ventricular interface. Six 23 mm bioprosthetic aortic roots fixed with 0.5% buffered glutaraldehyde at zero pressure, and a size 23 mm stented porcine aortic bioprosthesis were tested in this modified simulator, at the conditions of maximum and minimum input compliance. RESULTS: The pressure and flow waveforms for the fixed aortic roots showed considerable differences at the conditions of maximum and minimum input compliance. Indeed, the extreme pressure oscillations observed at minimum compliance (infinite input impedance) were not present at maximum compliance, and the forward flow waveform was much smoother. In contrast, for the stented valve, the differences in the pressure and flow waveforms between maximum and minimum input compliance were minimal, but this was expected due to the lack of compliance in the stented valve itself. In addition, the flow and pressure waveforms at maximum compliance in the VIA were comparable for the fixed aortic roots and the stented bioprosthesis, thus allowing direct comparison of the characteristics of these two different devices. Using test conditions of maximum input compliance, effective orifice area for the roots was 1.69 cm2 compared with 1.47 cm2 for the stented valve. CONCLUSION: An appropriate physiological model for the hydrodynamic testing of compliant tissue roots has been established.

Clinical comparison of tolerance to elemental or polymeric enteral feedings in the postoperative patient.

Thirty consecutive patients (19-71 years of age) undergoing abdominal operations and having feeding catheter jejunostomy tubes placed, were prospectively randomized and studied for tolerance to elemental (amino acid) or polymeric (intact protein isolates) dietary formulas. The groups were matched for sex, age, height, weight, operations, and caloric goal. Nutritional profiles of the patients were similar preoperatively. The number of stools/day and stool consistency were direct indicators of tolerance; nutrient intake was an indirect indicator. Diarrhea is defined as greater than or equal to five stools/day. We found no significant difference between the groups. There were no patients with diarrhea on days 1 or 2. Formula intake as an indirect measure of tolerance was not significantly different for the two groups from days 1-4. On day 5, intake of the elemental group exceeded that of the polymeric group (p less than 0.02). Enteral caloric intake as percent of caloric goal did not differ. Nitrogen intake, urinary nitrogen, serum prealbumin, body weight, serum sodium, and serum potassium did not differ significantly between the two groups throughout the study. Serum chloride decreased significantly (105 to 99.8 mEq/L) in the elemental group (p less than 0.03). Our study shows that patients undergoing routine gastrointestinal operations will tolerate early enteral feedings (day 1) and that there is no significant difference in tolerance to elemental or polymeric dietary formulas.

Gamma-globulin enhances survival in pneumococcal-challenged asplenic infant rats.

Early augmentation of a patient's immune system can be a valuable adjunct to standard supportive and antibiotic treatment of overwhelming postsplenectomy sepsis (OPSS). Normal humoral immune factors against pneumococcal sepsis are replenished by the parenteral administration of human gamma-globulin (HGG). Monthly prophylactic administration of HGG to asplenic individuals to prevent OPSS has been suggested. The cost of such measures is prohibitive, and the risk of serum-transmitted disease is significant. We administered HGG to splenectomized infant rats with pneumococcal sepsis to determine if mortality rates could be reduced and survival time prolonged. Fifty-six three-day-old rats underwent splenectomy and another 56, laparotomy without splenectomy. Twenty-eight animals from each operative group were administered HGG and the other 28, human serum albumin (HSA), 12 and 24 hours after inoculation with varying dosages of log-phase Streptococcus pneumoniae. The LD50 for asplenic animals was less than 50 colony forming units (cfu) per animal, while for the group with spleens, the LD50 was 250 to 500 cfu. There were no significant intragroup variations in LD50 between HGG and HSA subgroups. Survival times were compared using the BMDP1L-Life Tables and Survival Functions, and the generalized Wilcoxon t-test. These data show that host immunity to pneumococcal challenge in asplenic infant animals might be fully restored by the administration of HGG, even after the onset of symptoms. Survival of an asplenic child with evidence of OPSS might be enhanced by immediate administration of HGG.

"Spot" urine collections do not accurately represent 24-hour sodium excretion in surgically stressed children.

Deranged metabolism in posttraumatic or surgically stressed children makes fluid and electrolyte management difficult. Clear guidelines for salt and fluid administration have not been established. Recent management trends utilize four-hour and eight-hour "spot" urine collection measurement to imply 24-hour requirements. Six children, having suffered traumatic disease or surgical stress, were studied on an hourly basis for characterization of urinary sodium loss. Measured hourly values were combined to represent four-hour and eight-hour "spot" collections and then extrapolated to represent 24-hour losses. A great variation in sodium excretion was demonstrated on hourly samples; the variations were compounded by extrapolation. The extrapolated values varied from the measured hourly sodium losses by 0.66 to 123%. The four-hour extrapolations varied from measured values 14 to 198% (mean 55.2%). The eight-hour combinations varied 6.59 to 136% (mean 44.1%). On the basis of these data, we discourage the use of extrapolated values to imply 24-hour requirements. We support the use of a standard intravenous fluid (one-half strength normal saline or Ringer's lactate) with frequent urinary sodium determinations to individualize fluid and electrolyte management.

Efficacy of anomalous pancreatic drainage in choledochal cysts correlates with age of presentation and suggests etiology.

The etiology and pathogenesis of choledochal cysts, although frequently debated, are as yet unknown. Findings in three recent patients suggest a possible etiology that may also explain the variability in age at presentation. Each of these patients (ages 12 months, four years, and ten years) was found to have an Alonso-Lej Type I cyst and at operation had an absence of the distal intraduodenal common bile duct, suggesting the lack of a common channel with the main pancreatic duct. Partial decompression of the anatomically obstructed bile duct was afforded by an anomalously high insertion of the accessory pancreatic duct and communication with the duodenum by way of the main pancreatic duct. All patients were managed by excision and retrocolic choledochojejunostomy. The efficacy of decompression correlated with the age of presentation and size of the cyst. These findings suggest agenesis-atresia of the distal common bile duct as one possible etiology of choledochal cysts and may explain the variable age at presentation.