Percutaneous Robot-Assisted versus Freehand S2 Iliosacral Screw Fixation in Unstable Posterior Pelvic Ring Fracture.

OBJECTIVES: To assess the efficiency, safety, and accuracy of S2 (IS) screw fixation using a robot-assisted method compared with a freehand method. METHODS: This is a retrospective clinical study. We analyzed the patients treated with S2 IS screw fixation for unstable pelvic fractures from January 2016 to January 2019 in our institution. Sixty-three patients (17 men and 46 women) aged between 21 and 55 years (with an average age of 39.22 ± 9.28) were included in this study. According to the Tile classification, there were 26 (41.3%) type B fractures and 37 (58.7%) type C fractures. All patients were divided into robot-assisted (RA) group (38 patients) or the traditional freehand (FH) group (25 patients). In RA group, the S2 IS screws were implanted with a robot-assisted technique. And S2 IS screws were implanted with a traditional freehand technique in FH group. The screw-related complications were recorded during and after the surgery. The position of all screws and fracture reduction was assessed by postoperative CT scans according to the Gras classification. The number of guide wire attempts and the radiation exposure for S2 screw implantation during operation were also recorded. Finally, the Matta standard was used to evaluate the fracture reduction of the IS joint. RESULTS: A total of 89 IS screws were implanted into S2 iliosacral joint. Fifty-four screws were placed by RA (38 patients) and 35 screws were by FH (25 patients). There was no difference between the two groups with respect to demographic data. There was no screw-related complications or revision surgery in any group. In terms of screw placement, the excellent and good rate was 100% in the RA group, better than that in the FH group where it was only 85.7% (P < 0.001). The fluoroscopy time was 8.06 ± 3.54 s in RA group, which was much less than that in the FH group (27.37 ± 8.82 s, P < 0.001). The guide wire attempts in the RA group (0.685 ± 0.820) were much less than those in the FH group (5.77 ± 3.34) (P < 0.001). Both the fluoroscopy time per screw and the number of guide wire attempts in the RA group were much less than those in the FH group (P < 0.001). The overall postoperative excellent and good rate of Matta standard in RA and FH groups were 86.8% (34/4) and 90.0% (23/25), respectively (P = 0.750), and there was no statistical difference. CONCLUSION: The robot-assisted surgery is an accurate and minimally invasive technique. S2 IS screw implantation assisted by TiRobot to treat the posterior pelvic ring fractures, have a high success rate than the freehand technique. Percutaneous RA S2 IS screw fixation for unstable posterior pelvic ring injuries is safe and clinically feasible and has great clinical application value.

Evaluation of a Bi-Planar Robot Navigation System for Insertion of Cannulated Screws in Femoral Neck Fractures.

OBJECTIVE: To evaluate the bi-planar robot navigation system for insertion of cannulated screws in femoral neck fractures. METHOD: Between January 2016 and December 2016, 60 patients with femoral neck fractures were separately treated using percutaneous cannulated screws assisted by the bi-planar robot navigation system (robot group) and conventional freehand surgery (freehand group). The fluoroscopy time, the number of drilling attempts, and the operation time were recorded during operations; the dispersion and parallelism of the cannulated screws on the posteroanterior and lateral images were measured after operations. Patients were followed up for 12-24 months and the Harris scores and the final results of the two groups were compared. RESULTS: During bi-planar robot navigation system-assisted surgery, the fluoroscopy time for acquisition of images was 2.3 seconds on average, and the time for planning screws during the operation was 2.8 min on average. The average fluoroscopy time during the placement of the guide pin was 5.7 seconds and 14.14 seconds (P = 0.00), respectively. The average time of the placement of the cannulated screws was 12.7 min and 19.4 min (P = 0.00), respectively, in the robot group and the freehand group. In the robot group, only one guide pin was replaced during the operation, and the average number of adjustments for each guide pin was 2.39 in the freehand group. The screw parallelism and dispersion measured by postoperative imaging in the robot group were significantly superior to those in the freehand group. From postoperative CT it was evident that there were 5 cases of screws exiting the posterior cortex in both groups. During the follow-up phase, 1 case of femoral head necrosis and 5 cases of femoral neck shortening of more than 10 mm occurred in the robotic navigation group; 3 cases of femoral head necrosis, 1 case of fracture nonunion, and 2 cases of shortening of more than 10 mm occurred in the freehand group. At 18 months after surgery, the average Harris scores of the patients were 85.20 and 83.45, respectively, with no significant difference. CONCLUSION: Using bi-planar robot navigation system-assisted placement of femoral neck cannulated screws can significantly reduce the time of intraoperative fluoroscopy, drilling attempts, and operation time. The placed screws are superior to the screws placed freehand in relation to parallelism and dispersion. However, it is still necessary for surgeons to have a good reduction of the femoral neck fracture before surgery and to be proficient in the operation of the robot navigation system. In summary, the bi-planar robot navigation system is an effective assistant instrument for surgery.

Percutaneous Sacroiliac Screw Placement: A Prospective Randomized Comparison of Robot-assisted Navigation Procedures with a Conventional Technique.

BACKGROUND: Sacroiliac (SI) screw fixation is a demanding technique, with a high rate of screw malposition due to the complex pelvic anatomy. TiRobot™ is an orthopedic surgery robot which can be used for SI screw fixation. This study aimed to evaluate the accuracy of robot-assisted placement of SI screws compared with a freehand technique. METHODS: Thirty patients requiring posterior pelvic ring stabilization were randomized to receive freehand or robot-assisted SI screw fixation, between January 2016 and June 2016 at Beijing Jishuitan Hospital. Forty-five screws were placed at levels S1 and S2. In both methods, the primary end point screw position was assessed and classified using postoperative computed tomography. Fisher's exact probability test was used to analyze the screws' positions. Secondary end points, such as duration of trajectory planning, surgical time after reduction of the pelvis, insertion time for guide wire, number of guide wire attempts, and radiation exposure without pelvic reduction, were also assessed. RESULTS: Twenty-three screws were placed in the robot-assisted group and 22 screws in the freehand group; no postoperative complications or revisions were reported. The excellent and good rate of screw placement was 100% in the robot-assisted group and 95% in the freehand group. The P value (0.009) showed the same superiority in screw distribution. The fluoroscopy time after pelvic reduction in the robot-assisted group was significantly shorter than that in the freehand group (median [Q1, Q3]: 6.0 [6.0, 9.0] s vs. median [Q1, Q3]: 36.0 [21.5, 48.0] s; χ2 = 13.590, respectively, P < 0.001); no difference in operation time after reduction of the pelvis was noted (χ2 = 1.990, P = 0.158). Time for guide wire insertion was significantly shorter for the robot-assisted group than that for the freehand group (median [Q1, Q3]: 2.0 [2.0, 2.7] min vs. median [Q1, Q3]: 19.0 [15.5, 45.0] min; χ2 = 20.952, respectively, P < 0.001). The number of guide wire attempts in the robot-assisted group was significantly less than that in the freehand group (median [Q1, Q3]: 1.0 [1.0,1.0] time vs. median [Q1, Q3]: 7.0 [1.0, 9.0] times; χ2 = 15.771, respectively, P < 0.001). The instrumented SI levels did not differ between both groups (from S1 to S2, χ2 = 4.760, P = 0.093). CONCLUSIONS: Accuracy of the robot-assisted technique was superior to that of the freehand technique. Robot-assisted navigation is safe for unstable posterior pelvic ring stabilization, especially in S1, but also in S2. SI screw insertion with robot-assisted navigation is clinically feasible.

[Progressive damage monitoring of corrugated composite skins by the FBG spectral characteristics].

In the present paper, a method of monitoring progressive damage of composite structures by non-uniform fiber Bragg grating (FBG) reflection spectrum is proposed. Due to the finite element analysis of corrugated composite skins specimens, the failure process under tensile load and corresponding critical failure loads of corrugated composite skin was predicated. Then, the non-uniform reflection spectrum of FBG sensor could be reconstructed and the corresponding relationship between layer failure order sequence of corrugated composite skin and FBG sensor reflection spectrums was acquired. A monitoring system based on FBG non-uniform reflection spectrum, which can be used to monitor progressive damage of corrugated composite skins, was built. The corrugated composite skins were stretched under this FBG non-uniform reflection spectrum monitoring system. The results indicate that real-time spectrums acquired by FBG non-uniform reflection spectrum monitoring system show the same trend with the reconstruction reflection spectrums. The maximum error between the corresponding failure and the predictive value is 8.6%, which proves the feasibility of using FBG sensor to monitor progressive damage of corrugated composite skin. In this method, the real-time changes in the FBG non-uniform reflection spectrum within the scope of failure were acquired through the way of monitoring and predicating, and at the same time, the progressive damage extent and layer failure sequence of corru- gated composite skin was estimated, and without destroying the structure of the specimen, the method is easy and simple to operate. The measurement and transmission section of the system are completely composed of optical fiber, which provides new ideas and experimental reference for the field of dynamic monitoring of smart skin.

[Percutaneous pelvic fracture stabilization using CT-based 3D navigation software combined with targeting mechanical arm: a cadaver model trial].

OBJECTIVES: To investigate a new targeting mechanical arm for CT-based navigated percutaneous fixation of pelvic fractures, and to evaluate the safety and efficiency of the procedures. METHODS: Using CT-based 3D navigation software combined with targeting mechanical arm, percutaneous insertion of pelvic models (3 dry human cadaver pelvic skeletons and 5 plastic Sybone pelvic models) were performed, 8 pelvic models allowed percutaneous cannulated screw insertion of both S-I joint (2 S-I screws placement for each side, total 32 screws in this experiment) and both superior ramus (1 ramus medullary screw placement for each side, total 16 screws in this experiment). Percutaneous insertion of pelvic models (4 dry human cadaver pelvic skeletons and 4 plastic Sybone pelvic models, 1 S-I screws and 1 ramus medullary scre placement for each side, 32 screws in this experiment) were performed using fluoro-navigation system (Stryker, USA). Time necessary for every screw insertion were recorded. Accuracy of screw placement was assessed using C-arm imaging and direct eyes inspecting. The time and accuracy of the two methods were compared. RESULTS: The time required for the CT-based 3D navigation procedure (3.6 ± 1.2) min was significantly less than using the targeting mechanical arm compared to drilling freehand with navigation (9.1 ± 0.8) min (t = 2.50, P < 0.01). There was no significant difference in accuracy between the two methods. CONCLUSION: CT-based 3D navigation software combined with targeting mechanical arm should be potential to apply percutaneous sacroiliac screwing for pelvic fractures with more accurate and more reliable.

Computer-assisted navigation systems for insertion of cannulated screws in femoral neck fractures: a comparison of bi-planar robot navigation with optoelectronic navigation in a Synbone hip model trial.

BACKGROUND: Computer-assisted procedures have recently been introduced for navigated femoral neck screw placement. Currently there is little information available regarding accuracy and efficiency of the different navigated procedures. The aim of this study was to compare two fluoroscopic navigation tracking technologies, a novel bi-planar robot navigation and standardized optoelectronic navigation, versus standard freehand fluoroscopic insertion in a Synbone hip model. METHODS: Eighteen fixed Synbone hip models were divided into 3 groups. C-arm navigated cannulated screws (AO-ASIF, diameter 7.3 mm) were inserted using freehand targeting (control group). A novel bi-planar robot system (TINAV, GD2000) and an optoelectronic system (Stryker OTS Navigation System) were used for the navigated procedures (robot group and optoelectronic group). Accuracy was measured using radiographic evaluation including the measurement of screw parallelism and decentralization, and joint penetration. To evaluate the efficiency, the number of guidewire passes, operative time and fluoroscopic images taken were noted. RESULTS: The two computer-assisted systems provided significantly improved accuracy compared to the freehand technique. Each of the parameters, including guidewire passes and number of fluoroscopy images, was significantly lower when using the computer-assisted systems than for freehand-unguided insertion (P <0.05), but operative time was significantly shorter when using freehand-unguided insertion than for the computer-assisted systems (P <0.05). Accuracy, operative time and number of fluoroscopy images taken were similar among the two navigated groups (P >0.05), but guidewire passes in the robot group were significantly less than in the optoelectronic group (P <0.05). CONCLUSIONS: Both bi-planar robot navigation and optoelectronic navigation were similarly accurate and have the potential to improve accuracy and reduce radiation for freehand fluoroscopic targeting for insertion of cannulated screws in femoral neck fractures. Guidewire passes in the robot group were significantly less than in the optoelectronic group. However, both navigated procedures were associated with time-consuming registration and high rates of failed matching procedures.

[Primary clinical application of traction reductor for lower limb fracture].

OBJECTIVE: To develop a traction reductor for the reduction of lower limb fractures during the minimally invasive surgery and explore its safety and efficacy. METHODS: From February 2007 to March 2009, closed or limited open reduction plus percutaneous plate and screw internal-fixation were conducted in 34 patients with fracture of distal femur and tibia metaphysic, among which there were 3 distal femoral fractures (2 33-B, 1 33-C), 14 proximal tibial fractures (9 41-A, 3 41-B, 2 41-C) and 17 distal tibial fractures (9 43-A, 5 43-B, 3 43-C, 2 Gustilo I a), according to the Association for Osteosynthesis-Orthopaedic Trauma Association (AO-OTA) classification. Besides, closed reduction plus interlocking intramedullary nailing on tibial shaft fracture were applied in 36 patients (7 42-A, 21 42-B, 8 42-C, 2 Gustilo I a). All the 70 patients, with an average age of 37.6 years (range: 17 to 63 years) and average time before surgery of 4.7 d (range: 0.7 to 12.0 d), underwent reduction by self-designed traction reductor for lower limb fracture in the surgery. The reduction duration and C-arm fluoroscopy time were recorded. Recovery of the force line of affected limbs after surgery was determined by whether the line from anterior superior iliac spine to the interdigit between the first and second toe-web passed the patella center. And the distance from bilateral anterior superior iliac spine to medial malleolus tip as well as the difference between lower limbs were recorded to determine the recovery of length after surgery. Meanwhile, the varus-valgus and anteroposterior angulations after reduction were measured by AP and lateral X-ray. RESULTS: The reduction duration was 12.7 min (range: 7 to 31 min); X-ray fluoroscopy time, 1.3 min (range: 0.4 to 3.0 min); length difference between both lower limbs (6.5 ± 1.1) mm; and axial alignment difference (7.0 ± 1.8) mm. The X-ray result showed that varus-valgus angle was (2.75 ± 0.16)°; and anteroposterior angulation (5.13 ± 0.51)°. CONCLUSION: The traction reductor for lower limb fracture could achieve satisfying fracture reduction in the minimally invasive surgery of distal femur, tibia metaphysic and tibial shaft fracture.

[Percutaneous screw fixation in treatment of fractures of acetabular columns using computer-assisted imaging navigation system: experiment with cadaver model].

OBJECTIVE: To establish a new imaging protocol to acquire the most appropriate fluoro-images for fluoro-navigated percutaneous fixation of acetabular fracture and to evaluate the safety and efficiency of the procedures. METHODS: Guide needles were inserted into the bilateral anterior and posterior columns of the acetabula of 4 dry human cadaver pelvic skeletons and 4 plastic pelvic models. Then the pelvis skeletons were fixed to imaging guided surgery mimic operation modules. Dynamic fluoroscopy was conducted with C-arm X-ray machine vertically on the 4 virtual planes of the acetabulum, inner, outer, anterior, and posterior from multiple angles. The fluoroscopic images clearly showing the guide needles, anterior and posterior columns, and acetabulum were selected as registration images, and the relative space positions between the C-arm X-ray fluoroscope and pelvis and operation table. Guided by the navigation system, totally 16 titanium hollow screws were inserted into bilateral anterior and posterior columns of acetabula of the 4 pelvis skeletons. The screw positions were estimated by visual method. The time needed to position the C-arm so as to obtain the standard registration image, time needed for fluoroscopy, and operation time, including establishment of navigation system, software interface operation, and screw insertion, were recorded. RESULTS: All the screws were inserted to the satisfying positions: placed within the desired bony corridor of the column and none of then were inserted into the joint. While inserting the screw into the anterior column fluoroscopy should be conducted with obturated oblique view, obturated inlet view, obturated oblique outlet view, or pelvic AP view. While inserting the screw into the posterior column fluoroscopy should be conducted with iliac-oblique view, obturated oblique view, pelvic inlet view, or obturated oblique outlet view. The total surgical time required for screw insertion was 11.7 min for anterior column, and was 9.2 min for posterior column. 9.5 and 7.3 minutes were needed to position the C-arm X-ray machine so as to obtain the images of the anterior and posterior columns respectively. 2.9 and 1.7 seconds were needed for the actual fluoroscopy during insertion of the screws into the anterior and posterior columns respectively. CONCLUSION: The standard registered fluoro-images are different from the conventional standard Judet-Letournel oblique views. How to get appropriate fluoro-images is the key point for fluoro-navigated percutaneous fixation of acetabular fractures.

[Accurate traction of long bone fracture with full-length planning module of orthopedic robot system: experiments in vitro and in vivo].

OBJECTIVE: To evaluate the precision in location and clinical flexibility of the newly designed full-length planning module of orthopedic robot system in treatment of fractures of long bone. METHODS: Nine plastic tibia models were selected for the image mosaicing. The full length of each tibia model was measured on the constructed panorama and compared with the real model length to record the length deviation and conduct the precision analysis. Fracture of tibia and fibula with shortening and angulation deformity was caused on a cadaver specimen with two lower limbs. Full-length planning was carried out on the entire tibial panorama with the fracture. After the reduction distance was determined quantitatively, automatic close traction procedure was carried out with the tibial reduction frame to analyze the precision and effectiveness of this module. At the same time, the relative length variation between the two bone fragments was monitored utilizing video camera to ensure the safety of the reduction operation. Image mosaicing, surgical planning, and bone traction were performed on a clinical case of tibial fracture to validate the clinical feasibility of the module. RESULTS: An entire tibial panorama could be constructed from 7 - 10 C-arm images collected during the operation. 1.5 min was needed for image collection. The average mosaicing and planning time was 3 min. The mosaicing error was less than 1.5 mm. The average time for the traction frame installation and traction operation was 4 min. Traction resulted in accurate reposition of the fracture ends meeting the requirement of surgery in both the cadaver specimen and the clinical case. CONCLUSION: The newly designed full-length planning module of orthopedic robot system is easy to use and provides effective and accurate traction result in long bone fracture therapy. This module can not only achieve the minimally invasive surgery, but also dramatically decrease the radiation damage to the medical staff.

[Intra-operative stereotactic accuracy of computer-assisted robot orthopaedic trauma surgery planning system].

OBJECTIVE: To investigate the feasibility and accuracy of the software computer-assisted robot orthopaedic trauma surgery planning system (CAOTS). METHODS: The software CAOTS was developed and used on 85 cases of stereotactic operation, 24 model bones, 21 cadaveric extremity bones, and 40 patients. 307 groups of directional targets in these cases were randomly sampled. The distribution of error sources for evaluating system performance was embodied using Monte-Carlo method in order to derive the theoretic guarantees for further optimizing and enhancing the system performance, then the software SPSS 2.0 was used to analyze the errors. RESULTS: The statistical area of deviation number was 0.0408 +/- 0.4578 mm, corresponding to the result by Monte-Carlo method. Punching succeeded at the first run for all 307 cases without wrong locking and other clinical complications. CONCLUSION: Accurate and reliable, CAOTS improves the intra-operative navigation techniques and facilitates the orthopedists to perform operation.

[Effects of medical robot-assisted surgical navigation system in distal locking of femoral intramedullary nails: an experimental study].

OBJECTIVE: To investigate the effects of medical robot-assisted surgical navigation system based on fluoroscopic images in distal locking of femoral intramedullary nails. METHODS: Using a robot-assisted computer-guided system designed based on modularization and minimization that permitted C-arm alignment assistance and real-time navigation control, provided constant feedback without the need for radiologic updates, thus avoiding constant X-ray exposure. The C-arm was used to collect the orthotopic and lateral X-ray images into the computer so as to calculate the locations of the target points. Nails were locked into 5 plastic femurs (Swiss Sybone, 35 holes), 2 dry human femoral specimens (12 holes), and one leg of fresh human cadaver (6 holes). Radiographs were taken to confirm that screws were positioned correctly, and fluoroscopic time associated with the locking procedure was recorded. RESULTS: All distal holes were locked successfully. In 6 (11.1%) of the 53 holes the drill bit touched the canal of the locking hole, albeit with no damage to the nail. The fluoroscopy time of per screw was 1.83 +/- 0.31 seconds. CONCLUSION: The medical robot-assisted surgical navigation system enables the physicians to precisely navigate surgical instruments throughout the procedure using just a few computer-calibrated radiographic images. The total radiation time per procedure can be significantly reduced because additional X-ray exposure is not required for tool navigation. The idea of a robot-assisted surgical navigation system is practicable.