| BackgroundIn The Yellow Emperor’s Classic of Internal Medicine,a compendium of ancient wisdom,nine exquisite needles grace its pages.Among them,the needle knife stands akin to its counterparts—the sharp needle and the beryllium needle—boasting a slender silhouette with a needle-like form and a narrow blade adorning its apex.This versatile instrument,capable of both needling and precise incisions,finds widespread application in the realm of soft tissue injuries and orthopedic afflictions.Its virtues lie in the swift amelioration of pain and restoration of function,rendering it accessible to a diverse spectrum of individuals.Alas,the limitations inherent to the blind manipulation of the needle knife obstruct the realization of its therapeutic potential,concurrently posing the perils of unintended harm.Consequently,a pressing imperative arises—to forge a visualized needle knife therapy,wherein real-time guidance orchestrates the needle knife’s act of closure and precise lesion localization,thereby transcending the barriers that impede efficacy and entailing untoward risks.The research team has successfully crafted a CT image-based visualized needle knife system,currently in its experimental phase.This innovative system has demonstrated enhanced clinical efficacy in acupuncture therapy,circumventing the peril of "blind"operations that may harm delicate nerves and blood vessels.Through meticulous animal experimentation,the safety of visualized acupuncture has been corroborated,shedding light on facets of acupuncture’s mechanism of action in treating femoral head necrosis.Nonetheless,certain concerns persist regarding the system’s precision and safety,necessitating further refinements.Thus,in a collaborative effort with the translation unit,the research team has meticulously enhanced the software system,hardware instruments,and functional modules via multidisciplinary synergy.Iterative simulation tests were conducted until the fruition of a visualized needle knife orthopedic robot,tailored to meet the exigencies of clinical treatment.This remarkable achievement aims to amplify navigation accuracy,enabling the needle knife treatment to attain meticulous positioning and precise intervention.Ultimately,it aspires to furnish clinicians with an efficient and precise therapeutic modality for femoral head necrosis,bridging the gap in the realm of intelligent implementation of Chinese medicine’s external treatment methods.Objective1.Build a new visualized needle knife orthopedic robot engineering prototype,supporting surgical instruments and software.2.Evaluate the positioning and alignment accuracy of the visualized needle knife orthopedic robot through simulation tests.3.Standardize the application of the visualized needle knife orthopedic robot to improve treatment efficiency and quality.4.To reveal the learning characteristics and patterns of the visualized needle knife orthopedic robot at different stages through exploratory clinical trials,to explore the factors that may affect the learning curve,to understand the training needs of robot operators,and to be able to provide references for the promotion of the robot in clinical applications.5.Evaluate the safety and effectiveness of visualized acupuncture in treating femoral head necrosis,analyze the relevant factors affecting the efficacy of visualized acupuncture therapy in treating femoral head necrosis,provide a theoretical basis and application reference for visualized acupuncture in treating femoral head necrosis,optimize the clinical treatment plan of femoral head necrosis,and further improve the efficacy of the treatment.MethodsThis study aims to analyze the problems and shortcomings of the previous CT visualization needle knife system,optimize the integration of hardware devices,develop adapted surgical instruments,and develop functional modules of computer-aided surgical navigation system,etc.,to build an engineering prototype of the visualization needle knife orthopedic robot,verify the positioning and alignment accuracy through simulation tests,and form a standardized visualization needle knife orthopedic robot.The operation specification.A prospective,single-center,single-arm exploratory innovative medical device clinical trial was used to include 30 patients with femoral head necrosis treated with the visualized needle knife orthopedic robot from December 2022 to February 2023 at The Third Affiliated Hospital of Beijing University of Chinese Medicine,with a total of 46 hips,to analyze the learning characteristics and patterns of the visualized needle knife orthopedic robot at different stages,and to explore the factors affecting the learning curve.And evaluate the safety and effectiveness of the treatment and analyze the relevant factors affecting the efficacy of visualized acupuncture therapy for femoral head necrosis.CHAPTER 1 System implementation of Needle Knife Orthopedic Robot based on Electromagnetic Navigation with Visualization1.1 Taking clinical needs as the guide,we analyzed the problems and shortcomings in the application of the previous CT visualization needle knife system and proposed the construction plan of the new generation visualization needle knife orthopedic robot:optimizing the integrated hardware equipment,developing the adapted surgical instruments,and developing the functional modules of the computer-aided surgical navigation system.1.2 Evaluate the positioning accuracy and alignment accuracy through detection position repeatability test and point cloud alignment test.1.3 Develop standardized operating procedures for the visualized needle knife orthopedic robot and standardize the operating procedures and steps.CHAPTER 2 Exploratory clinical study of electromagnetic navigation-based visualized needle-knife orthopedic robot2.1 This study used a prospective,single-center,single-arm exploratory innovative medical device clinical trial to enroll a total of 30 patients with 46 hips who were seen at The Third Affiliated Hospital of Beijing University of Chinese Medicine from December 2022 to February 2023 and received the visualized small needle orthopedic robot for the treatment of femoral head necrosis.After enrollment,one treatment session was performed,and VAS score,hip mobility,and Harris score were recorded before,1 day,1 week,2 weeks,and 3 months after treatment.The total time of the visualized needle knife robotic procedure(image processing time,alignment time,and treatment time)during treatment was also recorded as well as the NASA-TLX workload form that the surgeon was asked to fill out at the end of each procedure.The CUSUM method was used to calculate the learning curve for the operation time to analyze the characteristics and patterns of learning at different stages and to explore the factors that may affect the learning curve.The workload during the operation was also evaluated.2.2 This study used a prospective,single-center,single-arm exploratory innovative medical device clinical trial to enroll a total of 30 cases and 46 hips of patients who attended The Third Affiliated Hospital of Beijing University of Chinese Medicine from December 2022 to February 2023 and received the visualized small needle orthopedic robot for the treatment of femoral head necrosis.The patients were treated once after enrollment,and one session was recorded before treatment,1 day,1 week,2 weeks and 3 months after treatment,VAS score,hip mobility,Harris score,SF-36 quality of life score,and clinical case data information of the patients were collected by double recording and personal verification,including:medical record number,name,sex,age,height,weight,body mass index(BMI),disease duration,occupation,etiology,International Society for Circulation Research(ARCO)stage,lesion size,joint effusion,and other information.The t-test or non-parametric test was used to analyze the efficacy,and ANOVA was used to compare the differences in the efficacy of relevant factors such as duration of disease,type of occupation,ARCO stage,etiology,lesion size,and degree of joint effusion.Adverse events and complications during acupuncture treatment were recorded.ResultsCHAPTER 1 Implementation of a visually-guided miniaturized robotic needle knife system based on electromagnetic navigation technology.1.1 The technical route to a visualized needle knife orthopedic robot based on electromagnetic navigation was determined.The hardware system integrates electromagnetic navigation into the design of the surgical robot cart,redesigns the magnetic positioning fixture for the needle knife,and integrates magnetic sensors.The computer-aided navigation system has optimized the design of data management,image processing,path planning and simulation,spatial positioning alignment,and visualization guidance system,which has significantly improved the accuracy,speed,and stability of the visualized needle knife orthopedic robot,while reducing the space and resources occupied by the device.After overcoming the above technical difficulties one by one,we finally successfully completed the construction of the engineering prototype of the visualized needle knife orthopedic robot.1.2 The maximum deviation of detection distance mean D was 0.84 mm,1.01 mm,1.12 mm,and 1.08 mm in vertical,rotational,anterior-posterior,and left-right postures,respectively,all of which were less than the design deviation of 1.5 mm,and the point cloud alignment error was(0.91 ± 0.07)mm,with the maximum error of 1.03 mm and the minimum error of 0.69 mm.1.3 A standardized operation procedure for the visualized small needle orthopedic robot was successfully developed.CHAPTER 2 Exploratory clinical study of electromagnetic navigation-based visualized needle-knife orthopedic robot2.1 A total of 30(46 hip)subjects were included in this study for analysis.The learning curve equations showed the minimum number of surgical cases to reach the stage of proficiency were 18 for image processing,15 for alignment,and 16 for total surgical time.Multiple linear regression results showed a significant effect(P<0.05)of the treatment site on the total time of visualized needle surgery,with OT=220.75+10.370*V1+ 15.376*V2+21.832*V3+39.335*V4,where Vn is a dummy variable set according to the different treatment sites,V1 is the apex of the greater trochanter,V2 is the adductor V3 is the hip capsule,and V4 is the gluteus maximus.The results of subjective workload between physicians in group A in the initial learning phase and group B in the later proficiency phase showed significant differences(P<0.01)in scores for psychological demands(6 vs.4 points),time demands(7 vs.3.5 points),performance(5.5 vs.3.5 points),effort(6.5 vs.4 points),and frustration(4.5 vs.2 points).While the difference in physical demands(5 points vs.4 points)was not statistically significant(P>0.05).The difference was statistically significant(P<0.01)before and after in terms of overall workload using the visualized needle orthopedic robot(35.5 vs.19.5 points).2.2 A total of 30 subjects(46 hips)were included in this study for analysis,and the overall treatment results showed that the VAS score before treatment were 5.54± 1.32,and 1 day,1 week,2 weeks,and 3 months after treatment were:4.30 ± 1.17,3.92 ± 1.23,3.31 ± 1.29,and 3.03± 1.01,all of which were better than before treatment,and the differences were statistically The differences were statistically significant(P<0.05).Hip mobility was 184.51 ± 33.73° before treatment and 221.87 ± 40.29°,225.93 ±37.12°,235.30 ± 30.12° and 240.11±38.07° at 1 day,1 week,2 weeks and 3 months after treatment,respectively,all of which were better than before treatment,with statistically significant differences(P<0.05).Harris score before treatment was 66.82 ± 10.98,and 1 day,1 week,2 weeks and 3 months after treatment were:72.03±12.13,73.19 ± 11.88,77.45 ± 13.49 and 85.28 ±12.71,respectively,all of which were better than before treatment,with statistically significant differences(P<0.05).The results of multiple analyses with different factors showed that:(1)the comparison of clinical efficacy of subjects with different disease duration at the first and last follow-up showed that at the first follow-up,hip mobility improved by 25.52°(P<0.05)when comparing the disease duration>1 year and the disease duration<6 months;at the last follow-up,hip mobility improved by 25.75°(P<0.05)when comparing the disease duration from 6 months to 1 year and the disease duration<6 months.At the last follow-up,hip mobility improved by 40.33°(P<0.01)between those with disease duration>1 year and those with disease duration<6 months.That is,subjects with femoral head necrosis of>1 year duration had significantly better improvement in hip mobility after visualized acupuncture treatment than those with duration of disease<6 months and those with duration of disease between 6 months and 1 year.(2)The comparison of clinical efficacy between subjects with different lesion sizes at the first and last follow-up showed that the improvement in hip mobility was 25.33° between large and small lesions at the first follow-up(P<0.05)and 32.09°between large and small lesions at the last follow-up(P<0.01).That is,the improvement in hip mobility after treatment was significantly better in subjects with large femoral head necrosis lesions than in those with small lesions.(3)Comparison of clinical efficacy of subjects with different degrees of joint effusion at the first and last follow-up,at the first follow-up,the improvement of VAS score was 1.29 points(P<0.05)for grade Ⅱ and 0 compared,1.38 points(P<0.05)for grade Ⅲ and 0 compared,1.03 points(P<0.05)for grade Ⅱ and Ⅰ compared,and 1.12 points(P<0.05)for gradeⅢ and Ⅰ compared VAS score improved by 1.12 points(P<0.05);at the final follow-up,VAS score improved by 1.31 points(P<0.05)for grade Ⅱ and 0 comparison,1.06 points(P<0.05)for grade Ⅲ and 0 comparison,and 1.18 points(P<0.05)for grade Ⅱand Ⅰ comparison.That is,subjects with joint effusion level Ⅱ and Ⅲ had significantly better pain relief after treatment than subjects with level 0 and I.The results of the SF-36 quality of life score indicated that the visualized small needle orthopedic robot was effective in improving the physiological condition and quality of life of the subjects(P<0.05).Conclusions:1.This study has built an engineered prototype of the visualized needle knife orthopedic robot by integrating hardware and adopting advanced software technology,which improves the accuracy and safety of complex needle knife treatment and provides a more efficient and safe solution and helps to further promote technological innovation and development in the field of Chinese medicine external treatment.2.The visualized needle knife orthopedic robot has high positioning accuracy and stability,which can meet the needs of clinical applications.3.The learning curve of the visualized needle knife orthopedic robot is divided into the initial learning stage and the later proficiency stage,and the minimum number of cases for experienced orthopedic surgeons to reach the proficiency stage is 16.After reaching the learning curve,the operation time is significantly shortened,and the psychological load of the operator is significantly reduced.At the same time,the limitation of movement in different directions of the hip joint had a significant effect on the total time of the needle knife surgery.According to the results of the learning curve analysis,the initial learning phase needs to focus on the training of alignment to ensure that the operator quickly overcomes the learning curve and masters the key operational skills of the visualized needle knife orthopedic robot.4.The visualized needle knife orthopedic robot can significantly relieve the pain of femoral head necrosis,improve the function of the hip joint,and effectively improve the physiological condition and quality of life of the subjects.The duration of the disease and the size of the lesion before treatment were important factors affecting the improvement of hip mobility by the visualized needle knife orthopedic robot,and the longer the duration of the disease and the larger the lesion,the more obvious the improvement of hip mobility.The degree of joint effusion was an important factor influencing the visualized needle knife orthopedic robot to relieve hip pain,the more serious the degree of joint effusion,the more obvious the pain relief.5.No adverse events and complications occurred during the treatment,which proved that the visualized needle knife orthopedic robot is a safe and reliable treatment method. |
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