Reliability of early stage symptoms/clinical findings of osteonecrosis of the jaw: Japanese Osteoporosis Intervention Trial-05 (JOINT-05).

INTRODUCTION: To investigate the differences in the incidence rates of suspected stage 0/1 osteonecrosis of the jaw (ONJ) and incidence risk of relevant clinical findings of suspected stage 0 ONJ between patients treated with sequential therapy comprising weekly teriparatide for 72 weeks followed by alendronate for 48 weeks vs. those who received monotherapy with alendronate for 120 weeks. MATERIALS AND METHODS: Suspected stage 0/1 ONJ was defined by non-specific symptoms. Tooth mobility and periodontal symptoms (gingival bleeding, swelling, and/or pain) were selected as clinical findings of suspected stage 0 ONJ. Poisson regression models were applied to calculate the incidence rate ratios of suspected stage 0/1 between the teriparatide group (TG) and alendronate group (AG). Generalized linear models were used to calculate the risk ratios of clinical findings between groups. RESULTS: Two hundred and sixty-one participants in the TG and 344 in the AG answered a structured questionnaire on oral health and were included in this study. There were no significant differences between the groups in the incidence rate of suspected stage 0/1 ONJ at both 72 and 120 weeks. The risk ratio of the TG to AG for tooth mobility was 0.34 (95% confidence interval [CI] 0.13-0.88, p = 0.02) at 72 weeks and 0.90 (95% CI 0.40-2.03, p = 0.83) at 120 weeks. The incidence rate of tooth mobility related to periodontal symptoms decreased in the TG and increased in the AG during the study. CONCLUSION: Tooth mobility accompanied by clinical periodontal symptoms may be a useful early sign of stage 0 ONJ.

Congenital atlanto-occipital dislocation in a patient with Down syndrome: a case report.

Down syndrome, also known as trisomy 21, is associated with congenital cervical spine abnormalities, including atlantoaxial instability with or without os odontoideum, atlanto-occipital instability, and hypoplasia of the atlas. Herein, we report a case of Down syndrome complicated by congenital atlanto-occipital dislocation. The patient presented with severe cervical myelopathy at 13 years of age after a 10-year follow-up. Radiography and computed tomography revealed os odontoideum protruding into the foramen magnum and congenital anterior atlanto-occipital dislocation. Additionally, a bifurcated internal occipital crest with a thinned central portion of the occipital bone was noted. Magnetic resonance imaging revealed kyphotic alignment of the spinal cord with severe compression at the foramen magnum level. As the neurological impairment was partially improved by halo vest immobilization, we performed in situ O-C2 fusion with an iliac autograft and decompression of the foramen magnum and posterior arch of C1. An improvement was observed immediately after surgery. Two years after surgery, radiography and computed tomography showed solid O-C2 segment fusion. The accumulation of similar cases is essential for determining the prognosis or optimal treatment for this rare congenital condition.

Long-term safety and effectiveness of denosumab in Japanese patients with osteoporosis: 3-year post-marketing surveillance study.

INTRODUCTION: Denosumab is a humanized IgG2 monoclonal antibody that was approved for the treatment of osteoporosis in Japan in 2013. This study aimed to investigate the long-term safety and effectiveness of denosumab in Japanese patients with osteoporosis in daily clinical practice. MATERIALS AND METHODS: This 3-year, prospective, observational, post-marketing study included patients who initiated treatment with denosumab (60 mg/6 months) for osteoporosis. Data were assessed at baseline, 3, 6, 12, 24 and 36 months. Key endpoints were adverse events (AEs), adverse drug reactions (ADRs), occurrence of osteoporotic fractures, bone mineral density (BMD), and bone turnover markers. Multivariate analyses were conducted to identify predictors of hypocalcaemia and percent change in BMD. RESULTS: Overall, 3534 patients were assessed (mean 75.7 years; 89.8% women). In total, 298 patients (8.4%) developed ADRs; the most common was hypocalcaemia (3.9%). Hypocalcaemia risk was significantly increased in patients with creatinine clearance < 30 mL/min, no prior use of bisphosphonates, prior use of calcium and vitamin D preparations, baseline serum calcium < 8.5 mg/dL, and no concomitant use of calcium or vitamin D preparations. Six patients had adjudicated osteonecrosis of the jaw. Lumbar spine BMD increased significantly from baseline (mean percent change: 11.4% at 36 months). All bone turnover markers decreased significantly from baseline. Over 3 years, 3.3% of patients developed a new osteoporotic fracture. CONCLUSIONS: This study confirmed the long-term safety and effectiveness of denosumab in Japanese patients with osteoporosis in daily clinical practice. No new safety signals were identified.

Hydrated Phospholipid Polymer Gel-Like Layer for Increased Durability of Orthopedic Bearing Surfaces.

Recently, traditional strategies for manipulating orthopedic bearing substrates have attempted to improve their wear resistance by adjusting polyethylene substrate through cross-linking and antioxidant blending. However, further research is required on the substrate, as well as the surface focused on the structure and role of articular cartilage. We therefore develop an orthopedic bearing surface comprising a nanometer-scale hydrated gel-like layer by grafting highly hydrophilic poly(2-methacryloyloxyethyl phosphorylcholine), with the aim of mimicking the lubrication mechanism of articular cartilage, and investigate its surface characteristics, bulk characteristics, and behavior under load bearing conditions upon accelerated aging. Neither the hydrophilicity nor lubricity of the gel-like surface was influenced by accelerated aging; instead, high stability was revealed, even under strong oxidation conditions. The characteristics of the hydrated gel-like surface potentiated the wear resistance of the cross-linked polyethylene liner, irrespective of accelerated aging. These results suggest that the hydrated gel-like surface enhances the longevity of cross-linked polyethylene bearings even under load-bearing conditions. Furthermore, the inflection point on the time series of wear can be a suitable indicator of the durability of the life-long protectant. In conclusion, the hydrated gel-like surface can positively increase orthopedic implant durability.

Clinical and Radiographic Outcomes of Total Hip Arthroplasty With a Specific Liner in Small Asian Patients: Influence of Patient-Related, Implant-Related, and Surgical Factors on Femoral Head Penetration.

BACKGROUND: We evaluated the clinical and radiographic outcomes, including femoral head penetration, of total hip arthroplasty performed using a specific polyethylene (PE) liner in small Asian patients at 10 years after the index surgery. In addition, we investigated whether femoral head penetration was affected by patient-related, implant-related, and surgical factors. METHODS: Between August 2002 and June 2005, for cementless primary total hip arthroplasty, we used acetabular PE liners that were manufactured from GUR 1050 resin, machined from isostatic compression-molded bar stock, and sterilized with a gamma ray irradiation in argon gas. We assessed 82 hips in 78 patients who received these liners. RESULTS: The mean Harris hip score improved from 41.0 preoperatively to 84.5 at 10 years postoperatively. Periprosthetic osteolysis was observed in 7 hips (9.8%). No acetabular component migration was detected, and no revision surgery was performed 10 years postoperatively. The mean steady-state wear rate was 0.031 mm/y, which was lower than the wear rate for other conventional PE liners of the previous studies. Among the patient-related, implant-related, and surgical factors, sex was significantly associated with the mean steady-state wear rate, with a higher rate in male patients than in female patients. CONCLUSION: PE acetabular liners used in small Asian patients show similar clinical outcomes and reduced wear compared with those of other liners. In addition, sex is significantly associated with the mean steady-state wear rate, and the steady-state wear rate is higher in male patients than in female patients.

Multidirectional wear and impact-to-wear tests of phospholipid-polymer-grafted and vitamin E-blended crosslinked polyethylene: a pilot study.

BACKGROUND: Modifying the surface and substrate of a crosslinked polyethylene (CLPE) liner may be beneficial for high wear resistance as well as high oxidative stability and excellent mechanical properties, which would be useful in contributing to the long-term performance of orthopaedic bearings. A grafted poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC) layer on a vitamin E-blended crosslinked PE (HD-CLPE[VE]) surface may provide hydrophilicity and lubricity without compromising the oxidative stability or mechanical properties. QUESTIONS/PURPOSES: (1) Will the modifications (PMPC grafting and vitamin E blending) affect the lubrication characteristics of the CLPE surface? (2) Will the modifications affect wear resistance? (3) Will the modifications affect fatigue resistance? METHODS: We investigated the effects of surface and substrate modifications (PMPC grafting and vitamin E blending) on the wear and fatigue fracture of thin CLPE samples. For each of the untreated and PMPC-grafted CLPE surfaces with and without vitamin E blended (four groups), wettability and lubricity surface analyses were conducted as well as multidirectional wear and impact-to-wear tests using a pin-on-disk testing machine. RESULTS: The water wettability and lubricity (CLPE [mean ± 95% confidence interval]: 23.2° ± 1.8°, 0.005 ± 0.001; HD-CLPE[VE]: 26.0° ± 2.3°, 0.009 ± 0.003) of the PMPC-grafted surfaces were greater (p < 0.001) than that (CLPE: 90.3° ± 1.2°, 0.067 ± 0.015; HD-CLPE[VE]: 90.8° ± 2.0°, 0.063 ± 0.008) of the untreated surface regardless of vitamin E additives. It was observed that the PMPC grafting (CLPE: 0.23 ± 0.06 mg; HD-CLPE[VE]: 0.05 ± 0.10 mg) was associated with reduced gravimetric wear (CLPE: 0.53 ± 0.08 mg, p = 0.004 HD-CLPE[VE]: 0.23 ± 0.07 mg, p = 0.038) in the multidirectional wear test. The PMPC-grafted surface characteristics did not appear to affect the impact fatigue resistance regardless of vitamin E blending. CONCLUSIONS: PMPC grafting improved the surface hydrophilicity and lubricity, and it reduced the gravimetric wear in terms of multidirectional sliding. It did not result in differences in terms of the impact-to-unidirectional sliding regardless of vitamin E blending. Further research is needed to evaluate the wear resistance of PMPC-grafted HD-CLPE(VE) in long-term hip simulator tests under normal and severe conditions, which may offer useful clues to the possible performance of these materials in vivo. CLINICAL RELEVANCE: Our preliminary in vitro findings suggest that some improvement in the wear performance of crosslinked polyethylene acetabular liners in total hip arthroplasty could be obtained using PMPC grafting. Further research is needed to evaluate the wear resistance of PMPC-grafted HD-CLPE(VE) in long-term hip simulator tests under normal and severe conditions, which may offer useful clues to the possible performance of these materials in vivo.

Clinical and radiographic outcomes of total hip replacement with poly(2-methacryloyloxyethyl phosphorylcholine)-grafted highly cross-linked polyethylene liners: three-year results of a prospective consecutive series.

OBJECTIVES: This study aimed to evaluate the clinical safety and wear-resistance of the novel highly cross-linked polyethylene (HXLPE) acetabular liner with surface grafting of poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC) at 3 years after total hip replacement (THR). METHODS: Eighty consecutive patients underwent cementless THR using a 26-mm diameter cobalt-chromium-molybdenum alloy femoral head and a PMPC-grafted HXLPE liner for the bearing couplings. We evaluated the clinical and radiographic outcomes of 76 patients at 3 years after the index surgery. RESULTS: The clinical results at 3 years were equivalent to a Harris hip score of 95.6 points. No adverse events were associated with the implanted PMPC-grafted HXLPE liner, and no periprosthetic osteolysis was detected. The mean femoral head penetration rate was 0.002 mm/year, representing marked reduction compared with other HXLPE liners. CONCLUSIONS: A PMPC-grafted HXLPE liner is a safe option in THR and probably reduces the generation of wear particles.

A dynamic pedicle screw system using polyethylene insert for the lumbar spine.

Rigid spinal fusion with instrumentation has been widely applied in treating degenerative spinal disorders and has shown excellent and stable surgical results. However, adjacent segment pathology or implants' loosening could be problematic due to the spine's segmental fusion. Therefore, this study verified a novel concept for posterior stabilization with polyethylene inserts inside a pedicle screw assembly using bone models. We observed that although the gripping capacity of the dynamic pedicle screw system using a tensile and compression tester was less than half that of the rigid pedicle screw system, the flexion-extension moment of the dynamic pedicle screws was significantly lower than that of the rigid pedicle screws. Furthermore, while the bending force of the rigid pedicle screw assembly increased linearly with an increase in the bending angle throughout the test, that of the dynamic pedicle screw assembly also increased linearly until a bending angle of 2.5° was reached. However, this angle decreased at a bending angle of more than 2.5°. Additionally, the fatigue test of 1.0 × 106 cycles showed that the pull-out force of the dynamic pedicle screws from two different polyurethane foam blocks was significantly higher than that of the rigid pedicle screws. Therefore, based on our results, we propose that the device can be applied in clinical cases to reduce screw loosening and adjacent segment pathology.

Efficacy of hydrated phospholipid polymer interfaces between all-polymer bearings for total hip arthroplasty.

Measurements of wear resistance and metal ion release are important for designing bearing couples or interfaces in total hip arthroplasty (THA). In this study, we investigated wear resistance and metal ion release of surface-modified metal-free all-polymer hip bearings, such as poly(ether-ether-ketone), (PEEK) on cross-linked polyethylene (PEEK-on-CLPE), with a hydrated gel-like surface layer, to propose an improved alternative to the conventional materials used to design THA bearings. The PEEK surface resulted in less metal ion release than the cobalt-chromium-molybdenum (Co-Cr-Mo) alloy surface owing to the lack of metal. The PEEK-on-CLPE bearing (6.33 mg/106 cycles) had lower wear (rate) than the bearing with Co-Cr-Mo alloy-on-CLPE (10.47 mg/106 cycles) under controlled laboratory conditions; the wear performance of the all-polymer hip bearings was further improved with hemi- or both-surface modified with a hydrated poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC) layer (3.74 and 3.06 mg/106 cycles, respectively). The PMPC-grafted interface of PEEK-on-CLPE will be especially suitable for THA candidates. This study is of key importance for the design of lifelong THA and a better understanding of the limitations resulting from using PEEK. Further studies are necessary to evaluate the possibility of using this material in artificial hips.

The relationship between atlas hypoplasia and os odontoideum in children with Down syndrome: a preliminary case report.

The purpose of this study was to evaluate the relationship of os odontoideum and the size of atlas among children with Down syndrome. Understanding the risk of developing myelopathy in asymptomatic cases is important in children with Down syndrome. Children with os odontoideum are considered to be at high risk of developing myelopathy because of instability; however, in cases that are complicated by atlas hypoplasia, the risk remains the same, regardless of instability. This retrospective case-control study assessed atlas hypoplasia in children with Down syndrome with or without os odontoideum. We retrospectively assessed the records of 59 patients (36 males and 23 females) with Down syndrome who underwent spinal X-ray evaluations at our hospital. The average age at examination was 5.0 years (range, 4-7). We evaluated the following radiologically: the presence of os odontoideum; atlas-dens interval; space available for the spinal cord at the atlas level (C1SAC); instability index; sagittal atlas diameter (SAD) as an index of atlas hypoplasia and C5 level SAC (C5SAC), adjusted for child growth. Os odontoideum was present in seven cases (12%). Between the groups with and without os odontoideum, there was no significant difference in age (mean, 5.2 vs. 5.0 years) or male/female ratio (57 vs. 62% males). The SAD/C5SAC (mean, 1.6 vs. 1.9) was significantly smaller in the group with os odontoideum than in those without os odontoideum. The instability index was not significantly different between the two groups. Children with Down syndrome and os odontoideum have small SAD. Evaluations for atlas hypoplasia are necessary.

[Odanacatib (MK-0822)].

Bone homeostasis is maintained by delicate balance between bone resorption by osteoclasts and bone formation by osteoblasts. Bisphosphonates are widely used nowadays by suppressing bone resorption to treat patients with osteoporosis, which results from high bone turnover, causing excessive bone resorption phase. While bisphosphonates increase bone mineral density and improve back pain due to spinal compression fracture, they may have some problems such as osteonecrosis of jaw and excessive suppression of bone turnover. Cathepsin K inhibitor, which has a new mechanism in addition to function of suppressing bone resorption, is recently focused. Cathepsin K is a protease which specifically expresses in osteoclasts and plays an important role in resolution of bone collagen. Cathepsin K inhibitor has a potential of inhibiting bone resorption without suppressing bone formation and could be an attractive therapeutic target of osteoporosis.

Iliotibial band friction syndrome after knee arthroplasty.

Iliotibial band (ITB) friction syndrome is known to be one of the main causes of lateral knee pain related to an overuse injury. In the field of knee arthroplasty, ITB traction syndrome has been reported following guided motion total knee arthroplasty, due to posterior femoral translation and internal tibial rotation during knee flexion. However, ITB friction syndrome following conventional knee arthroplasty has not been reported. This paper reports four cases of this syndrome following conventional knee arthroplasty, mainly caused by an obstruction just under the ITB. Cases 1 and 2 presented extruded cement at the femoral component's lateral side after total knee arthroplasty. Case 3 presented a highly sharp-edged bearing at the lateral compartment after bicompartmental knee arthroplasty. Case 4 presented an osteophyte at the femoral component's lateral side after total knee arthroplasty. Although none of the cases responded well to conservative treatment, ITB friction syndrome was completely relieved just after excising the obstruction. Excision of an obstruction should be considered for ITB friction syndrome caused by obstruction just under the ITB following knee arthroplasty.

2-Methacryloyloxyethyl Phosphorylcholine Polymer Coating Inhibits Bacterial Adhesion and Biofilm Formation on a Suture: An In Vitro and In Vivo Study.

Initial bacterial adhesion to medical devices and subsequent biofilm formation are known as the leading causes of surgical site infection (SSI). Therefore, inhibition of bacterial adhesion and biofilm formation on the surface of medical devices can reduce the risk of SSIs. In this study, a highly hydrophilic, antibiofouling surface was prepared by coating the bioabsorbable suture surface with poly(2-methacryloyloxyethyl phosphorylcholine (MPC)-co-n-butyl methacrylate) (PMB). The PMB-coated and noncoated sutures exhibited similar mechanical strength and surface morphology. The effectiveness of the PMB coating on the suture to suppress adhesion and biofilm formation of methicillin-resistant Staphylococcus aureus and methicillin-susceptible Staphylococcus aureus was investigated both in vitro and in vivo. The bacterial adhesion test revealed that PMB coating significantly reduced the number of adherent bacteria, with no difference in the number of planktonic bacteria. Moreover, fluorescence microscopy and scanning electron microscopy observations of adherent bacteria on the suture surface after contact with bacterial suspension confirmed PMB coating-mediated inhibition of biofilm formation. Additionally, we found that the PMB-coated sutures exhibited significant antibiofouling effects in vivo. In conclusion, PMB-coated sutures demonstrated bacteriostatic effects associated with a highly hydrophilic, antibiofouling surface and inhibited bacterial adhesion and biofilm formation. Therefore, PMB-coated sutures could be a new alternative to reduce the risk of SSIs.

Multi-layered PLLA-nanosheets loaded with FGF-2 induce robust bone regeneration with controlled release in critical-sized mouse femoral defects.

To overcome clinical issues caused by large bone defects and subsequent nonunion, various approaches to bone regeneration have been researched, including tissue engineering, biomaterials, stem cells and drug screening. Previously, we developed a free-standing biodegradable polymer nanosheet composed of poly(L-lactic acid) (PLLA) using a simple fabrication process consisting of spin-coating and peeling techniques. We reported that sandwich-type PLLA nanosheets loaded with recombinant human bone morphogenetic protein-2 (rhBMP-2) displayed long-lasting, sustained release of rhBMP-2, and markedly enhanced bone regeneration in mouse calvarial bone defects. Here, we fabricated multi-layered nanosheets loaded with fibroblast growth factor-2 (FGF-2), and investigated their application for long bone regeneration. Subcutaneously implanted tri-layered PLLA nanosheets displayed sustained release of loaded rhFGF-2 for about 2 weeks. Next, we prepared critical-sized mouse femoral defects and implanted mono- or tri-layered nanosheets, or a gelatin hydrogel with rhFGF-2. Amongst these conditions, the tri-layered nanosheet most efficiently induced bone regeneration. Indeed, bone regeneration was enhanced even after 4 weeks in the tri-layered nanosheet group, and was accompanied by FGFR1 activation and subsequent osteoblast differentiation. Multi-layered PLLA nanosheets loaded with rhFGF-2 may be useful for bone regenerative medicine. Furthermore, the multi-layered PLLA nanosheet structure may potentially be applied as a potent sustained-release carrier. STATEMENTS OF SIGNIFICANCE: Here, we describe multi-layered poly(L-lactic acid) (PLLA) nanosheets loaded with recombinant human fibroblast growth factor-2 (rhFGF-2) as a modified sustained-release carrier for bone regeneration. In vivo imaging system analysis revealed that subcutaneously implanted tri-layered PLLA nanosheets displayed sustained release of loaded rhFGF-2 for 2 weeks. In critical-sized mouse femoral defects, tri-layered nanosheets loaded with rhFGF-2 most efficiently induced bone regeneration. Notably, bone regeneration was enhanced even after 4 weeks in the tri-layered nanosheet group, and was accompanied by FGFR1 activation and subsequent osteoblast differentiation. Multi-layered PLLA nanosheets loaded with rhFGF-2 may be useful for bone regenerative medicine. Furthermore, the multi-layered PLLA nanosheet structure may potentially be applied as a potent sustained-release carrier.

Effects of a roughened femoral head and the locus of grafting on the wear resistance of the phospholipid polymer-grafted acetabular liner.

Although laboratory tests and mid-term clinical outcomes show the clinical safety and remarkable wear resistance of the highly cross-linked polyethylene (HXLPE) acetabular liner with a nanometer-scaled graft layer of poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC), the wear resistance of the layer under severe abrasive conditions is concerning. We evaluated the effects of a roughened femoral head and the grafting locus on the wear resistance of the PMPC-grafted HXLPE liner and the effect of PMPC grafting on wear resistance of the HXLPE substrate by removing the PMPC-grafted layer using a severely roughened femoral head. Against a moderately roughened femoral head, the PMPC-grafted HXLPE liner showed negative wear, although an untreated HXLPE liner increased the wear by 154.1% compared with wear against a polished femoral head, confirming that PMPC grafts were unaffected. Against a severely roughened femoral head, the PMPC-grafted layer of the head contact area might be removed under severe conditions. However, the wear rate was reduced by 52.5% compared to that of untreated HXLPE liners. Moreover, the head non-contact area-modified PMPC-grafted HXLPE liner against a polished femoral head reduced the wear by 76.8% compared with untreated HXLPE liner; thus, this area may be also important in the development of fluid-film lubrication. STATEMENT OF SIGNIFICANCE: Here we describe effects of a roughened femoral head and the locus of grafting on the wear-resistance of the phospholipid polymer grafted highly cross-linked polyethylene (PMPC-HXLPE) liner. Against a moderately roughened femoral head, the PMPC-HXLPE liner showed negative wear, confirming that PMPC grafts were unaffected. After removing the PMPC layer of the head contact area using a severely roughened femoral head, the wear rate not only exceeded that of untreated HXLPE liners, but was reduced by 52.5%, confirming that PMPC grafting does not affect the wear-resistance of the HXLPE substrate. In addition, the head non-contact area-modified PMPC-HXLPE liner reduced the wear by 76.8%. Thus, this area may also may be important in the development of fluid-film lubrication.

MKK6-p38 MAPK signaling pathway enhances survival but not bone-resorbing activity of osteoclasts.

Phosphorylated p38 mitogen-activating kinase (MAPK) is observed in osteoclasts under in vivo inflammatory situations. However, the role of p38 MAPK in osteoclast function has not been elucidated, because all external stimuli tested hitherto failed to induce the phosphorylation of p38 MAPK in osteoclasts in culture. In this study, a constitutively active form of MKK6 (MKK6CA) was expressed in osteoclasts using adenoviral gene transfer in vitro. MKK6CA expressed in osteoclasts phosphorylated p38 MAPK and enhanced the survival of osteoclasts. Dentine-resorbing activity of osteoclasts was not enhanced by the MKK6CA expression. These results suggest that p38 MAPK signaling plays a critical role in the survival of osteoclasts in inflammatory diseases.

A phospholipid polymer graft layer affords high resistance for wear and oxidation under load bearing conditions.

Manipulating the surface and substrate of cross-linked polyethylene (CLPE) is an essential approach for obtaining life-long orthopedic bearings. We therefore proposed a bearing material comprised of an antioxidative substrate generated by vitamin E blending (HD-CLPE[VE]) with a poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC)-grafted surface, and investigated its wear resistance and oxidative stability under accelerated aging and load bearing conditions. Neither the hydration nor friction kinetics of the molecular network structure of the PMPC-grafted surface or the HD-CLPE(VE) substrate were influenced by accelerated aging but rather exhibited high stability even under high oxidation conditions. The characteristics of the PMPC-grafted surface improved the wear and impact fatigue resistance of the HD-CLPE(VE) liner regardless of accelerated aging. Notably, the PMPC-grafted surface was found to affect the potential oxidative stability at the rim part of the acetabular liner. PMPC chains serve several important functions on the surface regardless of load bearing, such as high lubricity or low lipophilicity attributed to phosphorylcholine groups and/or surrounding water-fluid film, and suppression of lipid diffusion attributed to methacrylate main chains on the surface. Together, these results provide preliminary evidence that the PMPC graft layer and vitamin E-blended substrate might positively affect the extent of orthopedic implant durability.

The effects of presence of a backside screw hole on biotribological behavior of phospholipid polymer-grafted crosslinked polyethylene.

One of the important factors in determining the success of joint replacement is the wear performance of polyethylene. Although highly crosslinked polyethylene (CLPE) is presently used, it is still not adequate. We have developed a surface modification technology using poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC) in an attempt to improve wear performance. In this study, we evaluated the wear and creep deformation resistances of 3-mm and 6-mm thick PMPC-grafted CLPE disks, set on a metal back-plate, with and without a sham screw hole. The gravimetric wear and volumetric change of the disks were examined using a multidirectional pin-on-disk tester. PMPC grafting decreased the gravimetric wear of CLPE regardless of the presence of a screw hole, and did not affect the volumetric change. The volumetric change in the bearing and backside surfaces of the 3-mm thick disk with a screw hole was much larger than that of those without a screw hole or those of the 6-mm thick disk, which was caused by creep deformation. PMPC grafting on the bearing surface can be a material engineering approach to reduce the wear without changing the creep deformation resistance, and is a promising surface modification technology that can be used to increase the longevity of various artificial joints. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 610-618, 2018.

Wear resistance of poly(2-methacryloyloxyethyl phosphorylcholine)-grafted carbon fiber reinforced poly(ether ether ketone) liners against metal and ceramic femoral heads.

Younger, active patients who undergo total hip arthroplasty (THA) have increasing needs for wider range of motion and improved stability of the joint. Therefore, bearing materials having not only higher wear resistance but also mechanical strength are required. Carbon fiber-reinforced poly(ether ether ketone) (CFR-PEEK) is known as a super engineering plastic that has great mechanical strength. In this study, we focused on poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC)-grafted CFR-PEEK and investigated the effects of PMPC grafting and the femoral heads materials on the wear properties of CFR-PEEK liners. Compared with untreated CFR-PEEK, the PMPC-grafted CFR-PEEK surface revealed higher wettability and lower friction properties under aqueous circumstances. In the hip simulator wear test, wear particles generated from the PMPC-grafted CFR-PEEK liners were fewer than those of the untreated CFR-PEEK liners. There were no significant differences in the size and the morphology of the wear particles between the differences of PMPC-grafting and the counter femoral heads. Zirconia-toughened alumina (ZTA) femoral heads had significantly smoother surfaces compared to cobalt-chromium-molybdenum alloy femoral heads after the hip simulator test. Thus, we conclude that the bearing combination of the PMPC-grafted CFR-PEEK liner and ZTA head is expected to be a lifelong bearing interface in THA. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 1028-1037, 2018.

A hydrated phospholipid polymer-grafted layer prevents lipid-related oxidative degradation of cross-linked polyethylene.

The surface and substrate of a cross-linked polyethylene (CLPE) liner are designed to achieve resistance against oxidative degradation in the construction of hip joint replacements. In this study, we aimed to evaluate the oxidative degradation caused by lipid absorption of a highly hydrophilic nanometer-scaled thickness layer prepared by grafting a poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC) layer and a high-dose gamma-ray irradiated CLPE with vitamin E blending (HD-CLPE[VE]). The HD-CLPE(VE) and PMPC-grafted HD-CLPE(VE) exhibited extremely high oxidation resistance regardless of lipid absorption, even though residual-free radical levels were detectable. The water wettability of the PMPC-grafted CLPE and PMPC-grafted HD-CLPE(VE) surfaces was considerably greater than that of untreated surfaces. The hydrated PMPC-grafted layer also exhibited extremely low solubility for squalene. Lipids such as squalene and cholesterol esters diminished the oxidation resistance of CLPE despite the vitamin E improvement. Notably, the PMPC-grafted surface was resistant to lipid absorption and diffusion as well as subsequent lipid-related oxidative degradation, likely because of the presence of the hydrated PMPC-grafted layer. Together, these results provide preliminary evidence that the resistance against lipid absorption and diffusion of a hydrated PMPC-grafted layer might positively affect the extent of resistance to the in vivo oxidation of orthopedic implants.