Quincke's edema in a dialysis patient after administration of acrylic bone cement: Possible role of ethylene oxide allergy

Summary A 33-year-old female dialysis patient suffered from osteomyelitis and luxation of the dens axis with cervical myelopathy. In the past she had had three attacks of anaphylaxis after treatment with dialyzers that had been sterilized with ethylene oxide. IgE-type antibodies directed against human serum albumin-ethylene oxide complexes could be demonstrated in the patient's serum by radioallergosorbent techniques. Immediately after an operation in which acrylic bone cement (Palacos-R) sterilized with ethylene oxide was implanted for stabilization of the cervical spine, the patient developed massive edema of the larynx, pharynx, and tongue, suggesting Quincke's edema. It is concluded that ethylene oxide present in acrylic bone cement may induce acute allergic reactions in sensitized patients. Dialysis patients may be at special risk, since the incidence of ethylene oxide allergy in this patient population is about 10%.

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Zusammenfassung Eine 33jährige Dialysepatientin litt an einer Osteomyelitis und einer cervikalen Myelopathie bei Luxation des Dens axis. Bei der Patientin war in der Vergangenheit dreimal ein anaphylaktischer Schock aufgetreten, nach Behandlung mit Dialysatoren, die mit Ethylenoxid sterilisiert worden waren. Eine Ethylenoxid-Allergie mit Nachweis von IgE-Antikörpern gegen Komplexe aus Humanalbumin und Ethylenoxid konnte mit der Radioallergosorbent-Technik (RAST) gesichert werden. Unmittelbar im Anschluß an eine operative Stabilisierung der Halswirbelsäule mit Knochenzement (Palacos R) kam es zu einem Quincke-Ödem mit massiven Schwellungen des Larynx, Pharynx und der Zunge. Palacos wird mit Ethylenoxid sterilisiert. Wir schließen daraus, daß restliches Ethylenoxid im Knochenzement bei sensibilisierten Patienten zu akuten allergischen Reaktionen führen kann. Dialysepatienten sind als besondere Risikogruppe für solche anaphylaktischen Reaktionen anzusehen, da die Inzidenz einer Ethylenoxid-Allergie in dieser Patientengruppe bei etwa 10% liegt.

     

Ethylene oxide sterilization of bone grafts: Residual gas concentration and fibroblast toxicity

We examined the concentration of ethylene oxide in bone allografts after gas sterilization. Chips of the human femoral head were investigated. Residual gas concentration was determined by gas chromatography after the bone chips had been subjected to defatting and freeze-drying, followed by ethylene oxide gas sterilization. Bones were prepared in various ways in an attempt to reduce the concentration of residual ethylene oxide. The concentration was higher when gas sterilization was performed before freeze-drying than when it was done afterwards. An experiment performed with fibroblasts showed the high toxicity of residual ethylene oxide in bone chips, even when the concentration was very low. The growth of fibroblast was reduced more in medium which had been shaken with bones sterilized with ethylene oxide before freeze-drying than in medium which had been shaken with bones sterilized after freeze-drying. The higher residual ethylene oxide concentrations resulted in a decrease in fibroblastic culture activity. Our experiment showed the importance of reducing the residual ethylene oxide gas concentration. Defatting and freeze-drying result in lower residual ethylene oxide concentrations.     

Gamma irradiation and ethylene oxide in the sterilization of native reindeer bone morphogenetic protein extract.

BACKGROUND AND AIMS: For human use, it is necessary to sterilize bone morphogenetic proteins (BMPs), in order to reduce the risk of infections and associated complications. We compared the effects of ethylene oxide and gamma irradiation in the sterilization of native reindeer BMP extract with regard to bone induction in the Balb/C mouse thigh muscle pouch model. MATERIALS AND METHODS: BMP extract, sterilized with ethylene oxide gas (Steri-Vac 4XL, temperature 29 degrees C, exposure time 4 h, ethylene oxide concentration 860 mg/l), or gamma irradiation at doses of 3.15 MRad was administered in implants containing 5 or 10 mg of BMP extract with collagen carrier. Non-sterilized collagen implants served as controls. New bone formation was evaluated based on the incorporation of Ca45 and radiographically three weeks after implantation. RESULTS: The collagen was not able to induce new bone visible in radiographs. The mean Ca45 incorporation in the gamma sterilized group containing 5 mg of BMP extract was 30% (p = 0.04) and that containing 10 mg of BMP extract was 60% (p = 0.02) higher than seen in the corresponding ethylene oxide sterilized groups. The mean new bone areas were 45% higher in the gamma sterilized groups than in the corresponding ethylene oxide sterilized groups, but the differences were not significant. The mean optical density of new bone in the gamma sterilized group containing 5 mg of BMP extract was 75% (p = 0.00) and in that containing 10 mg of BMP extract was 70% (p = 0.00) higher than seen in the corresponding ethylene oxide sterilized groups. CONCLUSION: Native reindeer BMP extract is more sensitive to the effects of ethylene oxide gas sterilization than gamma irradiation. These results suggest that gamma irradiation is recommendable for the sterilization of BMP extracts.     

Obstetrical analgesia in a woman allergic to ethylene oxide

A case is reported of a 28 year old woman, with untreated mitral valve disease and a professional allergy to ethylene oxide and phthalic anhydride, who presented with acute hydramnios during the 35th week of pregnancy. Emergency caesarean section having been decided on, a urinary catheter--sterilized by gamma rays and not ethylene oxide--was inserted; the gloves used had however been sterilized in ethylene oxide gas, and the patient rapidly presented with anaphylactic shock. The needles and intravenous infusion equipment used were all either sterilized in gamma rays or rinsed in large quantities of liquid. It was decided to abandon the caesarean section and attempt a vaginal delivery using morphine spinal analgesia; epidural analgesia was absolutely contraindicated because the catheters were sterilized in ethylene oxide and the patient's haemodynamic state was too precarious. Caudal anaesthesia with 0.25% bupivacaine was used to complete the spinal analgesia and speed up cervical dilation. The child was delivered with forceps and the diagnosis of oesophageal atresia was confirmed.     

The failure of ethylene oxide gas-sterilized freeze-dried bone graft for thoracic and lumbar spinal fusion

Thirty-seven patients underwent posterior and/or posterolateral spinal fusion using ethylene oxide gas-sterilized freeze-dried bank bone graft. Thirteen patients had discogenic back pain, eight with prior failed laminectomy procedures, and five undergoing initial spinal surgery. Six patients had isthmic spondylolisthesis, three with associated radicular complaints, and two patients had degenerative spondylolisthesis. Seven patients with spinal fractures and nine patients with scoliosis underwent spinal fusion with associated instrumentation. Pseudarthroses were detected in 28 patients (76%), and 18 patients (49%) underwent pseudarthrosis repair procedures using autogenous iliac bone graft. At surgery, the prior gas-sterilized freeze-dried bone graft was noted to have been almost completely resorbed. Ethylene oxide sterilization has been found experimentally in animal models to damage the osteoinductive ability of bone grafts. Ethylene oxide gas-sterilized freeze-dried bank bone graft is inferior to autogenous bone graft or bank bone graft preserved and/or sterilized by other methods. Its use in thoracic or lumbar posterior or posterolateral fusion cannot be recommended.     

Ethylene oxide sterilization of autologous bone flaps following decompressive craniectomy

Summary ¶Introduction. In patients undergoing decompressive craniectomy, the bone flap is temporarily preserved either in the subcutaneous tissue of the patient or frozen. However, there are some drawbacks related to these methods. Material and methods. In 16 patients in whom the bone flap was removed for decompressive craniectomy, the bone was firstly washed in hydrogen peroxide and then placed in hermetically-sealed bags and sterilized using ethylene oxide. The bone was repositioned after an average period of 4.3 months. Results. One patient sustained an infection of the surgical wound which required permanent exclusion of the bone flap. In all the others, esthetic and functional results were good after an average follow-up of 20 months. Control CT-scan of the bone flap demonstrated preservation of its structural features with fusion of the bone margins and revitalization of the flap. On MRI a subdural space was again visible. Conclusions. Sterilization of the bone flap with ethylene oxide in patients undergoing decompressive craniectomy avoids some of the drawbacks related to the techniques currently used. The easiness, low cost, good aesthetic and functional results of this procedure make it a valid alternative to other techniques for preservation of autologous bone in decompressive craniectomies.Published online September 26, 2003     

Fracture and fatigue properties of acrylic bone cement: the effects of mixing method, sterilization treatment, and molecular weight

The purpose of this study was to characterize the relative and combined effects of sterilization, molecular weight, and mixing method on the fracture and fatigue performance of acrylic bone cement. Palacos R brand bone cement powder was sterilized using ethylene oxide gas (EtO) or gamma irradiation. Nonsterile material was used as a control. Molecular weights of the bone-cement powders and cured cements were measured using gel permeation chromatography. Hand and vacuum mixing were employed to mold single edge-notched bend specimens for fracture toughness testing. Molded dog-bone specimens were used for fatigue tests. Electron microscopy was used to study fracture mechanisms. Analysis of variance and Student t-tests were used to compare fracture and fatigue performance between sterilization and mixing groups. Our results indicate that vacuum mixing improved significantly the fracture and fatigue resistance (P<.05, P<.07) over hand mixing in radiation-sterilized and EtO-sterilized groups. In vacuum-mixed cement, the degradation in molecular weight resulting from gamma irradiation decreased fracture resistance significantly when compared with EtO sterilization and control (P<.05). A corresponding decrease in fatigue resistance was observed in the cement that was degraded severely by a radiation dose of 10 MRad (P<.05). In contrast, EtO sterilization did not result in a significantly different fracture resistance when compared with unsterilized controls for vacuum-mixed cement (P>.1). For hand-mixed cement, fracture and fatigue resistance appeared to be independent of sterilization method. This independence is believed to be the result of higher porosity that compromised the mechanical properties and obscures any effect of sterilization. Our results indicate that a combination of nonionizing sterilization and vacuum mixing resulted in the best mechanical performance and is most likely to contribute to enhanced longevity in vivo.     

Complications associated with bone cementing for the treatment of giant cell tumors of bone

A retrospective review was conducted of giant cell tumors treated between 1984 and 1998 using the technique of aggressive curettage through a large bone window followed by acrylic cement reconstruction. Fifteen patients with a mean follow-up time of 46 months (range, 24–188 months) were identified. One patient had a local recurrence 24 months postoperatively. All the patients showed a radiolucent zone at the bone–cement interface up to 2.5 mm in width during the first 6 months after operation. However, the radiolucent zones were nonprogressive and did not affect the stability of the bone cement. Osteoarthritis of the knee joint occurred 14 years postoperatively in one patient with an intraarticular fracture at presentation. A stress fracture occurred in one patient who had the largest tumor in the distal femur. Acrylic cement reconstruction is a safe and effective procedure that provides local adjuvant therapy. Giant cell tumors with an associated intraarticular fracture remain a challenging problem to treat. Received: August 31, 2001 / Accepted: November 30, 2001     

Use of peracetic acid to sterilize human donor skin for production of acellular dermal matrices for clinical use

We previously reported methods for sterilizing human skin for clinical use. In a comparison of gamma-irradiation, glycerol, and ethylene oxide, sterilization with ethylene oxide after treatment with glycerol provided the most satisfactory dermis in terms of structure and its ability to produce reconstructed skin with many of the characteristics of normal skin. However, the use of ethylene oxide is becoming less common in the United Kingdom due to concerns about its possible genotoxicity. The aim of this study was to evaluate peracetic acid as an alternative sterilizing agent. Skin sterilized with peracetic acid was compared with skin sterilized using glycerol alone or glycerol with ethylene oxide. The effect of subsequently storing peracetic acid sterilized skin in glycerol or propylene glycol was also examined. Acellular dermal matrices were produced after removal of the epidermis and cells in the dermis, processed for histological and ultrastructural analysis, and the biological function was evaluated by reconstitution with keratinocytes and fibroblasts. Results showed that sterilized acellular matrices retained the integrity of dermal structure and major components of the basement membrane. There were no overall significant differences in the ability of these matrices to form reconstructed skin, but peracetic acid alone gave a lower histologic score than when combined with glycerol or propylene glycol. We conclude that peracetic acid sterilization followed by preservation in glycerol or propylene glycol offers a convenient alternative protocol for processing of human skin. It is suggested that this sterile acellular dermis may be suitable for clinical use.     

Graft perforations favor osteoinduction. Studies of rabbit cortical grafts sterilized with ethylene oxide.

The healing of freeze-dried, ethylene oxide sterilized, segmental, allogenic cortical bone grafts was investigated in 15 rabbits using a 2-cm ulnar diaphyseal defect. Five different groups of bone grafts were evaluated: 1) unperforated undemineralized, 2) perforated undemineralized, 3) unperforated demineralized, 4) perforated demineralized, and 5) perforated demineralized grafts enclosed by silicone rubber (Silastic) sheets. There were 3 animals in each group. At 18 days, the study was terminated, and the implants were examined using radiographs and qualitative histologic preparations. We observed that healing of perforated demineralized bone was superior to unperforated demineralized bone, that undemineralized bone was partially sequestered in reactive lacunae, and that perforations in demineralized bone became centers of osteoinduction. Demineralized bone sterilized with ethylene oxide by this method vigorously formed new bone.     

The use of bone cement induces an increase in serum astroglial S-100B protein in patients undergoing total knee arthroplasty

Cerebral microemboli can occur during arthroplasty with the use of bone cement. Astroglial S-100B protein is a sensitive marker of cerebral damage. Therefore, we designed this study to determine the effect of bone cement on the brain by investigating serum levels of S-100B protein in patients undergoing bone surgery with or without bone cement. Fourteen patients undergoing knee arthroplasty (n = 7) or reamed intramedullary nailing for tibial fracture (n = 7) requiring a pneumatic tourniquet were enrolled in this study. Bone cement containing polymethyl methacrylate and methyl methacrylate was used for every patient undergoing knee arthroplasty. Serum samples were obtained from venous blood before the induction of general anesthesia, 15 min after deflation of a pneumatic tourniquet, and 3 days after the operation. The serum level of S-100B protein was significantly increased 15 min after a pneumatic tourniquet deflation in the knee arthroplasty group compared with the tibial fracture group (0.41 and 0.08 ng/mL, respectively; P < 0.05). In all patients studied, no neurological abnormalities were noted in the postoperative period. These results suggest that, in patients undergoing knee arthroplasty, bone cement may transiently induce astroglial injury, although it does not alter neurological outcome. IMPLICATIONS: Serum S-100B protein was significantly increased 15 min after a pneumatic tourniquet deflation in patients undergoing knee arthroplasty with bone cement, but not in those undergoing reamed intramedullary nailing for tibial fracture without bone cement. These results suggest that bone cement may transiently induce astroglial injury.     

聚羟基丁酸酯可吸收缝线灭菌方法的实验研究

目的：研究不同的灭菌方法对聚羟基丁酸酯（PHB）可吸收缝线的降解性和力学特性的影响。方法：将聚羟基丁酸酯（PHB）可吸收缝线进行酒精浸泡、环氧乙烷、紫外线照射三种方法进行灭菌处理后,用细菌培养检测灭菌效果,用粘度法测定聚合物分子量从而观察缝线的降解性,用拉伸试验测定缝线的力学特性。结果：①酒精浸泡灭菌组有10%检出细菌,环氧乙烷及紫外线灭菌组未检出细菌;②紫外线照射灭菌和酒精浸泡灭菌组可使缝线黏度下降并具有显著性差异,环氧乙烷对缝线黏度下降的影响没有显著性差异;③经酒精和紫外线灭菌后缝线的断裂强度降低明显,差异具有显著性,经环氧乙烷灭菌后缝线的断裂强度降低无显著性差异。经紫外线灭菌后缝线的断裂伸长率明显降低,差异具有显著性,经酒精和环氧乙烷灭菌后缝线的断裂伸长率无明显降低。结论：环氧乙烷灭菌对PHB可吸收缝线的降解性和力学特性影响较小,是PHB可吸收缝线较理想的灭菌方法。     

Craniofacial contouring and porous acrylic cement

Porous acrylic cement permitting ingrowth of soft and hard tissue was developed in the mid-1970s. After several years of animal experimentation, a clinical trial started in 1978. Twenty-nine selected patients had craniofacial contouring with in situ curing porous acrylic cement. It is an easy one-stage procedure with a good fixation of the prosthesis. The result is a definite good contour reconstruction. It offers the craniofacial surgeon a useful alternative in selected cases when autogenous bone grafting or an intracranial approach is not indicated or not sought by the patient.     

Use of acrylic in anterior cervical discectomy: technical note

Acrylic was inserted into the intervertebral space after anterior cervical discectomy in five patients. The application of the acrylic was simple and quick to perform and atraumatic to the patient. The intervertebral space was preserved satisfactorily and consistently in all five patients. With this technique, the complications associated with bone grafts can be avoided.     

Fracture and fatigue properties of acrylic bone cement

The purpose of this study was to characterize the relative and combined effects of sterilization, molecular weight, and mixing method on the fracture and fatigue performance of acrylic bone cement. Palacos® R brand bone cement powder was sterilized using ethylene oxide gas (EtO) or gamma irradiation. Nonsterile material was used as a control. Molecular weights of the bone-cement powders and cured cements were measured using gel permeation chromatography. Hand and vacuum mixing were employed to mold single edge-notched bend specimens for fracture toughness testing. Molded dog-bone specimens were used for fatigue tests. Electron microscopy was used to study fracture mechanisms. Analysis of variance and Student t-tests were used to compare fracture and fatigue performance between sterilization and mixing groups. Our results indicate that vacuum mixing improved significantly the fracture and fatigue resistance (P < .05, P < .07) over hand mixing in radiation-sterilized and EtO-sterilized groups. In vacuum-mixed cement, the degradation in molecular weight resulting from gamma irradiation decreased fracture resistance significantly when compared with EtO sterilization and control (P < .05). A corresponding decrease in fatigue resistance was observed in the cement that was degraded severely by a radiation dose of 10 MRad (P < .05). In contrast, EtO sterilization did not result in a significantly different fracture resistance when compared with unsterilized controls for vacuum-mixed cement (P > .1). For hand-mixed cement, fracture and fatigue resistance appeared to be independent of sterilization method. This independence is believed to be the result of higher porosity that compromised the mechanical properties and obscures any effect of sterilization. Our results indicate that a combination of nonionizing sterilization and vacuum mixing resulted in the best mechanical performance and is most likely to contribute to enhanced longevity in vivo.     

In vitro immune response to acrylic cement particles in patients with cemented joint replacements

Immunological reaction to bone cement in tissue could be considered one of the important causes to induce the loosening of the prosthesis in patients with cemented prostheses. To study whether or not bone cement is immunogenic in human in vitro, the effect of acrylic cement particles on specific or non-specific blastformation reaction of peripheral blood mononuclear cells (PBM) or of non-adherent cells (NAC) was studied. Acrylic cement particles showed neither mitogenic nor cytotoxic effect on human PBM. No statistically significant enhancing effect of acrylic cement particles was found on specific or non-specific blastformation reaction of PBM or NAC from patients with cemented prostheses. No significant difference in those reactions to cement was seen between patients with loosened prostheses and with non-loosened prostheses. In some cases, however, acrylic cement particles showed significant enhancing effects on some macrophage-dependent blastformation reaction systems. As many of them were patients with cemented prostheses, it is highly possible that bone cement could induce significant macrophage-dependent immunological reaction in some particular population.     

充填材料对经皮椎体后凸成形术疗效影响的观察

目的观察不同充填材料对经皮椎体后凸成形术(PKP)治疗骨质疏松性椎体压缩性骨折(OVCF)疗效的影响。方法 OVCF共69例(69椎),均为女性。分成3组:A组23例(23椎),充填材料为聚甲基丙烯酸甲酯骨水泥(PMMA)。B组23例(23椎),充填材料为丙烯酸树脂骨水泥。C组23例(23椎),充填材料为注射型自固化磷酸钙骨水泥(CPC)。手术均在局部麻醉下由同一组医生负责完成。术前骨密度测量(DXA)值为0.62～0.88g/cm2,平均0.72±0.16g/cm2,提示3组均存在重度骨质疏松。比较3组术前、术后1w、术后8w椎体前、中份高度,脊柱后凸角度,主观满意度(VAS评分、止痛药使用评分),骨水泥渗漏率等指标。观察3种充填材料对PKP疗效的影响。结果 3组年龄,术前椎体前、中份高度,脊柱后凸角度,VAS评分,止痛药使用评分均无统计学差异(P>0.05)。术后1w,3组椎体前、中份高度,脊柱后凸角度均较术前有显著改善(P<0.01)。术后8w,C组椎体前、中份高度较术后1w有轻度丢失(P<0.05)。术后1w,3组VAS评分、止痛药使用评分均较术前有不同程度改善(P<0.05),其中A、B组对疼痛改善程度无统计学差异(P>0.05),但均优于C组(P<0.05)。术后8w,3组对疼痛改善程度无统计学差异(P>0.05)。3组术中骨水泥充填量及骨水泥渗漏率无统计学差异(P>0.05)。结论充填材料对PKP治疗OVCF的疗效可能存在一定的影响。PMMA与丙烯酸树脂骨水泥近期止痛效果确切,CPC充填后患者卧床时间相对较长,但远期疗效可能优于前者。     

人工关节置换充填骨水泥对血液动力学的影响

目的观察人工关节置换术中充填骨水泥对血液动力学的影响。方法40例ASAⅡ～Ⅲ级行人工关节置换术的患者，观察骨水泥充填后10min内血液动力学的变化。结果充填骨水泥后10min内患者血液动力学都有显著变化（P〈0．05），个别患者血压下降严重。需升压药支持。结论人工关节置换术中充填骨水泥可致血液动力学严重波动，应引起重视。     

经皮椎体成形术后骨水泥渗漏的回顾性分析及预防策略

目的 回顾性分析我院152例187节胸腰椎骨折椎体成形术后患者(PVP或PKP)骨水泥渗漏的发生率及预防措施.方法 2007年5月～2012年5月共152例骨质疏松性胸腰椎体压缩性骨折(187节椎体)患者施行经皮椎体成形术(PVP)75节或经皮椎体后凸成形术(PKP)112节,术后对责任椎常规复查CT,统计显示骨水泥渗漏共65节(34.76%),其中PVP术38节(50.66%),PKP术27节(24.11%),渗漏至椎管内15节(8.02%,PVP术9节,PKP术6节)、椎间隙内13节(6.95%,PVP术7节,PKP术6节)、穿刺针道内8节(4.28%,PVP术4节,PKP术4节)、椎间静脉渗漏5节(2.67%,均为PVP节)、椎体周缘(椎体前缘、椎体旁)23节(12.30%,PVP术12节,PKP术11节)、神经根管内1节(0.53%,为PVP术),观察术后疗效,总结造成骨水泥渗漏的原因及预防方法.结果 所有患者术后疼痛明显减轻,出现骨水泥渗漏并发症的患者中,1例渗漏至神经根管内患者出现神经压迫症状,减压术后症状缓解,其余患者术后均无明显神经压迫症状.结论 椎体成形术后渗漏发生率较高(34.76%),以椎体周缘渗漏(35.38%)最为常见,但因渗漏而有临床症状者较少(1.53%).骨水泥渗漏与术前检查是否充分、术前阅片是否仔细、手术操作是否熟练密切相关.     

Einfluss von Prozessierung und Sterilisation auf die Festigkeit von Pins aus boviner Tibiakompakta

In a biomechanical study pins made of xenogenous cortical bone were tested in vitro. Forty pins of 3 mm diameter and 60 mm length were made of eight different cattle tibiae and allocated to five different treatment groups. Freeze-dried pins served as control group. Pins of the second group were preserved in concentrated sodium chloride solution and defatted with acetone (Tuto-plast processing). Pins of groups three to five were treated with sodium chloride and acetone and afterwards sterilized by different means (ethylene oxide, autoclavation, or gamma radiation). All pins were subjected to a three-point-bending test and a shear test. We found that bending strength and shearing strength were most increased after sodium chloride and acetone treatment, whereas after sterilization with ethylene oxide or autoclaving, the stability of the pins was similar to the control group. The stability was considerably diminished after gamma radiation. Taking into account possible toxic side effects of ethylene oxide, we conclude that Tutoplast processing followed by autoclavation presents a reliable preparation method for the clinical use of implants made of bovine cortical bone.