Design and In Vitro Validation of an Orthopaedic Drill Guide for Femoral Stem Revision in Total Hip Arthroplasty.

OBJECTIVE: Cemented total hip arthroplasty (THA) demonstrates superior survival rates compared to uncemented procedures. Nevertheless, most younger patients opt for uncemented THA, as removing well-fixed bone cement in the femur during revisions is complex, particularly the distal cement plug. This removal procedure often increases the risk of femoral fracture or perforation, haemorrhage and weakening bone due to poor drill control and positioning. Aim of this study was to design a novel drill guide to improve drill positioning. METHODS AND PROCEDURES: A novel orthopaedic drill guide was developed, featuring a compliant centralizer activated by a drill guide actuator. Bone models were prepared to assess centralizing performance. Three conditions were tested: drilling without guidance, guided drilling with centralizer activation held, and guided drilling with centralizer activation released. Deviations from the bone centre were measured at the entry and exit point of the drill. RESULTS: In the centralizing performance test, the drill guide significantly reduced drill hole deviations in both entry and exit points compared to the control ([Formula: see text]). The absolute deviation on the exit side of the cement plug was 10.59mm (SD 1.56) for the 'No drill guide' condition, 3.02mm (SD 2.09) for 'Drill guide - hold' and 2.12mm (SD 1.71) for 'Drill guide - release'. The compliant drill guide centralizer significantly lowered the risk of cortical bone perforation during intramedullary canal drilling in the bone models due to better control of the cement drill position. Clinical and Translational Impact Statement: The drill guide potentially reduces perioperative risks in cemented femoral stem revision. Future research should identify optimal scenarios for its application.

"O.R. GOES GREEN": a first step toward reducing our carbon footprint in the operating room and hospital.

Hospitals in Europe produce approximately 6 million tons of medical waste annually, about one-third of this originating in operating rooms. Most of it is solid waste, which can be recycled if bodily fluids do not contaminate it. Only 2-3% of hospital waste must be disposed of as infectious waste, and this is much lower than the 50-70% of garbage in the biohazard waste stream. In June 2021, at the main operating room of the Department of General Surgery of the University of Turin, we began a separate collection program for materials consisting of plastic, paper, TNT (material not contaminated by bodily fluids), and biohazardous waste. We calculated the number of boxes and the weight of special waste disposed produced every month in one operating room for 18 months. The monthly number of Sanibox and the monthly weight of biohazardous waste decreased during the observation period. The reduction trend was not constant but showed variations during the 18 months. Direct proportionality between number of low-complexity procedures and production of biohazardous waste was found (p = 0.050). We observed an optimization in the collection and filling of plastic, paper and TNT boxes separated and sent for recycling. One of the barriers to recycling hospital waste, and surgical waste in particular, is the failure to separate infectious waste from clean waste. A careful separate collection of waste in the operating room is the first step in reducing environmental pollution and management costs for the disposal of hospital waste.

An implantable magnetic drive mechanism for non-invasive arteriovenous conduit blood flow control.

OBJECTIVE: Hemodialysis patients usually receive an arteriovenous fistula (AVF) in the arm as vascular access conduit to allow dialysis 2-3 times a week. This AVF introduces the high flow necessary for dialysis, but over time the ever-present supraphysiological flow is the leading cause of complications. This study aims to develop an implantable device able to non-invasively remove the high flow outside dialysis sessions. METHODS: The developed prototype features a magnetic ring allowing external coupling and torque transmission to non-invasively control an AVF valve. Mock-up devices were implanted into arm and sheep cadavers to test sizes and locations. The transmission torque, output force, and valve closure are measured for different representative skin thicknesses. RESULTS: The prototype was placed successfully into arm and sheep cadavers. In the prototype, a maximum output force of 78.9±4.2 N, 46.7±1.9 N, 25.6±0.7 N, 13.5±0.6 N and 6.3±0.4 N could be achieved non-invasively through skin thicknesses of 1-5 mm respectively. The fistula was fully collapsible in every measurement through skin thickness up to the required 4 mm. CONCLUSION: The prototype satisfies the design requirements. It is fully implantable and allows closure and control of an AVF through non-invasive torque transmission. In vivo studies are pivotal in assessing functionality and understanding systemic effects. SIGNIFICANCE: A method is introduced to transfer large amounts of energy to a medical implant for actuation of a mechanical valve trough a closed surface. This system allows non-invasive control of an AVF to reduce complications related to the permanent high flow in conventional AVFs.

Design and evaluation of a smart passive dynamic arm support for robotic-assisted laparoscopic surgery.

Surgeons performing robotic-assisted laparoscopic surgery experience physical stress and overuse of shoulder muscles due to sub-optimal arm support during surgery. The objective is to present a novel design and prototype of a dynamic arm support for robotic laparoscopic surgery to evaluate its ergonomics and performance on the AdLap-VR simulation training device. The prototype was designed using the mechanical engineering design process: Technical requirements, concept creation, concept selection, 3D-design and built of the prototype. A crossover study was performed on a marble sorting task on the AdLap-VR. The first group performed four trials without the arm support, followed by four trials with the arm support, and the other group executed the sequence vice versa. The performance parameters used were time to complete (s), path length (mm), and the number of collisions. Afterward, the participants filled out a questionnaire on the ergonomic experience regarding both situations. 20 students executed 160 performed trials on the AdLap-VR Significant decreases in the subjective comfort parameters mental demand, physical demand, effort and frustration were observed as a result of introducing the novel arm support. Significant decreases in the objective performance parameters path length and the number of collisions were also observed during the tests. The newly developed dynamic arm support was found to improve comfort and enhance performance through increased stability on the robotic surgery skills simulator AdLap-VR.

The MISLI-Drive, a modular sterilizable robotic driver for steerable laparoscopic instruments.

Introduction: Based on the success of the former "Shaft-Actuated, Tip-Articulated" SATA-Drive, a prototype robotic instrument driver for modular, steerable, laparoscopic instruments, a new driver is designed and tested to improve previously lacking features concerning cleanability, instrument adaptation, practical application and control. The design of the driver engages these issues with a modular design aimed at re-use of both the instrument and the driver, for which a set of design requirements are established. Methods: A new modular design has been developed to improve cleanability through separation of the electro-motors and the instrument mechanism which clutches the instrument. Contamination of the driver's robotic side is prevented though a combination of a drape and a Sterile barrier interface, while the instrument side is made sterilizable. A novel instrument clutching mechanism enables quick-release features, while a motor-axis latching mechanism enables plug-and-play assembly. Embedded sensors allow precise and fast control. A user-experiment was conducted on instrument exchange and assembly time, while mechanical and electrical tests were conducted on the driver's responsiveness. Results: The driver has proven its ability to control the instrument, after which it can be disassembled for cleaning and inspection. The driver is designed for re-use through disassembled sterilization where all possibly contaminated surfaces are exposable for cleaning and inspection. The new standardized instrument clutches allow easy instrument (dis-)assembly. Instrument exchange is possible in two methods, the fastest of which is a median of 11 (6.3-14.6) seconds. The driver's instrument mechanism is separated in a median of 3.7 (1.8-8.1) seconds. After assembly, the driver is operational in less than 2 s. Discussion: Instrument exchange times are similar to the semi-reusable Da Vinci systems, yet the MISLI-Drive is designed for sterilization, inspection and continual re-use. The modular build of the driver also allows easier parts replacement during maintenance, and requires minimal adaptation to different future scenarios, which is expected to reduce the overall cost of use.

Design and Evaluation of a Balanced Compliant Laparoscopic Grasper.

In laparoscopic surgery, quality of haptic feedback is reduced compared to conventional surgery, leading to unintentional tissue damage during grasping. From the perspective of haptics, poor mechanical design of laparoscopic instrument joints induces friction and a nonlinear actuation-tip force relation. In this study, a novel laparoscopic grasper using compliant joints and a magnetic balancer is presented, and the reduction in hysteresis and friction is evaluated. The hysteresis loop of the novel compliant grasper and two conventional laparoscopic graspers (high quality leading commercial brand and low quality unbranded grasper) were measured. In order to assess quality of haptic feedback, the lowest grasper tip load perceivable by instrument users was measured with the novel and the conventional laparoscopic graspers. The hysteresis loop measurement yielded a mechanical efficiency of 43% for the novel grasper, compared to- 25% and 23% for the Aesculap and the unbranded grasper, respectively. The forces perceivable by the user through the novel grasper were significantly lower (mean 1.37N, SD 0.44N) than those of conventional graspers (mean 2.15N, SD 0.71N and mean 2.65N, SD 1.20N, respectively). The balanced compliant grasper technology has the ability to improve the quality of haptic feedback compared to conventional laparoscopic graspers. Research is needed to relate these results to soft and delicate tissue grasping in a clinical setting, for which this instrument is intended.

Escape of surgical smoke particles, comparing conventional and valveless trocar systems.

BACKGROUND: During minimal access surgery, surgical smoke is produced which can potentially be inhaled by the surgical team, leading to several health risks. This smoke can escape from the abdominal cavity into the operating room due to trocar leakage. The trocars and insufflator that are used during surgery influence gas leakage. Therefore, this study compares particle escape from a valveless (Conmed AirSeal iFS), and a conventional (Karl Storz Endoflator) system. MATERIALS AND METHODS: Using an in vitro model, a conventional and a valveless trocar system were compared. A protocol that simulated various surgical phases was defined to assess the surgical conditions and particle leakage. Insufflation pressures and instrument diameters were varied as these are known to affect gas leakage. RESULTS: The conventional trocar leaked during two distinct phases. Removal of the obturator caused a sudden release of particles. During instrument insertion, an average of 211 (IQR 111) particles per second escaped when using the 5 mm diameter instrument. With the 10 mm instrument, 50 (IQR 13) particles per second were measured. With the conventional trocar, a higher abdominal pressure increased particle leakage. The valveless trocar demonstrated a continuously high particle release during all phases. After the obturator was removed, particle escape increased sharply. Particle escape decreased to 1276 (IQR 580) particles per second for the 5 mm instrument insertion, and 1084 (IQR 630) particles per second for 10 mm instrument insertion. With the valveless trocar system, a higher insufflation pressure lowered particle escape. CONCLUSIONS: This study shows that a valveless trocar system releases more particles into the operating room environment than a conventional trocar. During instrument insertion, the leakage through the valveless system is 6 to 20 times higher than the conventional system. With a valveless trocar, leakage decreases with increasing pressure. With both trocar types leakage depends on instrument diameter.

Crossover-effects in technical skills between laparoscopy and robot-assisted surgery.

INTRODUCTION: Robot-assisted surgery is often performed by experienced laparoscopic surgeons. However, this technique requires a different set of technical skills and surgeons are expected to alternate between these approaches. The aim of this study is to investigate the crossover effects when switching between laparoscopic and robot-assisted surgery. METHODS: An international multicentre crossover study was conducted. Trainees with distinctly different levels of experience were divided into three groups (novice, intermediate, expert). Each trainee performed six trials of a standardized suturing task using a laparoscopic box trainer and six trials using the da Vinci surgical robot. Both systems were equipped with the ForceSense system, measuring five force-based parameters for objective assessment of tissue handling skills. Statistical comparison was done between the sixth and seventh trial to identify transition effects. Unexpected changes in parameter outcomes after the seventh trial were further investigated. RESULTS: A total of 720 trials, performed by 60 participants, were analysed. The expert group increased their tissue handling forces with 46% (maximum impulse 11.5 N/s to 16.8 N/s, p = 0.05), when switching from robot-assisted surgery to laparoscopy. When switching from laparoscopy to robot-assisted surgery, intermediates and experts significantly decreased in motion efficiency (time (sec), resp. 68 vs. 100, p = 0.05, and 44 vs. 84, p = 0.05). Further investigation between the seventh and ninth trial showed that the intermediate group increased their force exertion with 78% (5.1 N vs. 9.1 N, p = 0.04), when switching to robot-assisted surgery. CONCLUSION: The crossover effects in technical skills between laparoscopic and robot-assisted surgery are highly depended on the prior experience with laparoscopic surgery. Where experts can alternate between approaches without impairment of technical skills, novices and intermediates should be aware of decay in efficiency of movement and tissue handling skills that could impact patient safety. Therefore, additional simulation training is advised to prevent from undesired events.

Question-based development of high-risk medical devices: A proposal for a structured design and review process.

INTRODUCTION: The recent introduction of the European Medical Device Regulation poses stricter legislation for manufacturers developing medical devices in the EU. Many devices have been placed into a higher risk category, thus requiring more data before market approval, and a much larger focus has been placed on safety. For implantable and Class III devices, the highest risk class, clinical evidence is a necessity. However, the requirements of clinical study design and developmental outcomes are only described in general terms due to the diversity of devices. METHODS: A structured approach to determining the requirements for the clinical development of high-risk medical devices is introduced, utilizing the question-based development framework, which is already used for pharmaceutical drug development. An example of a novel implantable device for haemodialysis demonstrates how to set up a relevant target product profile defining the device requirements and criteria. The framework can be used in the medical device design phase to define specific questions to be answered during the ensuing clinical development, based upon five general questions, specified by the question-based framework. RESULTS: The result is a clear and evaluable overview of requirements and methodologies to verify and track these requirements in the clinical development phase. Development organizations will be guided to the optimal route, also to abandon projects destined for failure early on to minimize development risks. CONCLUSION: The framework could facilitate communication with funding agencies, regulators and clinicians, while highlighting remaining 'known unknowns' that require answering in the post-market phase after sufficient benefit is established relative to the risks.

Force-based assessment of tissue handling skills in simulation training for robot-assisted surgery.

INTRODUCTION: Although robotic-assisted surgery is increasingly performed, objective assessment of technical skills is lacking. The aim of this study is to provide validity evidence for objective assessment of technical skills for robotic-assisted surgery. METHODS: An international multicenter study was conducted with participants from the academic hospitals Heidelberg University Hospital (Germany, Heidelberg) and the Amsterdam University Medical Centers (The Netherlands, Amsterdam). Trainees with distinctly different levels of robotic surgery experience were divided into three groups (novice, intermediate, expert) and enrolled in a training curriculum. Each trainee performed six trials of a standardized suturing task using the da Vinci Surgical System. Using the ForceSense system, five force-based parameters were analyzed, for objective assessment of tissue handling skills. Mann-Whitney U test and linear regression were used to analyze performance differences and the Wilcoxon signed-rank test to analyze skills progression. RESULTS: A total of 360 trials, performed by 60 participants, were analyzed. Significant differences between the novices, intermediates and experts were observed regarding the total completion time (41 s vs 29 s vs 22 s p = 0.003), mean non zero force (29 N vs 33 N vs 19 N p = 0.032), maximum impulse (40 Ns vs 31 Ns vs 20 Ns p = 0.001) and force volume (38 N3 vs 32 N3 vs 22 N3 p = 0.018). Furthermore, the experts showed better results in mean non-zero force (22 N vs 13 N p = 0.015), maximum impulse (24 Ns vs 17 Ns p = 0.043) and force volume (25 N3 vs 16 N3 p = 0.025) compared to the intermediates (p ≤ 0.05). Lastly, learning curve improvement was observed for the total task completion time, mean non-zero force, maximum impulse and force volume (p ≤ 0.05). CONCLUSION: Construct validity for force-based assessment of tissue handling skills in robot-assisted surgery is established. It is advised to incorporate objective assessment and feedback in robot-assisted surgery training programs to determine technical proficiency and, potentially, to prevent tissue trauma.

Dynamic characteristics of skin reaction force in different body postures.

Mechanical stress influences scarring of a surgical wound. Several lines have been proposed for the best excision direction. It is unknown if these lines still apply when the body posture changes. The objective is to measure the skin reaction force in four directions and determine the direction of least force. Secondary objective is to determine if the reaction force varies in a different body posture. Skin reaction force was measured with the compressiometer in 30 participants on four different locations (forearm/upper arm/shoulder blade/lower back) in four directions (0°-45°-90°-135°) and two body postures. The direction of least skin reaction force changed with a different body posture and was significant for the forearm (p < 0.01) and shoulder blade (p = 0.05) The skin reaction force in all four direction changed significantly in a different body posture, except the 45° line in the upper arm and shoulder blade. Our results demonstrate that the skin reaction force in four directions in four locations varies with change in body posture. Focus should therefore not only lay on choosing the right direction, but also on managing skin tension postoperatively.

Reprocessing Zamak laryngoscope blades into new instrument parts; an 'all-in-one' experimental study.

Introduction: Disposable instruments in healthcare have led to a significant increase of medical waste. The aim of this study is to validate the recycling of disposable Zamak laryngoscope blades into new medical components by using a new 'all-in-one' affordable reprocessing setup as alternative for die-casting. Methods: A n "all-in-one" casting set-up was designed and built. Laryngoscope blades, recovered from two hospitals, were disinfected, melted and cast into dog-bones and into new instrument parts. The quality of the cast material was evaluated using X-ray fluorescence spectrometry. The mechanical properties were obtained by assessing the Ultimate Tensile Strength (UTS) and tensile tests. Results: A recovery of 93 % Zamak was obtained using a melting temperature of 420 °C for 3 h. The XRF Spectro data showed higher Zinc and silicon concentrations when compared with Virgin Zamak. The dog-bones tests resulted in an average UTS, Yield Strength (YS) and Young's Modulus (YM) of 236 ± 61 (MPa), 70 ± 43 and 9 ± 3, respectively, representing 82 %, 103 % and 64 % of the UTS, YS and YM of standard Zamak. Functional instrument parts with extensions and inner chambers were cast with a maximal shrinkage percentage of 1 ± 1 %. Discussion: This study demonstrates that the created "all-in-one" reprocessing method can process contaminated disposable Zamak laryngoscope blades into new raw base material and new instrument parts. Although material and surface properties can deteriorate, reprocessed Zamak still has sufficient mechanical properties and can be used to cast complex parts with sufficient dimensional tolerances and minimal shrinkage. Conclusion: A micro reprocessing method was designed and used to turn disposed laryngoscope blades into new basis material and semi-finished components. Follow up studies are needed to scale and optimize this process towards a functional alternative for die casting. It should be further investigated how this process can contribute to further medical waste reduction and a circular healthcare economy.

Design of an Affordable, Modular Implant Device for Soft Tissue Tension Assessment and Range of Motion Tracking During Total Hip Arthroplasty.

Background: In hip arthroplasties, surgeons rely on their experience to assess the stability and balance of hip tissues when fitting the implant to their patients. During the operation, surgeons use a modular, temporary set of implants to feel the tension in the surrounding soft tissues and adjust the implant configuration. This process is naturally subjective and therefore depends on the operator. Inexperienced surgeons undertaking hip arthroplasties are twice as likely to experience errors than their experienced colleagues, leading to dislocations, pain and discomfort for the patients. Methods: To address this issue, a new, 3DOF force measurement system was developed and integrated into the modular, trial implants that can quantify forces and movements intraoperatively in 3D. The prototypes were evaluated in three post-mortem human specimens (PMHSs), to provide surgeons with objective data to help determine the optimal implant fit and configuration. The devices comprise a deformable polymer material providing strain-based displacements measured with electromagnetic-based sensors and an inertial measurement unit (IMU) for motion data. Results: Device results show a relative accuracy of approx. 2% and a sensitivity of approx. 1%. PMHS results indicated that soft tissue forces on the hip joint peak in the order of ~100 N and trend with positions of the leg during range of motion (ROM) tests, although force patterns differ between each PMHS. Conclusion: By monitoring forces and force patterns of hip soft tissues, in combination with standardised ROM tests, the force patterns could shed a light on potential anomalies that can be addressed during surgery. Clinical and Translational Impact Statement: The development of an instrumented hip implant device for use during surgery knowledge will eventually allow us to develop a predictive model for soft tissue balancing, that can be used for pre- and intra-operative planning for each patient on a tailored and personalised basis. Ultimately, we hope that with this device, patients will benefit from a faster recovery, from a more-precisely fitted hip, and an improved quality of life.

Using Acoustic Vibrations as a Method for Implant Insertion Assessment in Total Hip Arthroplasty.

The success of total hip arthroplasty depends on the experience of the surgeon, and one of the ways the surgeon currently determines the final implant insertion depth is to listen to the change in audible pitch of the hammering sound. We investigated the use of vibration emissions as a novel method for insertion quality assessment. A non-invasive contact microphone-based measurement system for insertion depth estimation, fixation and fracture detection was developed using a simplified in vitro bone/implant (n = 5). A total of 2583 audio recordings were analyzed in vitro to obtain energy spectral density functions. Out of the four main resonant peaks under in vitro conditions, broach insertion depth statistically correlates to increasing 3rd and 4th peak frequencies. Degree of fixation was also observed as higher goodness of fit (0.26-0.78 vs. 0.12-0.51 between two broach sizes, the latter undersized). Finally, however, the moment of fracture could not be predicted. A cadaveric in situ pilot study suggests comparable resonant frequencies in the same order of magnitudes with the bone model. Further understanding of the signal patterns are needed for an early warning system diagnostic system for imminent fractures, bone damage, improving accuracy and quality of future procedures.

Characterisation of trocar associated gas leaks during laparoscopic surgery.

BACKGROUND: During laparoscopy, the abdominal cavity is insufflated with carbon dioxide (CO2) that could become contaminated with viruses and surgical smoke. Medical staff is potentially exposed when this gas leaks into the operating room through the instruments and past trocar valves. No detailed studies currently exist that have quantified these leakage pathways. Therefore, the goal of this study was to quantify the gas leakages through trocars and instruments, during minimally invasive procedures. METHODS: A model of the surgical environment was created, consisting of a rigid container with an interface for airtight clamping of laparoscopic equipment such as trocars and surgical instruments. The model was insufflated to 15 mm Hg using a pressure generator and a pneumotachograph measured the equipment gas leak. A protocol of several use cases was designed to simulate the motions and forces the surgeon exerts on the trocar during surgery. RESULTS: Twenty-three individual trocars and twenty-six laparoscopic instruments were measured for leakage under the different conditions of the protocol. Trocar leakages varied between 0 L/min and more than 30 L/min, the instruments revealed a range of leakages between 0 L/min and 5.5 L/min. The results showed that leakage performance varied widely between trocars and instruments and that the performance and location of the valves influenced trocar leakage. CONCLUSIONS: We propose trocar redesigns to overcome specific causes of gas leaks. Moreover, an international testing standard for CO2 leakage for all new trocars and instruments is needed so surgical teams can avoid this potential health hazard when selecting new equipment.

Validation of the portable virtual reality training system for robotic surgery (PoLaRS): a randomized controlled trial.

BACKGROUND: As global use of surgical robotic systems is steadily increasing, surgical simulation can be an excellent way for robotic surgeons to acquire and retain their skills in a safe environment. To address the need for training in less wealthy parts of the world, an affordable surgical robot simulator (PoLaRS) was designed. METHODS: The aim of this pilot study is to compare learning curve data of the PoLaRS prototype with those of Intuitive Surgical's da Vinci Skills Simulator (dVSS) and to establish face- and construct validity. Medical students were divided into two groups; the test group (n = 18) performing tasks on PoLaRS and dVSS, and the control group (n = 20) only performing tasks on the dVSS. The performance parameters were Time, Path length, and the number of collisions. Afterwards, the test group participants filled in a questionnaire regarding both systems. RESULTS: A total of 528 trials executed by 38 participants were measured and included for analyses. The test group significantly improved in Time, Path Length and Collisions during the PoLaRS test phase (P ≤ 0.028). No differences was found between the test group and the control group in the dVSS performances during the post-test phase. Learning curves showed similar shapes between both systems, and between both groups. Participants recognized the potential benefits of simulation training on the PoLaRS system. CONCLUSIONS: Robotic surgical skills improved during training with PoLaRS. This shows the potential of PoLaRS to become an affordable alternative to current surgical robot simulators. Validation with similar tasks and different expert levels is needed before implementing the training system into robotic training curricula.

Assessment of technical skills based on learning curve analyses in laparoscopic surgery training.

BACKGROUND: Objective force- and motion-based assessment is currently lacking in laparoscopic skills curricula. This study aimed to evaluate the added value of parameter-based assessment and feedback during training. METHODS: Laparoscopy-naïve surgical residents that took part in a 3-week skills training curriculum were included. A box trainer equipped with the ForceSense system was used for assessment of tissue manipulation- (MaxForce) and instrument-handling skills (Path length and Time). Learning curves were established using linear regression tests. Pre- and post-course comparisons indicated the overall progression and were compared to predefined proficiency levels. A post-course survey was carried out to assess face validity. RESULTS: In total, 4,268 trials, executed by 24 residents, were successfully assessed. Median (interquartile range) MaxForce outcomes improved from 2.7 Newton (interquartile range 1.9-3.8) to 1.8 Newton (interquartile range 1.2-2.4) between pre- and post-course assessment (P ≤ .009). Instrument Path length improved from 7,102.2 mm (interquartile range 5,255.2-9,025.9) to 3,545.3 mm (interquartile range 2,842.9-4,563.2) (P ≤.001). Time to execute the task improved from 159.8 seconds (interquartile range 119.8-219.0) to 60.7 seconds (interquartile range 46.0-79.5) (P ≤ .001). The learning curves revealed during what training phase the proficiency benchmarks were reached for each trainee. In the survey outcomes, trainees indicated that this curriculum should be part of a surgical residency program (mean visual analog scale score of 9.2 ± 0.9 standard deviation). CONCLUSION: Force-, motion-, and time-parameters can be objectively measured during basic laparoscopic skills curricula and do indicate progression of skills over time. The ForceSense parameters enable curricula to be designed for specific proficiency-based training goals and offer the possibility for objective classification of the levels of expertise.

A new bone-cutting approach for minimally invasive surgery.

AIMS: Resection of bone is performed in over 75% of all orthopaedic procedures and the electrically powered oscillating saw is commonly used to cut bone. Drawbacks are relatively large incisions and tissue damage due to overshooting often occur. Therefore, the goal of this study is to develop an improved bone-cutting system that has minimally invasive characteristics. METHODS: A new reusable sawing system was designed that can be used in Minimally Invasive Surgery (MIS) consisting of a steerable wire passer and a tissue saving wire saw guide. The system was tested during surgery on a human cadaveric tibia and calcaneus. RESULTS: A MIS steerable compliant Nitinol needle was built and successfully used in a cadaveric surgery to position the cutting wire around a tibia and calcaneus. A wire saw operating system was built that was successfully used to cut the tibia and calcaneus. CONCLUSION: A MIS bone-cutting system was successfully designed, manufactured and used in a cadaver study showing that safe minimally invasive bone-cutting is feasible for two bone types with minimal damage to the surrounding tissue. Design optimization is needed to stabilize the compliant Nitinol needle during wire saw positioning and to allow cutting of bones with smaller diameters.