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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., (© 2024. The Author(s), under exclusive licence to Springer Nature B.V.)

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., (© 2021. The Author(s), under exclusive licence to Springer Nature B.V.)

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., (© 2021. The Author(s), under exclusive licence to Springer Nature B.V.)

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., (© 2021. The Author(s), under exclusive licence to Springer Nature B.V. part of Springer Nature.)

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 × 10 4  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., (© 2021. The Author(s), under exclusive licence to Springer Nature B.V. part of Springer Nature.)

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.

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.

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.

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.

The objective of this study is to determine whether a residual moisture analyzer (RMA) can be an acceptable instrument for measuring the residual moisture in lyophilized demineralized bone matrix (DBM). Instruments from two different manufacturers with differing configurations and controls were compared: the Ohaus MB45 and Arizona Instrument MAX4000XL. The effects of various factors such as test temperature, drying profile, end point criteria, lift compensation, chamber configuration, and rehydration on residual moisture (RM) are examined. The performance of the RMAs is based on their ability to reproduce RM results obtained by the current standard gravimetric method. RMAs provide reliable, accurate and reproducible results in a number of industries that rely on the determination of RM. We hypothesize that RMAs are suitable for measuring RM in DBM and provide validation study data with optimized settings for these two instruments. Potentially, such studies will provide justification for allowance of this methodology as an acceptable alternative to the current gravimetric method allowed by American Association of Tissue Banks Standards.

Osteoarticular allograft is one possible treatment in wide surgical resections with large defects. Performing best osteoarticular allograft selection is of great relevance for optimal exploitation of the bone databank, good surgery outcome and patient's recovery. Current approaches are, however, very time consuming hindering these points in practice. We present a validation study of a software able to perform automatic bone measurements used to automatically assess the distal femur sizes across a databank. 170 distal femur surfaces were reconstructed from CT data and measured manually using a size measure protocol taking into account the transepicondyler distance (A), anterior-posterior distance in medial condyle (B) and anterior-posterior distance in lateral condyle (C). Intra- and inter-observer studies were conducted and regarded as ground truth measurements. Manual and automatic measures were compared. For the automatic measurements, the correlation coefficients between observer one and automatic method, were of 0.99 for A measure and 0.96 for B and C measures. The average time needed to perform the measurements was of 16 h for both manual measurements, and of 3 min for the automatic method. Results demonstrate the high reliability and, most importantly, high repeatability of the proposed approach, and considerable speed-up on the planning.

Bone allografts are a useful and sometimes indispensable tool for the surgeon to repair bone defects. Microbial contamination is a major reason for discarding allografts from bone banks. To improve the number of safe allografts, we suggest chemical cleaning of the grafts followed by antibiotic impregnation. Comparison of two chemical cleaning processes for bone allografts aiming for antibiotic impregnation and consequently delivery rates in vitro. Bone chips of 5-10 mm were prepared from human femoral heads. Two cleaning methods (cleaning A and cleaning B) based on solutions containing hydrogen peroxide, paracetic acid, ethanol and biological detergent were carried out and compared. After the cleaning processes, the bone chips were impregnated with gentamicin. Bacillus subtilis bioassay was used to determine the gentamicin release after intervals of 1-7 days. Differences were compared with non-parametric Mann-Whitney U tests. The zones of inhibition obtained from the bone grafts cleaned with both cleaning processes were similar between the groups. The concentration of the released antibiotic was decreasing gradually over time, following a similar pattern for both groups. The cleaning procedure A as well as the cleaning procedure B for bone allografts allowed the impregnation with gentamicin powder in the same concentrations in both groups. The delivery of gentamicin was similar for both groups. Both cleaning procedures were easy to be carried out, making them suitable for routine use at the bone banks.

The aim of the current study is to evaluate fresh-frozen human bone allografts (FHBAs) used in vertical ridge augmentation clinically and by computed tomography, and to analyze the resulting bone formation and graft resorption. Sixteen FHBAs were grafted in the maxillae and mandibles of 9 patients. The FHBAs, which were provided by the Musculoskeletal Tissue Bank of Marilia Hospital (Unioss), were frozen at -80°C. After 7 months, dental implants were placed and bone parameters were evaluated. Vertical bone formation was measured by computerized tomography before (T0) and at 7 months (T1) after the surgical procedure. Bone graft resorption was measured clinically from a landmark screw head using a periodontal probe. The results were analyzed by Student's t-test. Significant differences existed in the bone formation values at T0 and T1, with an average change of 4.03 ± 1.69 mm. Bone graft resorption values were 1.0 ± 0.82 mm (20%). Implants were placed with varying insertion torque values (35-45 Ncm), and achieved primary stability. This study demonstrates that FHBAs promote satisfactory vertical bone formation with a low resorption rates, good density, and primary implant stability.

In the advent of the EU guidelines 2004/23/EG and 2006/17/EG requiring extensive safety and quality steps in bone banking, the prevalence and risk of infection disease transmission from bone allograft needs to be reconsidered. Therefore, we prospectively reviewed the screening process of bone donations and the outcome of surgeries utilizing bone allografts from our internal hospital bone bank with regard to infections according to CDC criteria. One-hundred and eighty-eight allogenic bone transplantation procedures in 160 patients were followed-up for 12-64 months (mean 32 months). Bacterial infection occurred in 11 patients, the overall infection rate therefore was 6.9%. After review of the clinical and intraoperative findings, none of the infections were likely to have been caused by the bone graft. Although no follow-up serologic testing was performed, no HIV of hepatitis infections were observed. Frozen bone allografts derived from live donors and provided by hospitals can generally be considered safe. However, without new and relevant clinical expertise, continuing this technique will be impeded by the new EU guidelines and their national implementations.

Musculo-skeletal allografts sterilized and deep frozen are among the most common human tissue to be preserved and utilized in modern medicine. The effects of a long deep freezing period on cortical bone has already been evaluated and found to be insignificant. However, there are no reports about the influences of a protracted deep freezing period on osteochondral allografts. One hundred osteochondral cylinders were taken from a fresh specimen and humeral heads of 1 year, 2 years, 3 years and 4 year old bones. Twenty chips from each period, with a minimum of 3 chips per humeral head. Each was mechanically tested by 3 point compression. The fresh osteochondral allografts were significantly mechanically better than the deep frozen osteochondral allografts. There was no statistical significant time dependent difference between the deep frozen groups in relation to the freezing period. Therefore, we conclude that, from the mechanical point of view deep freezing of osteochondral allografts over a period of 4 years, is safe without further deterioration of the biomechanical properties of the osteochondral allografts.

Background: ISO 11137-2006 (ISO 11137-2a 2006) provides a VDmax 15 method for substantiation of 15 kGy as radiation sterilisation dose (RSD) for health care products with a relatively low sample requirement. Moreover, the method is also valid for products in which the bioburden level is less than or equal to 1.5. In the literature, the bioburden level of processed bone allografts is extremely low. Similarly, the Queensland Bone Bank (QBB) usually recovers no viable organisms from processed bone allografts. Because bone allografts are treated as a type of health care product, the aim of this research was to substantiate 15 kGy as a RSD for frozen bone allografts at the QBB using method VDmax 15-ISO 11137-2: 2006 (ISO 11137-2e, Procedure for method VDmax 15 for multiple production batches. Sterilisation of health care products - radiation - part 2: establishing the sterilisation dose, 2006; ISO 11137-2f, Procedure for method VDmax 15 for a single production batch. Sterilisation of health care products - radiation - part 2: establishing the sterilisation dose, 2006)., Materials: 30 femoral heads, 40 milled bone allografts and 40 structural bone allografts manufactured according to QBB standard operating procedures were used., Method: Estimated bioburdens for each bone allograft group were used to calculate the verification doses. Next, 10 samples per group were irradiated at the verification dose, sterility was tested and the number of positive tests of sterility recorded. If the number of positive samples was no more than 1, from the 10 tests carried out in each group, the verification was accepted and 15 kGy was substantiated as RSD for those bone allografts., Results: The bioburdens in all three groups were 0, and therefore the verification doses were 0 kGy. Sterility tests of femoral heads and milled bones were all negative (no contamination), and there was one positive test of sterility in the structural bone allograft. Accordingly, the verification was accepted., Conclusion: Using the ISO validated protocol, VDmax 15, 15 kGy was substantiated as RSD for frozen bone allografts manufactured at the QBB.

The use of massive bone allografts is increasing year by year and selection method remains unchanged. Superposition of patient's radiograph over allograft image and comparison of distances is the gold standard. Experiment was led to test selection procedure of a major european tissue bank. Four observers were asked to select an allograft for 10 fictive recipients. Nine allografts were provided. To simulate a perfect allograft, recipient himself was inserted in the pool of allografts (trap graft). The 10 potential bone transplants were classified in four categories (from adequate to unacceptable). In addition, observers were asked to choose the three best grafts for a given recipient. Quadratic kappa measuring agreement on classification between two observers ranged between 0.74 (substantial) and 0.47 (moderate). Trap graft was quoted by observers as adequate four times (10%) and was cited eight times (20%) among the three best matching allografts. None of the observers discovered that recipient was among allograft panel. This study demonstrates that current selection method is inaccurate for hemipelvic allograft selection. New methods should be developed and tested to assist tissue banks in bone allograft selection.

National Blood Service (NBS) Tissue Services (TS) operates living donor and deceased donor tissue banking programmes. The living bone donor programme operates in collaboration with 91 orthopaedic departments across the country and collects bone donations, in the form of surgically removed femoral heads (FHs), from over 5,000 patients per annum undergoing total hip replacement. Bone donated via the living programme constitutes approximately 55% of the total bone donated to NBS. Non-NBS tissue banks, primarily in hospital orthopaedic departments, also bank donated bone for the UK. A survey of information received from 16 collaborating orthopaedic centres, between April 2003 and August 2004, identified 709 excluded donors. The total number of donations banked from these sites was 1,538. Donations can be excluded before collection if there are contraindications noted in a potential donor's medical history before their operation. Donors may also be excluded after collection of the FH, for instance because of reactive microbiology tests for blood borne viruses, or if the donation storage conditions or related documentation have not met stringent quality requirements. In this survey, bone or joint conditions were the major reasons for excluding potential donors before donation (154 of 709 exclusions, 22%), followed by a current or a past history of malignancy (139 of 709 exclusions, 20%). Local staffing and operational difficulties sometimes resulted in potential donors being missed, or specific reasons for exclusion not being reported (117 exclusions). These out numbered exclusions due to patient refusal (80 exclusions). A small number (< 5) appear to have been excluded erroneously. There was considerable local variation in the reasons given for exclusion and certainly under-reporting. A survey of donations discarded after collection in the same period highlighted that 43% were donor related; 110 of 370 did not provide a follow-up blood sample. More than 30% were due to delays in forwarding blood samples to the microbiological laboratory for testing, resulting in deterioration of the sample quality. Training to ensure that standards are complied with and a firm evidence base for exclusion criteria, applied uniformly, will help focus donor identification efforts on individuals meeting rational criteria so that fewer potential donations are lost.