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Surface-immobilized polyethylene oxide for bacterial repellence.

Polyethylene terephthalate films were surface-modified with polyethylene oxide (18,500 g/mol) using a solution technique described previously. These films were investigated for their resistance to bacterial adhesion. Three bacterial strains most commonly associated with implant infections, Staphylococcus epidermidis, Staphylococcus aureus and Pseudomonas aeruginosa, were cultured in tryptic soya broth, human plasma and human serum on the polymeric substrates. Significant reductions (between 70 and 95%) in adherent bacteria were observed on the polyethylene oxide-modified substrates compared to the untreated control polyethylene terephthalate. Surface modification with polyethylene oxide may reduce the risk of implant-associated infections. Plasma fibrinogen was observed to play an important role in the adhesion of all three of these species on both the polyethylene oxide-modified and control polyethylene terephthalate materials.

Bacterial Adhesion↗

Aggressive wear testing of a cross-linked polyethylene in total knee arthroplasty.

Recently, highly cross-linked polyethylenes with high wear and oxidation resistance have been developed. These materials may improve the in vivo performance of polyethylene components used in total knee arthroplasty. To date, the in vitro knee wear testing of these new polyethylenes has been done under conditions of normal gait. However, their critical assessment also must include aggressive in vitro fatigue and wear testing. In the current study, an aggressive in vitro knee wear and device fatigue model simulating a tight posterior cruciate ligament balance during stair climbing was developed and used to assess the performance of one type of highly cross-linked polyethylene tibial knee insert in comparison with conventional polyethylene. The highly cross-linked inserts and one group of conventional inserts were tested after sterilization. One additional group of conventional inserts was subjected to accelerated aging before testing. The articular surfaces of the inserts were inspected visually for surface delamination, cracking, and pitting at regular intervals during the test. The aged conventional polyethylene inserts showed extensive delamination and cracking as early as 50,000 cycles. In contrast, the unaged conventional and highly cross-linked polyethylene inserts did not show any subsurface cracking or delamination at 0.5 million cycles. The appearance and location of delamination that occurred in the aged conventional inserts tested with the current model previously have been observed in vivo with posterior cruciate-sparing design knee arthroplasties with a tight posterior cruciate ligament.

Knee Prosthesis↗

Porous high-density polyethylene implants in auricular reconstruction.

OBJECTIVE: To evaluate the ability of porous high-density polyethylene (Medpor) implants to tolerate exposure and support skin grafts when used to reconstruct defects in auricular cartilage in an animal model. DESIGN: Polyethylene implants placed in surgically created defects in auricular cartilage and covered with a skin flap were then exposed at either 4, 7, or 21 days after implantation. The exposed implants were then allowed to heal secondarily or received a skin graft 1 week later. The ability of polyethylene implants to tolerate exposure and support skin grafts was observed clinically and via histological study of the implantation sites. SUBJECTS: Nine adult New Zealand rabbits. RESULTS: Polyethylene implants demonstrated excellent ability to tolerate wound exposure as early as 4 days after implantation, with extrusion of 1 of the 36 implants placed. The degree of secondary wound healing increased as the interval from implantation to exposure increased from 4 to 21 days. Exposed polyethylene implants in all groups also supported all 18 skin grafts placed 1 week after exposure of the implant surface. CONCLUSIONS: Polyethylene implants are well tolerated as replacements for native cartilage in auricular reconstruction. Polyethylene implants tolerated wound exposure as early as 4 days after implantation and demonstrated the ability to heal by secondary intention and support skin grafts. This is likely because of the extent of fibrovascular ingrowth from surrounding tissue, which allows the material to behave more like native tissue and less like a foreign body in this setting.

Animals↗

Inability of energy dispersive X-ray analysis to identify particulate polyethylene.

There are limitations to all techniques used to identify particulate polyethylene in histological specimens. The goal of our study was to determine if remnant metal elements used during the catalytic production of ultra high molecular weight polyethylene, could be used as markers for particulate polyethylene detection in histological specimens. It was hypothesized that these catalyst elements could be detected in polyethylene using energy dispersive X-ray elemental analysis. Six samples from five different companies were evaluated. These included virgin polymer powder, polyethylene bar stock, and artificial joint components. Five specimens from each of the six samples were analyzed with energy dispersive X-ray elemental analysis. After elemental analysis was completed, only 2 of 30 specimens were positive for the catalyst elements. In the remaining 28 specimens, catalyst elements were not detected. Our investigation demonstrates that energy dispersive X-ray elemental analysis is not currently a feasible method of particulate polyethylene detection. Additional techniques will need to be developed to accurately identify particulate polyethylene in histological specimens.

Beryllium↗

Accumulation of LPS by polyethylene particles decreases bone attachment to implants.

Molecules absorbed on the surface of particulate wear debris may contribute to inflammatory reactions that lead to aseptic loosening of implants. Lipopolysaccharide (LPS), a bacterial endotoxin, can attach to many biomaterials and stimulate macrophages to secrete osteoclast-activating cytokines. We tested the adsorption of LPS by polyethylene particles in vitro and examined the biological effects of LPS absorption on bone remodeling around implants in vivo. Polyethylene particles were incubated in radiolabeled LPS solutions, and adsorption of LPS by the particles was quantified by radioassay. Because polyethylene particles are hydrophobic and less dense than water, they floated and clumped when incubated in a water solution of LPS, resulting in low adsorption of LPS. However, when particles were incubated in an ethanol solution of LPS, most of the LPS was adsorbed by the particles, and was resistant to washing with water. Triton X-100 (10%), however, effectively washed the LPS off the particles. In a rat model, the presence of polyethylene particles around the implant in the femoral canal decreased bone attachment to the implant at 6 weeks. Incubating the particles with LPS before implantation, or intermittent administration of LPS systemically, further decreased bone-implant attachment to similar extents, but had no effect on the bone density of the control side femurs. Our data indicate that polyethylene particles have high affinity for LPS, depending on many factors, especially the solvents of the LPS. Intermittent systemic administration of LPS affects bone remodeling but only occurs in the area containing polyethylene particles and titanium implants, supporting the hypothesis that the presence of polyethylene particles around implants can result in accumulation of LPS from exogenous sources. This may cause local levels of LPS that are high enough to affect bone remodeling around implants.

Adsorption↗

Cryoprotection of purified rat kidney transamidinase by polyethylene glycol.

Polyethylene glycol is a water-soluble polymer which is widely used in the pharmaceutical, cosmetic, and chemical industries. In this study, it is shown that polyethylene glycol is an effective cryoprotectant of rat kidney transamidinase purified from both the mitochondria and cytosol. Much of the activity is lost when the purified enzyme is frozen and thawed in sodium-potassium phosphate buffer in the absence of cryoprotectants. Polyethylene glycols with molecular weights of 4000 to 10,000 were effective cryoprotectants. However, polyethylene glycols with a molecular weight of 1000 or lower inhibited the purified enzyme. A concentration of only 0.01% polyethylene glycol 4000, 8000, or 10,000 was required for complete cryoprotection. In addition to polyethylene glycol, 0.5 mM ethylenediaminetetraacetic acid was required in the phosphate buffer for complete cryoprotection. The stabilization of purified transamidinase by polyethylene glycol will facilitate characterization experiments designed to compare the properties of the mitochondrial and cytosolic isozymes.

Amidinotransferases↗

Late porous polyethylene implant exposure after motility coupling post placement.

PURPOSE: To report the probable association of motility coupling post placement and late porous polyethylene implant exposure. DESIGN: Retrospective, observational case series. METHODS: This was a retrospective analysis of 27 patients who had primary porous polyethylene orbital implantation from February 1999 to November 2000. Data on demographics, previous surgery, ocular diagnosis, type of surgery, size of the implant, and motility coupling post placement were collected. Complications of porous polyethylene implants and implant exposure were documented. RESULTS: Among the 27 patients, 18 eyes (66.7%) received motility coupling post insertion after primary porous polyethylene implantation. Implant exposure occurred in six (33.3%) of the 18 eyes with motility coupling post insertion. None of the eyes without insertion had implant exposure. The mean interval between porous polyethylene implantation and motility coupling post placement for the implant exposure group (6 of 18) was 6.5 +/- 0.4 months, which was not statistically significant compared with 7.2 +/- 0.6 months in the nonexposure group (12 of 18). For these 6 cases of implant exposure, the mean interval between implantation and implant exposure was 24.2 +/- 11.8 months, and the mean interval between pegging and exposure was 17.6 +/- 11.7 months. Among these 6 patients, 4 underwent removal of exposed porous polyethylene implants and reimplantation of hydroxyapatite implant or dermis fat reconstruction. CONCLUSIONS: We found a trend (P =.07) of increasing risk of porous polyethylene implant exposure with motility coupling post placement. Although the pegging group did not show a statistically significant higher rate of exposure compared with the nonpegging group, we believe that more care was needed when performing motility coupling post placement. In addition, longer postoperative follow-up is needed after insertion of a motility coupling post.

Adolescent↗

Selective removal of polyethylene or polypropylene from their blends based on difference in their adsorption behaviour.

The adsorption of polyethylene and polypropylene on zeolites depends on the nature of zeolite, the solvent as well as the molar mass of the polymer sample. For example, linear polyethylene is strongly retained on zeolite SH-300 from decalin, while isotactic, syndiotactic or atactic polypropylene is fully eluted in this system. On the other hand, polypropylene is retained on zeolite CBV-780 from diphenylether, while linear polyethylene is eluted. These differences in the elution behaviour have been utilised for selective removal of either linear polyethylene or polypropylene from blends of both polymers. The desorption of the retained polymer is difficult, or at times impossible. However, the selected adsorption systems have complimentary character, i.e. either one or second component is eluted or fully retained. Thus these sorbent/solvent systems, identified herein, are the first isocratic chromatographic systems, which enable selectively to remove polyethylene or polypropylene from their mixture. Moreover, decalin/SH-300 enables the removal of both linear and branched polyethylene from mixtures with random ethylene/propylene copolymers (polyethylene fully retained, ethylene/propylene copolymers eluted).

Adsorption↗

Study of the composition of tars produced from blends of coal and polyethylene wastes using high-performance liquid chromatography.

Tars produced at semi-industrial scale in a coke oven of 6 x 10(3) kg capacity were used to investigate the effect of using polyethylene waste as an additive in the carbonization process with coal. The polyethylene wastes used were low-density polyethylene from the agriculture greenhouses and high-density polyethylene from domestic sources. The high-performance liquid chromatography analysis of the soluble fractions in toluene and carbon disulfide, using two polystyrene-divinylbenzene columns and a mixture of dichloromethane-methanol as a mobile phase, provides useful information on the composition of tars and their derived pitches in terms of the substitution and molecular topology of polynuclear aromatic compounds (PACs). Differences in composition of tars produced with polyethylene waste at 1% (w/w) have been found to be negligible, while a higher amount of the waste (3%, w/w) promoted the formation of peri-condensed PACs at the expense of the substituted cata-condensed PACs. This behaviour is due to more extensive secondary reactions of tar precursors via dealkylation and aromatic condensation taking place during the carbonization process as a consequence of a more viscous co-carbonizing system. Changes in tar composition caused by this amount of polyethylene waste addition were comparable to those promoted by an increase in the carbonization temperature at semi-industrial and industrial ovens and by the coal preheating before the carbonization process. The characteristic features in tar composition were also found for the derived pitches from tars obtained with the polyethylene waste addition.

Chromatography, High Pressure Liquid↗

Elution behavior of polyethylene in polar mobile phases on a non-polar sorbent.

Linear polyethylene standards in the range of 1-500 kg/mol, dissolved in 1,2,4-trichlorobenzene, were injected into a column packed with oligo(dimethylsiloxane) modified silica gel. Fifteen polar solvents (cyclohexanone, cyclohexylacetate, cyclohexanol, nonylalcohol, dimethylformamide, dimethyl sulfoxide, ethylene- and diethylene glycol monobutyl ether, benzylalcohol, hexylacetate, bis(2-ethyl-hexyl)phthalate, N,N-dimethylacetamide, propylene carbonate, dipropylene glycol and N-methyl-pyrrolidone) were evaluated as mobile phases. Depending on the type of mobile phase evaluated, different elution behaviors are observed for polyethylene: (1) polyethylene was eluted in the size exclusion mode, (2) polyethylene was eluted together with the sample solvent peak at constant elution volume, (3) polyethylene was partially or fully retained on the column. The retained polymer was easily removed from the column by injecting a small volume of trichlorobenzene. The use of ethylene glycol monobutyl ether as the mobile phase enabled separation of the polyethylene from polypropylene. In this case polypropylene is eluted in the size exclusion mode, while polyethylene is eluted at a constant elution volume or remains in the column.

Polyethylene↗

Large-scale preparation of human thrombin: polyethylene glycol potentiates the factor Xa-mediated activation of prothrombin.

We investigated the ability of polyethylene glycol 4000 to accelerate thrombin generation in a mixture of prothrombin and factor X at concentrations of 1-30%. In the presence of 5 mM of CaCl2, polyethylene glycol 4000 promoted prothrombin activation at concentrations above 1%. The peak of activation was seen at levels of 14 and 20% of polyethylene glycol 4000. The effect of the polyethylene glycol was remarkably dependent on its molecular weight; molecular weights greater than 2000 were required for accelerating thrombin generation. Under optimal conditions, polyethylene glycol 4000, in the presence of CaCl2, promoted conversion of all of the prothrombin into thrombin and its derivatives. We conclude that polyethylene glycol 4000, at concentrations ranging from 14 to 20%, effectively accelerates thrombin generation in the presence of 5 mM of CaCl2. This new method for preparing thrombin is based on the use of polyethylene glycol 4000 and CaCl2 and is applicable to the manufacture of thrombin.

Calcium Chloride↗

Polyethylene cross-linking by two different methods reduces acetabular liner wear in a hip joint wear simulator.

Advances in cross-linking have led to the development of wear resistant ultrahigh molecular weight polyethylene for total joint replacement. This study compared wear reduction by two different cross-linking methods as measured in a hip wear simulator. One highly cross-linked polyethylene was treated with 7.5 Mrad gamma irradiation with post-irradiation annealing and a sterilization dose of 2.5 Mrad (10 Gamma), while the other used 9.5 Mrad warm irradiation with 10 MeV electron-beam (9.5 EB). Liners of the same design, made from nominally cross-linked (gamma sterilized) polyethylene were also tested. Gravimetric wear analysis was performed every 500,000 cycles for 5,000,000 cycles. After correcting for weight gain due to water absorption, the nominally cross-linked liners demonstrated mean wear rates of 15.7 (+/-1.7) and 12.5 (+/-1.0) mg/million cycles. Both highly cross-linked polyethylene liners demonstrated significantly less wear than their respective controls (with mean wear rates of 1.5 (+/-1.2) and -1.4 (+/-1.5) mg/million cycles). The 9.5 EB liners gained weight presumably due to increased fluid absorption, in addition to that measured in loaded-soaked control implants. Any wear occurring was therefore assumed to have been more than offset by weight gain. Highly cross-linked polyethylene was significantly more wear resistant than non- or nominally cross-linked polyethylene. The differences in wear rates between the two highly cross-linked polyethylene designs (9.5 EB or 10 Gamma) are probably too small to be clinically significant.

Acetabulum↗

"Tannenbaum" Teflon stents versus traditional polyethylene stents for treatment of malignant biliary stricture.

BACKGROUND: Premature stent clogging is the major limitation with plastic stents used in the treatment of malignant biliary structures. A pilot study suggested improved duration of patency of the Tannenbaum stent compared with polyethylene stents. The aim of this prospective, multicenter randomized trial was to compare the Tannenbaum Teflon stent with a conventional polyethylene endoprosthesis (Cotton-Leung biliary stent set) for the treatment of malignant biliary strictures. METHODS: Patients over age 18 years with symptoms caused by nonhilar malignant biliary strictures were enrolled. Patients were randomized to receive a 10F Tannenbaum or polyethylene stent after a guidewire was passed beyond the stricture. One hundred six patients (mean age 72 years and 71 years, respectively) were enrolled (54 Tannenbaum, mean age 72 years; 52 polyethylene, mean age 71 years). RESULTS: Tannenbaum and polyethylene stent placement was successful in, respectively, 100% and 96% of procedures without complications. The mean (SD) 90-day stent patency of the Tannenbaum stent was 67% (7%) compared with 73% (7%) for the polyethylene stents. CONCLUSIONS: The present study demonstrated no difference in ease of implantation or stent patency between Tannenbaum and polyethylene stents.

Aged↗

Comparison of oral sodium phosphate to polyethylene glycol-based solution for bowel preparation for colonoscopy in children.

Thirty-four patients, aged 3 to 17 years, were randomized to receive oral sodium phosphate solution or a polyethylene glycol-based solution in preparation for elective colonoscopy. Nineteen patients received two doses of oral sodium phosphate solution (45 mL/1.7 m2/ dose) and 15 received polyethylene glycol-based solution (4 L/1.7 m2). Compliance with oral sodium phosphate solution was judged as easy or tolerable in 15 of 19 patients, but only in 5 of 15 who were given polyethylene glycol-based solution. The quality of colon cleansing was rated by an endoscopist who was blinded to the colon preparation method used. The bowel preparation was excellent or good (only liquid remaining in the colonic lumen) in 18 of 19 patients who received oral sodium phosphate solution and in 6 of 15 who received polyethylene glycol-based solution. The incidence of vomiting was similar in both groups, but abdominal pain occurred more frequently in the polyethylene glycol-based solution group. Hyperphosphatemia developed in patients who received oral sodium phosphate solution (serum phosphorus = 2.3 +/- 0.7 mmol/L (7.2 +/- 2.2 mg/dL; mean +/- SD), but only in 1 of 15 patients in the polyethylene glycol-based solution group. Patients did not exhibit symptoms of hyperphosphatemia and serum calcium concentrations were similar in both groups. In summary, oral sodium phosphate solution is better tolerated than polyethylene glycol-based solution for bowel preparation in children. However, hyperphosphatemia occurred frequently in patients who received oral sodium phosphate solution. Further studies are needed to determine the optimal dose for safety and efficacy for the use of these solutions in children.

Adolescent↗

Clinical and histologic behavior of exposed porous high-density polyethylene implants.

Reconstruction in the head and neck is difficult and often requires complex solutions to restore functional and aesthetic form. While autogenous tissue is preferred, many alloplasts have been investigated. These materials, however, are foreign bodies, and most alloplasts tolerate exposure and infection poorly. An alloplast's in vivo behavior is a function not only of its composition but also of its form and macrostructure, as well as the interaction at the host-implant interface. Porous high-density polyethylene is well tolerated by surrounding tissue, and its porous core is rapidly infiltrated by host tissue. In order to further investigate the response of porous high-density polyethylene under adverse conditions, we implanted three porous high-density polyethylene disks and one silicone disk underneath the dorsal skin in each of 12 rats. The implants were exposed at differing times after implantation. After 7 days, the exposed areas were either skin grafted or allowed to close by secondary intention. Silicone implants all tolerated exposure poorly. Porous high-density polyethylene implants exposed soon after implantation also tolerated exposure poorly; however, none of these extruded. Porous high-density polyethylene implants exposed after the host tissue had invaded the pores tolerated exposure well, healing either by secondary intention or by skin grafting. Porous high-density polyethylene is a safe and reliable material for use in aesthetic and functional reconstruction of the head and neck. Porous high-density polyethylene and possibly other porous alloplasts tolerate exposure well once host fibrovascular tissue has invaded the implant pores. Further investigation of differing clinical settings and implant behavior is currently in progress.

Animals↗

Polyethylene wear debris and long-term clinical failure of the Charité disc prosthesis: a study of 4 patients.

STUDY DESIGN: A clinical case series of 4 patients undergoing anterior lumbar revision due to failure of total disc replacement surgery. OBJECTIVES: To assess the clinical significance of polyethylene wear debris in salvage surgery after initial total disc replacement, the pattern and the mechanisms of polyethylene wear in the retrieved cores, and the extent of polyethylene debris in the periprosthetic tissues obtained from 4 patients. SUMMARY OF BACKGROUND DATA: Previous in vitro wear tests have demonstrated low wear rates for lumbar artificial discs, suggesting that implant wear may not be a clinically relevant issue with total disc replacement. However, only long-term clinical investigations with analysis of retrieved implants and periprosthetic tissue can ultimately establish the significance of polyethylene wear debris for total disc arthroplasty. METHODS: Starting in 2004, we began routinely performing salvage procedures in patients with failed total disc replacements. We report on the short-term outcomes of 4 patients at our institution who were revised with a Charité prosthesis (DePuy Spine, Raynham, MA). Wear analysis of the retrieved prosthesis and histologic examination of the periprosthetic tissue were also performed. RESULTS: All of the retrieved polyethylene cores showed evidence of wear, but the extent and severity varied among the 4 patients. Wear and fracture of the core were associated with osteolysis of the underlying sacrum in 1 patient. Histologic examination of the periprosthetic tissues confirmed the presence of wear debris lying in inflammatory fibrous tissue. In 3 of the 4 patients, implant wear was associated with an unfavorable biomechanical environment (e.g., subsidence, migration, undersizing, and adjacent fusion). The mechanisms of wear included adhesive/abrasive wear of the central domed region of the polyethylene core, as well as chronic rim impingement, resulting in rim fatigue and fracture. CONCLUSIONS: This study demonstrates the clinical significance of polyethylene wear debris and the potential for osteolysis with total disc replacements. The authors recommend that patients undergoing lumbar disc arthroplasty receive long-term follow-up to monitor the wear and functional status of their implants.

Adult↗

Fibrovascularization of porous polyethylene (Medpor) orbital implant in a rabbit model.

PURPOSE: To evaluate the porous polyethylene (Medpor) orbital implant in a rabbit model and compare it with three other currently available porous implants: Bio-Eye coralline hydroxyapatite (HA), FCI(3) synthetic HA, and aluminum oxide (Bioceramic). METHODS: The porous polyethylene implant was examined macroscopically and microscopically (with scanning electron microscopy). Implantation was performed in 10 adult male New Zealand albino rabbits. Each animal underwent enucleation of the right globe under general halothane gas anesthesia, followed by placement of a 12-mm porous polyethylene implant. In 5 animals, the implant was encased in polyglactin 910 (Vicryl mesh); in the other 5, it was left unwrapped. The implants were moistened in saline before placement. Implant vascularization was evaluated by histopathology at 4, 8, 12, 16, and 24 weeks. RESULTS: The porous polyethylene implant was found to have a smoother exterior surface than the Bio-Eye, FCI(3) synthetic HA, and aluminum oxide implants. Rather than a uniform interconnected porous architecture, there was an extensive system of interconnected channels through the implant, ranging in size from 125 to 1000 microm. On high-power examination there was a more solid, woven appearance without any sign of the microcrystals seen in the other porous implants. One rabbit had a retrobulbar hemorrhage after surgery and was euthanized. All the other rabbits tolerated the implant well, and there were no complications. On histopathologic examination, fibrovascularization gradually increased over time. One implant was completely vascularized at 12 weeks, and both implants harvested at 16 weeks were completely vascularized. The implant harvested at 24 weeks showed only partial vascularization (14%). CONCLUSIONS: The porous polyethylene orbital implant represents an alternative implant for use after enucleation or evisceration or for secondary implantation. In our rabbit model, the porous polyethylene implant was well tolerated without complication. Complete fibrovascularization was first seen at 12 weeks. Porous polyethylene orbital implants appear to vascularize more slowly than Bio-Eye coralline HA, FCI(3) synthetic HA, and aluminum oxide implants.

Animals↗

Polyethylene glycol 4000 vs. lactulose for the treatment of neurogenic constipation in myelomeningocele children: a randomized-controlled clinical trial.

AIM: To compare the therapeutic effectiveness and tolerability of low daily doses of polyethylene glycol 4000 vs. lactulose in the treatment of neurogenic constipation in children with myelomeningocele. METHODS: Sixty-seven children with chronic neurogenic constipation were randomized allocated to receive either polyethylene glycol 4000 (0.50 g/kg) or lactulose (1.5 g/kg) for 6 months. Patients or their parents reported frequency and modality of evacuation and side effects on a diary card. Primary outcome was bowel frequency > or =3/week, and the second one was side effects at the end of treatment. RESULTS: Complete remission of constipation was reported by a significantly (P < 0.01) higher number of patients treated with polyethylene glycol compared with lactulose. At the end of the study, 46% patients of polyethylene glycol group and 22% of the lactulose group were asymptomatic. Compared with lactulose, patients treated with polyethylene glycol reported higher bowel frequency (5.1 vs. 2.9 bowel movements/week, P < 0.01) and reduction of encopresis. Neither lactulose nor polyethylene glycol caused clinically-significant serious side effects and palatability was similar. CONCLUSIONS: Polyethylene glycol 4000 compared with lactulose provided a higher success rate, without significant side effects, for the treatment of constipation in myelomeningocele children.

Analysis of Variance↗