Study On The Application Of The Guide In The Osteotomy

BackgroundIn the last century forty or fifty’s, the Russian orthopedics doctor, Gavriiil.A Ilizarov,developed a multi-purpose ring external fixation to treat bone fracture. By an accident of history, after finished the extension of the tibial osteotomy to one patient,he left hospital for business,and didn’t do the same work as Warner’s extend methods of Internal fixation and bone grafting, he was surprised to found the retractor bone defect area was filled with new bone. Additional,when he gave a knee compress fusion to one patient,he told the patient to rotate the screw nut at the direction of bone fracture fragments pressurizing,but the patient made a mistake,he had rotated the screw nut at the opposite direction,and made the fracture ends extended.One month later,when the patient came back to hospital,the X-ray examination showed that the extended end of the fracture was full of callus. These two cases of accidental phenomenon made Gavriiil.A Ilizarov recognized that not only compress could promote the bone healing,but also Slow traction could promote bone regeneration. To further understand this kind of imagination, Gavriiil.A Ilizarov conducted animal experiments,he broken the dog’s legs and proceeded slowly drawing after installation of external fixation, and he made success, which Initially confirmed the theory that stress to bone ends may induce bone regeneration. Ilizarov applied the discovery in the clinical, and success to treat many patients which had bone defects,limb deformities or infected bone defect. Through his repeated practice and summary, Ilizarov put forward the theory "distaction organization",which believed when given slow, continuous draw tension, biological tissue could regenerate and grow actively,and Its growth pattern was consistent with the fetal tissue, which was both cell mitosis. As to bone regeneration, it claimed as "distaction bone regeneration". And this theory was considered as the 20th century landmark discovery and innovation in orthopedics.After the success of clinical, Gavriiil.A Ilizarov promoted his theory to the outside world Actively, but the process is not smooth. In 1951, He had gone to Moscow to show his external fixator and the theory, and claim for patent, but was rejected by the orthopedic experts and the Patent Office. In 1968, Gavriiil.A Ilizarov successfully cured an Olympic high jump champion (Valery Brumel) who had suffered failure surgery many times in Moscow. The Olympic high jump champion was suffering Osteomyelitis and bone defect at the lower end of the tibia, but next year after the treatment, he returned to playing fields and succeeded to jump to the height more than 2 meters. After that, Ilizarov became famous through the Soviet Union and his theory also got admited. In order to better use and promotion of the technology, the former Soviet Union Invested heavily in Kurgan to built Ilizarov orthopedic reconstruction and trauma centers and "Soviet youth trauma and orthopedic surgery school", from then on, Ilizarov techniques and his theories were quickly spreaded throughout the former Soviet Union. Ilizarov techniques and his theories became world famous were from the treatment to an famous Italian explorer Carla Mauri. In 1980, Ilizarov successfully treated Carlo Mauri, who was left leg shortening and deformity foot drop after 7 surgeries in Italy. The treatment was so successful that it had shocked the west medicine and spreaded out to the west from then on. In 1986, after finished training in Kurgan, American Physicians Dror Paley began to carry out Ilizarov techniques training courses in New York in 1987, and held it once a year, which further accelerate the promotion of Ilizarov technique to the world. It was later when Ilizarov technique and theory came into our country. In May 1991, Ilizarov was invited to Beijing 301 hospital for a lecture and consultation, and also during that time, many domestic external fixation experts, such as Qu Long, Xia Hetao, Qin Sihe, had finished training, and return from Kurgan one after another, and spreded out this technique in our country gradually.After clinical practice for more than half cencury, Ilizarov technique currently used in the clinic include:1. chronic osteomyelitis, infectious or non-infectious nonunion. In the case of chronic osteomyelitis and infected nonunion, bacteria is hiding in the marrow cavity, conventional treatments can not thoroughly clean off the bacteria, which lead to recurrent infection. When applying with Ilizarov technique in the treatment, the infected bone segments can be complete removal of, and the bone defect can be filled with bone transport through distraction. Because of the complete removal of the infected bone segments, the infection can be eradicated; 2. congenital limb shortening deformities (such as dwarfism), bone shortening after bone fracture healing, stump of the limb extending after the amputation, and so on. When applying with Ilizarov technique in the treatment, the bone can rebirth in the condiction of continuous distraction stress from external fixation, and gradually grow longer, which can reach longer limbs and make shortening deformity of the bones back to normal; 3. elbow, wrist, knee, ankle and other joints contracture, stiffness, clubfoot deformity and so on. By Ilizarov external fixator multi-plane, multi-directional adjustment, without surgical incision, the contracture soft tissue can regenerate, which can extend contracture skin, tendon, joint capsule, ligaments and other soft tissues, and correct joint contracture deformity, restore normal appearance and function; 4. complex limb deformities, such as X-type legs, O-type legs and radial hand crank deformity, etc. Complex limb deformities conclude with not only limb shortening or too long, but also associated with body rotation, angulation, etc. By Ilizarov external fixator multi-plane, multi-directional adjustment, which can make bones and soft tissue newborn together, and can correct a variety of skeletal deformities, and get magic result that conventional surgery can not achieve.In order to achieve the best results, avoid accidents, some respective principles should be obeyed when applying the Ilizarov technique, these principles include:1. minimally invasive osteotomy technique, which refer to maximum protect the blood supply to bone and the surounding tissues. During the osteotomy procedure, it needs to maximum preserve the periosteum and bone marrow, which can provide a good physiological basis to bone regeneration. Furthermore, osteotomy should try to perform at the metaphyseal, because the ability of bone formation at the metaphysea are more strong, and it is more easily to get bone healing due to larger metaphyseal bone contacting; 2. sufficiently stable external fixation, which can eliminate activities of osteotomy ends, help distraction osteogenesis and avoid breaking newly formed callus; 3. before the start of the distraction, it needs a delay period of 7-10 days. After the delay period, tissue edema caused by osteotomy can be eliminated, and our body can initial form a good environment for distraction osteogenesis. Duration of the delay period is depend on the patient’s age, the local anatomical and physiological conditions, the extent of the damage of the blood supply to bone marrow and bone suroundings during the osteotomy.4. starting at the speed about lmm per day, and be adjusted according to the real status of bone regeneration. If the speed of the distraction too fast, it can cause delayed healing, Conversely, if the speed too slow, it can cause early Healing which needs re-osteotomy treatment.5. high-frequency and small steps during distraction, Theoretically, the higher the frequency, the better. In practice, at least 4 times per day, also mean every 6 hours, the distance of each distaction is 0.25mm.6. callus mineralization period is needed after distraction osteogenesis is finish, it can let new bone ossification fully. callus mineralization period is about 2-3 times of the distraction time, the external fixator can not be removed until the newborn bone has gotten fully mineralization.7. during the distracion period, the affected limb needs normal physiological activities. These activities can promote new bone ossification, and prevent joint contractures, muscle atrophy and other complications.Among these principles which should be obeyed when applying the Ilizarov technique, minimally invasive osteotomy is a key part. when osteotomy, maximum protect is needed to the intramedullary and extramedullary blood supply. Theoretically, corticotomy is the best way. Scholars had conducted animal experiments, and found distraction osteogenesis was best in this way, but it can not be operated in clinical. Michaelf Rierson etc had compared three osteotomy ways: corticotomy, multiple drill holes and transverse osteotomy and oscillating saw osteotomy. They found that although corticotomy was the best way for distraction osteogenesis, but it was difficult be operated in clinical; multiple drill holes and transverse osteotomy was simple operation, distraction osteogenesis was much better than oscillating saw osteotomy. The way of multiple drill holes and transverse osteotomy was recommended, and now it becomes the main method of osteotomy. During multiple drill holes and transverse osteotomy, each drill hole should be parallel, and at the same time, the osteotome needs to go through the plane of the drill holes. To meet these requirements, unarmed drilling and osteotome osteotomy are obviously very difficult. Malaysia Professor Su Yi etc had designed a simple drill guide device, which consists of a plurality of parallel drill sleeves. During the drilling, its guiding can make the drill holes parallel and have equal intervals. But it still needs to determine the direction of the drill during drilling, and also can not be the guidance for osteotome, therefore, it’s effect is limited.In order to to achieve optimum results of the method:multiple drill holes and transverse osteotomy, it is necessary to guide both drilling and osteotome osteotomy, so that it can let the drill holes in the same plane, and the osteotome tracks are overlapping with the drill holes. At present, there are no devices which can both guide drill and osteotome. Therefore, the design of such a guide device would help to reduce the difficulty of osteotomy by the means of multiple drill holes and transverse osteotomy, and improve the quality and efficiency of the osteotomy.PurposeThe project intends to design the osteotomy guide device based on digital medicine research, utilization of computer graphics and image processing, calculation medicine, modern clinical anatomy and orthopedics, and through these cross-disciplinary, multi-disciplinary research, to design a guiding auxiliary device which can both guide drill and osteotome. The guide device will be improve by simulative operation on skeleton models, and eventually be applied in clinical. It will improve the quality and efficiency of the osteotomy, and benefit patients, improve medical therapy standards.MethodsDesign of the osteotomy guide device:it needs to meet the requirements that can simultaneously guide drill and osteotome, and to be improve by clinical experience. At first, the guide device are designed using CAD software by software engineers, and it’s three-dimensional construction drawings will be draw out and be simulatively operated on computer. After the modifications is completed, it’s three-dimensional construction drawings will be sended to device processing company, and then molded osteotomy guide devce wil be manufactured.Osteotomy guide device application on the models:take 60 femoral moulds which cover with bubble to simulate human femurs, and a 3cm long,2cm wide crack was made in the bubble(femoral moulds lateral sides, and 10cm from lateral supracondylar)to imitate the operating incision(figure 4). Divided these femoral moulds into 3 groups:without guided group, simple drill guided group and drill-osteotome guided group, each group were 20 cases(as for the drill guiding group and drill -osteotome guiding group,2 pins were needed to fix into the middle of the femoral moulds,perpendicularly to the longitudinal axis of the femur, which were to simulate the external fixation pins for bone transport and limb lenghening). The drill Diameter was 3.2mm,and drill 4 holes before osteotome cutting. The osteotome was 20mm wide and 2mm thick, no times limit for the use of the osteotome before it finish the osteotomy.Osteotomy guide device application in clinic:From 2010 January to 2013 August, patients enrolled in our department which diagnosis were Infected nonunion of tibia and needed bone tansport treatment were randomly divided into two groups: without guided group 13 cases, guided group 13 cases. The method of grouping was computer randomly divided the odd-numbered patients (according to the admission order) into without unguided group or guided group, then,the follow even-numbered patients would be the opposite group. The osteotomy method was multiple drill holes and transverse osteotomy, and the osteotomy location was below the tibial tubercle. The drill diameter was 3.2mm, and drill 4 holes before osteotome cutting. The osteotome was 20mm wide and 2mm thick, no times limit for the use of the osteotome before it finish the osteotomy. Without guided group performed osteotomy conventionally; guided group performed osteotomy through the osteotomy guide device.Statistical analysis:the results are expressed as X±s, and statistical analysis by SPSS 19.0 statistical software. Statistical methods included One-Way ANOVA, Independent-Samples T Test, and so on. The difference was statistically significant by settiing P<0.05.Research contentDesign of the osteotomy guide device:1 guide accuracy:under the guide drilling, whether each drill is on the same plane, and Its deviation value; under the guide osteotomy, Whether the osteotome tracks are overlap with the drill holes, and Its deviation value; 2 mechanical testing of the guide device:test the force range of the guide device, Whether it can meet the clinical situation; 3 the portability of the guide device:Test the guide device, whether it is simple and easy guide to use.Osteotomy guide device application on the models:Divided these femoral moulds into 3 groups:without guiding group, simple drill guiding group and drill-osteotome guiding group. After osteotomy,recorded the cost time, the variation range of the drill holes(incision side and the contralateral side), the variation range of the osteotome incisions(incision side and the contralateral side),and the match rate of drill holes and osteotome incision.Osteotomy guide device application in clinic:after osteotomy, recorded the cost time. Every patient were followed up, recorded the distance of bone transport, the bone transport healing index,which calculated as the cost time from the beginning of bone transport to the completion of bone mineralization divided by the distance of bone transport, expressed in month(s) per centimeter.ResultThe designed guide device is simple and lightweight, its practical application is easy to use, its drill holes and osteotome tracks are in the same plane, further more, there are a chute in the guide device, and by moving the chute, it can free to choose the location of the osteotomy.Osteotomy guide device application on the models:without guided group:the cost time of osteotome was 9.5±2.8 minutes, the variation range of the drill holes(incision side was 2.0±1.1 mm, the contralateral side was 11.2± 2.5mm), the variation range of the osteotome incisions(incision side was 4.5±1.1 mm, the contralateral side was 11.7±3.5 mm), and the match rate of drill holes and osteotome incision was 55%. Simple drill guided group:the cost time of osteotome was 6.3±1.2 minutes, the variation range of the drill holes(incision side was 0.0±0.0 mm, the contralateral side was 0.0±0.0 mm), the variation range of the osteotome incisions(incision side was 3.2±0.6 mm, the contralateral side was 4.8±1.2 mm), and the match rate of drill holes and osteotome incision was 80%. drill-osteotome guided group:the cost time of osteotome was 5.5±0.6 minutes, the variation range of the drill holes(incision side was 0.0±0.0 mm, the contralateral side was 0.0±0.0 mm), the variation range of the osteotome incisions(incision side was 2.1±0.3 mm, the contralateral side was 1.9±0.3 mm), and the match rate of drill holes and osteotome incision was 100%. The data of three groups(the cost time of osteotome, the variation range of the contralateral incision side drill holes, the variation range of the contralateral incision side osteotome incisions) used One-Way ANOVA to analyze, P value of comparison between groups was<0.05,the difference had statistical significance.Osteotomy guide device application in clinic:without guided group:the cost time of osteotome was 12.5+2.9 minutes, the distance of bone transport was 6.3± 1.2cm, the bone healing index was 0.81±0.24. Guided group:the cost time of osteotome was 9.5±1.6 minutes, the distance of bone transport was 6.6±1.0cm, the bone healing index was 1.02±0.09.The data of two groups(the cost time of osteotome, the bone healing index) used Independent-Samples T Test, P value was <0.01,the difference had statistical significance.ConclusionDuring multiple drill holes and transverse osteotomy, unguided operation is need to determine repeatly the position and the direction of the drill holes, the position and the direction of the osteotome, which will waste much time. At the same time, unguided operation unable to make the drill holes and the osteotome tracks in the same plane, which will increase the the difficulty of the osteotomy and the damage to the surrounding tissue. When using the guide device, the drilling and the osteotome cutting are through the device, which save the cost time for repeated positioning during unguided operation, Therefore, it can significantly shorten the operation time; In addition, the drill holes and the osteotome tracks are in the same plane, which can make osteotomy easier, less damage to surrounding tissue, thus less damage to the blood supply of intramedullary and extramedullary at the osteotomy plane, and its transport bone healing index is significantly much better than patients with unguided operation. According to the above, guide has important significance in the application of the osteotomy, and is worthy of clinical promotion.