[Principles, organization and application of a bone bank].
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The Marburg Bone Bank System 'Lobator sd-2' is widely used to process human femoral heads removed during aseptic surgery by thermal disinfection. The inactivating capacity of the thermodisinfection system was validated in compliance with current standards using a newly developed femoral head model. The following micro-organisms, bacteria and fungi, taken from the American Type Culture Collection were investigated: Staphylococcus aureus, Staphyloccus epidermidis, Enterococcus faecium, Pseudomonas aeruginosa, Bacillus subtilis including spores, Clostridium sporogenes, Mycobacterium terrae, Candida albicans and Aspergillus niger spores. Highly enriched suspensions of these micro-organisms were applied to the centre of the femoral heads. The reduction in the number of micro-organisms was determined by counting the colony-forming units (cfu) before and after processing the spiked test device in the 'Lobator sd-2' system. Vegetative bacteria, fungi and fungal spores were completely inactivated (reduction factor >/=6 log(10)). The numbers of B. subtilis and C. sporogenes spores, both known to be heat-resistant, were reduced by one to two orders of magnitude. These bacteria serve as a model for spore forming pathogens which are not relevant in femoral heads from living donors. By processing human femoral heads from living donors by thermal disinfection using the Marburg Bone Banking system, a high level of safety is achieved regarding clinically relevant pathogens. To further increase the safety of the thermally treated femoral heads, we recommend that the medical history and present state of the donor, as well as the necessary serological tests should be taken into account.
A prospective trial was carried out in 156 unselected patients (41 men, mean age 67.5 years, 115 women, mean age 71.4 years) who had undergone total hip joint replacement because of degenerative or inflammatory arthritis or fracture of the neck of the femur. The excised femoral heads were subjected to three-stage bone bank screening so as to ascertain how many of them would pass the clinical, biochemical and microbiological exclusion criteria. Only 26 out of 156 femoral heads (17%) proved to be acceptable for the bone bank. Ninety patients (58%) were excluded on clinical grounds such as old age (over 80 years), malignant neoplasms, rheumatoid arthritis, previous intraarticular injections or long-term steroid medication. Positive hepatitis serology excluded 19%, and raised preoperative neopterin concentration excluded 25%, though three months postoperatively this was confirmed in only 2%. Routine neopterin assay seems to be a useful step towards improved bone bank screening, since neopterin concentration is clearly increased in recent virus infections such as HIV. Bacterial contamination was of no practical importance. Because of the low proportion of femoral heads passed as suitable for the bone bank, the existing exclusion criteria will have to be critically scrutinized, and alternative procedures for harvesting bone safe for transplantation (freeze drying, autoclaving, irradiation) will have to be employed.
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The aim of the study was to describe the bacteriology of bone allografts, which were harvested for the bone bank at Hvidovr Hospital, and to evaluate any infections in the recipients, which may have been caused by microbiological contamination of the transplanted bone allografts. It was carried out as a retrospective examination of bone bank records and patient records allowing at least 12 months for possible manifestation of bacterial infection by the bone allograft. During donation of bone, both the capita femora and the acetabulum were cultured with swabs both an- and aerobically along with the already sterilized glass specimen jar used for storage. Of the 110 donated bone allografts, 10 were not used for transplantation, but only one allograft was discarded because of the development of a positive culture (Staphylococcus epidermidis). All cultures from the sterilized glass specimen jars were without microbiological growth. Three incidences of deep infection (one Acinetobacter calcoaceticus and two Staphylococcus aureus) followed the transplantation of 100 bone allografts in 58 patients at 62 operations. We conclude that the precautions (i.e. careful selection and screening of donor) and strict aseptic technique (including the use of perioperative administration of antibiotics) used, when bone allografts are harvested, ensure the procurement of non-contaminated bone in more than 99% of the donations. Culturing the already sterilized glass specimen jars seems unnecessary. The bone allograft per se was not contaminated and probably did not cause any infections. The rate of infection after transplantation of bone allograft is not higher than in other complicated surgery.
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Bone allografts are being used in increasing numbers by orthopedic surgeons, yet many surgeons are unfamiliar with their preparation and processing, as well as their use as safe and effective transplants. This article reviews current sources of bone allografts, new methods of processing to achieve optimal results, the biology of incorporation of allografts, and new bone substitutes.
Ethylene oxide gas (EOG) is widely used for sterilization of freeze-dried bone. Recently EOG is regulated for clinical use because of cytotoxicity and environmental pollution concerns. Low Temperature Plasma Sterilization (LTPS) has no toxicity and mutagenicity working with a hydrogen peroxide gas plasma at 45 degrees centigrade. We have now used this method experimentally and clinically to sterilize freeze-dried bone. Cortical bone with a thickness of 5 mm and cancellous bone with a 10 mm cubic size were prepared, washed, defatted, dehydrated by freeze drying and finally sterilized by LTPS. As a Microbiological test, defatted freeze-dried bone was contaminated with B. subtilis, and after then the contaminated bone was treated with LTPS and the bacteria was proven inactive. Mechanical testing on rabbit cortical bone was investigated by compression testing using a mechanical testing machine. No differences between EOG treated and LTPS treated bone were found. From December 1996, 52 patients who had small and middle bone defects were treated with defatted, freeze-dried and LTPS sterilized bone. Clinical result was good. No deep infections, no transmission of virus infections or severe graft absorption were noted. The LTPS bank bone is safe and useful to reconstruction to small bone defects.
A three years' practice of a hospital-based non-commercial bone bank is presented. Altogether 121 allografts were collected from primary hip arthroplasties for osteoarthritis. Altogether 41 of the grafts were used in our hospital, 47 grafts were transported to other hospitals at a non-profit basis. The grafts were stored fresh-freezed at -80 degrees C. The allograft recipient patients in our hospital were reviewed. Main indication for the use of allografts was revision arthroplasty of the hip or knee. Other indications included difficult nonunions, arthrodeses of the knee or spine, difficult major primary fractures in osteoporotic bone and a large bone cyst. Of the nonunions, 3/10 failed to unite and of the revision arthroplasties, 1/19 had to be reoperated on. Three infections were recorded, all of which were unrelated to the allograft transplantation. The infections all healed without surgical intervention.
The objective of the study was to investigate occult abnormalities in bone bank allograft with the use of histomorphometry that may otherwise go unidentified with current screening techniques. This was a prospective pathology review in which 40 transcortical trephine bone biopsies were taken from the iliac crest of bone donors and examined by light microscopy and semiautomated histomorphometry. Current routine screening techniques for allograft bone donors include history, serology, and culture. Additional screening for unsuspected pathology and for parameters related to metabolic bone disease may predict the effectiveness of the donor bone. Light-microscopic findings showed 1 case suspicious for chronic myeloproliferative disorder, which had otherwise not been detected by standard screening techniques. On histomorphometric analysis, 3 specimens showed severe osteoporosis. In conclusion, iliac crest bone biopsy may need to be considered as an adjunct in screening for both unsuspected hematological disease and metabolic bone disease.
In a nationwide survey, all orthopaedic clinics were surveyed via a questionnaire about the use of bone allografts and how they managed their bone banks. Thirty-two clinics (100 per cent) responded to the questionnaire (mid 1991). Seventeen clinics had established bone banks on the basis of femoral heads obtained from donors during primary hip replacement. Only five used bone substitutes. The mean consumption was 30 capita per year (10-132) and ten clinics estimated an increasing demand for allografts. The storage method was by freezing at temperatures varying from minus 20 to minus 80 degrees Celsius. Contraindications to procurement comprised history of infection and malignancy, all clinics tested donors for HIV antibodies and all but one for hepatitis B. Testing for hepatitis C was about to be introduced. All but one clinic developed cultures from the procured bone. Informed consent was employed by nearly all clinics, but very few obtained written consent. Since this survey, revised recommendations have been directed from the Danish National Board of Health, these listing that an HIV-test should be performed with a 90-day interval, and that testing should also be done for hepatitis B and C. International experience and this survey show that the establishment of more specific and general national recommendations would be preferable to present practice.
Transplantation of human tissues has become increasingly popular, and associated with this increase are reports of the transmission of diseases including acquired immune deficiency syndrome. To reduce the risk of transmitting disease through transplantation, careful scrutiny of current tissue transplantation procedures is necessary. Bone banking in Canada was evaluated by questionnaire, sent to the head operating room nurse of every Canadian hospital listed in the 1986 Canadian Medical Directory as having 100 or more beds. From this questionnaire, the authors identified 60 bone banks in Canada, many of which failed to meet recommended guidelines. The authors review the literature relating to bone banking procedures and present in detail the results of their survey.
The operative technique of autogenous bone banking of a femoral head from a symptomatic degenerative hip undergoing a primary total hip arthroplasty into an osseous deficiency of an asymptomatic, contralateral, loose acetabular component is described. The rationale for bone banking an autogenous femoral head versus the use of an allograft or iliac crest autograft at a later date is discussed.
An organism resembling Burkholderia (formerly Pseudomonas) cepacia was isolated from cultures taken during processing of six bone grafts. The source of the contamination was traced to a water de-ionizer; the problem had begun when procedures had been changed, so that water from the de-ionizer had been used without sterilization. Cultures of bone for grafting not only protect recipients from infection, but act also as useful controls for processes involved in bone banking.
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