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This paper present the content effectiveness of self-made reduction brace in the fixation of femoral shaft fracture by the intramedullary nail with lock.
Journal of military pharmaco-medicine no5-2020 EFFECTIVENESS OF REDUCTIVE BRACE IN THE CLOSED REDUCTION OF ADULT FEMORAL SHAFT FRACTURE BY INTRAMEDULLARY NAIL WITH LOCK AT SAINT PAUL HOSPITAL Doan Anh Tuan1,2, Nguyen Thai Son3, Vu Nhat Dinh1 SUMMARY Objectives: To assess the effectiveness of self-made reduction brace in the fixation of femoral shaft fracture by the intramedullary nail with lock Subjects and methods: A prospective study on 62 patients with 63 femoral shaft fractures fixed by the self-made locked intramedullary nail without opening the fracture at the Department of Traumatology and Orthopedics, Saint Paul Hospital, from January 2013 to December 2015 Results: The average age was 32.98 ± 12.7 (18 - 65 years old) Technique was successful in all of the fractures (100%) Average reduction time: 4.92 ± 1.945 minutes (3 - 13 minutes); number of X-ray emission: 8.06 ± 3.13 times (4 - 16 times), emission time: 8.55 ± 3.54 seconds (6.0 - 22.3 seconds); average operative time: 50.94 ± 8.81 minutes (40 - 75 minutes) The anatomical results: 71.4% non-displaced, and 28.6% less displaced Conclusions: The reduction brace is well designed It is considered a practical and straightforward technique Furthermore, it causes less damage to soft tissue and fulfills the advantages of minimally invasive intervention for femoral shaft fracture fixation * Keywords: Femoral shaft fracture; Closed reduction; Intramedullary nail technique; Reduction brace INTRODUCTION A femoral fracture happens in one of the chief bones in the body at every age It has various causes, mainly due to vehicle and occupational accidents accounting for - 2% of all adult fractures [1] The average age is 27.2 [2] For adult fractures, the surgical indication is absolute, and intramedullary nail with lock is now the most common treatment This technique with opening the fracture has been widely performed in many national medical units Recently, some hospitals have deployed the locked intramedullary nail without opening the fracture for fixation thanks to being well-equipped with C-arm and orthopedic operation table It takes advantages over the traditional method, such as less trauma, Center for Orthopedic and Trauma, Military Hospital 103, Vietnam Military Medical University Traumatology and Orthopaedics Department, Dong Anh General Hospital Duc Giang General Hospital Corresponding author: Doan Anh Tuan (datuansp@gmail.com) Date received: 09/6/2020 Date accepted: 25/6/2020 174 Journal of military pharmaco-medicine no5-2020 less blood loss, less pain, less nosocomial infection, better bone healing, and shorter scar Femoral shaft fracture is highly and variously displaced; therefore, the reduction for fixation is challenging, long-reduction time To improve the efficacy of closed reduction and shorten the operation time, different techniques were proposed, such as temporary Schanz nail for both femurs or the reduction brace [3, 4] At Saint Paul Hospital, we designed the reduction brace for the femoral shaft fracture before nailing It has brought an optimized result [5] In order to draw experiences and improve the quality of treatment in femoral shaft fracture, we conducted this study: To assess effectiveness of the self-designed reductive brace in the closed reduction of femoral shaft fracture SUBJECTS AND METHODS Subjects 62 patients with 63 femoral shaft fractures were reduced and fixed by a locked intramedullary nail without opening the fracture site, with the self-designed reduction brace at the Department of Traumatology and Orthopedics, Saint Paul Hospital from January 2013 to December 2015 Methods A prospective study without a control group Materials * The reduction brace: - Design: Figure 1: The reduction brace completely assembled (1: Reduction rod number 1; 2: Reduction rod number 2; 3: Reduction handle; 4: Reduction plane created by the reduction rods) The self-designed eight-shaped brace includes the disassemblable components (picture 1) There are the limit bars at two heads This reduction brace is made by inox bar with 16 mm diameter and 500 mm length, and another transverse bar with 22 mm diameter and 310 mm length Two transverse bars are stabilized at four places, which are easy for installation 175 Journal of military pharmaco-medicine no5-2020 - Operation principle: Lever mechanism: transverse bars base on two sides of fracture from outside and relocate according to the sum of vector force (the vector force of reduction is the bisector of two displaced surfaces) Therefore, the reduction is only performed in the bisector surface (instead of on two surfaces of displacement) (picture 2) This tool is easy for reinstallation Figure 2: Combined reduction vector force * Surgical tools: - Intramedullary nail AO model (Global Products Corporation Medical Ltd) - Additional tools for intramedullary locked nail - Guidewires and soft drills - Orthopedic table, C-arm * Surgical technique (picture 3): - The phase of reduction: After local or endotracheal anesthesia, the patient is put on the reduction table The fractured leg is pulled straight to its axis, adduction, and internal rotation 10o C-arm is put at the location, which helps to observe the fracture, mark the fracture on the skin The reduction of shortened displacement is performed Then, put the self-designed 176 brace under the thigh, the assistant performs the reduction with C-arm guidance - The phase of guidewire insertion: Incise skin cm from the greater trochanteric, dissect the gluteus maximus, drill the entrance to the medullar under Carm guidance, insert guidewire, then relocate the displacement in the bisector plain as described above Reassess the reduction under C-arm, insert guidewire - The fixation phase: Ream the medullary canal using the flexible reamer Choose the intramedullary nail with the diameter one size smaller than the reamer; the nail is then introduced through the guidewire Check the reduction result, uninstall the brace to reduce the soft tissue pressure Drill the locking screws according to the brace Journal of military pharmaco-medicine no5-2020 - Closed-incision phase: Figure 3: A patient with a proximal third femoral shaft fracture reduced using the reduction frame under C-arm (1: X-ray fracture of femoral; 2: Check the fracture line under C-arm; 3: Self-designed reduction brace; 4: Successful reduction of guidewire insertion) Evaluation * Evaluation criteria: - A good reduction is defined as the reduction without opening the fracture, guidewire approaches the peripheral fracture, and nailing properly - Time of reduction: Measured from the brace installation to the guidewire insertion into the peripheral fracture - Times of X-ray emission: From the reduction to the finish of nailing - The number of successful closed reduction/the number of the minimal incision - The anatomical result based on the post-operative radiograph - The accidents during reduction phase: The soft tissue damage such as vessel, nerve rupture * Data processing: By SPSS23.0 RESULTS The patient characteristics - Age and gender: 62 patients, including 46 males and 16 females, ranging from 18 to 65 years old, the average age was 32.98 ± 12.7 years old - The cause of fracture: Traffic accident: 87.1%; living accident: 9.7%; occupational accident: 3.2% 177 Journal of military pharmaco-medicine no5-2020 Site and characteristics of fractures Table 1: The correlation between the Winquist-Hansen’s classification and fracture sites Winquist-Hansen’s classification Fracture sites (n, %) 1/3 proximal 1/3 middle 1/3 distal Total Type 0 (0.0) (12.7) (1.6) (14.3) Type I (4.8) 12 (19.0) (4.8) 18 (28.6) Type II (4.8) (14.3) (7.9) 17 (27.0) Type III (4.8) (14.3) (3.2) 14 (22.2) Type IV (0.0) (6.3) (1.6) (7.9) (14.3) 42 (66.7) 12 (19.0) 63 (100.0) Total Effectiveness of the self-designed brace 63 femoral shaft fractures were successfully relocated by this brace without opening the fracture Table 2: The correlation between type of fracture according to Winquist-Hansen’s classification and the reduction time Time of reduction < minutes - 10 minutes Winquist-Hansen’s classification > 10 minutes Total n (%) Type (24.3) (0.0) (0.0) (14.3) Type I 12 (32.4) (20.0) (100.0) 18 (28.6) Type II (24.3) (32.0) (0.0) 17 (27.0) Type III (16.2) (32.0) (0.0) 14 (22.2) Type IV (2.7) (6.0) (0.0) (7.9) 37 (100.0) 25 (100.0) (100.0) 63 (100.0) Total p 0.062 There was no correlation between type of fractures and time of reduction, and the guidewire insertion into the peripheral medullar The difference was not statistically significant with p = 0.062 The average time of reduction was 4.92 ± 1.945 minutes (3 - 13 minutes) 178 Journal of military pharmaco-medicine no5-2020 Table 3: Frequency of X-ray emission Frequency of emission Number of fratures Rate (%) < 10 times 47 74.6 10 - 20 times 16 25.4 63 100.0 Total The average frequency of X-ray emission was 8.06 ± 3.13 times (4 - 16 times) The average total time of emission was 8.55 ± 3.54 seconds (6.0 - 22.3 seconds) Table 4: The relationship between Winquist-Hansen’s classification and time of Xray emission Winquist-Hansen’s classification Time of emission of reduction Min - max Type 6.27 ± 0.86 6.2 - 6.4 Type I 7.53 ±1.83 6.0 - 12.3 Type II 8.93 ± 3.91 6.0 - 16.5 Type III 9.5 ± 3.28 6.4 - 22.3 Type IV 12.36 ± 3.54 6.0 - 22.3 p 0.012 Table 5: The relationship between type of fractures according to Winquist-Hansen’s classification and the operative time Operative time 30 - 45 minutes > 45 - 60 minutes Winquist-Hansen’s > 60 - 90 minutes Total n (%) classification Type (22.2) (7.1) (12.5) (14.3) Type I (29.6) (25.0) (37.5) 18 (28.6) Type II (22.2) 10 (35.7) (12.5) 17 (27.0) Type III (22.2) (25.0) (12.5) 14 (22.2) Type IV (3.7) (7.1) (25.0) (7.9) 27 (100.0) 28 (100.0) (100.0) 63 (100.0) Total p 0.413 There was no relationship between the operative time and the type of fractures with p = 0.413 The average operative time was 50.94 ± 8.81 minutes (40 - 75 minutes) The length and size of the nail: the length was from 340 - 400 mm, among which the length of 360 - 380 mm was the most used (46 cases) The diameter of the nail was mm, used in 62/63 cases 179 Journal of military pharmaco-medicine no5-2020 Table 6: The relationship between type of fractures according to Winquist-Hansen’s classification and the outcome of anatomical reduction The outcome of anatomical reduction No displacement Less displacement Total Winquist-Hansen’s n (%) classification Type (20.0) (0.0) (14.3) Type I 17 (37.8) (5.5) 18 (28.6) Type II 10 (22.2) (38.9) 17 (27.0) Type III (15.6) (38.9) 14 (22.2) Type IV (4.4) (16.7) (7.9) 45 (100.0) 18 (100.0) 63 (100.0) Total p 0.004 Little displacement was defined as the angle less than 5o or the fragment displacement less than one-third of the bone shaft There was a relationship between type of fractures and outcome of reduction The average hospitalization time was 8.98 ± 4.68 days, the shortest was days, the longest was 31 days DISCUSSION The importance of reduction brace in the closed intramedullary nailing for femoral shaft treatment An increasing tendency in fracture treatment in general, and femoral shaft fracture in particular, is the closed reduction and nailing without opening the fracture In the femoral fracture fixation by the intramedullary nail without opening, the successful reduction plays an important role The femoral bone is covered by the strong and thick muscles, which cause significant displacement in fracture The reduction and internal fixation without opening has many difficulties It is not a big problem with the shortened displacement However, the angulated one is challenging, 180 leading to mal orientate the guide wire then the nail Some surgeons tried to manipulate the reduction Nevertheless, it is difficult to maintain because of longer operative time, and more exposure to X-ray In some cases, surgeons have to minimally open to reduce the fracture leading to increase the tissue damage and the infectious risks The effectiveness of the selfdesigned brace Many authors have proposed method of reduction in the intramedullary nail Chen reported 43 adult patients with closed femoral shaft fracture with an average age of 41.7 (26 - 69 years old) who were performed reduction and fixation by reduction brace and interlocking Journal of military pharmaco-medicine no5-2020 intramedullary nail Reduction outcome was successful in 100% of patients, of which 26 patients (60.5%) had no displacement after fixation, and 17 patients (39.5%) had angulated displacement The average operative time was 58.3 minutes (40 - 85 minutes) The exposure time was 9.2 seconds (4.1 - 21.8 seconds) [3] Zhang Yingze also invented the reduction brace without a surgical table for reduction which was advantageous but bulky and complicated As a result, 22 cases were operated successfully: 100% closed reduction, operation time: 58 minutes (43 - 95 minutes), minimal time for the reduction: 9.1 minutes (6 - 15 minutes), time for fluoroscopy: 13.2 seconds (4.5 - 41 seconds), and the volume of blood loss: 87 mL (60 - 150 mL) [6] Mitkovic invented the reduction brace, which can be controlled from a distance, and could help to relocate the fracture and decrease the exposure risk of the Xray beam However, its cost was high and difficult to apply in most hospitals [7] Zhan-leZheng used screws Schanz for reduction in 15 cases The results: 100% closed reduction, no accidents during surgery, 13 patients (86.7%) with well-aligned reduction, patients (13.3%) with slight displacement (cubitus varus 3o and 5o) There were no infectious complications and shortened, angulated displacement [8] Our study showed a good outcome in 63 femoral shaft fractures, including 45 cases without displacement, 18 cases with slight angulated displacement There was no significant displacement or rupture during the reduction Our reduction brace is light and easy to install and reinstall The reduction of femoral shaft fracture required the lateral decubitus position and repetition of C-arm Therefore, it is harmful to nurses and doctors health because of X-ray beam exposure This brace helps to maintain reduction stability and reduce the X-ray exposure temporarily It is well indicated with the young, obesity patients with anterioposterior, late romedial displacements This reduction brace temporarily stabilizes the fracture for the insertion of the guidewire through the fracture site The reinstallation is easy The mobilization of the middle bar helps to adapt to every size of the thigh, and the lever mechanism (the peripheral head will be anteriorly pushed, and the central head will be posteriorly pushed, this mechanism helps to fix the angulated displacement) Thus, the fracture would be relocated in the condition that the brace's surface is always perpendicular to the two surfaces of fracture heads The pressure of brace on the soft tissue was recorded; however, there was no trauma CONCLUSIONS The excellent outcome without opening the fracture site was 100% (63/63 femoral shaft fractures); the average time of reduction was 4.92 ± 1.945 minutes (3 - 13 minutes), the frequency of X-ray emission was 8.06 ± 3.13 times (4 - 16 times), the time of X-ray exposure was 8.55 ± 3.54 seconds (6.0 - 22.3 seconds); there was no complications The self-designed reduction brace in the relocation of the intramedullary nail for femoral shaft fracture shows a successful outcome without opening the fracture site 181 Journal of military pharmaco-medicine no5-2020 REFERENCES Hammad A Locking plate construct for femoral shaft fractures in skeletally immature patients Acta Orthop Belg 2008; 74(5):630-635 Kluwer Rockwood and Green’s fractures in adults Wolters Kluwer Health 2015; 1:2149-2228 Wei Chen, Yongmin Jing, Zhiyong Hou, et al Displaced femoral shaft fractures treated by antegrade nailing with the assistance of an intramedullary reduction device Int Orthop 2016; 40(8):1735-1739 Nitesh Raj Pandey, Sumendra raj pandey, Jue-HuaJing, et al Technique for closed reduction of femoral shaft displaced fracture using intramedullary nail with Steinmann pin support: Case study International Journal of Science Inventaions Today 2017; 6(4):285-292 182 Yan Gao, Ning-Ning Qiao, Yong-Hong Zhang, et al Application of fracture-sustaining reduction frame in closed reduction of femoral shaft fracture J Orthop Surg Res 2019; 14(1):147 Wei Chen, Tao Zhang, Juan Wang, et al Minimally invasive treatment of displaced femoral shaft fractures with a rapid reductor and intramedullary nail fixation International Orthopaedics (SICOT) 2015 M Mitkovic, I Micica, D Mladenovica, et al Closed fracture reduction using motorized remote controlled reduction device Biotechnol & Biotechnol 2014:209-214 Zhan-le ZHENG, Xian YU, Guo-qiang XU, et al Four pins assisted reduction of complex segmental femoral fractures: A technique for closed reduction J Huazhong Univ Sci Technol［Med Sci］2014; 34(6):912-916 ... An increasing tendency in fracture treatment in general, and femoral shaft fracture in particular, is the closed reduction and nailing without opening the fracture In the femoral fracture fixation... Times of X-ray emission: From the reduction to the finish of nailing - The number of successful closed reduction /the number of the minimal incision - The anatomical result based on the post-operative... closed reduction of femoral shaft fracture SUBJECTS AND METHODS Subjects 62 patients with 63 femoral shaft fractures were reduced and fixed by a locked intramedullary nail without opening the fracture