1.Oral Herombopag Olamine and subcutaneous recombinant human thrombopoietin after haploidentical hematopoietic stem cell transplantation
Dai KONG ; Xinkai WANG ; Wenhui ZHANG ; Xiaohang PEI ; Cheng LIAN ; Xiaona NIU ; Honggang GUO ; Junwei NIU ; Zunmin ZHU ; Zhongwen LIU
Chinese Journal of Tissue Engineering Research 2025;29(1):1-7
BACKGROUND:Allogeneic hematopoietic stem cell transplantation is an important treatment for malignant hematological diseases,and delayed postoperative platelet implantation is a common complication that seriously affects the quality of patient survival;however,there are no standard protocols to improve platelet implantation rates and prevent platelet implantation delays. OBJECTIVE:To compare the safety and efficacy of oral Herombopag Olamine versus subcutaneous recombinant human thrombopoietin for promoting platelet implantation in patients with malignant hematological diseases undergoing haploid hematopoietic stem cell transplantation. METHODS:Clinical data of 163 patients with malignant hematological diseases who underwent haploidentical hematopoietic stem cell transplantation from January 2016 to October 2022 were retrospectively analyzed.A total of 72 patients who started to subcutaneously inject recombinant human thrombopoietin at+2 days were categorized into the recombinant human thrombopoietin group;a total of 27 patients who started to orally take Herombopag Olamine at+2 days were categorized into the Herombopag Olamine group;and 64 patients who did not apply Herombopag Olamine or recombinant human thrombopoietin were categorized into the blank control group.The implantation status,incidence of acute graft-versus-host disease of degree II-IV within 100 days,1-year survival rate,1-year recurrence rate,and safety were analyzed in the three groups. RESULTS AND CONCLUSION:(1)The average follow-up time was 52(12-87)months.The implantation time of neutrophils in the blank control group,recombinant human thrombopoietin group,and Herombopag Olamine group was(12.95±3.88)days,(14.04±3.71)days,and(13.89±2.74)days,respectively,with no statistically significant difference(P=0.352);the implantation time of platelets was(15.16±6.27)days,(17.67±6.52)days,and(17.00±4.75)days,with no statistically significant difference(P=0.287).(2)The complete platelet implantation rate on day 60 was 64.06%,90.28%,and 92.59%,respectively,and the difference was statistically significant(P<0.001).The subgroup analysis showed that the difference between the blank control group and the recombinant human thrombopoietin group was statistically significant(P<0.001),and the difference between the blank control group and the Herombopag Olamine group was statistically significant(P=0.004).The difference was not statistically significant between the recombinant human thrombopoietin group and Herombopag Olamine group(P=0.535).(3)100-day II-IV degree acute graft-versus-host disease incidence in the blank control group,recombinant human thrombopoietin group,and Herombopag Olamine group were 25.00%,30.56%,and 25.93%,respectively,and the difference was not statistically significant(P=0.752).(4)The incidence of cytomegalovirus anemia,cytomegalovirus pneumonia,and hepatic function injury had no statistical difference among the three groups(P>0.05).(5)During the follow-up period,there was no thrombotic event in any of the three groups of patients.(6)The results showed that recombinant human thrombopoietin and Herombopag Olamine could improve the platelet implantation rate of malignant hematological disease patients after haploidentical hematopoietic stem cell transplantation,with comparable efficacy and good safety.
2.Analysis of factors associated with spread through air spaces(STAS) of small adenocarcinomas(≤2 cm) in peripheral stage ⅠA lungs and modeling of nomograms
Jing FENG ; Wei SHAO ; Xiayin CAO ; Jia LIU ; Jialei MING ; Ya’nan ZHANG ; Jianbing YIN ; Jin CHEN ; Honggang KE ; Lei CUI
Chinese Journal of Thoracic and Cardiovascular Surgery 2024;40(3):129-136
Objective:To investigate the relationship between spread through air spaces(STAS) of peripheral stage ⅠA small adenocarcinoma of the lung(≤2 cm) and related factors such as clinical and CT morphological features, and to construct a nomogram model.Methods:Relevant clinical, pathological and imaging data of patients who underwent lung surgery and were diagnosed as peripheral stage ⅠA small lung adenocarcinoma by postoperative pathology in the Affiliated Hospital of Nantong University from 2017 to 2022 were collected, of which cases that met the inclusion criteria from 2017 to 2021 served as the training group, and those that met the inclusion criteria in 2022 served as the validation group. The independent risk factors for the occurrence of STAS in peripheral stage ⅠA lung small adenocarcinoma were investigated by using univariate analysis and multifactorial logistic regression analysis, based on which a nomogram prediction model was constructed, and the subjects were analyzed by using the receiver operating characteristic curve( ROC), correction model, etc. were used to evaluate the model. Results:A total of 430 patients who met the criteria were included, including 351 patients in the training group(109 STAS-positive and 242 STAS-negative) and 79 patients in the validation group(23 STAS-positive and 56 STAS-negative). Univariate analysis showed that the patients in the two groups showed a significant difference in age(>58 years old), gender, smoking history, tumor location(subpleural, non-subpleural), pleural pull, nodule type, nodule maximal diameter, solid component maximal diameter, consolidation tumor ratio(CTR), lobulation sign, burr sign, bronchial truncation sign, vascular sign(includes thickening and distortion of blood vessels in/around the nodes), satellite lesions, and ground-glass band sign were statistically significant( P<0.05). The results of multifactorial logistic regression analysis showed that CTR( OR=4.98, P<0.001), lobulation sign( OR=4.07, P=0.013), burr sign( OR=3.66, P<0.001), and satellite lesions( OR=3.56, P=0.009) were the independent risk factors for the occurrence of STAS. Applying the above factors to construct the nomogram model and validate the model, the results showed that the ROC curve was plotted by the nomogram prediction model, and the area under the ROC curve( AUC) of the training set was 0.840(sensitivity 0.835, specificity 0.734), and the validation set had an AUC value of 0.852(sensitivity 0.786, specificity 0.783), and the training set and validation set calibration curves have good overlap with the ideal curve. Conclusion:CTR, lobular sign, burr sign, and satellite lesions are independent risk factors for STAS, and the nomogram model constructed in this study has good predictive value.
3.Preliminary teaching application of a new microsurgery simulation training platform based on real clinical scenarios
Lei CUI ; Yan HAN ; Yuting WANG ; Zeya ZHANG ; Guojun YANG ; Zhaoqi TAN ; Honggang SU ; Yudi HAN
Chinese Journal of Plastic Surgery 2024;40(3):318-324
Objective:A microsurgical simulation training device based on real clinical scenes was designed and its effectiveness was tested.Methods:From January 1, 2020 to January 1, 2023, postgraduate students in the Plastic and Reconstructive Surgery Department of the First Medical Center of PLA General Hospital and the Plastic Surgery Hospital of Chinese Academy of Medical Sciences were enrolled in this prospective study. The simulation training device consists of four parts: (1)Blood perfusion system, which is used to simulate living animal blood vessels.(2)The inner baffling rod system, which is used to simulate the operation in deep cavity.(3) The exterior baffling rod system, which is used to simulate the operation in difficult positions.(4) A pulsating platform system is used to simulate microsurgery under the influence of respiratory movement. Preliminary verification of the effect of the simulated training device was as follows: Surgeons with no experience in microsurgery were completely randomized assigned to the control group (traditional microsurgery training group) and the experimental group (training group using the simulated training device). After 4 weeks of microsurgical training, the trainees were assigned to perform two surgical skill assessments, the first using a live animal model for end-to-end anastomosis of rat tail arteries, and the second assessment using end-to-end anastomosis of free latissimus dorsi flap arteries in a real case. The performance of the two groups was compared by using operation time and microsurgical GRS score scale including four items of dexterity, visuospatial ability, operative flow and judgment. Chi-squared test was used to analyze gender between the two groups. GRS scores between the two groups were compared by the Mann-Whitney U test. Participants’ ageand operation time between the two groups was compared by independent t-test. P<0.05 was considered statistically significant. Results:A total of 18 trainees were enrolled, including 10 in the control group, 6 males and 4 females, with an average age of (27.80±1.87) years. There were 8 subjects in the experimental group, 4 males and 4 females, with an average age of (28.10±1.56) years old. There were no significant differences in age, gender and other baseline characteristics between the two groups ( P>0.05). There was no significant difference in GRS score and operation time between the control group and the experimental group ( P> 0.05) in the first assessment. However, in the second assessment of real cases, the GRS score of the experimental group was significantly higher than that of the control group(14.25 vs. 5.70), and the operation duration of the experimental group was also shorter than that of the control group, and the difference was statistically significant[(100.37±24.65 ) min vs. (105.60±22.84) min] ( P<0.05). Conclusion:Compared with traditional microsurgery training methods, using microsurgery training devices based on clinical real scenes can effectively shorten the learning curve and enable trainees to master complex micromanipulation skills more quickly.
4.Overview of animal models of idiopathic inflammatory myopathy-associated interstitial lung disease
Zhichao LIU ; Xiaohe LI ; Honggang ZHOU ; Na ZHANG
Tianjin Medical Journal 2024;52(7):709-713
Idiopathic inflammatory myopathy(IIM)is a heterogeneous autoimmune disease of unknown etiology characterized by proximal limb muscle involvement and chronic inflammation.Multiple systems may be involved,with interstitial lung disease(ILD)being the most common manifestation of respiratory system involvement in IIM.This article summarizes the current methods of myositis animal models and myositis-associated ILD model construction methods,so as to provide reference for the subsequent construction and research of IIM-ILD models.
5.Study on the Medication Law of Postoperative Treatment of Colorectal Cancer by Piao Bingkui Based on Data Mining
Xin CHEN ; Feibiao XIE ; Runshun ZHANG ; Jin GAO ; Huibo YU ; Susu MA ; Honggang ZHENG ; Baojin HUA
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(10):24-30
Objective To study the medication law of postoperative treatment of colorectal cancer by national TCM doctor Professor Piao Bingkui.Methods Professor Piao Bingkui's electronic medical records and paper medical records of colorectal cancer postoperative patients at Guang'anmen Hospital,China Academy of Chinese Medical Sciences and Beijing Yiqingtang Chinese Medicine Clinic were collected and organized from their outpatients from January 1st,2002 to February 28th,2022.R4.2.1 was used to study the prescriptions,including high-frequency drugs,drug types,properties of Chinese materia medica,yin yang and five elements and dosage of drugs,as well as the law of multi-drug association in postoperative patients with colorectal cancer.Results Totally 642 colorectal postoperative cancer patients were included,involving 2 226 prescriptions,180 kinds of Chinese materia medica,and a total frequency of 39 988 times.The high-frequency drugs were Astragali Radix,fried Aurantii Fructus with wheat bran,Dioscoreae Rhizoma,etc.The main drugs in terms of efficacy were tonics for tonifying deficiency,disinfectants,etc.;the main properties were warm and neutral,the main tastes were sweet,pungent and bitter,and the main meridians were spleen meridians and stomach meridians.Ascending medicines were often used,and the drug were basically non-toxic.The frequency of using yang tonifying medicine was high,and the five elements were commonly used as local medicines;the dosage was mostly 10,15 and 20 g.The complex network analysis and clustering analysis of the association between multiple drugs found that Professor Piao Bingkui's basic prescription for treating colorectal cancer included Astragali Radix,fried Aurantii Fructus with wheat bran,Dioscoreae Rhizoma,salt Alpiniae Oxyphyllae Fructus,Citri Reticulatae Pericarpium,Smilacis Glabrae Rhizoma,Pseudostellariae Radix,and fried Atractylodis Macrocephalae Rhizoma with wheat bran.Conclusion In the treatment of colorectal cancer,Professor Piao Bingkui focuses on reinforcing the healthy qi,nourishing spleen and stomach function,combined with detoxication method and clearing heat,expelling phlegm and dampness,guiding stagnation and dispelling stasis methods,making syndrome differentiation as well as tonifying and benefiting qi,regulating qi movement,so as to realize the"treating middle-energizer as balance"and achieve mild level when treating colorectal cancer.
6.Clinical features of hereditary leiomyomatosis and renal cell carcinoma syndrome-associated renal cell carcinoma: a multi-center real-world retrospective study
Yunze XU ; Wen KONG ; Ming CAO ; Guangxi SUN ; Jinge ZHAO ; Songyang LIU ; Zhiling ZHANG ; Liru HE ; Xiaoqun YANG ; Haizhou ZHANG ; Lieyu XU ; Yanfei YU ; Hang WANG ; Honggang QI ; Tianyuan XU ; Bo YANG ; Yichu YUAN ; Dongning CHEN ; Dengqiang LIN ; Fangjian ZHOU ; Qiang WEI ; Wei XUE ; Xin MA ; Pei DONG ; Hao ZENG ; Jin ZHANG
Chinese Journal of Urology 2024;45(3):161-167
Objective:To investigate the clinical features and therapeutic efficacy of patients with hereditary leiomyomatosis and renal cell carcinoma(RCC) syndrome-associated RCC (HLRCC-RCC) in China.Methods:The clinical data of 119 HLRCC-RCC patients with fumarate hydratase (FH) germline mutation confirmed by genetic diagnosis from 15 medical centers nationwide from January 2008 to December 2021 were retrospectively analyzed. Among them, 73 were male and 46 were female. The median age was 38(13, 74) years. The median tumor diameter was 6.5 (1.0, 20.5) cm. There were 38 cases (31.9%) in stage Ⅰ-Ⅱand 81 cases (68.1%) in stage Ⅲ-Ⅳ. In this group, only 11 of 119 HLRCC-RCC patients presented with skin smooth muscle tumors, and 44 of 46 female HLRCC-RCC patients had a history of uterine fibroids. The pathological characteristics, treatment methods, prognosis and survival of the patients were summarized.Results:A total of 86 patients underwent surgical treatment, including 70 cases of radical nephrectomy, 5 cases of partial nephrectomy, and 11 cases of reductive nephrectomy. The other 33 patients with newly diagnosed metastasis underwent renal puncture biopsy. The results of genetic testing showed that 94 patients had FH gene point mutation, 18 had FH gene insertion/deletion mutation, 4 had FH gene splicing mutation, 2 had FH gene large fragment deletion and 1 had FH gene copy number mutation. Immunohistochemical staining showed strong 2-succinocysteine (2-SC) positive and FH negative in 113 patients. A total of 102 patients received systematic treatment, including 44 newly diagnosed patients with metastasis and 58 patients with postoperative metastasis. Among them, 33 patients were treated with tyrosine kinase inhibitor (TKI) combined with immune checkpoint inhibitor (ICI), 8 patients were treated with bevacizumab combined with erlotinib, and 61 patients were treated with TKI monotherapy. Survival analysis showed that the median progression-free survival (PFS) of TKI combined with ICI was 18 (5, 38) months, and the median overall survival (OS) was not reached. The median PFS and OS were 12 (5, 14) months and 30 (10, 32) months in the bevacizumab combined with erlotinib treatment group, respectively. The median PFS and OS were 10 (3, 64) months and 44 (10, 74) months in the TKI monotherapy group, respectively. PFS ( P=0.009) and OS ( P=0.006) in TKI combined with ICI group were better than those in bevacizumab combined with erlotinib group. The median PFS ( P=0.003) and median OS ( P=0.028) in TKI combined with ICI group were better than those in TKI monotherapy group. Conclusions:HLRCC-RCC is rare but has a high degree of malignancy, poor prognosis and familial genetic characteristics. Immunohistochemical staining with strong positive 2-SC and negative FH can provide an important basis for clinical diagnosis. Genetic detection of FH gene germ line mutation can confirm the diagnosis. The preliminary study results confirmed that TKI combined with ICI had a good clinical effect, but it needs to be confirmed by the results of a large sample multi-center randomized controlled clinical study.
7.Preliminary teaching application of a new microsurgery simulation training platform based on real clinical scenarios
Lei CUI ; Yan HAN ; Yuting WANG ; Zeya ZHANG ; Guojun YANG ; Zhaoqi TAN ; Honggang SU ; Yudi HAN
Chinese Journal of Plastic Surgery 2024;40(3):318-324
Objective:A microsurgical simulation training device based on real clinical scenes was designed and its effectiveness was tested.Methods:From January 1, 2020 to January 1, 2023, postgraduate students in the Plastic and Reconstructive Surgery Department of the First Medical Center of PLA General Hospital and the Plastic Surgery Hospital of Chinese Academy of Medical Sciences were enrolled in this prospective study. The simulation training device consists of four parts: (1)Blood perfusion system, which is used to simulate living animal blood vessels.(2)The inner baffling rod system, which is used to simulate the operation in deep cavity.(3) The exterior baffling rod system, which is used to simulate the operation in difficult positions.(4) A pulsating platform system is used to simulate microsurgery under the influence of respiratory movement. Preliminary verification of the effect of the simulated training device was as follows: Surgeons with no experience in microsurgery were completely randomized assigned to the control group (traditional microsurgery training group) and the experimental group (training group using the simulated training device). After 4 weeks of microsurgical training, the trainees were assigned to perform two surgical skill assessments, the first using a live animal model for end-to-end anastomosis of rat tail arteries, and the second assessment using end-to-end anastomosis of free latissimus dorsi flap arteries in a real case. The performance of the two groups was compared by using operation time and microsurgical GRS score scale including four items of dexterity, visuospatial ability, operative flow and judgment. Chi-squared test was used to analyze gender between the two groups. GRS scores between the two groups were compared by the Mann-Whitney U test. Participants’ ageand operation time between the two groups was compared by independent t-test. P<0.05 was considered statistically significant. Results:A total of 18 trainees were enrolled, including 10 in the control group, 6 males and 4 females, with an average age of (27.80±1.87) years. There were 8 subjects in the experimental group, 4 males and 4 females, with an average age of (28.10±1.56) years old. There were no significant differences in age, gender and other baseline characteristics between the two groups ( P>0.05). There was no significant difference in GRS score and operation time between the control group and the experimental group ( P> 0.05) in the first assessment. However, in the second assessment of real cases, the GRS score of the experimental group was significantly higher than that of the control group(14.25 vs. 5.70), and the operation duration of the experimental group was also shorter than that of the control group, and the difference was statistically significant[(100.37±24.65 ) min vs. (105.60±22.84) min] ( P<0.05). Conclusion:Compared with traditional microsurgery training methods, using microsurgery training devices based on clinical real scenes can effectively shorten the learning curve and enable trainees to master complex micromanipulation skills more quickly.
8.Development and validation of a feature visualization prediction system for invasion depth of superficial esophageal squamous cell carcinoma
Renquan LUO ; Lihui ZHANG ; Chaijie LUO ; Honggang YU
Chinese Journal of Digestive Endoscopy 2024;41(10):774-781
Objective:To construct a feature visualization system utilizing deep learning for superficial esophageal squamous cell carcinoma (SESCC) under magnifying endoscopy with narrow band imaging (ME-NBI) to predict the infiltration depth of SESCC.Methods:The feature visualization system consisted of four models: two for segmenting the intrapapillary capillary loops (IPCL) area and avascular area (AVA) in ME-NBI images of SESCC lesions (models 1 and 2, respectively), one for obtaining the principal component of color (PCC) in ME-NBI images of SESCC lesions (model 3), and another for automatically predicting the depth of SESCC infiltration based on the features extracted from the first three models (model 4). A total of 2 341 ME-NBI images of SESCC lesions from April 2016 to October 2021 were used to develop the feature visualization system, which was divided into 3 datasets: dataset 1 (1 077 ME-NBI images) was used to train and test models 1-3, dataset 2 (1 069 ME-NBI images) was expanded by 20 times through feature combination to generate 21 380 feature synthetic images to train and test model 4, and dataset 3 (195 ME-NBI images), containing 146 ME-NBI images with lesion invasion depth from the epithelium to the upper 1/3 of the submucosa (EP-SM1), and 49 ME-NBI images with lesion invasion depth from the middle 1/3 to the lower 1/3 of the submucosa (SM2-SM3), was used to validate the diagnostic performance of the feature visualization system in predicting the invasion depth of SESCC (EP-SM1/SM2-SM3). In order to evaluate the superiority of the feature visualization system, the prediction results of dataset 3 of the traditional deep learning system (trained directly with ME-NBI images), single-item feature models (single-item IPCL feature model, single-item AVA feature model and single-item PCC feature model) were compared with the prediction results of the feature visualization system. In order to evaluate the clinical utility of the feature visualization system, 4 expert physicians (with more than 10 years of endoscopic operation, expert physician group) and 5 senior physicians (with more than 5 years of endoscopic operation, senior physician group) were invited to participate in the human-computer competition to diagnose dataset 3, and the results were compared with the feature visualization system.Results:The accuracy, sensitivity and specificity of the feature visualization system in predicting the invasion depth of SESCC (EP-SM1/SM2-SM3) were 83.08% (162/195), 82.88% (121/146) and 83.67% (41/49), respectively. The above indicators were 60.00% (117/195), 52.05% (76/146) and 83.67% (41/49) for the traditional deep learning system, 74.87% (146/195), 75.34% (110/146) and 73.47% (36/49) for the single IPCL feature model, 58.97% (115/195), 60.27% (88/146) and 55.10% (27/49) for single AVA feature model, 71.28% (139/195), 71.23% (104/146) and 71.43% (35/49) for single PCC feature model, respectively. The results were 66.67%, 78.22% and 32.24% in senior physician group, and 72.31%, 85.96% and 31.63% in expert physician group, respectively. The accuracy of the feature visualization system in predicting the invasion depth of SESCC was significantly higher than that of the other 6 groups ( P<0.05). The sensitivity of feature visualization system was slightly higher than that of senior physician group ( χ2=1.59, P=0.21) and single-item IPCL feature model ( χ2=2.51, P=0.11), slightly lower than that of expert physician group ( χ2=0.89, P=0.35), and significantly higher than that of three other groups ( P<0.05). The specificity of the feature visualization system was similar to the traditional deep learning system ( χ2=0.00, P=1.00), slightly higher than that of single-item IPCL feature model ( χ2=1.52, P=0.22) and single-item PCC feature model (χ2=2.11, P=0.15), and significantly higher than that of the single AVA feature model ( χ2=9.42, P<0.01), senior physician group ( χ2=44.71, P<0.01) and expert physician group ( χ2=43.57, P<0.01). Conclusion:The developed deep learning-based feature visualization system using ME-NBI shows excellent diagnostic performance in predicting the infiltration depth of SESCC (EP-SM1/SM2-SM3), surpassing the accuracy levels of experienced endoscopists with over 10 years of experience.
9.Cost-effectiveness of Artificial Intelligence-assisted Endoscopy Screening in Countries With High Incidence of Gastric Cancer
Xia TAN ; Liwen YAO ; Lihui ZHANG ; Chen CHEN ; Honggang YU
Chinese Journal of Gastroenterology 2023;28(9):513-522
Background:Slight mucosal lesions in the early stage of gastric cancer(GC)are difficult to recognize,and the miss rate of early GC by conventional endoscopy is high.Artificial intelligence(AI)systems can assist in the identification of gastric neoplastic lesions and reduce miss rate,but it is not clear whether AI-assisted endoscopic screening is cost-effective.Aims:The subjects of this study were to evaluate the cost-effectiveness of a population-based endoscopy screening program for GC in high-incidence countries(China,Japan and South Korea),and to explore the applicability of domestic AI--Intelligent and real-time endoscopy analytical device(IREAD)-assisted endoscopy for GC screening in these three countries.Methods:Based on the natural history of GC,a Markov model with cycle year of 1 year was constructed to compare cost-effectiveness of two strategies for GC screening in recommended age group:no screening(the control strategy),conventional endoscopy screening and IREAD-assisted endoscopy screening.Data such as transition probabilities of different states and treatment costs were obtained from previously published studies.The cost-effectiveness analysis was conducted from the perspective of society by calculating cost,Quality adjusted life years(QALY),Incremental cost effectiveness ratio(ICER).Results:The cohort results showed that 15.87%and 24.52%of GC-related deaths could be respectively avoid by conventional endoscopy screening and IREAD-assisted endoscopy screening in China,which the screening effects were similar to Japan;In South Korea,Conventional endoscopic screening and IREAD-assisted endoscopic screening averted 41.34%and 53.15%of GC-related deaths,respectively.Between the two strategies,IREAD-assisted endoscopic screening is more economic,with ICER of $34 827.61/QALY,$87 978.71/QALY and $10 574.30/QALY in China,Japan and South Korea,respectively,which were lower than the willingness-to-pay(WTP)threshold.Conclusions:When the threshold of WTP is 3 times Gross domestic product per capita,the application of AI-assisted endoscopy for GC screening in age-specific population in high-incidence countries may be more cost-effective.Meanwhile,this study provides important evidence for the promotion of domestic IRAED-assisted endoscopy in GC screening in China,Japan and South Korea.
10.The application of restricted kinematic alignment in total knee arthroplasty
Zhiqiang SHAO ; Dengxian WU ; Honggang CAI ; Zheng LIU ; Kai SONG ; Xiaofeng ZHANG ; Zhihong XU ; Qing JIANG
Chinese Journal of Orthopaedics 2023;43(16):1076-1084
Objective:To investigate the feasibility and therapeutic effect of total knee arthroplasty (TKA) with cruciate-retaining (CR) prosthesis by using FEM-X1 femoral extramedullary positioning instrument based on the theory of restricted kinematic alignment (rKA).Methods:Thirty five cases who underwent total knee arthroplasty in Nanjing Drum Tower Hospital from November 2019 to December 2020 were retrospectively analyzed, including 7 males and 28 females with an average age of 71± 8 years (ranging from 55 to 85 years) Following the guidance of rKA alignment, the FEM-X1 femoral extramedullary positioning instrument was used for TKA with CR prosthesis. Before the operation, the full-length lower limb radiographs of both anteroposterior and lateral views were taken in a standing position for preoperative assessment of lateral distal femoral angle (LDFA), the medial proximal tibial angle (MPTA) and hip-knee-ankle angle (HKA). According to the principle of rKA alignment, the target LDFA, MPTA and HKA were calculated. The proximal end of tibia and distal end of femur were cut using extramedullary positioning instrument respectively. The posterior femoral condyle was cut according to the tibial plateau and mediolateral soft tissue tension. The prosthesis was installed after osteotomy. The release of collateral ligaments, PCL function, release of PCL, patellofemoral trajectory, release of patellofemoral support band, the amount of blood loss and time of operation were recorded. Postoperative LDFA, MPTA, HKA, and posterior slope angle of tibial prosthesis were measured on X-ray images. The Knee Society Score (KSS) was used for functional evaluation.Results:Thirty five cases of TKA with CR prosthesis following rKA alignment were successfully completed. The operation time was 100 (90, 110) min, and the blood loss was 100 (100, 200) ml. 30 of them were followed up for 12.5±0.7 months (ranging from 12 to 14 months). The pre-operative and post-operative LDFA were 1.0°(-2.0°, 4.0°), 0°(-2.0°, 2.0°), MPTA were -4.0°(-5.0°, -1.0°), -2.0°(-3.0°, -1.0°), HKA were -3.0°(-3.0°, -1.0°), -2.0°(-3.0°, -1.0°). There was no significant difference between the three angles before and after operation ( Z=-0.89, P=0.372; Z=1.87, P=0.061; Z=1.03, P=0.302). The average posterior tibial slope was 5°(3°, 7°). At the follow-up of one year, the KSS clinical score was 94(92, 97) and functional score was 80(70, 90) in 30 cases. During the operation, PCL was released in 1 case because of excessive tension; and lateral retinacular release was performed in 1 case because of poor patellofemoral track. Conclusion:ITKA with CR prosthesis by using the extramedullary positioning instrument on the theory of rKA alignment showed a good clinical outcome at a short follow up.

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