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Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXIII | Pages 125 - 125
1 May 2012
Nguyen H Gineyts E Wu A Cassady A Bennett M Morgan D Delmas P Forwood M
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It is not known if the radiation sterilisation dose (RSD) of 25 kGy affects mechanical properties and biocompability of allograft bone by alteration of collagen triple helix or cross-links. Our aim was to investigate the mechanical and biological performance, cross-links and degraded collagen content of irradiated bone allografts. Human femoral shafts were sectioned into cortical bone beams (40 × 4 × 2 mm) and irradiated at 0, 5, 10, 15, 20, and 25 kGy for three-point bending tests. Corresponding cortical bone slices were used for in vitro determination of macrophage activation, osteoblast proliferation and attachment, and osteoclast formation and fusion. Subsequently, irradiated cortical bone samples were hydrolised for determination of pyridinoline (PYD), deoxypyridinoline (DPD), and pentosidine (PEN) by high performance liquid chromatography (HPLC) and collagen degradation by the alpha chymotrypsin (ï. j. CT) method. Irradiation up to 25 kGy did not affect the elastic properties of cortical bone, but the modulus of toughness was decreased from 87% to 74% of controls when the gamma dose increased from 15 to 25 kGy. Macrophages activation, the proliferation and attachment of osteoblasts on irradiated bone was not affected. Osteoclast formation and fusion were less than 40% of controls when cultured on bone irradiated at 25 kGy, and 80% at 15 kGy. Increasing radiation dose did not significantly alter the content of PYR, DPD or PEN but increased the content of denatured collagen. Cortical allografts fragility increases at doses above 15 kGy. Decreased osteoclast viability at these doses suggests a reduction in the capacity for bone remodelling. These changes were not correlated with alterations in collagen cross-links but in degradation to the collagen secondary structure as evidenced by increased content of denatured collagen


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_17 | Pages 45 - 45
24 Nov 2023
Dendoncker K Putzeys G Cornu O Nieuwenhuizen T Bertrand M Valster H Croes K
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Aim

Local antibiotics released through a carrier is a commonly used technique to prevent infection in orthopaedic procedures. An interesting carrier in aseptic bone reconstructive surgery are bone chips impregnated with AB solution. Systemically administered Cefazolin (CFZ) is used for surgical site infection prophylaxis however in vitro study showed that fresh frozen and processed bone chips impregnated with CFZ solution completely release the CFZ within a few hours. On the other hand irradiated freeze-dried bone chips, treated with supercritical CO2 (scCO2) have been shown to be an efficient carrier for the antibiotics vancomycine or tobramycine.

With this pilot study we wanted to investigate if CFZ solution impregnation of bone chips treated with scCO2 shows a more favorable release pattern of CFZ.

Method

The bone chips were prepared using the standard scCO2 protocol and were impregnated with 100 mg/ml cefazolin at different timepoints during the process: before freeze drying (BC type A), after freeze drying (BC type B) and after gamma-irradiation. 0.5g of the impregnated bone grafts were incubated with 5ml of fetal calf serum (FCS) at 37°C. At 2, 4, 6, 8 and 24h of incubation 200µl of eluate was taken for analysis. After 24h the remaining FCS was removed, bone grafts were washed and new FCS (5ml) was added. Consecutive eluate samples were taken at 48, 72 and 96h of incubation.

The concentration of CFZ in the eluates was measured with the validated UPLC-DAD method. Analysis was performed in triplicate.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 23 - 23
1 Feb 2020
Yasuda S Weiqi S Sugino T Keita U Tomita N
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Introduction

Aseptic loosening is a major cause of revision of total joint arthroplasty (TJA). Although crosslinked Ultra-high molecular weight polyethylene (UHMWPE) have improved wear resistance, residual radicals remaining in the material have a possibility to increase bio-reactivity of particles [2]. In this study, we attempt to evaluate the effects of irradiation and residual radicals on bio-reactivity of the material with a new method called the inverse culture method [1].

Material and methods

UHMWPE particles (10µm diameter in average, Mitsui chemicals Co., LTD) along with irradiated particles (RAD, 300kGy electron irradiation) and particles annealed after the irradiation (RAD+ANN, 100°C 72 hours) are co-incubated with mouse macrophage cell line RAW264 using the inverse culture method. The amount of TNF-α was measured with ELISA.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXIII | Pages 211 - 211
1 May 2012
Stalley P
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Extracorporeal irradiation of resected bone segments has been used for pelvic reconstruction for 12 years in our unit. The technique allows for a perfect fit, preservation of muscle attachments, and thus, facilitating reconstruction, more rapid osteotomy of autograft bone, low cost, and a low infection rate.

Of particular interest is its use in children; revascularisation appears more complete with irradiated autograft, as compared to allograft. There is sparing of adjacent growth plates if the irradiation is given outside the body, whereas external beam radiation would destroy the proximal femoral growth plate—leading to significant leg length discrepancy.

Avoiding external beam irradiation also removes any risk of late radiation induced sarcoma and removes the late effects of soft tissue fibrosis due to external beam irradiation.

Twenty-seven pelvic reconstructions have been done over a 12-year period, with three failures due to infection and seven due to further disease. Four of these have been for de-differentiated chondrosarcoma of the pelvis, where local recurrence led to failure. In the presence of de-differentiated pelvic chondrosarcoma, we do not recommend this form of reconstruction.

Long term functional outcome scores for the first 50 cases completed between August 1996 and June 2003 gave a TESS score of 82% and MSTS score of 78%. This is more than comparable to published series using other forms of reconstruction.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 469 - 469
1 Dec 2013
Muratoglu O Oral E Neils A Doshi B
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Introduction:

Irradiated ultra-high molecular weight polyethylene (UHMWPE), used in the fabrication of joint implants, has increased wear resistance [1]. But, increased crosslinking decreases the mechanical strength of the polymer [2], thus limiting the crosslinking to the surface is desirable. Here, we usedelectron beam irradiation with low energy electrons to limit the penetration of the radiation exposure and achieve surface cross-linking.

Methods:

Medical grade 0.1 wt% vitamin E blended UHMWPE (GUR1050) was consolidated and irradiated using an electron beam at 0.8 and 3 MeV to 150 kGy. Fourier Transform Infrared Spectroscopy (FTIR) was used from the surface along the depth at an average of 32 scans and a resolution of 4 cm−1. A transvinylene index (TVI) was calculated by normalizing the absorbance at 965 cm−1 (950–980 cm−1) against 1895 cm−1 (1850–1985 cm−1). TVI in irradiated UHMWPE is linearly correlated with the radiation received [3]. Vitamin E indices were calculated as the ratio of the area under 1265 cm−1 (1245–1275 cm−1) normalized by the same. Pin-on-disc (POD) wear testing was conducted on cylindrical pins (9 mm dia., 13 mm length, n = 3) as previously described at 2 Hz [4] for 1.2 million cycles (MC). Wear rate was measured as the linear regression of gravimetric weight change vs. number of cycles from 0.5 to 1.2 MC. Double notched IZOD impact testing was performed (63.5 × 12.7 × 6.35 mm) in accordance with ASTM F648. Cubes (1 cm) from 0.1 wt% blended and 150 kGy irradiated pucks (0.8 MeV) were soaked in vitamin E at 110°C for 1 hour followed by homogenization at 130°C for 48 hours.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 586 - 586
1 Dec 2013
Whitaker D Liao Y Nakamura T Hardaker C
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Introduction:

Moderately crosslinked polyethylene maintains a balance of wear resistance and mechanical properties. The GVF poly was manufactured from GUR1020 UHMWPE bars, sealed in vacuumed foil package, and gamma sterilized at 4 Mrads. The MARATHON® polyethylene inserts were manufactured from GUR1050 UHMWPE bars, crosslinked by gamma irradiation at 5 Mrad, and followed by a remelting process that eliminates free radicals. The final sterilization method is gas plasma (GP) or ethylene oxide (EtO). Both methods will not introduce free radicals. Previous studies have shown MARATHON polyethylene (GP sterilized) with 83% lower wear than conventional polyethylene in a simulation test [1], compared to a 10-year clinical study that showed 77% wear reduction [2]. There is no study to compare the wear performance of MARATHON (EtO sterilized) and conventional poly.

Materials and Methods:

Four groups of polyethylene inserts (Table 1) were paired with matching femoral heads that were manufactured from CoCrMo (ASTM F1537) with diameters of 28, 32, and 36 mm. The inserts were chosen to have similar thickness at the dome for MARATHON, while for GVF it was the largest head size available.

Wear testing was performed on an AMTI Hip Simulator per the ISO 14242-1 standard [3] at 1 Hz using the described inputs (Table 2), which provide a larger range of motion than the ISO standard. The cups were mounted in accordance with ISO 14242-1 using custom fixturing and secured with cement while the femoral heads were mounted on a vertical taper support. Testing was performed in 25% bovine calf serum at 37 ± 2°C. Wear of the inserts was determined gravimetrically. Finally, wear rates were calculated by linear regression and then compared between the groups using ANOVA analysis (α = 0.05).


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 316 - 316
1 Mar 2013
Russell N Rives A Bruce W Pelletier M Walsh W
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Introduction. Gamma Irradiation is often considered the gold standard for sterilizing bone allograft. However, a dose dependant decrease in the static mechanical properties of gamma irradiated bone has been well established. Supercritical Fluid Sterilization (SCF) using carbon dioxide represents a potential alternate method to sterilize allografts. This study aimed to evaluate the effect of SCF on the static and dynamic (fatigue) properties of cortical bone in 3-point bending. Methods. Eighty paired 18-month old rabbit humeri were randomized to 4 treatments: Gamma Irradiation at 10 kGy or 25 kGy, SCF Control and SCF with Peracetic Acid (Figure 1) (n=20 pairs per group). One side was treated while the other acted as a control. Ten pairs in each group were tested statically at 5 mm/min; while ten were tested dynamically between 15–150 N at 4 Hz. Samples were fatigued to failure or 50000 cycles (run-out). All testing was performed at room temperature in a saline bath. A 2-tailed t-test was used to test for significance within pairs and a one-way ANOVA with Games-Howell post-hoc test was used to test between groups. Results. There was a dose dependant decrease in both maximum load and energy to failure observed in the Gamma irradiated treatment groups in static 3 point bending (Figure 2). A dose of 10 kGy decreased the maximum load and energy by 12% and 26% respectively. While a dose of 25 kGy resulted in more substantial reductions of 18% (P = 0.02) and 44% (P = 0.005) respectively. Similarly, fatigue testing demonstrated a statistically significant (p < 0.05) dose dependant decrease in the fatigue properties of the bone following gamma irradiation (Figure 3). Supercritical fluid treatment with or without additive had no significant effect on any of the measured mechanical parameters in 3-point bending. Furthermore, there was no significant change in fatigue behaviour following either SCF treatment. No significant difference was detected between groups in the untreated control samples based on ANOVA. However, a statistically significant change was detected in the gamma irradiated samples between the 10 kGy and 25 kGy dose, and compared to both SCF groups. No statistical differences were detected between either SCF group. Conclusions. Gamma irradiation at a low and standard dose compromised the static as well as the fatigue properties of the bone. This raises some concerns over the utility of gamma irradiation for load bearing allografts. SCF treatment has a bactericidal and virucidal effect [1, 2] and the results of this study demonstrate it maintains the mechanical integrity of bone in both static as well as dynamic loading


Introduction. In vivo, UHMWPE bearing surfaces are subject to wear and oxidation that can lead to bearing fatigue or fracture. A prior study in our laboratory of early antioxidant (AO) polyethylene retrievals, compared to gamma-sterilized and highly cross-linked (HXL) retrievals, showed them to be more effective at preventing in vivo oxidation. The current analysis expands that early study, addressing the effect of:. manufacturing-variables on as-manufactured UHMWPE;. in vivo time on these initial properties;. identifying important factors in selecting UHMWPE for the hip or knee. Methods. After our prior report, our IRB-approved retrieval laboratory received an additional 96 consecutive AO-retrievals (19 hips, 77 knees: in vivo time 0–6.7 years) of three currently-marketed AO-polyethylenes. These retrievals represented two different antioxidants (Vitamin E and Covernox) and two different delivery methods: blending-prior-to and diffusing-after irradiation cross-linking. Consecutive HXL acetabular and tibial inserts, received at retrieval, with in vivo time of 0–6.7 years (260 remelted, 170 annealed) were used for comparison with AO-retrievals. All retrievals were analyzed for oxidation and trans-vinylene index (TVI) using a Thermo-Scientific iN10 FTIR microscope. Mechanical properties were evaluated for 35 tibial inserts by uniaxial tensile testing using an INSTRON load frame. Cross-link density (n=289) was measured using a previously published gravimetric gel swell technique. Oxidation was reported as maximum ketone oxidation index (KOI) measured for each bearing. TVI was reported as the average of all scans for each material. Cross-link density and mechanical properties were evaluated as a function of both TVI and oxidation. Results. Minimal increase in oxidation was seen in these AO-retrievals, out to almost 7 years in vivo. In contrast, HXL-retrievals showed increasing KOI with time in vivo (annealed-HXL = 0.127/year, remelted-HXL = 0.036/year, p<0.001). HXL oxidation rate was higher in knees (0.091/year) than in hips (0.048/year), p<0.001. Cross-link density (XLD) correlated positively with TVI for both HXL (Pearson's correlation=0.591, p<0.001) and AO (Pearson's correlation=0.598, p<0.001) retrievals. AO-materials had higher TVI for the same or similar XLD than did HXL polyethylene. XLD correlated negatively with KOI for HXL retrievals (Pearson's correlation=−0.447, p<0.001). Mechanical properties varied by material across all materials evaluated, with tensile toughness correlating negatively with increasing TVI (Pearson Correlation=−0.795, p<0.001). Discussion. Irradiation cross-linking has been used effectively to improve wear resistance. Residual free radicals from irradiation are the target of AO-polyethylene, to prevent loss of UHMWPE XLD, resulting from in vivo oxidation of free radicals as seen in HXL retrievals, and toughness, resulting from oxidation or initial remelting. Despite different manufacturing variables, AO-polyethylene retrievals in this cohort had minimal oxidation and no change in XLD or toughness due to oxidation. However, toughness did vary with irradiation dose as did cross-link density. To achieve the same level of cross-linking as HXL-polyethylene required a higher irradiation dose in blended AO-polyethylene. AO-polyethylenes evaluated in this study had toughness that decreased with irradiation dose, but avoided loss of toughness due to remelting. Because AO-polyethylenes did not oxidize, they did not show the decrease of cross-link density, and potential loss of wear resistance, seen in HXL-polyethylene. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 106 - 106
1 Apr 2019
Feskanin H Barnes B Loftus E Stroud N
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INTRODUCTION. Since the early 2000s, highly cross-linked (HXL) UHMWPE's have become a popular option with multiple experimental and clinical studies showing that gamma or electron radiation doses between 50–100kGY reduce wear and potentially extend the bearing life of UHMWPE. However, the increased wear resistance came at a compromise to mechanical properties due to the cross-linking process. Vitamin E has been added to some HXL UHMWPE materials to offer a solution to the compromise by increasing oxidation resistance and maintaining sufficient fatigue strength. However, limited data is available on the effect of the fabrication process, especially the method of irradiation, on the properties of the Vitamin E blended HXL UHMWPE. The purpose of this study was to evaluate the effects of adding the antioxidant vitamin E to highly crosslinked UHMWPE on wear rates. METHODS. Wear testing was performed on six highly crosslinked UHMWPE acetabular liners containing vitamin E (0.1% wt. alpha tocopherol) fabricated using the Cold Irradiation Mechanically Annealed (CIMA) process, initially cross-linked with approximately 100 kGy gamma irradiation, and terminally gamma sterilized. The liners were paired with three 40mm CoCr femoral heads and 40mm three ceramic femoral heads. Testing was completed per ASTM F1714 and ISO 14242 on an orbital hip joint wear simulator (Shore Western, California) and lubricated with 90% bovine calf serum, 20mM EDTA, 0.2% wt. NaN. 3. and DI water. A 1.1Hz Paul-type loading waveform with a peak of 2kN was used for a total of 5E6 wear cycles. Three loaded soak controls were used in parallel to adjust for fluid absorption. Samples were weighed every 5E5 wear cycles. RESULTS. The wear rates for the HXL blended vitamin-E liners were calculated using the slope of the linear regression over the steady state and resulted in a wear rate of 0.49mg/Mc. This is a decrease of approximately 95% compared to the 9.54 mg/Mc 28mm ID conventional UHMWPE wear rates as well as a notable difference for the other HXL UHMWPE liner wear rates discussed in the review. DISCUSSION. HXL blended vitamin-E 40mm liners demonstrated an approximate 95% reduction in wear rates compared to a 28mm ID conventional UHMWPE. The reduced wear rate confirmed the design expectation that a higher irradiation dose in the fabrication process resulted in an increased amount of polymer crosslinking. Additionally, the wear rate of the HXL blended vitamin-E liners studied was well below 20mg/Mc, which was shown by Dowd et al. to be the threshold of osteolysis in THA. SIGNIFICANCE. The HXL vitamin E blended UHMWPE liner tested in this study demonstrated reduced wear rates by approximately 95% compared to conventional polyethylene. Osteolysis-causing wear debris is reduced while maintaining other mechanical properties. This liner material and manufacturing process is a promising alternative to conventional polyethylene, but long-term clinical results are warranted


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_22 | Pages 121 - 121
1 Dec 2016
De Smet K
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Heterotopic ossification (HO) is the formation of bone at extra-skeletal sites. Genetic diseases, traumatic injuries, or severe burns can induce this pathological condition and can lead to severe immobility. While the mechanisms by which the bony lesions arise are not completely understood, intense inflammation associated with musculoskeletal injury and/or highly invasive orthopaedic surgery is thought to induce HO. The incidence of HO has been reported between 3% and 90% following total hip arthroplasty. While the vast majority of these cases are asymptomatic, some patients will present decreased range of motion and painful swelling around the affected joints leading to severe immobility. In severe cases, ectopic bone formation may be involved in implant failure, leading to costly and painful revision surgery. The effects of surgical-related intraoperative risk factors for the formation of HO can also play a role. Prophylactic radiation therapy, and anti-inflammatory and biphosphonates agents have shown some promise in preventing HO, but their effects are mild to moderate at best and can be complicated with adverse effects. Irradiation around surgery could decrease the incidence of HO. However, high costs and the risk of soft tissue sarcoma inhibit the use of irradiation. Increased trials have demonstrated that nonsteroidal anti-inflammatory drugs (NSAID) are effective for the prevention of HO. However, the risk of gastrointestinal side effects caused by NSAID has drawn the attention of surgeons. The effect of the selective COX-2 inhibitor, celecoxib, is associated with a significant reduction in the incidence of HO in patients undergoing THA. Bone morphogenetic proteins (BMP) such as BMP2 identified another novel druggable target, i.e., the remote application of apyrase (ATP hydrolyzing agent) in the burn site decreased HO formation and mitigated functional impairment later. The question is if apyrase can be safely administered through other, such as systematical, routes. While the systemic treatments have shown general efficacy and are used clinically, there may be great benefit obtained from more localised treatment or from more targeted inhibitors of osteogenesis or chondrogenesis. In the surgical setting, prophylaxis for HO is regularly indicated due to the considerable risk of functional impairment. Heterotopic ossification is a well-known complication of total hip arthroplasty, especially when the direct lateral approach is used. Possible intraoperative risks are the size of incision, approach, duration of surgery and gender that can be associated with higher rates of HO or increase of the severity of HO. Like inflammation and tissue damage/ischemia are likely to be the key in the formation of HO, kindness to the soft tissues, tissue preserving surgery, pulse lavage to remove bone inducing factors and avoiding damage to all tissues should be erased as a comorbidity. Incision length, tissue dissection and subsequent localised trauma and ischemia, blood loss, anesthetic type and length of surgery may all contribute to the local inflammatory response. Data suggest that the surgeon may control the extent and nature of HO formation by limiting the incision length and if possible the length of the operation. Currently resection of HO is generally suggested after complete maturation (between 14–18 months), since earlier intervention is thought to predispose to recurrence. Reliable indicators of maturation of HO are diminishing activity on serial bone scans and/or decreasing levels of alkaline phosphatase. Although usually asymptomatic, heterotopic bone formation can cause major disability consisting of pain and a decreased range of motion in up to 7% of patients undergoing THA. Patients benefit from early resection of the heterotopic ossification with a proper and reliable postoperative strategy to prevent recurrence of HO with clinical implications


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLIV | Pages 81 - 81
1 Oct 2012
Lazennec J Rousseau M Rangel A Gozalbes V Chabane S Brusson A Picard C Catonne Y
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Background. Recent literature points out the potential interest of standing and sitting X-rays for the evaluation of THA patients. The accuracy of the anterior pelvic plane measures is questionable due to the variations in the quality of lateral standing and sitting X-rays. The EOS® (EOS imaging, Paris, France) is an innovative slot-scanning radiograph system allowing the acquisition of radiograph images while the patient is in weightbearing position with less irradiation than standard imagers. This study reports the “functionnal” positions of a 150 THA cohort, including the lateral orientation of the cups. Methods. The following parameters were measured: sacral slope (SS), pelvic tilt (PT), pelvic incidence (PI) and anterior pelvic plane (APP) sagittal inclination (ASI), frontal inclination (AFI) and planar anteversion (ANT). Irradiation doses were calculated in standing and sitting acquisitions. Variations of sagittal orientation of the cup were measured on lateral standing and sitting images. Descriptive and multivariate analysis were performed for the different parameters studied. Results. The mean doses for full body were 0,80 mGy ± 0,13 for standing position and 0,94 mGy ± 0,25 for sitting position. The mean value for PI was 55,8° ± 11,4. The mean values standing position were 39,01° ± 9,9 for SS, 17,23° ± 10,2 for PT, and 0,74° ± 8,4 for APP. The mean values were 46,36° ± 9,8 for AFI, 39,49° ± 15,1 for ASI and 22,09° ± 11,1 for ANT. In sitting position, the mean values were 20,87° ± 10,2 for SS, 35,37° ± 13,1 for PT and 21,13° ± 11,2 for APP. The mean values were 56,41° ± 12,3 for AFI, 51,71° ± 14,7 for ASI and 33,45° ± 12,9 for ANT. Conclusions and Clinical Relevance. Unexpected variations of the anterior pelvic plane can be observed as well as the influence of pelvic incidence on pelvic orientation. The EOS® imaging system provides new informations regarding the pelvis functionnal anatomy in THA patients with potential applications for the study of unstable cases and wear phenomenons