Background::A phase II trial on recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) has previously shown its preliminary efficacy in ST elevation myocardial infarction (STEMI) patients. This study was designed as a pivotal postmarketing trial to compare its efficacy and safety with rrecombinant human tissue-type plasminogen activator alteplase (rt-PA) in Chinese patients with STEMI.Methods::In this multicenter, randomized, open-label, non-inferiority trial, patients with acute STEMI were randomly assigned (1:1) to receive an intravenous bolus of 16 mg rhTNK-tPA or an intravenous bolus of 8 mg rt-PA followed by an infusion of 42 mg in 90 min. The primary endpoint was recanalization defined by thrombolysis in myocardial infarction (TIMI) flow grade 2 or 3. The secondary endpoint was clinically justified recanalization. Other endpoints included 30-day major adverse cardiovascular and cerebrovascular events (MACCEs) and safety endpoints.Results::From July 2016 to September 2019, 767 eligible patients were randomly assigned to receive rhTNK-tPA ( n = 384) or rt-PA ( n = 383). Among them, 369 patients had coronary angiography data on TIMI flow, and 711 patients had data on clinically justified recanalization. Both used a –15% difference as the non-inferiority efficacy margin. In comparison to rt-PA, both the proportion of patients with TIMI grade 2 or 3 flow (78.3% [148/189] vs. 81.7% [147/180]; differences: –3.4%; 95% confidence interval [CI]: –11.5%, 4.8%) and clinically justified recanalization (85.4% [305/357] vs. 85.9% [304/354]; difference: –0.5%; 95% CI: –5.6%, 4.7%) in the rhTNK-tPA group were non-inferior. The occurrence of 30-day MACCEs (10.2% [39/384] vs. 11.0% [42/383]; hazard ratio: 0.96; 95% CI: 0.61, 1.50) did not differ significantly between groups. No safety outcomes significantly differed between groups. Conclusion::rhTNK-tPA was non-inferior to rt-PA in the effect of improving recanalization of the infarct-related artery, a validated surrogate of clinical outcomes, among Chinese patients with acute STEMI.Trial registration::www.ClinicalTrials.gov (No. NCT02835534).

High tibial osteotomy (HTO) is an effective treatment for knee osteoarthritis. With the application of bi-planer open wedge osteotomy high tibial osteotomy and new angular stable locking plates, HTO has become more accuracy, minimally invasive and standard, achieved satisfactory long-term treatment outcome. The indications of HTO are expanding. We need to comprehensively consider whether the patient has varus deformity, the location and severity of the deformity, the stage of osteoarthritis, age and the demand of activity, as well as individual factors such as weight, gender, bone condition and joint activity, and strive to give the best individualized treatment to osteoarthritis patients in different stages.

Objective:To investigate the sagittal and torsional changes in the tibia after a medial open wedge high tibial osteotomy (OWHTO) and their correlation with the corrective angle of proximal tibial coronal plane.Methods:A prospective analysis was conducted on patients who underwent OWHTO at Department of Orthopaedic Surgery, Beijing Chaoyang Emergency Medical Center from March 2019 to July 2019.The operation were performed by the same surgeon. X-ray and CT were performed before and 3 days after the operation. The mechanical axis angle (mFTA), medial proximal tibial angle (MPTA), posterior tibial slope (PTS) and tibial torsion angle (TTA) were measured and compared by paired t-test. Pearson correlation coefficient was used to analyze the correlation between the changes of PTS and TTA and the correction angle of MPTA. Results:A total of 13 patients (19 knees) were recruited. There were 9 males (13 knees) and 4 females (6 knees), aged (39.4±14.4) years (range:20 to 60 years). The mFTA improved from (8.1±2.8) degrees preoperatively to (-1.4±1.6) degrees postoperatively ( t=14.819, P=0.000). The MPTA was changed from (81.1±2.4) degrees pre-operatively to (90.4±3.4) degrees postoperatively ( t=-15.579, P=0.000). The PTS decreased from (79.6±3.2) degrees to (76.8±3.1) degrees ( t=9.709, P=0.000). The differences of mFTA, MPTA and PTS were statistically significant. There was no significant difference in TTA between before and after operation ((28.2±1.5) ° vs. (27.3±6.3) °, t=1.925, P=0.070). There was no correlation between the correction angle of MPTA and the change of PTS and TTA ( r=0.384, P=0.105; r=0.321, P=0.181). Conclusions:Even if the intra-operative measures were used to control tibial slope, the PTS still increased significantly after OWHTO, while the TTA has no significant change. No correlation was seen between the change of sagittal and torsional and the corrective angle of proximal tibial coronal plane.

High tibial osteotomy (HTO) is an effective treatment for knee osteoarthritis. With the application of bi-planer open wedge osteotomy high tibial osteotomy and new angular stable locking plates, HTO has become more accuracy, minimally invasive and standard, achieved satisfactory long-term treatment outcome. The indications of HTO are expanding. We need to comprehensively consider whether the patient has varus deformity, the location and severity of the deformity, the stage of osteoarthritis, age and the demand of activity, as well as individual factors such as weight, gender, bone condition and joint activity, and strive to give the best individualized treatment to osteoarthritis patients in different stages.

Objective:To investigate the sagittal and torsional changes in the tibia after a medial open wedge high tibial osteotomy (OWHTO) and their correlation with the corrective angle of proximal tibial coronal plane.Methods:A prospective analysis was conducted on patients who underwent OWHTO at Department of Orthopaedic Surgery, Beijing Chaoyang Emergency Medical Center from March 2019 to July 2019.The operation were performed by the same surgeon. X-ray and CT were performed before and 3 days after the operation. The mechanical axis angle (mFTA), medial proximal tibial angle (MPTA), posterior tibial slope (PTS) and tibial torsion angle (TTA) were measured and compared by paired t-test. Pearson correlation coefficient was used to analyze the correlation between the changes of PTS and TTA and the correction angle of MPTA. Results:A total of 13 patients (19 knees) were recruited. There were 9 males (13 knees) and 4 females (6 knees), aged (39.4±14.4) years (range:20 to 60 years). The mFTA improved from (8.1±2.8) degrees preoperatively to (-1.4±1.6) degrees postoperatively ( t=14.819, P=0.000). The MPTA was changed from (81.1±2.4) degrees pre-operatively to (90.4±3.4) degrees postoperatively ( t=-15.579, P=0.000). The PTS decreased from (79.6±3.2) degrees to (76.8±3.1) degrees ( t=9.709, P=0.000). The differences of mFTA, MPTA and PTS were statistically significant. There was no significant difference in TTA between before and after operation ((28.2±1.5) ° vs. (27.3±6.3) °, t=1.925, P=0.070). There was no correlation between the correction angle of MPTA and the change of PTS and TTA ( r=0.384, P=0.105; r=0.321, P=0.181). Conclusions:Even if the intra-operative measures were used to control tibial slope, the PTS still increased significantly after OWHTO, while the TTA has no significant change. No correlation was seen between the change of sagittal and torsional and the corrective angle of proximal tibial coronal plane.

Objective Perioperative myocardial infarction remains a severe complication in non-cardiac surgery and is one of the major causes of death.Cardiac troponin (cTn) Ⅰ elevation is associated with short-term and long-term mortality.The aim of the study was to assess the proportion rate of cTnⅠ elevation and its clinical characteristics among patients admitted for orthopaedic surgery with or without cardiovascular events.Methods This is a retrospective study including 27 744 patients aged 50 years or older who admitted for orthopaedic surgery from 2009-2015 in Beijing Jishuitan Hospital.Results Two hundred and sixty-five patients [age (71.7±9.9) years] had cTnⅠ level＞ 0.04 μg/L with 66％ (175 patients) of them being female.Among them,59 patients were isolated troponin rise (ITR) (n=59),13 were preoperative acute myocardial infarction (AMI),and 193 were postoperative AMI.The proportion of postoperative AMI was 0.69％.Those patients were more likely to have a history of coronary artery disease or hypertension.Non-ST-segment elevation myocardial infarction (NSTEMI) was more common (93.3％) than ST-segment elevation myocardial infarction in these patients.Most of them did not experience ischemic symptoms.Totally 76.7％ of the AMI occurred within 3 days of surgery;and the in-hospital mortality rate was 10.4％.Conclusions Perioperative elevation of troponin is common in patients undergoing orthopaedic surgery.Most postoperative AMI were NSTEMI and with absent or atypical ischemia symptoms.Monitoring troponin levels and electrocardiograph in at-risk patients is needed to find most of the AMI.

Objective:To describe the surgical technique of direct anterior approach to total hip arthroplasty and to report the early clinical outcomes.Methods: A series of 100 consecutive,unselected patients who had 116 primary total hip arthroplasty surgeries (16 bilateral) done through direct anterior approach from March 11 2015 to June 21 2016 was reviewed.There were 50 male patients and 50 female patients.The average patient age was 51 years,and the average body mass index was 24.69 kg/m2.The preoperative diagnosis included avascular necrosis of femoral head,hip osteoarthritis,osteoarthritis se-condary to acetabular dysplasia,sequelae of hip old infection,ankylosing spondylitis,rheumatoid arthritis and avascular necrosis of femoral head after cannulated screws fixation of femoral neck fracture.There were 7 hips which had surgical history prior to the index hip arthroplasty,including 3 cases with bone graft treatment for avascular necrosis of femoral head through Smith-Peterson approach,2 cases with acetabular shelf procedures for acetabular dysplasia through Smith-Peterson approach,and 2 cases with cannulated screws fixation for femoral neck fracture (internal fixation residual).All were uncemented hips.The stems used in this study included 67 Triloc stems (DePuy company,USA),45 Corail stems (DePuy company,USA),2 Accolade stems (Stryker company,USA),1 Synergy stem (Smith-Nephew company,USA) and 1 Polarstem (Smith-Nephew company,USA).Results: The average follow up period was 8.5 months,the average incision scar length was 10 cm,and the average postoperative Harris score was 93.62.There was 95％ postoperative leg length discrepancy within 3 mm.The average cup inclination angle was 38.7°with 94.8％ in the range of 30° to 50°.The average cup anteversion angle was 14.3° with 94.2％ within the target range of 5° to 25°.The were 15 (12.9％) operative complications,including two femoral perforations (changing stem from Triloc to Corail),three calcar fractures (treated with cerclage wires),four greater trochanter fractures (2 were treated wire tension band,and 2 nondisplaced fractures untreated),one deep infection (debridement and retaining of the prothesis),one superficial infection (debridement),one hematoma and three wound healing complications (debridement).All the complications were successfully treated without any sequelae at the end of the latest follow-up.There was no postoperative dislocation.There was no major nerve and vascular injuries.There were 35 cases (30.2％) reporting symptoms of lateral femoral cutaneous nerve palsy.Conclusion: Direct anterior approach to total hip arthroplasty allows accurate and reproducible cup orientation positioning and leg length restoration and decreases the risk of postoperative dislocation,which is helpful for early rapid postoperative recovery.

Objective To study the changes of serum myeloperoxidase(MPO)in patients with acute ischemic stroke ,and to probe into the relationship of serum MPO with types of carotid atherosclerotic plaques ,the degree of neural function defect and the activi‐ties of daily living (Barthel Index) .Methods Totally 78 cases of patients with acute ischemic stroke was selected as observation ob‐jects .The patients with acute ischemic stroke were divided into good ,medium and poor three groups according to Barthel index . Based on the scoring of neurologic impairment degree from standards of CSS :mild impairment group(0 to 15 points) ,moderate im‐pairment group(16 to 30 points) ,and severe impairment group(31 to 45 points) .Based on the type of atherosclerotic plaques all pa‐tients were divided into soft plaque group ,mixed plaque and hard plaque group .The 1evels of serum MPO was compared between different group .Results The heavier nerve function defect degree ,the levels of serum MPO in patients with ischemic stroke were higher ,and it had significant difference between groups (P<0 .05) .The Barthel index was the better ,the levels of serum MPO was lower .The levels of serum MPO was different among the soft plaque group ,mixed plaque and hard plaque group ,and its were sig‐nificantly different between the three groups ,and the type of atherosclerotic plaque was related to the neural function defect and Barthel index level .Conclusion Ischemic stroke is associated with serum MPO levels ,neurological deficits ,Barthel index and stabil‐ity of atherosclerotic plaque ,and the levels of serum M PO is helpful for judging state of the disease and guiding in clinical diagnosis and treatment .

Objective:To evaluate the effectiveness of Ponseti method in the treatment of congenital talipes equinovarus (CTE) in children older than 6 months. Methods: Ponseti method was used to treat 157 cases (227 feet) of CTE in children older than 6 months. All cases were classified by age and by the degree of deformity severity. The age group classification was: (1) Ⅰ Group (6 months to 12 months),113 feet in 81 cases; (2) ⅡGroup (1 to 3 years old), 78 feet in 52 cases; (3) Ⅲ Group (>3 years old), 36 feet in 24 cases. The degree of deformity of CTE was evaluated with Pirani scoring system. The cases were classified into three groups according to the deformity degree : (1) Mild Group (scoring 1-2. 5) , 85 feet in 56 cases; (2) Moderate Group (scoring 3-4. 5) , 104 feet in 71 cases; (3) Severe Group (scoring 5-6) , 38 feet in 30 cases. A Pirani score of 0-0. 5 is regarded as an excellent result. For each group, we evaluated the number of casts used, the percentage of excellent result according to the Pirani score, and the percentage of percutaneous achillotenotomy. The result was compared among different groups. Results: The overall percentage of excellent result among all cases was 96.92%. A-mong the age groups, the percentage of excellence was not statistically different between Ⅰ Group and Ⅱ Group (P>0. 05). The percentage of excellence was lower in the Ⅲ group than the other groups (P> 0. 01). Among the groups classified by deformity degree, the percentage of excellence was the lowest in severe group (P<0. 05), and the difference between the mild group and moderate group was not statistically different (P>0. 05). The number of casts used among different groups were different (P<0. 01). Among different groups, the percentages of percutaneous achillotenotomy were significantly different (P<0. 01). 209 feet in 148 caseswere followed up for average time duration of 3 years and 11 months. Re-lapse was observed in 40 feet in 29 cases. The percentages of relapse were not statistically different among different groups (P>0. 05). Conclusion: Using Ponseti method to treat CTE for children older than 6 months can achieve excellent results in this study.

Biodegradable magnesium-alloy stents have been employed in animal experiments and clinical researches in recent years. Magnesium-alloy stents have been reported to be biocompatible, and degradable due to corrosion after being implanted into blood vessel. However, magnesium alloy is brittle compared with stainless steel. This may cause strut break under large deformation. In this paper, a finite element model of magnesium-alloy stent was set up, with reference to pictures from Biotronik Corporation, to simulate the expanding and bending processes. The results of analysis show that the maximum strain during expanding reaches 20%, being greater than the elongation limit of the commercially available magnesium alloys. Therefore, to avoid strut breakage during expanding, the magnesium alloys should be custom-made. The plasticity of the material should be improved by grain refinement processes before practicable magnesium-alloy stents could be developed.
Absorbable Implants ; Alloys ; Angioplasty, Balloon, Coronary ; instrumentation ; Finite Element Analysis ; Humans ; Magnesium ; Materials Testing ; Prosthesis Design ; Stents ; Stress, Mechanical ; Surface Properties