[A central bone bank for bone transplantation].
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Although bone banks have existed for many years, the elements of organizing and maintaining a hospital bone bank have not been well documented. The experience with a bone bank at the Massachusetts General Hospital between 1971 and 1980 provides a model on which to base an explanation and discussion of methods of procurement, storage, and retrieval, and the costs associated with such a facility. In 1979, the procurement rate averaged one donor per month; during that year a total of ninety-one bones were stored and six different surgeons utilized more than twenty allografts from the bank. During the same year, the approximate cost of maintaining the bank was more than $50,000. On the basis of the number of bones used, the cost averaged more than $2000 per implant. Such a hospital facility offers the benefits of quality control of the banked bone but is expensive and may not be feasible for many hospitals.
Cadaver bone for spinal fusion operations is as safe as autografts. The author's 35 years' experience using cadaver bone for interbody spinal fusion operations has led to the development of a simplified bone bank method. Unsterile bone removed from young, fresh cadavers is cut into appropriate sizes and shapes, washed clean, packaged and sterilized with ethylene oxide gas, then aerated and stored at room temperature. The results of spinal fusion, both cervical and lumbar, using 187 gas-sterilized bone grafts in 58 patients operated on over the past year and half, were reviewed and compared with fusions using autografts or banked bone from proven methods. The rate and percentage of fusion of gas-sterilized bone was comparable to other bone grafts with no untoward complications.
Bone banks large enough to support an allograft program require dedicated medical personnel to manage them. A large potential donor population, extensive financial resources, and modern storage facilities are necessary. Infected donors and contamination of procured bones during storage and retrieval must be avoided at all costs. Detailed record keeping is of vital importance to clinical investigations, especially for evaluating complications. These considerations must be taken into account before embarking on an institutional bone banking program, to provide safe and satisfactory allogeneic bone for clinical use.
A simple dowel arthrodesis of the talonavicular joint in an early stage of destruction can reduce pain and prevent the development of valgus deformity in the rheumatoid hindfoot. Previously, we used autogenous dowels made from the iliac crest. In order to facilitate the operation and to get a better fitting dowel, we tried defatted cancellous allograft dowels from which marrow tissue had been removed. The dowels were prepared from femoral heads in our surgical bone bank. At operation, the dowels were embedded in fresh marrow aspirate from the iliac crest and the arthrodeses were stabilized with a staple. Results were evaluated by clinical examination and radiography. The results of four patients were compared with an earlier study of eight patients using autogenous dowels taken from the iliac crest. With both techniques, the patients were relieved of pain in the talonavicular joint, but some had pain from other hindfoot joints. With autogenous dowels, all eight patients healed with radiographic bony union, but with allogenous dowels, the four patients developed fibrotic nonunion. The results indicate that talonavicular arthrodesis should be made using only autologous dowels.
Both cost effectiveness and safety can be realized in the operation of a community bone bank by adoption of the following measures: deep freezing, rather than freeze drying; allogenic bone is collected from femoral heads excised from total hip arthroplasties; and careful donor and graft selection controls ensure an allograft free of disease which can be transmitted to the recipient. Two-year follow-up data reveal no complications or infections from implantation of 101 allografts.
Many forms of banked bone allograft are available to the surgeon. Among the grafts available are fresh, fresh-frozen, freeze-dried, and demineralized bone. Each one of these grafts carries risks and has unique limitations and handling properties. In order to use these materials appropriately, the surgeon must be familiar with the properties of each and must feel confident that the bone bank providing the graft is supplying a safe and sterile graft. In the future, allograft bone will become obsolete. In place of banked bone, surgeons will use synthetically produced bone morphogenic protein that has been incorporated into an absorbable matrix. These materials will exist in a time-release form that will allow the graft material to grow and mature with the patient. Until this goal is achieved and is available clinically, surgeons must be familiar with the capabilities and limitations of banked bone graft.
Since December 1988 the Leiden Bone Bank Foundation, in cooperation with the BIS Foundation, makes allogeneic bone and related soft tissue available for transplantation. Bone banking has become a scientifically high level medical activity in which international standards are established in order to provide safe and effective allografts. Careful donor selection and extensive laboratory testing are the cornerstones for the prevention of disease transmission. In the first 5 years of the existence of the Leiden Bone Bank 450 deep frozen massive bone allografts, of which 221 osteoarticular and intercalary allografts, were shipped to different clinics inside and outside the Netherlands. Furthermore, 322 deep frozen soft tissues, 1877 units of freeze dried bone grafts and 5629 units of demineralized grafts were distributed. The number of transplants with allogeneic bone and related soft tissue from the Leiden Bone Bank increased each year by at least 30% Bone and related soft tissue allografts were used in orthopaedic surgery, neurosurgery and maxillofacial surgery. There are no known cases of transmission of infectious diseases by grafts distributed by the Leiden Bone Bank.
The first temporal bone histopathology laboratory in Canada was established at the University of Toronto in 1966. Its organization is outlined. More than 600 bones have been processed and more than 45 publications produced. These are broadly classified as new discoveries, new techniques of temporal bone processing, clinical pathological case reports, and papers on clinical entities. The laboratory has a major teaching role for the trainee in otolaryngology. The history of the temporal bone bank program in North America and of the Ontario Temporal Bone Bank is outlined.
The banking of femoral heads from patients who undergo total hip arthroplasty provides a valuable resource for orthopedic surgery. Quality assurance of the banked bone used in clinical procedures requires documented policies for screening, procuring, storing and distributing. Potential donors are screened at the time of donation for malignant disease, possible communicable disease, sepsis and high-risk life-styles. After negative culture results are confirmed and appropriate documentation has been completed, the bone is frozen at -70 degrees C. A quarantine period of 90 days follows. The donor is followed up 90 days or more postoperatively. At that time written consent is obtained for donation of the recovered tissue to the bone bank and for serology testing for human immunodeficiency virus (HIV-1) antibody, hepatitis B surface antigen (HBsAG), hepatitis B core antibody (HBcAb) and syphilis, and the donor is rescreened for contraindications. This protocol meets or exceeds all existing standards. The combination of obtaining consent and serology testing at 90 days streamlines the logistics of banking bone from surgical donors.
The use of deep freeze bank bone grafts in maxillofacial surgery is described. The prerequisites for establishing a bone bank and the selection of bone graft material and donors are discussed. The use of deep freeze graft material is possible in virtually any area of maxillofacial surgery. Thus, patients with minor defects can be spared the stress of autogenous bone removal. The potential risk of disease transmission is emphasized.
The National University of Singapore (NUS) Bone Bank was started in October 1988 and is the first such bank in Singapore. Two Revco Freezers were installed to store bones at -80 degrees C. The NUS Bone Bank Protocol follows the multi-centre protocol in USA with Massachusetts General Hospital as the Central Registry. It strictly follows the guidelines for banking of musculo-skeletal tissues set up by the American Association of Tissue Banks. Strict donor selection is practised including screening for Aids, hepatitis, syphilis and infection. It does not provide for storage of articular cartilage. Currently, procurement is obtained from living donors. Mainly femoral heads have been obtained (63 donors to date). One whole tibia, one whole fibula, one lower end of femur have also been procured. Bone allograft transplantation has been safely performed in 14 recipients--mainly spinal fusions (seven cases), Sub-talar joint fusion in children (three cases) and packing Giant Cell tumors (two cases). Other cases include revision hip surgery (one case) and augmenting of hypoplastic mandible (one case). The biggest problem faced by the NUS Bone Bank is lack of donors. There is definitely a need for bone allografts in Singapore where such transplantation is legal. Presently, there is also a demand for whole bones to bridge large bone defects resulting from tumour resection and for reconstructing post-traumatic defects. This can only be met if we can procure more whole bones especially from cadaveric donors.
The costs of a bone-bank working in accordance with the guidelines of the german federal chamber of physicians are described. Establishing a bone-bank storing deep-frozen bone is not very expensive. The main costs are due to laboratory costs for excluding HIV, hepatitis, syphilis and bacterial contamination of bone grafts. In our experience with 206 bone grafts about 20% of them are to be discharged because of positive laboratory tests. The costs of each bone graft are DM 327. A second HIV-Test of the donor 3 months after explantation of a bone graft will cause rising of costs up to 47%. About 20-30% of bone graft donors will probably not carry out this test. In this case discharging of the bone graft is necessary.
Heterologous bone grafting has increased considerably due to improved preservation and the development of bone banks. We analyzed the forensic aspects of organ procurement, transformation, processing and preservation specifically related to bone grafts. Topics considered included the organization of the responsible authorities and their activities in the context of ethical medical considerations. The surgeon is often faced with a complex heterogeneous situation without clear legal requirements.
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Lipid extraction by chloroform methanol previously has been found to increase the incorporation of frozen bone allografts. This effect may be because of a decreased immunologic response. In the present study, the ingrowth capacity into a grafted bone defect was investigated by using the bone harvest chamber model in rabbits. In a series of experiments, defatted and frozen allografts were compared at 1, 2, and 3 weeks; defatted allografts and defatted autografts were compared at 3 weeks; and frozen or defatted allografts and nongrafted defects were compared at 3 weeks. Evaluation was performed through histology, histomorphometry, and 99mTc-MDP scintimetry. The incorporation was better with defatted grafts: by histology at 1 week, mesenchymal tissue filled the intertrabecular space in defatted specimens and new bone formation started to occur. In contrast, frozen specimens showed a central soft tissue necrosis surrounded by inflammatory cells. Histomorphometry showed more new bone and more graft resorption in defatted allografts. At 2 and 3 weeks, there was no significant difference in new bone area, but at 3 weeks the scintimetric activity was higher in defatted allografts, probably caused by an increased remodeling rate. Since defatting did not cause increased scintimetric activity in previous autograft studies, these findings could indicate that there is a detrimental immunologic influence on frozen allografts. There were no differences between defatted autografts and allografts. In a second experiment, the biomechanical properties of defatted bone were investigated with a compression test on defatted and frozen bone cylinders taken from the calf femoral neck. No difference in biomechanical properties was found. It was concluded that lipid extraction produced a graft that was better incorporated than a nondefatted graft, with no loss of mechanical function.
In previous rabbit chamber experiments, lipid extraction has been shown to increase bank bone incorporation, as measured by scintimetric activity at 3 weeks. In the present study, the new bone ingrowth distance was measured by histomorphometry at 6 weeks using a titanium chamber model in rats. By insertion into bilateral bone conduction chambers, frozen grafts were compared with grafts that had been processed by lipid extraction. To evaluate the effects of lipid extraction further, the group of 26 rats was divided into three subgroups according to MHC haplotype, namely a heterogeneous group (outbred Sprague-Dawley rats), a mismatched group, and a syngeneic group. In the total material, defatted grafts showed a 58% greater new bone ingrowth distance and a 31% higher scintimetric activity over controls. The effect of defatting was not shown to be due to immunologic factors. In general, rats with a lower capacity to incorporate bone grafts showed a larger positive effect of defatting.
The increasing volume of orthopaedic reconstructive procedures requiring replacement of bone stock justifies the initiation of programs of bone banking in community hospitals. Provided that strict criteria are followed to assure rigorous screening of donor bone and the reliable preservation of bone graft material, community banking is safe and cost-effective. Banked allograft bone can be used successfully in a wide variety of orthopaedic procedures performed in community hospitals. In general, the best uses are filling bone cavities, buttressing, and augmenting the quantity of autograft bone. In revision reconstructive surgery of the hip, bank bone is used to replace bone stock in protrusio, acetabular dysplasia, and proximal femoral deficiency. The best and most common indication for the use of bank bone in tumor surgery is after curettage or excision of benign lesions. Allografts may be used to reconstruct bony defects after excision of malignant tumors and in the surgical treatment of metastatic disease. These instances require larger bone bank facilities than those commonly available in a community hospital setting. Medicolegal considerations related to bone banking and the use of allografts in community practice include the regulatory requirements outlined in the UAGA, questions concerning negligence liability, and theories of strict product liability. Overall, good medical practice and obtaining informed consents will minimize legal risks related to bone banking and transplantation in a community setting.