Establishing a bone bank within a hospital setting in India: early insights from a tertiary care center in Northern India-a review article.

When addressing bone defects resulting from trauma, infection, or tumors, the use of allogenic bone is often necessary. While autografts are considered the standard, they have limitations and can lead to donor site morbidity. Consequently, there has been exploration into the feasibility of utilizing allogenic bone and bone graft replacements. Allogenic bone transplants are acquired from donors following rigorous procurement, sterile processing, and donor screening procedures. To ensure the safe storage and effective utilization of allograft material, a bone banking system is employed. Establishing and managing an orthopedic bone bank, entails navigating complex legal and medical organizational aspects. This paper examines the establishment and operation of bone banks in India, drawing upon our first-hand experience in managing one at a tertiary care center in Northern India.Level of evidence: Level IV.

[Budget impact analysis of the implementation of a bone tissue bank in a Chilean health service]. / Análisis de impacto presupuestario de un banco de tejido óseo en un servicio de salud de Chile.

This research aimed to analyze the costs of bone grafting through a bone tissue bank in a Chilean regional health service. Methods: First, we developed a preliminary epidemiological study to obtain the necessary data for the analysis, specifically on bone graft procedures in a local health service (Servicio Salud Concepción). Next, we performed a budget impact analysis. Results: We analyzed a total of 6,252 cc of bone grafts, with a total cost of USD$156,000 per year. We found a potential recovering capacity of 302 ± 16 femoral heads per year from the total hip replacement procedures. Based on these results, bone tissue banks could save USD$145,000 hospital costs annually. Studying a representative health service from Chile, this analysis revealed a dependency on imported bone substitutes and autografts. These requirements can be supplied sustainably by a bone tissue bank based on donations of femoral heads under the current legislation of the Chilean health authority.

The quality assessment of the University hospital bone bank in Central Serbia: the second audit after fourteen years.

We analyzed the prevalence and predisposing factors for the overall rejection rate after retrieval of 267 fresh femoral head allografts over the past 7 years. The present study aimed to assess the quality system of institutional bone banking that can provide high-standard allografts with a low infection rate. Retrospective analysis of bone banking from June 2013 to December 2019 was conducted on 267 donors and 153 recipients. Of the 267 donated femoral heads, 74 were rejected, giving an overall rejection rate of 27.71%. The leading cause of allograft rejection was the inability to perform serology tests due to donor death; the absence of serological tests itself, and the donor refusal to perform the serology 6-month retest in 42 donors (15.72%). At retrieval, 12 allografts were positive, giving an overall contamination rate of 4.49%. Seven (2.62%) of the 267 allografts failed the blood screening tests. Thirteen allografts (4.86%) were discarded because of suspected damage to the packaging or disuse during surgery. An infection rate of 1.30% was found following transplantation. Over the past 7 years of bone banking, our results show that the overall rejection rate and the allograft-related infection rate correlate with international standards. The leading cause of allograft rejection was the inability to perform serology tests due to donor death and their refusal to perform the serology retests. Besides stringent aseptic allograft handling, donor motivation to participate in bone banking is extremely important for its efficient functioning.

Allograft bone banking experience in Pakistan.

To share our experience of establishing a bone bank in Pakistan, and the clinical use of these indigenously produced bone grafts. We retrospectively reviewed our experience of the procurement, processing, and storage of bone grafts at a bone bank in Karachi, Pakistan, the first bone bank to be established in a public sector hospital in Pakistan. The bone bank was established at Sindh Institute of Urology and Transplantation (SIUT), Karachi, in collaboration with Department of Orthopaedic Surgery, Dow University of Health Sciences/Civil Hospital, Karachi (CHK) in May, 2015. Since then, a large number of bone grafts from the tissue bank have been used for various orthopedic procedures. This paper describes the problems and challenges faced in establishing and running a tissue bank in a Muslim and a developing country and the progress of the bone bank over the first 4 years. A total of 93 bone grafts were retrieved and preserved in the bone bank over the 4-year period. Among these, 56 (60.2%) bones were retrieved from male donors and 37 (39.8%) from females. The mean age of all donors was 55.9 ± 15.34 years (range: 16-90 years). All bone donors were living patients. No c bones were obtained from deceased donors. Types of bone grafts included: femoral heads, 68; head with neck of femur, 19; radius and ulna, 1; lower femur, knee joint, lower leg and foot bones, 4; and skull bone, 1. All grafts were subjected to aerobic and anaerobic bacterial cultures, as well as fungal cultures. Microbiological contamination was observed in 18/93 (19.35%). All culture positive bones were discarded. Bone grafts issued from the bank and transplanted were 51/93 (54.8%) in all. Bone grafts were used in a variety of tumor and non-tumor orthopaedic procedures in CHK. Nine bone grafts were donated to the other hospitals to be used for revision total hip replacement and tumor surgeries. There were no service charges. Two patients (3.92%) developed infections postoperatively, one superficial and one deep. No other complications were noted. This is the preliminary report on the establishment and functioning of a bone bank in a public sector hospital in Pakistan. The favorable outcome has inculcated confidence in orthopedic surgeons for greater use of bone allografts for a variety of indications in this country.

Principles of bone and tissue banking in Saudi Arabia: 10-year experience report.

BACKGROUND: The role of bone and tissue banking is well known to meet the ever-growing need of bone and soft tissue allografts. Strict guidelines have been established to ensure high standard and minimize complications related to bone transplantation. METHODS: The Bone Bank in King Faisal Specialist Hospital and Research Centre (KFSH&RC), affiliated with the Saudi Council of Organ Transplantation, was inaugurated in 2010, and it has since been an integral part of the KFSH&RC organ retrieval team. The bank has a very strict regulations which were described. RESULTS: Between January 2010 and January 2020, there were 143 multi-organ donors (mean age: 36 years, range: 24-55 years). The total number of allografts used was 2191 which were utilized in 1047 patients. CONCLUSIONS: In this paper, we present our 10-year experience of administrative structure, donor and recipient testing protocols, allograft retrieval, processing procedures, and the internal audit safety arrangements. The utilization of allografts in various pathologies such as revision joint replacement, spine surgery, and tumor surgery is discussed with our results over a 10-year period.

The contamination of allografts in multi-organ donors: a bone bank experience.

As a consequence of the preference for homologous tissues, bone banks are the primary source of bone and tendon grafts. However, the bacterial, viral, and fungal contamination of these grafts remains a considerable challenge in bone banks and often results in high rates of graft discarding and infections in patients. This study intended to investigate bacterial contamination in 509 bone grafts harvested from 110 multiorgan donors. Specimen collection included bone and soft tissue retrieved from culture-swabbing as well as bone and capsule for histopathology. Microbiological, histopathological, and radiographic analyses were carried out. Secondary sterilization was also conducted using cobalt 60 at the dose of 2.5 × 104 Gy. There were 106 multi-organ donors. Of the 506 grafts, there were 54 Hemi pelvis, 191 femur, 142 tibia, and 119 fibulae. The surface swab contamination rate for all the grafts retrieved was 16.6%, and bone culture from all the grafts was 6.1%. When we looked at the incidence of contamination according to the location than the surface swab contamination rate for hemipelvis was 18 (33.3%), femur 30 (15.7%), tibia 21(14.7%) and fibula 15 (12.6%). The bone cultures were hemipelvis 12 (22.2%) femur 8 (4.1%), tibia 5 (3.5%) and fibula 6 (5.04%). These findings suggest that separate harvesting of the grafts in reverse order may help prevent contamination. The study also recommends discarding all grafts contaminated even with low pathogenicity organisms. However, bioburden needs to be further investigated to be detected and reduced.

Management of regional bone bank during declaration of a state of emergency concerning the COVID-19 in Japan.

Bone banks are necessary for providing biological allografts for a series of orthopedic procedures. As nations cope with new realities driven by the 2019 coronavirus disease (COVID-19) pandemic, health-care providers, institutions, and patients share a particular concern about the effect of COVID-19 on organ donation and transplantation. Here, we describe the management of the Kitasato University Bone Bank during the state of emergency declared in response to COVID-19. Living donors received pre-operative screening by PCR, and allograft bone from COVID-19-negative donors was cryopreserved as transplantable tissues. The weekly rate of infection gradually increased from February 2-9 to April 5-11 in the dead donor-derived allograft bone-harvesting region covered by the Bank. It is becoming clear that the virus can be transmitted by asymptomatic patients, and that this route may have facilitated the spread of COVID-19. Therefore, the Bank stopped dead donor donation to consider the safety of medical staff. Three recipients received bone allografts following pre-operative COVID-19 screening by PCR. All patients were asymptomatic after bone allograft. Our experience may provide helpful information for the management of tissue banks.

ESTABLISHMENT OF THE BONE TISSUE BANK AT MOSTAR UNIVERSITY CLINICAL HOSPITAL.

Bone tissue banks are necessary for collection, production, testing, packaging, storage and delivery of bone transplants. Bone tissue bank is a link between the donor and the recipient by which the donation becomes a medium of health improvement for both the donor and the recipient. At the Department of Orthopedics, Mostar University Clinical Hospital, about 200 total hip replacements are performed per year. Most patients undergoing total hip replacement surgery (90%) have been diagnosed with osteoarthritis, and they are suitable donors, having in mind their age and comorbidities. In the same Department, around 50 procedures that require bone transplants are performed per year. A team of highly competent surgeons are working on an intensive process of adaptation oriented to quality improvement and intensification of the activity, both with the goal of meeting the standards of excellence in orthopedic surgery. The presence of a bone tissue bank has a favorable impact on the quality of health care owing to bone transplant availability, as well as on the scientific role of a highly specialized institution that examines the properties of bone tissue.

[Allogeneic bone transplantation in hip revision surgery : Indications and potential for reconstruction]. / Allogene Knochentransplantation in der Hüftrevisionsendoprothetik : Indikationen und Rekonstruktionsmöglichkeiten.

The increasing number of people having joint replacements will lead to increasing numbers of revision operations. The transplantation of allogeneic bones might reconstruct bone defects and improve long-term anchorage of the implant. A sufficient primary stability of the implanted construct is necessary to achieve osseous incorporation as well as tight contact between the implanted allogeneic and host bones. Transplantation of bone can contribute to downgrading acetabular defects and so avoid bigger reinforcement implants. An improvement of bone stock due to reconstruction of femoral bony defects might also reduce the size of the stem necessary since the indication might be limited in case of extensive bone defects. According to good longterm results of modular revision stems the Impaction-Bone-Grafting has not yet generally been established.

[Bone banks : The state-of-the-art]. / Knochenbanken : State-of-the-Art.

Bone banks are responsible for the collection, production, testing, packaging, storage and delivery of osseous grafts. In compliance with legal and quality requirements, it is their main task to ensure the biological properties and the microbiological safety of the transplants as well. German legal requirements for bone banking are explained and current standards with respect to donor selection, laboratory tests and tissue processing, as well as labeling are discussed. Production and preparation procedures should include a validated microbiological inactivation method that largely preserves the biological properties of the tissue.

Effect of bone bank processing on bone mineral density, histomorphometry & biomechanical strength of retrieved femoral head.

BACKGROUND & OBJECTIVES: Standard processing of the bone grafts involves deep-freezing and sterilization with gamma irradiation which may alter mechanical properties of the bone graft. This study was aimed at measuring the effect of bone bank processing on the mechanical properties of bone allograft and its correlation with bone mineral density [BMD, dual-energy X-ray absorptiometry (DEXA Scan)] and histomorphometric indices. METHODS: Femoral heads retrieved from patients undergoing hip replacement surgeries were used as the material. Twenty femoral heads were under taken in the study. Each femoral head was cut into two equal cubes. One cube was subjected to BMD measurement using DEXA Scan followed by unilateral compression test. Histomorphometric indices such as trabecular number (Tb. N.), trabecular separation (Tb. S.), trabecular thickness (Tb. T.) and bone volume (B.V.) were calculated on the same specimen by a computer software. The other cube was kept in deep freezer (-76°C) for a minimum of three weeks, followed by gamma irradiation and subjected to similar tests. RESULTS: Results were compared in pre- and post-processed bone specimens. A significant loss of biomechanical strength (P<0.001) with mean a loss of 18.90 per cent was found in post-processed samples in uniaxial compression tests. Similarly, BMD (mean decrease by 13.8%, P<0.01) and histomorphometric indices such as Tb. T. (mean decrease by 12.37%, P<0.01), Tb. S. (mean increase by 12.60%, P<0.001) and B.V. (mean decrease by 20.84%, P<0.01) were found. However, Tb. N. was not significantly affected. INTERPRETATION & CONCLUSIONS: The current method of processing of bone allografts i.e. deep-freezing and gamma irradiation appeared to cause a significant reduction in the biomechanical strength of allogenic bone which was more suitable to be use in the morselized form. Appropriate consideration for decreased strength needs to be given when using allogenic bone graft as a structural graft.

Automatic allograft bone selection through band registration and its application to distal femur.

Clinical reports suggest that large bone defects could be effectively restored by allograft bone transplantation, where allograft bone selection acts an important role. Besides, there is a huge demand for developing the automatic allograft bone selection methods, as the automatic methods could greatly improve the management efficiency of the large bone banks. Although several automatic methods have been presented to select the most suitable allograft bone from the massive allograft bone bank, these methods still suffer from inaccuracy. In this paper, we propose an effective allograft bone selection method without using the contralateral bones. Firstly, the allograft bone is globally aligned to the recipient bone by surface registration. Then, the global alignment is further refined through band registration. The band, defined as the recipient points within the lifted and lowered cutting planes, could involve more local structure of the defected segment. Therefore, our method could achieve robust alignment and high registration accuracy of the allograft and recipient. Moreover, the existing contour method and surface method could be unified into one framework under our method by adjusting the lift and lower distances of the cutting planes. Finally, our method has been validated on the database of distal femurs. The experimental results indicate that our method outperforms the surface method and contour method.

[Improve the Rate of Bone Collection at Human Tissue Banks].

BACKGROUND: Lack of familiarity with collection and inspection procedures, incorrect bone-packaging procedures, and unclear instructions for bone placement during storage are primary reasons for the resultant low bone collection pass rate of bone banks. Moreover, 8 cases / operations were directly affected by this problem, which caused bone-nail dislocations during the post-operative period that nearly caused medical disputes. PURPOSE: The present project was designed to improve the pass rate of the bone of the human organ to 95%. METHODS: Education and training programs were planned, visual-aid posters depicting standard procedures were produced, the repository was remarked and relabeled, and a regular audit system was established with the medical team. RESULTS: The pass rate for the collection of the bone of the human organ increased from 71.4% pre-intervention to 96% post-intervention. CONCLUSIONS: The project reduced patient complaints and raised the accuracy of the bone collection process.

Allograft selection for distal femur through cutting contour registration.

Allograft reconstruction is an acceptable procedure for the recovery of normal anatomy after the bone tumor resection. During the past few years, several automated methods have been proposed to select the best anatomically matching allograft from the virtual donor bone bank. The surface-based automated method uses the contralateral healthy bone to obtain the normal surface shape of the diseased bone, which could achieve good matching of the defect and the selected allograft. However, the surface-based method focuses on the matching of the whole bone so that the matching of the contact surface between the allograft and the recipient bone may not be optimal. To deal with the above problem, we propose a cutting contour based method for the allograft selection. Cutting contour from the recipient bone could reflect the structural information of the defect and is seldom influenced by tumor. Thus the cutting contour can be used as the matching template to find the optimal alignment of the recipient bone and the allograft. The proposed method is validated using the data of distal femurs where bone transplantation is commonly performed. Experimental results show that the proposed method generally outperforms the surface-based method within modest extra time. Overall, our contour-based method is an effective complementary technique for allograft selection in the virtual bone bank.

Improving efficiency of a regional stand alone bone bank.

The introduction of a stand-alone Bone Bank in our Regional Orthopaedic Hospital has improved the availability of femoral head allograft. Benninger et al. (Bone Joint J 96-B:1307-1311, 2014), demonstrated their institutions bank to be cost effective despite a 30 % discard rate for harvested allograft. We sought to audit our own discard rates and subsequent cost-effectiveness of our bone bank. Donor recruitment. Before approaching a potential donor, our establishment's nurse specialists review their clinical notes and biochemical laboratory results, available on a regional Electronic Care Records. They view femoral head architecture on radiographs against set criteria, Patient Archive and Communication system (SECTRA, Sweden). In total 1383 femoral heads were harvested, 247 were discarded giving an overall rate of 17.9 %. The most common reasons for discard of harvested graft was a positive microbiology/bacteriology result, n = 96 (38.9 %). After a rise in discard rates in 2007, we have steadily reduced our discard rates since 2006/2007 (28.2 %), 2008/2009 (17 %), 2010/2011 (14.8 %), and finally to 10.3 % in 2012/2013. In the current financial year, our cost to harvest, test, store and release a femoral head is £ 610. With a structured donor recruitment process and unique pre-operative radiographic analysis we have successfully reduced our discard rates bi-annually making our bone bank increasingly cost-effective.

Post-operative infection with fresh frozen allograft: reported outcomes of a hospital-based bone bank over 14 years.

Femoral head bone allografts have traditionally been used to provide mechanical stability to areas of bony deficiency, or for its osteoinductive and osteoconductive properties. Concerns have been raised over increased infection rates following the use of fresh-frozen graft tissue. This retrospective study aims to investigate the outcomes of fresh frozen femoral heads kept in a regulated, non-commercial bone bank at a university teaching hospital.The local bone bank database was used to identify released femoral heads during a 14 year study period (September 1999-December 2013) whereby a retrospective review of patient records was undertaken to determine clinical outcome. During the observed study period, 427 femoral heads were released from cold storage. Of these, 270 femoral heads had a mean follow-up of 347 days. 157 femoral heads were excluded due to insufficient follow-up data (n = 132) or discarded due to breaks in the cold chain prior to use (n = 25). Of the 270 included femoral heads, 231 (85.6 %) had no reported complications with good graft incorporation. In the remaining 39 with reported complications, only 5 (2.6 %) developed a postoperative infection. Our findings suggest that the use of fresh frozen allograft does not materially increase the risk of post-operative bacterial infection. Our reported post-operative infection rates are comparable with infection rates of other similar studies on fresh frozen allograft use.

Bone transplantation and tissue engineering, part III: allografts, bone grafting and bone banking in the twentieth century.

During the 20th century, allograft implantation waned in popularity as a clinical activity. Reports appeared in the literature describing several small series of patients in whom bone was obtained from amputation specimens or recently deceased individuals. The concept of bone banking became a reality during and after World War II when the National Naval Tissue Bank was established in Bethesda and a number of small banks sprang up in hospitals throughout the world. Small fragments, either of cortical or medullary bone, from these banks were used heterotopically to augment spinal fusions, to implant into cyst cavities, or to serve as a scaffolding for repair of non- or delayed union of fractures of the long bones.

A retrospective study on annual evaluation of radiation processing for frozen bone allografts complying to quality system requirements.

Bone allografts have been used widely to fill up essential void in orthopaedic surgeries. The benefit of using allografts to replace and reconstruct musculoskeletal injuries, fractures or disease has obtained overwhelming acceptance from orthopaedic surgeons worldwide. However, bacterial infection and disease transmission through bone allograft transplantation have always been a significant issue. Sterilization by radiation is an effective method to eliminate unwanted microorganisms thus assist in preventing life threatening allograft associated infections. Femoral heads procured from living donors and long bones (femur and tibia) procured from cadaveric donors were sterilized at 25 kGy in compliance with international standard ISO 11137. According to quality requirements, all records of bone banking were evaluated annually. This retrospective study was carried out on annual evaluation of radiation records from 1998 until 2012. The minimum doses absorbed by the bones were ranging from 25.3 to 38.2 kGy while the absorbed maximum doses were from 25.4 to 42.3 kGy. All the bones supplied by our UMMC Bone Bank were sterile at the required minimum dose of 25 kGy. Our analysis on dose variation showed that the dose uniformity ratios in 37 irradiated boxes of 31 radiation batches were in the range of 1.003-1.251, which indicated the doses were well distributed.

Living donor bone banking: processing and discarding--from procurement to therapeutic use.

Skeletal muscle and osteoarticular tissue banks are responsible to procure, process, store and distribute tissues, from living and cadaveric donors. The procedures involve the application of protocols covering all aspects of the banking, ensuring the best tissue quality and maximum safety for the recipient. An analysis on the causes of bone tissue discarded by Biotar Tissue Bank between January 2005 and December 2012 was carried. Bone tissue was obtained from both hip and knee replacement (femoral heads and tibial plateau respectively) in living donors treated at different medical-surgical institutions in Argentina. These tissues were processed at the Bank to produce both frozen and lyophilized cancellous bone. Out of 3413 donated bones received by the Bank, 77.55 % resulted in final product, while the remaining 22.44 % was discarded in compliance with the quality standards of both the Bank and the regulatory authority. Comparing the last and the first year of the studied period, the number of discarded tissue increased 3.6 times, while the number of collected bones was approximately 10 times higher. Related to total disposed tissue, reactive serology was the most frequent cause (62.14 %), followed by inappropriate collection/storage of blood sample (30.81 %). A progressive reduction in the percentages of total discard was observed, and this was proportional to inappropriate collection/storage of blood sample. No significant differences were found in the discard rates due to positive serology throughout all the years studied. The success of a tissue bank requires full commitment of all the personnel especially the team members responsible for donor selection and the processing of allografts. It is important to critically screen donors in the early stages of donor recruitment. All of the procedures carried out by the tissue bank are parts of the quality control system which must be strictly carried out. Biotar Tissue Bank is continuously committed to ensure safety to the recipients.

Three-dimensional virtual bone bank system for selecting massive bone allograft in orthopaedic oncology.

PURPOSE: Although structural bone allografts have been used for years to treat large defects caused by tumour or trauma, selecting the most appropriate allograft is still challenging. The objectives of this study were to: (1) describe the establishment of a visual bone bank system and workflow of allograft selection, and (2) show mid-term follow-up results of patients after allograft implantation. METHODS: Allografts were scanned and stored in Digital Imaging and Communications in Medicine (DICOM) files. Then, image segmentation was conducted and 3D model reconstructed to establish a visual bone bank system. Based on the volume registration method, allografts were selected after a careful matching process. From November 2010 to June 2013, with the help of the Computer-assisted Orthopaedic Surgery (CAOS) navigation system, the allografts were implanted in 14 patients to fill defects after tumour resection. RESULTS: By combining the virtual bone bank and CAOS, selection time was reduced and matching accuracy was increased. After 27.5 months of follow-up, the mean Musculoskeletal Tumor Society (MSTS) 93 functional score was 25.7 ± 1.1 points. Except for two patients with pulmonary metastases, 12 patents were alive without evidence of disease at the time this report was written. CONCLUSIONS: The virtual bone bank system was helpful for allograft selection, tumour excision and bone reconstruction, thereby improving the safety and effectiveness of limb-salvage surgery.