Post-Marketing Surveillance of Qishe Pill () Use for Management of Neck Pain in a Chinese Patient Cohort to Determine its Safety, Tolerability and Effectiveness / 中国结合医学杂志

OBJECTIVE@#To evaluate the safety and effectiveness of Qishe Pill () on neck pain in real-world clinical practice.@*METHODS@#A multi-center, prospective, observational surveillance in 8 hospitals across Shanghai was conducted. During patients receiving 4-week Qishe Pill medication, Visual Analogue Scale (VAS) and Neck Disability Index (NDI) assessments have been used to assess their pain and function, while safety monitoring have been observed after 2 and 4 weeks.@*RESULTS@#Results from 2,023 patients (mean age 54.5 years) suggest that the drug exposure per unit of body mass was estimated at 3.41 ± 0.62 g/kg. About 8.5% (172/2,023) of all participants experienced adverse events (AEs), while 3.8% (78/2,023) of all participants experienced adverse reaction. The most common AEs were gastrointestinal events and respiratory events. The VAS score (pain) and NDI score (function) significantly decreased after 4-week treatment. An effect-quantitative analysis was also conducted to show that the normal clinical dosage may be consider as 3-4 g/kg, at which dosage the satisfactory pain-relief effect may achieve by 40-mm reduction in VAS.@*CONCLUSION@#These findings showed that patients with cervical radiculopathy who received Qishe Pill experienced significant improvement on pain and function. (Registration No. NCT01875562).

Surgical exposures of the distal humeral fractures: An anatomical study of the anterior, posterior, medial and lateral approaches / 中华创伤杂志(英文版)

PURPOSE@#Exposure of the articular surface is the key to the successful treatment of intra-articular fractures of distal humerus. Anterior, posterior olecranon osteotomy as well as medial and lateral approaches are the four main approaches to the elbow. The aim of this study was to compare the exposure of distal articular surfaces of these surgical approaches.@*METHODS@#Twelve cadavers were used in this study. Each approach was performed on six elbows according to previously published procedures. After completion of each approach, the exposed articular surfaces were marked by inserting 0.5 mm K-wires along the margins. The elbow was then disarticulated and the exposed articular surfaces were painted. The distal humeral articular surfaces were then closely wrapped using a piece of fibre-glass screen net with meshes. The exposed articular surfaces and the total articular surfaces were calculated by counting the number of meshes, respectively.@*RESULTS@#The average percentages of the exposed articular surfaces for the anterior, posterior olecranon osteotomy, medial and lateral approaches were 45.7% ± 2.0%, 53.9% ± 7.1%, 20.6% ± 4.9% and 28.5% ± 6.3%, respectively.@*CONCLUSION@#The anterior and posterior approaches provide greater exposures of distal humeral articular surface than the medial and lateral ones in the treatment of distal humeral fractures.

Biomechanics effect of screw-rod internal fixation for Tile B2 pelvic fractures / 医用生物力学

Objective To investigate the validity of screw-rod system for fixing pelvic fractures by comparing the biomechanical behaviors from using screw-rod system or steel plate for fixing Tile B2 type pelvic fractures. Methods The finite element models of normal pelvis including ligaments, and Tile B2 fractured pelvis fixed by different screw-rod fixations (2 screws at fractured side, 3 screws at fractured side and at healthy side), and steel plate fixation were established. The vertical load (500 N) was applied on the upper terminal plate of the first body of the sacrum to simulate pelvis load during double-leg standing, single-leg standing and sitting. The displacement and stress distributions on normal pelvis and fractured pelvis with screw-rod fixation or with steel plate fixation were compared and analyzed. Results Both the screw-rod system and steel plate could effectively fix the fractured pelvis, and the fixation models showed similar displacement and stress distribution as normal pelvis. The largest displacement of fractured pelvis with 3-screw fixation on the diseased side was smallest under each working condition, and its stress level was also obviously lower than that of the other internal fixation models. During double-leg standing, compared with 2 screws fixation, 3 screws at healthy side fixation, and steel plate fixation, the Von Mises stress for 3 screws at fractured side fixation was reduced by 30.4%, 20.8%, 20.3%; during single-leg standing, the Von Mises stress for 3 screws at fractured side fixation was reduced by 31.8%,25.4%,18.5%; during sitting, the Von Mises stress for 3 screws at fractured side fixation is reduced by -6.5%,28.0%,61.1%,respectively. Conclusions The screw-rod system can fix Tile B2 pelvic fracture effectively, especially for 3-screw fixation on the fractured side. The results can provide the theory basis for clinical treatment of pelvic fracture.

Biomechanics and imaging evaluation on stable structure of pelvis / 中国骨伤

The treatment of difficulty and prognosis of pelvic fracture are directly related to the pelvic girdle stability. Diagnosis of pelvic fracture is mainly imaging manifestations based on biomechanics of pelvic anatomy. With the progress of biomechanics experiment technology, previousopinion has changed, such as separation of symphysis pubis 2.5 cm could not be seen as distinguishing feature of type I and II for anterior-posterior compression;displacement of sacroilliac joints less than 1 cm could cause loss of vertical stability;lateral extrusion could also cause vertical instability;part description of Young-Burgess classification is not suitable for experiment results;ligament plays an important role in restricting displacement and having proprioceptors;SPECT-CT could improve sensitivity of diagnosis, but could not evaluate stability of pelvic fractures precisely.

Comparison of the effect of total hip arthroplasty through mini invasive direct anterior approach during learning curve period and posterolateral approach for the treatment of femoral head necrosis / 中国骨伤

<p><b>OBJECTIVE</b>To compare clinical results of treating femoral head necrosis staged Ficat III or IV with total hip arthroplasty (THA) between mini invasive direct anterior approach (DAA) and posterolateral approach.</p><p><b>METHODS</b>From January 2008 to December 2009, 48 patients with femoral head necrosis staged Ficat III or IV treated with THA were compared and analyzed. There were 21 patients in mini invasive direct anterior approach group including 11 males and 10 females with an average age of (65.2±4.3) years old;while there were 27 patients in posterolateral approach group including 16 males and 11 females with an average age of (63.6±4.0) years old. Operative time, blood loss during operation, bed rest time and complications of two groups were observed and compared. Acetabular abduction and stem shaft angle were measured 1 month after operation and compared between two groups. Postoperative Harris Hip scoring and VAS scoring were applied for evaluating hip function and pain at 1, 6 months and 5 years after operation respectively.</p><p><b>RESULTS</b>All patients were followed up for 48 to 73 months with an average of 60.4 months. Operative time, blood loss in DAA group was (78.30±5.08) min, (351.30±21.46) ml, respectively, in posterolateral approach group was (75.61±10.60) min, (362.20±26.15) ml, and no significant differences between two groups. Bed rest time in DAA group was (2.05±1.10) days, better than that of in posterolateral approach which was (3.30±1.35) days. No significant differences were found between two groups in acetabular abduction and stem shaft angle at 1 month after operation. There was no significant differences between two groups in HHS and VAS score at 1, 6 months and 5 years after operation. There was 1 case with injury of ascending branch of the lateral circumflex femoral artery, 1 case with great trochanter fracture and 1 case with superficial infection in DAA group, 1 case with dislocation in posterolateral group. No prosthesis loosening occurred in two groups.</p><p><b>CONCLUSIONS</b>Both DAA and posterolateral approach are effective in treating femoral head necrosis staged Ficat III or IV, and could obtain excellent outcomes. However, DAA seemed to has disadvantage in learing curve compared posteriolateral approach in complex cases.</p>

Treatment of distal femur nonunion with bone defect by less invasive stabilization system and fibular strut graft / 中国骨伤

<p><b>OBJECTIVE</b>To evaluate the therapeutic effects of less invasive stabilization system distal femur (LISS-DF) combined with fibular struts graft for distal femur nonunions and bone defects.</p><p><b>METHODS</b>A total of 12 patients with distal femur nonunion and bone defect were underwent revision operation with locked plating, plus a nonvascularized autologous fibular strut bone graft from June 2007 to September 2014, including 10 males and 2 females with an average age of (56.2±14.1) years old ranging from 30 to 77 years old. The mean time from the initial trauma to the last revision operation was (16.4±5.5) months (ranged from 9 to 26 months). All cases were atrophic nonunions according to Weber-Cech classification and type B1 (bone loss) according to Paley classification. All patients were followed up and evaluated with clinical and imaging results. The KSS (American Knee Society Score) scores including knee clinical score and knee functional score were compared before and after the treatment.</p><p><b>RESULTS</b>All patients were followed up from 12 to 17 months with an average of (13.7±1.9) months. All nonunions healed with an average time of (6.2±1.3) months (ranged from 4 to 8 months). The average range of movement (ROM) of the knee was improved from (67.1±29.6)° preoperatively to (102.5±13.6)° at the last follow up. KSS scores including knee pain, range of motion, clinical and functional score were significantly different before and after operation. No such complications as infection, hardware loosening or breakage occurred postoperatively.</p><p><b>CONCLUSIONS</b>LIFF-DF fixation and autologous fibular strut bone graft facilitated the successful treatment of distal femur nonunions with bone defects.</p>

Establishment and validation of finite element model for pelvis artery injury under impacts / 医用生物力学

Objective To construct and validate a 3D finite element model of pelvis-femur-soft tissue complex including artery, and investigate the mechanical response of pelvis artery under side impact loads. Methods The 3D finite element model of the pelvis-femur-soft tissue complex was constructed from CT images of one female volunteer, including bone tissues, arteries, enveloping soft tissues, cartilage and ligaments of the pelvic joints (sacroiliac joint, hip joint and pubic symphysis). The whole model utilized linear elastic solid elements to simulate bone tissues. Nonlinear elastic connector elements were employed to represent ligaments. Soft tissues, including the cartilage, enveloping soft tissues and arteries, were modeled as solid elements with hyper-elastic material. Side impact was conducted on the complex with impact mass of 22.1 kg at the impact velocity of 3.13 and 5 m/s, respectively, and the output of the complex model was then recorded. Results Simulation results matched the results of pelvic side impact experiments reported in literature. When the complex model was impacted at the velocity of 3.31 and 5 m/s, respectively, the maximum equivalent stress of arteries was 98 and 216 kPa, and the maximum principle strain was 14.9% and 20%, respectively. The risk of artery injury was relatively low. Conclusions This established pelvis-femur-artery complex model was validated and thus reliable to be used for investigating the dynamical response and injury analysis on pelvis artery under impact loads, and provides some biomechanical foundation for predicting artery injuries.

Relationship between mineral density and elastic modulus of human cancellous bone / 医用生物力学

Objective To measure the cancellous bone mineral density and axial elastic modulus from multiple anatomic sites, then build the constitutive equation between them, so as to provide specific data for finite element modeling of Chinese people. Methods Ten fresh adult cadavers were taken as sample sources. In every fresh cadaver, 5 different anatomic sites were selected: proximal tibia, greater trochanter, femoral neck, humeral head and lumbar vertebra. The raw samples were processed into standard specimens, which were approximately 6 mm in diameter and 30 mm or 40 mm in length. Both the size and volume for the cancellous bone specimens were measured, and their mineral densities were obtained with computed tomography. The mechanical properties of such specimens were tested with biomechanical testing machine for analyzing the elastic modulus of the cancellous bone at different anatomic sites. The linear and power regression between mineral density and axial elastic modulus were analyzed on SPSS 18.0. Results A total of 169 cancellous bone specimens which were availably tested were collected, including 52 proximal tibia, 31 greater trochanter, 15 femoral neck, 17 humeral head and 54 lumbar vertebrae. The analysis on measurement results showed that the mineral density and axial elastic modulus in cancellous bones from 5 anatomic sites were different, and had a solid linear relationship (0.850>r2>0.785), with 3 sites (proximal tibia, greater trochanter, lumbar vertebra) showing a solid power correlation (0.871>r2>0.825), and the other 2 sites (humeral head and femoral neck) showing relatively weak power correlation (0.671>r2>0.643). Conclusions There are solid linear and power relationship between mineral density and axial elastic modulus, while no significant difference is proved between the r2 values of the two regressions in this research. This discovery can be applied to detect patients’ bone quality in vitro and identify the precise position of bone loss, and further to predict fracture risk with the help of finite element modeling.

Biomechanical effects on sacroiliac fusion for treating low back pain / 医用生物力学

Objective Based on the finite element method, both sacroiliac fusion and sacroiliac contact models were built to compare the biomechanical differences between the two models and to explore the biomechanical mechanism in the treatment of low back pain by sacroiliac fusion. Methods Two pelvic finite element models were constructed, including the pelvic ring, sacrum, part of the femur, ligaments, cartilage and joint contact. The sacroiliac joints were set to be contact in one model and fusion in the other, respectively. Differences in mechanical conduction on the pelvic ring and the stress on the sacroiliac cartilage under 500 N load between the two models were explored. Results For the fusion model, stresses and displacement on the sacroiliac joint were significantly lower than that of the contact model, especially on the sacroiliac cartilage, where the displacement was reduced by 261% from 0.83 mm to 0.23 mm, and the stresses reduced by 32% from 6.6 MPa to 5.0 MPa. However, the transfer of stress on the pelvic ring was relatively more concentrated in the fusion model. Conclusions Sacroiliac fusion may provide better therapeutic effects on the treatment of low back pain, but the risk of disc herniation and femoral head necrosis must be assessed seriously in advance.

Testing of axial stiffness of human pelvis under gradient vertical loads / 医用生物力学

Objective To analyze the axial stiffness of human pelvis that were set with the double support standing posture and subjected to gradient vertical loads. Method Nine intact embalmed cadaver specimens were marked from 1# to 9# according to the test sequence, and then subjected to vertical static loads in the gradient of 100 N from 0 N to 500 N. The load displacement data were collected by using the beam sensor of electronic universal testing machine to calculate the axial stiffness of human pelvis. Results The differences of axial stiffness among individual pelvis were large (P=0.815), ranging from 240 N/mm to 776 N/mm. All the pelvic specimens were divided into three groups by cluster analysis (the first group: 1#、2#、3#、5#、9#, the second group: 4#、6#、8#, the third group: 7#). According to the processed results, there were statistical differences among the groups (P<0.05). The trends of pelvic axial stiffness were different under gradient loads. The axial stiffness of the first and third group, totally six specimens, increased with loads increasing; while the axial stiffness of the second group including three specimens increased first, but then decreased with the loads increasing. Conclusions There are significant individual differences in pelvic axial stiffness and its changing discipline within the physiological range; the cluster analysis can be used to analyze the changing discipline between the load and stiffness of human pelvis; as a whole, the pelvic axial stiffness increased with the loads increasing.

Combination of volar buttress plate with external fixator for the distal radial fractures of type C3 caused by high-energy injuries / 中国骨伤

<p><b>OBJECTIVE</b>To preliminarily explore the effect of combination of volar buttress plate with external fixator for the distal radial fractures of type C3 caused by high-energy injuries.</p><p><b>METHODS</b>From January 2001 to June 2007, 13 patients with distal radial fracture of type C3, 9 males and 4 females aged from 26 to 47 (average 37 years), were treated with volar buttress plate combined with external fixator plus the techniques of K-wires and bone grafting as necessary, whose effects were evaluated preliminarily through comparing the volar tilt, radial inclination, radial shortening and wrist function.</p><p><b>RESULTS</b>Followed up from 7 to 29 months (average 18 months), the volar tilt, radial inclination, radial shortening and wrist function of all patients recovered remarkably. Nine patients achieved excellent and 4 good according to Sarmiento score (modified by Stewart) in the radiological manifestation, while 5 patients displayed excellent, 6 good, and 2 fair according to Gartland-Werley functional assessment system.</p><p><b>CONCLUSION</b>1) Volar buttress plate could support the valor cortex in order to prevent comminuted fragment from displacing and maintain volar tilt and to provide the volar fulcrum for external fixator. 2) External fixator, with the assistance of volar fulcrum, could maintain the volar tilt and the height of distal radius and help unload the fossa. 3) Supplemental K-wires fixation and the bone graft may assist fracture stable.</p>