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OBJECTIVE@#Taking artificial hip joint test as the object, integrating ISO/IEC 17025 and GLP, and establishing a new set of management requirements for test influence factors.@*METHODS@#The requirements of ISO/IEC 17025 and GLP regulations for influencing factors were compared and analyzed, the similarities and differences were found, and the two were integrated to formulate new management requirements for each influencing factor.@*RESULTS@#From the personnel, equipment, materials, methods, reports, filing and other factors, a set of management requirements in line with ISO/IEC 17025 and GLP was formulated, so that the laboratory can provide the objective, real and accurate test data for medical equipment manufacturers and regulatory authorities.@*CONCLUSIONS@#It can improve the test quality of the laboratory and ensure the authenticity and reliability of the test data and conclusions.
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Reproducibility of Results , Laboratories , Hip JointABSTRACT
Objective@#To observe the effect of home visit on joint function and complications of patients undergoing hip replacement.@*Methods@#Ninety cases of patients with artificial hip replacement who were admitted to our hospital from January to December 2017 were randomly divided into two groups by random Number Table Method.45 patients in the control group were given routine nursing after discharge, and 45 patients in the observation group were treated with home visit nursing. The hip function and living ability of the two groups were evaluated 8, 12, 16 weeks after discharge,and the complication rate was compared.@*Results@#The self-care ability scores of the observation group at 8, 12 and 16 weeks after discharge were 102.23±11.20, 108.36±10.41, 116.25±10.36 higher than those of the control group at 97.86±10.35), 100.21±14.26, 104.23±15.6, with significant differences (t=1.922, 3.097, 4.294, P < 0.05 or 0.01). The Harris scores of the observation group at 8, 12 and 16 weeks after discharge were 82.31±11.27, 87.38±10.05, 95.10±11.23 higher than those of the control group at 78.02±10.23, 83.41±11.74, 89.43±11.62, with significant differences (t=1.891, 1.723, 2.343, P < 0.05). The incidence of complications in the observation group at 16 weeks after discharge was 0 lower than 13.33% (6/45) in the control group (χ2=6.429, P=0.011).@*Conclusions@#Home visit intervention can improve the self-nursing ability of the patients after hip joint operation, promote the recovery of hip function and life ability, and reduce the complications.
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Objective To observe the effect of home visit on joint function and complications of patients undergoing hip replacement. Methods Ninety cases of patients with artificial hip replacement who were admitted to our hospital from January to December 2017 were randomly divided into two groups by random Number Table Method.45 patients in the control group were given routine nursing after discharge, and 45 patients in the observation group were treated with home visit nursing. The hip function and living ability of the two groups were evaluated 8, 12, 16 weeks after discharge,and the complication rate was compared. Results The self-care ability scores of the observation group at 8, 12 and 16 weeks after discharge were 102.23±11.20, 108.36±10.41, 116.25±10.36 higher than those of the control group at 97.86±10.35), 100.21±14.26, 104.23±15.6, with significant differences (t=1.922, 3.097, 4.294, P<0.05 or 0.01). The Harris scores of the observation group at 8, 12 and 16 weeks after discharge were 82.31± 11.27, 87.38±10.05, 95.10±11.23 higher than those of the control group at 78.02±10.23, 83.41±11.74, 89.43 ± 11.62, with significant differences (t=1.891, 1.723, 2.343, P < 0.05). The incidence of complications in the observation group at 16 weeks after discharge was 0 lower than 13.33% (6/45) in the control group ( χ2=6.429, P=0.011). Conclusions Home visit intervention can improve the self-nursing ability of the patients after hip joint operation, promote the recovery of hip function and life ability, and reduce the complications.
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In order to explore the value of clinical pharmacist in the anti-infective treatment of the patients with late-onset infec-tion after artificial hip joints replacement,clinical pharmacists performed ward round and pharmaceutical care for one patient with infec-tion around the artificial joints after artificial hip joints replacement three years ago. According to the relevant literatures,clinical phar-macist provided medical advice for physician from the following aspects: surgical interventions, drug choice and dosage adjustment, and participated in the medicine therapeutic scheme for the patient. Physicians partly accepted the suggestions of clinical pharmacists, and the symptoms and imaging examination results of the patient improved after the treatment,which provided guarantee for the follow-up treatment. It is of great significance for clinical pharmacists to participate in the formulation of clinical medication plan to improve the rational drug use in clinical anti-infection treatment.
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OBJECTIVE:To investigate the effects of puerarin on bone mineral density around the femoral prosthesis of el-derly women after osteoporotic fracture artificial hip joint replacement. METHODS:99 elderly women after osteoporotic fracture artificial hip joint replacement were divided into control group(49 cases)and test group(50 cases)according to random number table. Control group received conventional treatment:calcium carbonate and vitamin D3+alendronate sodium+salmon calcitonin;test group was additionally given Puerarin injection 200-400 mg dissolved in Glucose injection 500 ml intravenously,qd,on the basis of control group. A treatment course lasted for 20 d,and both groups received 2 courses of treatment. The hip joint function score and bone mineral density around the femoral prosthesis of 2 groups were observed and compared after surgery,and the oc-currence of ADR was also observed. RESULTS:3 and 2 patients withdrew from control group and test group,respectively. 18 months after surgery,the patients with hip joint function score ranged 70-79 in test group was significantly less than in control group;the rate of excellent hip joint function score in test group was significantly higher than in control group,with statistical significance (P0.05);bone mineral density in R6-R7 range was signifi-cantly higher than control group(89.58% vs. 69.57%),with statistical significance(P<0.05). The prosthesis loosening was not found in both groups,and ADR was also not found as fever,erythra,nausea,vomiting,headache,dizziness,etc. CONCLU-SIONS:For the use of puerarin in elderly women after osteoporotic fracture artificial hip joint replacement,puerarin can increase the periprosthetic femur bone mineral density with good safety.
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For several centuries, orthopaedic surgeons have been given the task of managing the pain, limp, and gait disturbance that develop in association with various trauma and diseases of the hip joint. Progress has been made in development of surgical methods for the hip joint, and a recent concept was determined by introduction of the 'Clean Air Operating Enclosure' system and 'low frictional arthroplasty' in total hip arthroplasty (THA) by John Charnley, in 1960. THA has been performed as an exclusive method for hip joint reconstruction. We report on understanding of the current status from the past, present, and future trends with an introduction of the prior method of THA and a discussion of the history.
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Arthroplasty , Friction , Gait , Hip , Hip Joint , TacrineABSTRACT
Objective To investigate the wear mechanism of artificial hip joints and the criteria for wear life definition, analyze the causes of abnormal wear and the clinical manifestations of wear failure, establish the reasoning route of failure incidents. Methods The wear process and early factors on abnormal wear in artificial hip joints were studied through elastohydrodynamic lubrication computation and finite element analysis; the service life of artificial hip joints was determined through establishing criteria for wear life definition; the clinical manifestations of wear failure were introduced and classified through wear-osteolysis morphological matrix; the reasoning logic of failure incidents was established through clinical investigation. Results The minimal synovium thickness and contact stress between the femoral head and the acetabular cup were calculated, and the effect of relevant parameters was studied as theoretical references for wear analysis; the criteria on wear life definition of artificial hip joints were proposed, namely the mechanistic failure due to geometric change in artificial hip joints and the biological failure due to osteolysis; nine kinds of clinical manifestation for wear failure were found; the reasoning route for failure incidents was presented. Conclusions Primary wear process in artificial hip joints includes boundary and mixed friction, adhesive, ploughing and third-body wear; surface quality, fit clearance between the acetabular cup and the femoral head, and roundness have great impact on early abnormal wear; normal mechanistic life of metal-UHMWPE artificial hip joint can reach 40 years, but its maximum biological life is no more than 10-15 years, which is the constraint of prosthesis life today; the diversity of clinical manifestations for wear failure is the morphological Results of mechanical wear and osteolysis, which is helpful for the reasoning route of failure incidents.
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Objective To compare the method based on computational fluid dynamics (CFD) and fluid structure interaction (FSI) with the traditional Reynolds equation method in the study of an artificial hip joint lubrication system. Methods Using business software Adina as a computing platform, the metal-on-metal total hip replacement (MOM THR) model was developed as the subject to establish the rigid and elastic CFD model, respectively. Results The film- thickness curve obtained by the CFD&FSI method had a significant depression in the center, which was more reasonable than that obtained by the traditional Reynolds equation method. The model with elastic surface under the given load showed a significant deformation at the FSI surface of the acetabular cup femoral head, and the deformation was consistent with the pressure and film thickness distribution in fluid field. Conclusions The CFD&FSI method used here was more reasonable than the traditional method when computing the elasto-hydrodynamic lubrication of an artificial hip joint system.
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Objective To develop a wear prediction model for hard-on-hard hip joint replacement under the condition of complex dynamic loading and time-dependent motion, and to apply it to the study on wear prediction of the typical metal-on-metal hip joint replacement in the complicated three-dimensional (3D) physiological motion condition. Methods The finite element model for contact mechanics was established and the fixed-tracked method was adopted to make the dynamic wear reappear on the bearing surface of artificial hip joint with 3D Euler transformation, and the data communication about the corresponding contact and wear for simulation was also made. Results The wear prediction test showed that the spherical bearing geometry of the artificial hip joint gradually became the non-spherical form due to the wear with time; meanwhile, the corresponding contact area was increased, the distribution of the contact pressure tended to be flattened, and the maximum contact pressure was decreased. Conclusions The wear prediction model developed here for metal-on-metal hip joint replacements with bilateral bearing surfaces under the condition of complex dynamic loading and motion could be used to carry out simulation test for the wear prediction of metal-on-metal artificial joint, which provides a new method to understand the wear mechanism of hip joint replacement.
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PURPOSE: This paper is proposing an improved CT-free registration method which may provide us an accurate and reliable placement of acetabular cup without CT/MRI images. DESIGN AND METHODS: The proposed method employs a T-bar shaped gauge placed on the anatomical landmarks of the pelvis for the registration. The T-bar shaped gauge has its own LED markers and the position of the gauge is obtained through OPTOTRAK3020 system. These landmark points are the anterior superior iliac spines and the symphysis pubis defining anterior pelvic plane. Two subjects were tested to compare the landmark based registration and the proposed T-bar based registration. RESULTS: The measurement deviations of the pelvic obliquity in the frontal plane, tilt in the sagittal plane, and rotation in the transverse plane were 2.08, 1.41, and 2.51 degrees respectively in the point based registration. The T-bar based registration produced 40% smaller deviations(p<0.05): the pelvic obliquity in the frontal plane, tilt in the sagittal plane, and rotation in the transverse plane were 0.84, 0.81, and 1.17 degrees respectively in the T-bar based registration. There was no outlier exceeding 5 degrees in measurement deviation by the T-bar based registration while the outliers were found by the landmark based registration. CONCLUSIONS: We found that T-bar based CT free registration method is more reliable and accurate than the landmark based registration for the acetabular cup navigation. Also, the new method produced more precise registration(p<0.05). We are expecting some offset error of the new registration method due to the skin thickness existing between the T-bar frame and the bony pelvic frame, which may be compensated if we may accumulate sufficient database of the offset.
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Acetabulum , Arthroplasty, Replacement, Hip , Pelvis , Skin , SpineABSTRACT
PURPOSE: To propose a method providing an accurate femoral shaping for cementless total hip arthroplasty to maximize bone contact without femoral bone breakage and make secure correct position of the implant by eliminating the manual broach process MATERIALS AND METHODS: 5-cadaver specimens were tested with this system. A reamer-shaped registration gauge is inserted into the femoral canal. This gauge defines the position of the implant to be inserted. Then, the base frame is attached to the femur and the position of the gauge with respect to the base frame is measured. After removing the gauge, a mini robot is mounted on the frame and shapes the femoral canal. After the milling operation, model implant is inserted and its position and gap are measured. RESULTS: Anteversion angle error was 0.9degrees(S.D.1.7) and Varus/Valgus alignment error was 1.1degrees(S.D.1.5). 95%(S.D. 3.2) of contact surface had less than 0.3mm gap error. CONCLUSIONS: Proposed THA surgery system increased the accuracy of stem position and fitness compared with manual operation. Our mini robot THA surgery provides most of the benefits RobodocR does while operating procedure is much more simplified and economic.