Digitally enhanced hands-on surgical training (DEHST) enhances the performance during freehand nail distal interlocking.

PURPOSE: Freehand distal interlocking of intramedullary nails remains a challenging task. Recently, a new training device for digitally enhanced hands-on surgical training (DEHST) was introduced, potentially improving surgical skills needed for distal interlocking. AIM: To evaluate whether training with DEHST enhances the performance of novices (first-year residents without surgical experience in freehand distal nail interlocking). METHODS: Twenty novices were randomly assigned to two groups and performed distal interlocking of a tibia nail in mock operation under operation-room-like conditions. Participants in Group 1 were trained with DEHST (five distal interlocking attempts, 1 h of training), while those in Group 2 did not receive training. Time, number of X-rays shots, hole roundness in the X-rays projection and hit rates were compared between the groups. RESULTS: Time to complete the task [414.7 s (range 290-615)] and X-rays exposure [17.8 µGcm2 (range 9.8-26.4)] were significantly lower in Group 1 compared to Group 2 [623.4 s (range 339-1215), p = 0.041 and 32.6 µGcm2 (range 16.1-55.3), p = 0.003]. Hole projections were significantly rounder in Group 1 [95.0% (range 91.1-98.0) vs. 80.8% (range 70.1-88.9), p < 0.001]. In Group 1, 90% of the participants achieved successful completion of the task in contrast to a 60% success rate in Group 2. This difference was not statistically significant (p = 0.121). CONCLUSIONS: In a mock-operational setting, training with DEHST significantly enhanced the performance of novices without surgical experience in distal interlocking of intramedullary nails and hence carries potential to improve safety and efficacy of this important and demanding surgical task to steepen the learning curve without endangering patients. LEVEL OF EVIDENCE: II.

In Vitro Testing and Clinical Handling of a Novel Implant Positioning Technology for Proximal Humeral Plating.

BACKGROUND AND OBJECTIVES: Fractures of the proximal humerus are common, particularly in elderly populations. Anatomical locking plates target stabilization with a multitude of screws spanning into the humeral head. Sound implant placement and screw length determination are key for a successful clinical outcome but are difficult to obtain from planar X-rays. A novel implant positioning technology for proximal humerus plating (Xin1) outputs screw lengths suggestions and plate position based on hole projections in conventional X-ray images. This study investigated the performance of a prototype Xin1 system in a postmortem (in vitro) experiment as well as in a clinical handling test. MATERIALS AND METHODS: For in vitro testing, twelve shoulders from six anatomical specimens were randomized into two groups to compare the Xin1 technique to the conventional operation in terms of surgical precision, procedure time and X-ray exposure. For the clinical trial, 11 patients undergoing plating of the proximal humerus were included. The aim was to investigate clinical handling of the Xin1 marker clip and to retrospectively evaluate the system performance in a real-life fracture situation. Image pairs before and after insertion of the proximal screws were retrospectively processed to investigate the influence of potential bone fragment shifts on the system output. RESULTS: In the postmortem experiment, the use of the system significantly improved the surgical precision (52% error reduction), procedure time (38% shorter) and radiation exposure (64% less X-rays). Clinical handling demonstrated seamless embedding of the marker clip into existing clinical workflows without adverse events reported. Retrospective X-ray analysis on six eligible patients revealed differences in the calculated screw lengths of ≤2 mm before and after screw insertion for five patients. In one patient, the screw lengths differed up to 8 mm, which might indicate displacement of the head fragment. CONCLUSIONS: Results suggest a strong potential of the Xin1 assistance technology to enhance the surgical procedure and patient outcomes in the rising incidence of osteoporotic humeral fractures. Robust performance in a real-life fracture situation was observed. In-depth validation of the system is, however, needed before placing it into clinical practice.

Validity of a Novel Digitally Enhanced Skills Training Station for Freehand Distal Interlocking.

Background and Objectives: Freehand distal interlocking of intramedullary nails is technically demanding and prone to handling issues. It requires precise placement of a screw through the nail under fluoroscopy guidance and can result in a time consuming and radiation expensive procedure. Dedicated training could help overcome these problems. The aim of this study was to assess construct and face validity of new Digitally Enhanced Hands-On Surgical Training (DEHST) concept and device for training of distal interlocking of intramedullary nails. Materials and Methods: Twenty-nine novices and twenty-four expert surgeons performed interlocking on a DEHST device. Construct validity was evaluated by comparing captured performance metrics-number of X-rays, nail hole roundness, drill tip position and drill hole accuracy-between experts and novices. Face validity was evaluated with a questionnaire concerning training potential and quality of simulated reality using a 7-point Likert scale. Results: Face validity: mean realism of the training device was rated 6.3 (range 4-7). Training potential and need for distal interlocking training were both rated with a mean of 6.5 (range 5-7), with no significant differences between experts and novices, p ≥ 0.234. All participants (100%) stated that the device is useful for procedural training of distal nail interlocking, 96% wanted to have it at their institution and 98% would recommend it to colleagues. Construct validity: total number of X-rays was significantly higher for novices (20.9 ± 6.4 versus 15.5 ± 5.3, p = 0.003). Success rate (ratio of hit and miss attempts) was significantly higher for experts (novices hit: n = 15; 55.6%; experts hit: n = 19; 83%, p = 0.040). Conclusion: The evaluated training device for distal interlocking of intramedullary nails yielded high scores in terms of training capability and realism. Furthermore, construct validity was proven by reliably discriminating between experts and novices. Participants indicate high further training potential as the device may be easily adapted to other surgical tasks.

Growth modulation of angular deformities with a novel constant force implant concept-preclinical results.

PURPOSE: Varus-valgus deformities in children and adolescents are often corrected by temporary hemi-epiphysiodesis, in which the physis is bridged by an implant to inhibit growth. With standard implant solutions, the acting forces cannot be regulated, rendering the correction difficult to control. Furthermore, the implant load steadily increases with ongoing growth potentially leading to implant-related failures. A novel implant concept was developed applying a controlled constant force to the physis, which carries the potential to avoid these complications. The study aim was to proof the concept in vivo by analyzing the effect of three distinct force levels on the creation of varus deformities. METHODS: The proposed implant is made of a conventional cerclage wire and features a twisted coil that unwinds with growth resulting in an implant-specific constant force level. The proximal medial tibial physes of 18 lambs were treated with the implant and assigned to three groups distinct by the force level of the implant (200 N, 120 N, 60 N). RESULTS: The treatment appeared safe without implant-related failures. Deformity creation was statistically different between the groups and yielded on average 10.6° (200 N), 4.8° (120 N) and 0.4° (60 N) over the treatment period. Modulation rates were 0.51°/mm (200 N), 0.23°/mm (120 N) and 0.05°/mm (60 N) and were constant throughout the treatment. CONCLUSION: By means of the constant force concept, controlled growth modulation appeared feasible in this preclinical experiment. However, clinical trials are necessary to confirm whether the results are translatable to the human pathological situation.

In vivo test of a radiography-based navigation system for control of derotational osteotomies.

Malalignment of the femur is a frequently encountered problem in orthopaedics entailing manifold consequences for the affected patients. Corrective osteotomies, necessary to restore the physiological and anatomical relationships, face great challenges due to no existing reliable gold standard for intraoperative control of torsional malalignment. The aim of this study was to test a novel radiography-based navigation tool for control of derotational osteotomies in a clinical environment. In a first-and preliminary-case-controlled study on 12 patients (level 3 of evidence), the achieved torsional correction measured with implementation of the navigation tool was compared with measurements from pre- and postoperative computed tomography (CT) scans. The navigation tool was able to acquire and process all relevant data and capture possible malrotation during surgery with only little deviations of 1.61° ± 0.86° (mean ± standard deviation) from the measurements based on CT scans. Next, the system will be used to assist surgeons for more precise treatment avoiding maltorsion after derotational osteotomies.

Importance of locking plate positioning in proximal humeral fractures as predicted by computer simulations.

Multifragmented proximal humeral fractures frequently require operative fixation. The locking plates commonly used are often placed relative to the greater tuberosity, however no quantitative data exists regarding the effect of positional changes. The aim of the study was to establish the effects from variations in proximal-distal PHILOS humeral plate positioning on predicted fixation failure risk. Twenty-one left-sided low-density virtual humeri models were created with a simulation framework from CT data of elderly donors and osteotomized to mimic an unstable three-part malreduced AO/OTA 11-B3.2 fracture with medial comminution. A PHILOS plate with either four or six proximal screws was used for fixation. Both configurations were modelled with plate repositioning 2 and 4 mm distally and proximally to its baseline position. Applying a validated computational model, three physiological loading situations were simulated and fixation failure predicted using average strain around the proximal screws-an outcome established as a surrogate for cycles to failure. Varying the craniocaudal plate position affected the peri-implant strain for both four and six-screw configurations. Even though significant changes were seen only in the latter, all tests suggested that more proximal plate positioning results in decreased peri-screw strains whereas distalizing creates increases in strain. These results suggest that even a small distal PHILOS plate malpositioning may reduce fixation stability. Plate distalization increases the probability of being unable to insert all screws within the humeral head, which dramatically increases the forces acting on the remaining screws. Proximal plate shifting may be beneficial, especially for constructs employing calcar screws. © 2019 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res.

Biomechanical investigation of two long bone growth modulation techniques by finite element simulations.

Implants used to correct pathological varus-valgus deformities (VVD) and leg length discrepancies (LLD) may not be optimized for the specific treatment, as suggested by their off-label use. Detailed analysis of this issue has been limited by the poorly understood mechanical behavior of the growing physis and ignorance of the loads acting on the implants. The aim of this study was to predict and compare the loading conditions of a growth modulation implant in VVD and LLD treatments. Idealized finite element (FE) models of the juvenile distal femur treated with the Eight-Plate implant were developed for VVD and LLD. Bone growth was simulated using thermal strains. The axial force in the plate was compared between the two treatments. Case-specific plate forces were predicted by virtually reproducing the screw deformation visible on radiographs of LLD (N = 4) and VVD (N = 4) clinical cases. The simple FE models reproduced the clinical implant deformations well. The resulting forces ranged from 129 to 580 N for the VVD patients. For LLD, this range was from 295 to 1002 N per plate, that is, 590-2004 N for the entire physis. The higher forces in LLD could be explained by restricted screw divergence in the double-sided implant application. For the first time, the loading conditions of a growth modulation implant were investigated and compared between two treatments by FE analyses, and the range of case-specific loads was predicted. These simulation tools may be utilized for guiding appropriate usage and for efficient development of implants. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 36:1398-1405, 2018.

Introduction of a computer-based method for automated planning of reduction paths under consideration of simulated muscular forces.

PURPOSE: Reduction is a crucial step in the surgical treatment of bone fractures. Finding an optimal path for restoring anatomical alignment is considered technically demanding because collisions as well as high forces caused by surrounding soft tissues can avoid desired reduction movements. The repetition of reduction movements leads to a trial-and-error process which causes a prolonged duration of surgery. By planning an appropriate reduction path-an optimal sequence of target-directed movements-these problems should be overcome. For this purpose, a computer-based method has been developed. METHODS: Using the example of simple femoral shaft fractures, 3D models are generated out of CT images. A reposition algorithm aligns both fragments by reconstructing their broken edges. According to the criteria of a deduced planning strategy, a modified A*-algorithm searches collision-free route of minimal force from the dislocated into the computed target position. Muscular forces are considered using a musculoskeletal reduction model (OpenSim model), and bone collisions are detected by an appropriate method. RESULTS: Five femoral SYNBONE models were broken into different fracture classification types and were automatically reduced from ten randomly selected displaced positions. Highest mean translational and rotational error for achieving target alignment is [Formula: see text] and [Formula: see text]. Mean value and standard deviation of occurring forces are [Formula: see text] for M. tensor fasciae latae and [Formula: see text] for M. semitendinosus over all trials. These pathways are precise, collision-free, required forces are minimized, and thus regarded as optimal paths. CONCLUSIONS: A novel method for planning reduction paths under consideration of collisions and muscular forces is introduced. The results deliver additional knowledge for an appropriate tactical reduction procedure and can provide a basis for further navigated or robotic-assisted developments.

Biomechanical comparison of plate and screw fixation in anterior pelvic ring fractures with low bone mineral density.

INTRODUCTION: Osteosynthesis of anterior pubic ramus fractures can be challenging, especially in poor bone quality. The aim of the present study was to compare plate and retrograde endomedullary screw fixation of the superior pubic ramus with low bone mineral density (BMD). MATERIALS AND METHODS: Twelve human cadaveric hemi-pelvises were analyzed in a matched pair study design. BMD of the specimens was 35±30mgHA/cm(3), as measured in the fifth lumbar vertebra. A simulated two-fragment superior pubic ramus fracture model was fixed with either a 7.3-mm cannulated retrograde screw (Group 1) or a 10-hole 3.5-mm reconstruction plate (Group 2). Cyclic progressively increasing axial loading was applied through the acetabulum. Relative interfragmentary movements were captured using an optical motion tracking system. RESULTS: Initial axial construct stiffness was 424±116.1N/mm in Group 1 and 464±69.7N/mm in Group 2, with no significant difference (p=0.345). Displacement and gap angle at the fracture site during cyclic loading were significantly higher in Group 1 compared to Group 2. Cycles to failure, based on clinically relevant criteria, were significantly lower in Group 1 (3469±1837) compared to Group 2 (10,226±3295) (p=0.028). Failure mode in Group 1 was characterized by screw cutting through the cancellous bone. In Group 2 the specimens exclusively failed by plate bending. CONCLUSIONS: From biomechanical point of view, pubic ramus stabilization with plate osteosynthesis is superior compared to a single retrograde screw fixation in osteoporotic bone. However, the extensive surgical approach needed for plating must be considered.

A novel tool for continuous fracture aftercare - Clinical feasibility and first results of a new telemetric gait analysis insole.

Weight bearing after lower extremity fractures still remains a highly controversial issue. Even in ankle fractures, the most common lower extremity injury no standard aftercare protocol has been established. Average non weight bearing times range from 0 to 7 weeks, with standardised, radiological healing controls at fixed time intervals. Recent literature calls for patient-adapted aftercare protocols based on individual fracture and load scenarios. We show the clinical feasibility and first results of a new, insole embedded gait analysis tool for continuous monitoring of gait, load and activity. Ten patients were monitored with a new, independent gait analysis insole for up to 3 months postoperatively. Strict 20 kg partial weight bearing was ordered for 6 weeks. Overall activity, load spectrum, ground reaction forces, clinical scoring and general health data were recorded and correlated. Statistical analysis with power analysis, t-test and Spearman correlation was performed. Only one patient completely adhered to the set weight bearing limit. Average time in minutes over the limit was 374 min. Based on the parameters load, activity, gait time over 20 kg weight bearing and maximum ground reaction force high and low performers were defined after 3 weeks. Significant difference in time to painless full weight bearing between high and low performers was shown. Correlation analysis revealed a significant correlation between weight bearing and clinical scoring as well as pain (American Orthopaedic Foot and Ankle Society (AOFAS) Score rs=0.74; Olerud-Molander Score rs=0.93; VAS pain rs=-0.95). Early, continuous gait analysis is able to define aftercare performers with significant differences in time to full painless weight bearing where clinical or radiographic controls could not. Patient compliance to standardised weight bearing limits and protocols is low. Highly individual rehabilitation patterns were seen in all patients. Aftercare protocols should be adjusted to real-time patient conditions, rather than fixed intervals and limits. With a real-time measuring device high performers could be identified and influenced towards optimal healing conditions early, while low performers are recognised and missing healing influences could be corrected according to patient condition.

Computer-assisted fracture reduction: a new approach for repositioning femoral fractures and planning reduction paths.

PURPOSE: Reduction is a crucial step in the surgical treatment of bone fractures to achieve anatomical alignment and facilitate healing. Surgical planning for treatment of simple femoral fractures requires suitable gentle reduction paths. A plan with optimal movement of fracture fragments from the initial to the desired target position should improve the reduction procedure. A virtual environment which repositions the fracture fragments automatically and provides the ability to plan reduction paths was developed and tested. METHODS: Virtual 3D osseous fragments are created from CT scans. Based on the computed surface curvatures, strongly curved edges are selected and fracture lines are generated. After assignment of matching points, the lines are compared and the desired target position is calculated. Planning of reduction paths was achieved using a reference-coordinate-system for the computation of reduction parameters. The fracture is reduced by changing the reduction parameters step by step until the target position is reached. To test this system, nine different fractured SYNBONE models and one human fracture were reduced, based on CT scans with varying resolution. RESULTS: The highest mean translational error is 1.2 ± 0.9 (mm), and the rotational error is 2.6 ± 2.8 (°), both of which are considered as clinically acceptable. The reduction paths can be planned manually or semi-automatically for each fracture. CONCLUSIONS: Automated fracture reduction was achieved using a system based on preoperative CT scans. The automated system provides a clinically feasible basis for planning optimal reduction paths that may be augmented by further computer- or robot-assisted applications.