The passive diffusion improvement of Vitamin B12 intestinal absorption by Gelucire that fit for commercialized production.

Vitamin B12 (VB12) is a vital micronutrient to maintain the normal state of the hematopoietic system. It must be obtained from the diet since the human body cannot synthesize it. Moreover, the absorption of VB12 needs to be mediated by intrinsic factor on the gastrointestinal (GI) track. The abnormalities in the stomach or lack of such intrinsic factors may result in poor oral absorption of VB12. However, the very advanced formulation strategies were generally very costly and still in the development stage. Thus, the objectives of the present study were to increase the VB12 intestinal absorption by conventional excipients of Gelucire 44/14 (G44/14) or Labrasol, which could be potentially formulated as a cost effect balanced product. The in vitro Caco-2 cell model was applied for the absorption study. A novel VB12 solid dispersion was subsequently prepared and further characterized by Differential scanning calorimetry, Fourier transform infrared spectroscopy, and Scanning electron microscopy, respectively. The membrane permeability of the VB12 solid dispersion was finally evaluated using ex vivo rat everted gut sac method. The results suggested that G44/14 could significantly enhance the intestinal absorption of VB12 via P-glycoprotein inhibition in vitro (P < 0.01). The membrane permeability of VB12could be significantly (P < 0.01) improved by G44/14-VB12 solid dispersion at a proportion of carrier: drug ratio of 20:1.The liquidfied solid dispersion was finally directly filled in the hard gelatin capsules. In conclusion, the cheap and simplified process of VB12 complex prepared by G44/14 could potentially increase VB12 intestinal absorption, which may be liable to commercial manufacturing.

Mid-term low back pain improvement after total hip arthroplasty in 306 patients with developmental dysplasia of the hip.

BACKGROUND: Low back pain (LBP) from hip and spinal disorders has been one of the main reasons for visiting physicians in patients with developmental dysplasia of the hip (DDH). It is essential to identify the LBP improvement among all grades of DDH patients treated with total hip arthroplasty (THA) at 5-year follow-up. METHODS: The study included 407 hips of 306 patients (38 males, 268 females) who underwent THA between July 2007 and December 2016. There were 65 hips in Crowe I, 61 hips in Crowe II, 69 hips in Crowe III, and 212 hips in Crowe IV. One hundred and fourteen hips received subtrochanteric shortening. Patients included 101 bilateral THA (BTHA) and 205 unilateral THA (UTHA). The evaluation was performed through Back Pain Function Scale (BPFS), Harris hip score, Visual Analogue Scale (VAS), operative data and radiographic examinations. RESULTS: The BPFS in patients of unilateral Crowe III and IV relieved significantly more (p < 0.05). However, the BPFS in patients with bilateral symmetry DDH hips relieved significantly less than other groups of DDH hips (p < 0.05). Harris in hips of Crowe II improved significantly more (p < 0.05). The VAS in hips of Crowe II and III improved significantly more (p < 0.05). The unilateral THA surgical time, blood loss, blood transfusion, and osteotomy number and length in Crowe IV were significantly more (p < 0.05). CONCLUSION: THA is reliable to relieve LBP in DDH patients of unilateral Crowe III and IV; however, in patients with unilateral Crowe I, Crowe II, and bilateral DDH hips, the LBP improvements were limited. This should assist shared decision-making between orthopedic surgeons and patients. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

A biomimetic gradient porous cage with a micro-structure for enhancing mechanical properties and accelerating osseointegration in spinal fusion.

Objectives: Spinal fusion is a widely employed treatment of patients with degenerative disc disease, in which a cage is used to replace the disc for spinal fusion. But it often fails for insufficient mechanical strength and poor osseointegration. Here, we designed a polyether-ether-ketone (PEEK)/tantalum (Ta) composite cage with a biomimetic gradient porous micro-structure, simultaneously enhancing mechanical properties and accelerating osseointegration in spinal fusion. Materials and methods: In the study, based on the mechanical performances of PEEK and osteogenic potential of Ta, and the three-dimensional (3D) structures of cuttlebone and vertebra, the cages were respectively 3D printed by pure PEEK, PEEK with 5 wt% Ta (PEEK/Ta-5), PEEK with 10 wt% Ta (PEEK/Ta-10) and PEEK with 15 wt% Ta (PEEK/Ta-15), then verified in vitro and in sheep cervical fusion model systematically. Results: Vertebral Gyroid structure PEEK/Ta-15 cage exhibited superior mechanical properties than Cuttlebone-like structure PEEK/Ta-15 cage, closer to the cervical vertebra. Furthermore, PEEK/Ta-15 cage with higher Ta microparticles in PEEK provided a biomimetic gradient porous micro-structure with higher surface energy, guiding cell biological behavior, promoting new bone penetration, and accelerating osseointegration in vivo. Conclusion: In conclusion, the study designed a biomimetic gradient porous cage with a micro-structure for enhancing mechanical properties, accelerating osseointegration and forming an anatomical lock in the fusion segment through composites, mechanical efficiency, surface extension, and pores.

Cross-cultural adaptation and validation of the simplified Chinese version of the Exercise-Induced Leg Pain Questionnaire (EILP).

PURPOSE: This study cross-culturally adapted and psychometrically validated a simplified Chinese version of the Exercise-Induced Leg Pain Questionnaire (SC-EILP) for evaluating the severity of symptoms and sports ability among individuals with exercise-induced leg pain. MATERIALS AND METHODS: One hundred and fourteen participants with exercise-induced leg pain were included. To assess reliability, we calculated Cronbach's α and intra-class correlation coefficient (ICC). Construct validity was analysed by assessing the correlations between SC-EILP and visual analogue scale (VAS), University of California Los Angeles activity score (UCLA), and short form (36) health survey (SF-36). Factorial validity was used to establish the factor structure of the questionnaire. RESULTS: The EILP was cross-culturally well-adapted and translated into simplified Chinese. Each item was appropriately correlated with the total items. SC-EILP had nearly good reliability [Cronbach's α = 0.798, ICC = 0.897, 95% confidence interval 0.851-0.929]. The elimination of any one item in all did not result in a value of Cronbach's α of <0.80. SC-EILP had a very good correlation with VAS (-0.607, p < 0.01) and a moderate correlation with UCLA (0.581, p < 0.01) and physical domains of SF-36 (0.499-0.528, p < 0.01). Exploratory factor analysis revealed the 3-factor loading explained 74.736% of the total variance [Kaiser-Mayer-Olkin (KMO) = 0.672, C2 = 665.34, p < 0.001]. CONCLUSIONS: SC-EILP showed excellent acceptability, internal consistency, reliability, and construct validity, and could be recommended for individuals in Mainland China.

This study translated and cross-culturally adapted Exercise-Induced Leg Pain Questionnaire into a Simplified Chinese version, and evaluated its reliability and validity in individuals with exercise-induced leg pain.Moderate to substantial correlations between the Simplified Chinese version of the Exercise-Induced Leg Pain Questionnaire and VAS, UCLA, as well as physical subscales of SF-36 were observed.Exploratory factor analysis revealed that the 3-factor loading explained 74.736% of the total variance [Kaiser­Mayer­Olkin (KMO) = 0.672, C² = 665.34, p < 0.001].Simplified Chinese version of the Exercise-Induced Leg Pain Questionnaire was demonstrated to have acceptable simplicity, good reliability, and validity in individuals with exercise-induced leg pain, which could be recommended for patients in Chinese mainland.

Mid-term outcomes after total hip arthroplasty in 106 Crowe II/III hips: different hip center positions.

BACKGROUND: Under the obvious acetabular superolateral bone defect of Crowe II/III hips, this study aimed to investigate the difference in surgical technique of different hip center positions from the surgical data and clinical outcomes. METHODS: From July 2007 to December 2016, 87 patients (106 Crowe II/III hips) consecutively received total hip arthroplasty (THA). The minimum follow-up time was 5 years. The mean limb length discrepancy was 1.97 ± 1.81 cm. Twenty-four hips had surgical histories. The patients were divided into three groups according to the acetabular prosthesis positions, depending on the Crowe classification, respectively, group 1 (Crowe I), group 2 (Crowe II) and group 3 (Crowe III). The surgical data and clinical results were used to evaluate the outcome of different surgical techniques of different hip center positions, including surgical time, blood loss, blood transfusion, number of osteotomy hips, osteotomy length, the distribution of prothesis, postoperative inpatient days, Harris hip scores, Visual Analogue Scale (VAS), Back Pain Function Scale (BPFS) and complications. RESULTS: The mean follow-up time was 8.93 ± 2.55 years. Nineteen hips performed intraoperative osteotomy. From group 1 to group 3, the mean osteotomy length were 0.53 ± 1.11 cm, 0.05 ± 0.22 cm, and 0.00 ± 0.00 cm, respectively (p = 0.083); the surgical time were 142.57 ± 57.94 min, 118.4 ± 41.22 min, and 120.00 ± 84.85 min, respectively (p = 0.324); the blood loss were 498.21 ± 368.53 mL, 333.33 ± 167.62 mL, and 350.00 ± 212.13 mL, respectively (p = 0.255); the blood transfusion were 288.48 ± 381.68 mL, 128.00 ± 235.17 mL, and 385.00 ± 219.20 mL, respectively (p = 0.199); the postoperative inpatient days were 7.95 ± 4.42 d, 7.47 ± 4.29 d, and 6.50 ± 0.71 d, respectively (p = 0.831). Among the groups, the distribution of acetabular prosthesis, acetabular liner, acetabular prosthesis sizes, femoral head sizes and femoral prothesis distal sizes were not significantly different (p > 0.05). Only the distribution of femoral prosthesis was significantly different (p = 0.046); the Harris, VAS, BPFS, and the distribution of complications were not significantly different (p > 0.05). CONCLUSIONS: We provided a framework to guide decision-making in Crowe II/III hips for surgeons: the surgical technique of different hip center positions was stable and had good outcomes, but the acetabular prothesis position and femoral prothesis should be determined according to the intraoperative situation. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Simplified Chinese Version of the Back Pain Function Scale (BPFS) for Patients with Low Back Pain: Cross-Cultural Adaptation and Validation.

STUDY DESIGN: A cross-sectional study. OBJECTIVE: To translate and cross-culturally adapt back pain function scale (BPFS) into a simplified Chinese version (SC-BPFS), and evaluate the reliability and validity of SC-BPFS in patients with low back pain. SUMMARY OF BACKGROUND DATA: The BPFS is a reliable and valid evaluation instrument for low back pain. However, simplified Chinese version of BPFS has not been validated. METHODS: Cross-cultural adaptation was performed according to the internationally recognized guidelines of the American Academy of Orthopaedic Surgeons Outcome Committee. One-hundred and sixty-two participants with low back pain (LBP) were included in this study. Reliability was tested based on test-retest reliability and internal consistency. We calculated Cronbach alpha and intra-class correlation coefficient (ICC). Construct validity was analyzed by evaluating the correlations between SC-BPFS and the Oswestry disability index (ODI), the visual analogue scale (VAS), and the short form (36) health survey (SF-36). RESULTS: The original version of the BPFS was cross-culturally well adapted and translated into simplified Chinese. Each item of the SC-BPFS was properly responded and correlated with the total items. SC-BPFS had good reliability (Cronbach alpha = 0.847, intra-class correlation coefficient [ICC] = 0.891, 95% confidence interval [CI] 0.864-0.914). Elimination of any one item in all did not result in a value of Cronbach alpha of <0.80. SC-BPFS had a high correlation with ODI (0.712, P < 0.01) and a moderate correlation with VAS (0.484, P < 0.01). And it was also fairly to very well correlated with physical domains of SF-36 (0.334-0.632, P < 0.01), and not correlated with mental domains of SF-36 (0.022-0.119, P > 0.05). CONCLUSION: SC-BPFS demonstrated outstanding acceptability, internal consistency, reliability, and construct validity, and could be recommended for patients with LBP in Mainland China.Level of Evidence: 3.

A comparative study of total knee arthroplasty outcome for stiff knee with or without sequential antirheumatic drug treatment.

BACKGROUND: The aim of this study was to evaluate the influence of antirheumatic drug treatment on knee function of stiff knee patients after total knee arthroplasty (TKA). METHODS: Twenty-seven patients (44 knees) of active RA (rheumatoid arthritis) or AS (ankylosing spondylitis) with stiff knees were included in this study. And they were divided into two groups according to continue antirheumatic drug treatment or not after TKA: the therapeutic group (16 patients, 27 knees) and the controlled group (11 patients, 17 knees). The outcomes were assessed by Knee Society Score (KSS), Visual Analogue Scale (VAS), range of motion (ROM) (at week 6, month 6, year 1, and year 2), "Forgotten Joint" Scale (FJS), with or without crutch, satisfaction, and revision (at year 2). The knee prosthetic loosening was evaluated by the followed X-ray at each following time. RESULTS: The mean follow-up time was 51 months (34-69 months). The KSS was higher at week 6 after TKA in the therapeutic group (p < 0.05); however, the functional scores of KSS at month 6, year 1, and year 2 in the controlled group were more points improved. The therapeutic patients preferred the knee more at month 6, year 1, and year 2. The differences of KSS clinical scores (at month 6, year 1, and year 2), VAS, ROM, Crutch and FJS between the two groups were not statistically significant (p > 0.05). CONCLUSION: For patients with stiff knees, the sequential antirheumatic drug treatment after TKA had no obvious effect on postoperative KSS, but can improve the satisfaction. LEVEL OF EVIDENCE: Therapeutic level II. See Instructions for Authors for a complete description of levels of evidence.

Does the use of a closed-suction drain reduce the effectiveness of an antibiotic-loaded spacer in two-stage exchange Arthroplasty for Periprosthetic hip infection? A prospective, randomized, controlled study.

BACKGROUND: There is a concern regarding the use of a closed-suction drain (CSD) in two-stage exchange arthroplasty for periprosthetic joint infection as it may decrease the antibiotic concentrations in the joint fluids. The purpose of this study was to identify whether the use of a CSD could reduce local antibiotic concentrations following spacer implantation. METHODS: A prospective, randomized, controlled trial was conducted at our institution between January 2018 and November 2018. We enrolled 32 patients undergoing two-stage exchange arthroplasty for periprosthetic hip infection with an interim cement spacer containing 4-g vancomycin and 2-g meropenem per 40-g methyl-methacrylate cement polymer. Patients were randomized and evenly divided into the study group (non-CSD) and control group (CSD group) by sealed envelopes. Drainage samples of joint fluids (n = 160) were collected every 24 h for the first five days following spacer implantation. The antibiotic concentrations of drainage samples were measured by high-performance liquid chromatography, and the bioactivities of the drainage samples against methicillin-sensitive and methicillin-resistant Staphylococcus aureus (MSSA and MRSA) and E. coli were assessed. RESULTS: There was no significant difference in the decrease of vancomycin (study group vs. control group: 163.20 ± 77.05 vs. 162.39 ± 36.31; p = 0.917) and meropenem concentration (123.78 ± 21.04 vs. 117.27 ± 19.38; P = 0.548) between the two groups during the first five days following spacer implantation. All joint drainage samples in each group exhibited antibacterial activity against MSSA, MRSA and E. coli. CONCLUSIONS: The use of CSD following the implantation of an antibiotic-loaded cement spacer does not reduce the effectiveness of such a spacer in two-stage exchange arthroplasty. (Chinese Clinical Trial Registry, ChiCTR-INR-17014162. Registered 26 December 2017.).