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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_2 | Pages 45 - 45
2 Jan 2024
Gilsing R Hoogeveen M Boers H van der Weegen W
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Knee swelling is common after injury or surgery, resulting in pain, restricted range of movement and limited mobility. Accurately measuring knee swelling is critical to assess recovery. However, current measurement methods are either unreliable or expensive [1,2]. Therefore, a new measurement method is developed. This wearable (the ‘smart brace’) has shown the ability to distinguish a swollen knee from a not swollen knee using multi-frequency-bio impedance analysis (MF-BIA) [3]. This study aimed to determine the accuracy of this smart brace. The study involved 25 usable measurements on patients treated for unilateral knee osteoartritis with a 5mL injection of Lidocaïne + DepoMedrol (1:4). MF-BIA measurements were taken before and after the injection, both on the treated and untreated knee. The smart brace accurately measured the effect of the injection by a decrease in resistance of up to 2.6% at 100kHz (p<0.01), where commonly used gel electrodes were unable to measure the relative difference. Remarkably, both the smart brace and gel electrodes showed a time component in the MF-BIA measurements. To further investigate this time component, 10 participants were asked to lie down for 30 minutes, with measurements taken every 3 minutes using both gel electrodes and the smart brace on both legs. The relative change between each time step was calculated to determine changes over time. The results showed presence of a physiological aspect (settling of knee fluids), and for the brace also a mechanical aspect (skin-electrode interface) [4]. The mechanical aspect mainly interfered with reactance values. Overall, the smart brace is a feasible method for quantitatively measuring knee swelling as a relative change over time. However, the skin-electrode interface should be improved for reliable measurements at different moments in time. The findings suggest that the smart brace could be a promising tool for monitoring knee swelling during rehabilitation


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_5 | Pages 50 - 50
1 Apr 2022
Ferreira N Arkell C Fortuin F Saini A
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Introduction. The accuracy of hexapod circular external fixator deformity correction is contingent on the precision of radiographic analysis during the planning stage. The aim of this study was to compare the SMART TSF (Smith and Nephew, Memphis, Tennessee) in-suite radiographic analysis methods with the traditional manual deformity analysis methods in terms of accuracy of correction. Materials and Methods. Sawbones models were used to simulate two commonly encountered clinical scenarios. Traditional manual radiographic analysis and digital SMART TSF analysis methods were used to correct the simulated deformities. Results. The final outcomes of all six analysis methods across both simulated scenarios were satisfactory. Any differences in residual deformity between the analysis methods are unlikely to be clinically relevant. All three SMART TSF digital analyses were faster to complete than manual radiographic analyses. Conclusions. With experience and a good understanding of the software, manual radiographic analysis can be extremely accurate and remains the gold standard for deformity analysis. In-suite SMART TSF radiographic analysis is fast and accurate to within clinically relevant parameters. Surgeons can with confidence trust the SMART TSF software to provide analysis and corrections that are clinically acceptable


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_1 | Pages 35 - 35
1 Feb 2021
Hall T van Arkel R Cegla F
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Introduction & Aims. In other medical fields, smart implantable devices are enabling decentralised monitoring of patients and early detection of disease. Despite research-focused smart orthopaedic implants dating back to the 1980s, such implants have not been adopted into regular clinical practice. The hardware footprint and commercial cost of components for sensing, powering, processing, and communicating are too large for mass-market use. However, a low-cost, minimal-modification solution that could detect loosening and infection would have considerable benefits for both patients and healthcare providers. This proof-of-concept study aimed to determine if loosening/infection data could be monitored with only two components inside an implant: a single-element sensor and simple communication element. Methods. The sensor and coil were embedded onto a representative cemented total knee replacement. The implant was then cemented onto synthetic bone using polymethylmethacrylate (PMMA). Wireless measurements for loosening and infection were then made across different thicknesses of porcine tissue to characterise the sensor's accuracy for a range of implantation depths. Loosening was simulated by taking measurements before and after compromising the implant-cement interface, with fluid influx simulated with phosphate-buffered saline solution. Elevated temperature was used as a proxy for infection, with the sensor calibrated wirelessly through 5 mm of porcine tissue across a temperature range of 26–40°C. Results. Measurements for loosening and infection could be acquired simultaneously with a duration of 4 s per measurement. For loosening, the debonded implant-cement interface was detectable up to 10 mm with 95% confidence. For temperature, the sensor was calibrated with a root mean square error of 0.19°C at 5 mm implantation depth and prediction intervals of ±0.38°C for new measurements with 95% confidence. Conclusions. This study has demonstrated that with only two onboard electrical components, it is possible to wirelessly measure cement debonding and elevated temperature on a smart implant. With further development, this minimal hardware/cost approach could enable mass-market smart arthroplasty implants


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_9 | Pages 13 - 13
17 Apr 2023
Andreani L Vozzi G Petrini M Di Stefano R Trincavelli M Mani O Olivieri M Bizzocchi F Creati G Capanna R
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Traumatic acute or chronic tendon injuries are a wide clinical problem in modern society, resulting in important economic burden to the health system and poor quality of life in patients. Due to the low cellularity and vascularity of tendon tissue the repair process is slow and inefficient, resulting in mechanically, structurally, and functionally inferior tissue. Tissue engineering and regenerative medicine are promising alternatives to the natural healing process for tendon repair, especially in the reconstruction of large damaged tissues. The aim of TRITONE project is to develop a smart, bioactive implantable 3D printed scaffold, able to reproduce the structural and functional properties of human tendon, using FDA approved materials and starting from MSC and their precursor, MPC cell mixtures from human donors. Total cohort selected in the last 12 months was divided in group 1 (N=20) of subjects with tendon injury and group 2 (N=20) of healthy subject. Groups were profiled and age and gender matched. Inclusion criteria were age>18 years and presence of informed consent. Ongoing pregnancy, antihypertensive treatment, cardiovascular diseases, ongoing treatment with anti-aggregants, acetylsalicylic-acid or lithium and age<18 years were exclusion criteria. Firstly, we defined clinical, biological, nutritional life style and genetic profile of the cohort. The deficiency of certain nutrients and sex hormonal differences were correlated with tendon-injured patients. It was established the optimal amount of MPC/MSC human cell (collected from different patients during femoral neck osteotomy). Finally, most suitable biomaterials for tendon regeneration and polymer tendon-like structure were identified. Hyaluronic acid, chemical surface and soft-molecular imprinting (SOFT-MI) was used to functionalize the scaffold. These preliminary results are promising. It will be necessary to enroll many more patients to identify genetic status connected with the onset of tendinopathy. The functional and structural characterization of smart bioactive tendon in dynamic environment will represent the next project step


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 35 - 35
1 Jan 2016
Bell C Meere P Borukhov I Walker P
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Introduction. Evaluation of post-operative soft tissue balancing outcomes after Total Knee Arthroplasty (TKA) and other procedures can be measured by stability tests, with Anterior-Posterior (AP) drawer tests and Varus-Valgus (VV) ligamentous laxity tests being particularly important. AP stability can be quantified using a KT1000 device; however there is no standard way of measuring VV stability. The VV test relies on subjective force application and perception of laxity. Therefore we sought to develop and validate a device and method for quantifying knee balancing by analyzing VV stability. Materials and Methods. Our team developed a Smart Knee Fixture to measure VV angular changes using two dielectric elastomer stretch sensors, placed strategically over the medial and lateral collateral ligaments (see Figure 1). The brace is secured in position with the leg in full extension and the sensors locked with pre-tension. Therefore, contraction and elongation of either sensor is measured and the VV angular deviation of the long axis of the femur relative to that of the tibia is derived and displayed in real time using custom software. EMG muscle activity was previously investigated to confirm there is no resistive activity during the VV test obstructing ligamentous evaluations. The device was validated in two ways:. A bilateral lower body cadaver specimen, secured in a custom test rig, was used to compare the Smart Knee Fixture's readings to those measured from an optical surgical navigation system. Abduction and adduction force was gradually applied as varus and valgus moments with a wireless hand-held dynamometer up to 50N (19.8Nm) at 0 and 15° flexion. Two male volunteers were used to compare the Smart Knee Fixture's readings to those measured from fluoroscopic images. An arthroscopic distal thigh leg immobilizer was used to prevent rotation and lateral movements of the thigh when moments were applied at the malleoli. A C-arm Fluoroscope was then positioned focusing on the center of the joint. The tests were performed at full extension, 10 and 20° of flexion and force was gradually applied to 50N. Results and Discussion. R values were calculated to validate the Smart Knee Fixture's accuracy. Excellent correlation was observed between the Smart Knee Fixture and the gold standard of navigation (see Figure 2). The R values were 0.9909 and 0.9966. Correlation was also observed between Smart Knee Fixture and the measured fluoroscopic angular changes. The R values were 0.9118 and 0.7529. Conclusions. The strong R values allow us to conclude that the Smart Knee Fixture can potentially be used to accurately measure VV angular changes in a clinical setting and hence provide a quantified measure of coronal plane soft tissue balance. Clinical studies are underway to compare TKA patient outcomes to balancing measured by the Smart Knee Fixture. This information should further define balancing goals at the time of surgery. We also envisage broader applications to early detection of ligamentous injury associated with sporting activities, such as multiple ligamentous knee injuries in teenage females


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 82 - 82
1 May 2016
Chraim M Bock P Trnka H
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The surgical correction of hammer digits offers a variety of surgical treatments ranging from arthroplasty to arthrodesis, with many options for fixation. In the present study, we compared 2 buried implants for arthrodesis of lesser digit deformities: a Smart Toe® implant and a buried Kirschner wire. Both implants were placed in a prepared interphalangeal joint, did not violate other digital or metatarsal joints, and were not exposed percutaneously. A retrospective comparative study was performed of 117 digits with either a Smart Toe® implant or a buried Kirschner wire, performed from January 1, 2007 to December 31, 2010. Of the 117 digits, 31 were excluded because of a lack of 90-day radiographic follow-up. The average follow-up was 94 to 1130 days. The average patient age was 61.47 (range 43 to 84) years. Of the 86 included digits, 48 were left digits and 38 were right. Of the digits corrected, 54 were second digits, 24 were third digits and 8 were fourth digits. Fifty-eight Smart Toe® implants were found (15 with 19-mm straight; 2 with 19-mm angulated; 34 with 16-mm straight; and 7 with 16-mm angulated). Twenty-eight buried Kirschner wires were evaluated. No statistically significant difference was found between the Smart Toe® implants and the buried Kirschner wires, including the rate of malunion, nonunion, fracture of internal fixation, and the need for revision surgery. Of the 86 implants, 87.9% of the Smart Toe® implants and 85.7% of the buried Kirschner wires were in good position (0° to 10° of transverse angulation on radiographs). Osseous union was achieved in 68.9% of Smart Toe® implants and 82.1% of buried Kirschner wires. Fracture of internal fixation occurred in 12 of the Smart Toe® implants (20.7%) and 2 of the buried Kirschner wires (7.1%). Most of the fractured internal fixation and malunions or nonunions were asymptomatic, leading to revision surgery in only 8.6% of the Smart Toe® implants and 10.7% of the buried Kirschner wires. Both the Smart Toe® implant and the buried Kirschner wire offer a viable choice for internal fixation of an arthrodesis of the digit compared with other studies using other techniques


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_15 | Pages 112 - 112
1 Aug 2017
Murphy S
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Excellent outcomes following total hip arthroplasty require both optimal soft-tissue management and precise planning and placement of prosthetic components. The use of detailed and dynamic three-dimensional surgical plans combined with smart mechanical instruments for component placement facilitates precise and efficient surgery. Interest in these technologies has increased recently as surgeons and institutions are now responsible for poor outcomes in a growing percentage of the patient population. Cloud-based, patient-specific planning allows the surgeon to review and refine and execute surgical plans efficiently (HipXpert System, Surgical Planning Associates, Boston, MA). The surgical plans include cup size, cup orientation, stem size, head length, femoral anteversion, and planned change in leg length and offset, all in relation to the patients bony anatomy in 3D and multiplanar views. The associated smart tool is adjusted specifically for that patient and when docked, provides orientation information to the surgeon. The system has been proven to be robust, with repeated studies showing accurate cup placement in 100% of cases including by an independent study. This compares to a recent study of robotic methods that 88% of inclination and 84% for anteversion and to even greater inaccuracy of conventional surgery. Cloud-based 3D planning combined with smart mechanical navigation of cup placement offers the optimum combination of accuracy, speed, and simplicity for solving the ubiquitous problems of component sizing, orientation, and version, offset, and leg length correction. Knowledge of component sizing pre-operatively can facility inventory management and allows the surgery team to better anticipate the surgeon's goals during the procedure


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_6 | Pages 81 - 81
1 Mar 2017
Ward D Ward C
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Introduction. While component malposition remains a major short and long term problem associated with total hip arthroplasty, enhanced technologies such as navigation and robotics have not yet been widely adopted. Both expense and increased OR time can be obstacles to adoption. The current study assesses the effect of the use of a smart mechanical navigation system on surgery time in total hip arthroplasty. Patients and Methods. 514 consecutive primary total hip arthroplasties were performed by a single surgeon from January 1, 2015 through March 31, 2016. Of these, 40 were performed using a smart mechanical navigation system (the HipXpert System, Surgical Planning Associates Inc., Boston, Massachusetts) and 474 were performed without navigation. The patients were not randomized. Incision to closure time (surgery time) was recorded for each procedure. A two tailed t-test was performed to assess statistical significance. Results. Mean surgery time for the non-navigated cases was 66 minutes. Mean surgery time for the navigated cases was 70 minutes. The difference in surgery time between the two groups was statistically significant (p=0.003). Conclusion. Adoption and use of a smart mechanical navigation system has a measurable increase in OR time of 4 minutes. This increase in OR time is quite small and with experience, is likely to further decrease. The amount of surgery time necessary for the use of the system is small compared to traditional navigation systems and especially to robotic systems. The study demonstrates that the adoption of a new smart mechanical navigation system increased surgery time very little. We anticipate that increased experience with the system will allow for the reduction in the need for intraoperative radiographs, which will further decrease surgery time and associated cost while simultaneously improving accuracy


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_10 | Pages 56 - 56
1 Jun 2018
Murphy S
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Pre-operative knowledge. Knowledge-based total hip arthroplasty is becoming increasingly recognised for improved safety, efficiency, and accuracy. Pre-operative knowledge of native and planned femoral anteversion, the exact size of implants, neck length and offset, and head lengths can serve to safely accelerate surgery and reduce the need for intra-operative imaging. Pre-operative knowledge of the effect on change in leg length and offset effected by specific implant combinations can serve to minimise undesired changes. The use of a smart mechanical navigation tool superimposed on this knowledge, can serve to easily and swiftly achieve optimal component position. Cost savings. Economic data from Q1 2013 to Q2 2016 demonstrate that CMS-insured patients treated by knowledge-based surgery using the HipXpert mechanical navigation system combined with the superior hip approach have the lowest cost of all patients treated in Massachusetts by an average of more than $7,000 over 90 days for Medicare Part A expenditure (HipXpert System, Surgical Planning Associates, Boston, MA). The data show that these combined techniques outpace all other technology/technique combinations including robotics. Accuracy. The system has been proven to be robust, with repeated studies showing accurate cup placement in 100% of cases including an independent study. This compares to a recent study of robotic methods that showed only 88% accuracy in inclination and 84% for anteversion. Summary. Knowledge-based surgery with smart mechanical navigation has shown the potential to accelerate surgery, improve safety, lower cost and facilitate recovery


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 36 - 36
1 Sep 2012
Lou E Hill DL Moreau MJ Mahood JK Hedden DM Raso JV
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Purpose. To evaluate whether continuous training and education of posture can help children to improve kyphosis. Method. A smart harness consisting of a tight-fitting harness and a posture sensing system was developed to measure kyphosis and to provide vibratory feedback during daily activities. The posture sensing system consisted of two sensor units and both units contained a 3-axis accelerometer and a 2-axis gyroscope to calculate the orientation. The dimensions and weight of each unit were 55 mm x 35 mm x 15 mm and 25g, respectively. One unit served as a master (placed at the T3 vertebral level) and the second unit served as a slave (placed at the T12 level) and they communicated wirelessly. The master unit calculated the kyphotic angle, similar to the vertebral centroid method but based on the sagital profile, and provided the vibratory feedback. One volunteer wore the unit and performed different postures and activities (walking, sitting, bending and sudden change from sitting to walking) in a gait analysis laboratory. The posture sensing system was sampled at 30Hz and a gait analysis 8-camera system was sampled at 60Hz. The kyphotic angles captured by the smart harness and camera system were compared. After this validation, the system was tested by 5 normal subjects (M, 25 10 years old) 3 hours per day for 4 consecutive days. For the first 2 days there was no feedback and the last 2 days there was feedback. The system took a sample every 30 seconds. When an undesirable posture was detected, the system switched to a fast sample mode at which time the system took ten measurements with a sample rate of 10 Hz for 1 second to further validate the measured kyphotic angle. These 10 measures were averaged to avoid feedback for postures that lasted only for a very short period of time. Posture orientation data was stored in the sensing unit memory and downloaded for outcomes evaluation. Results. Compared with the gait analysis camera system, the differences in the kyphotic angle during static and dynamic activities were 1.6 1.2, and 3.5 1.9 degrees, respectively. The largest error was 6.8 degrees which occurred during a dramatic change in posture during dynamic activities. The baseline data from the first 2 days (without feedback) showed the kyphotic angle was 48 12 degrees, during which time all subjects were working in front of a computer. The feedback days showed a slight improvement of kyphotic angles from day 1 to day 2, from 45 11 to 42 8 degrees, respectively. There was 12% improvement on day 2 when compared with the baseline data. Conclusion. This study showed the kyphotic angle could be fairly accurately measured using the smart harness. The kyphotic angle had a slight improvement when feedback was provided, however a longer clinical trial will be required to determine how lasting the effect will be


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_17 | Pages 9 - 9
1 Nov 2014
Walker R Chang N Dartnell J Nash W Abbasian A Singh S Jones I
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Introduction:. In 2009 the Smart Toe implant was introduced as an option for lesser toe fusion in our department. The Smart Toe is an intramedullary device made from Nitinol, an alloy that can change shape with a change of temperature, expanding within the intramedullary canals of the proximal and middle phalanx to achieve fixation. The advantages of the Smart Toe are that patients are spared 6 weeks with K-wires protruding from their toes and there is no need for wire removal. We conducted a retrospective review of radiographic and clinical outcomes to assess the performance of this implant. Methods:. We present a consecutive series of 192 toe fusions using the Smart Toe implant in 86 patients, between January 2009 and November 2013. All radiographs and case notes were reviewed to assess for radiological fusion, satisfactory clinical outcome and complications. Results:. One patient was lost to all follow up. Radiographic follow up was available for 186 of 192 implants (95%). 137 toes (74%) were fused by 6 weeks, and 152 (81%) at final follow up. Clinical notes were available for 182 implants (94%) in 85 patients. At 6 weeks 50 patients reported satisfactory outcomes in 105 toe fusions (58%). At final follow up 70 patients reported satisfactory outcomes in 150 toe fusions (82%). 7 patients experienced complications in 19 toes (10%). 2 implants were broken and 2 implants had cut out. There were 3 phalanx fractures. In all 4 toes were revised, and there was 1 amputation. Clinically, out of the 34 non-united toes only 5 were symptomatic. Conclusion:. Overall 82% of toe fusions using the Smart Toe implant yielded entirely satisfactory clinical outcomes. Radiographic fusion occurred in 81% but most non-unions were asymptomatic. There were a small number of significant complications, and 4 patients out of 85 required revision surgery


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 452 - 452
1 Nov 2011
Scuderi G
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Surgical instrumentation for total knee arthroplasty has improved the accuracy, reproducibility and reliability of the procedure. In recent years, minimally invasive surgery introduced instrumentation that was reduced in size to fit within the smaller operative field; with this move the impact and influence of technology became proportionately larger. The introduction of computer navigation is an attempt to improve the surgeon’s visibility in a limited operative field, improve the position of the resection guides, and ultimately the position of the final components. While it may be appealing to rely on computer navigation to perform a TKA, it is not artificial intelligence and does not make any of the surgical decisions. The procedure still is surgeon directed with navigation serving as a tool of confirmation with the potential for improvements in surgical accuracy and reproducibility. The accuracy of TKA has always been dependent upon the surgeon’s judgment, experience, ability to integrate images, utilize pre-operative radiographs, knowledge of anatomic landmarks, knowledge of knee kinematics, and hand eye co-ordination. Recent advances in medical imaging, computer vision and patient specific instrumentation have provided enabling technologies, which in a synergistic manner optimize the accurate performance of the surgery. The successful use of this technology requires that it not replace the surgeon, but support the surgeon with enhanced intra-operative feedback, integration of pre-operative and intra-operative information, and visual dexterity during the procedure. In developing smart tools or robotic systems, the technology must be: safe; accurate; compatible with the operative field in size and shape, as well be able to be sterilized; and must show measurable benefits such as reduced operative time, reduced surgical trauma and improved clinical outcomes. Advocates believe this is attainable and robotic assisted TKA can achieve levels of accuracy, precision and safety not accomplished by computer assisted surgery. Smart instruments and robotic surgery are helping us take the next step into the operating room of the future. The role of robots in the operating room has the potential to increase as technology improves and appropriate applications are defined. Joint replacement arthroplasty may benefit the most due to the need for high precision in placing instruments, aligning the limb and implanting components. In addition, this technology will reduce the number of instruments needed for the procedure potentially further improving efficiency in the operating room. As technology advances, robots may be commonplace in the surgical theater and potentially transform the way total knee arthroplasty is done in the future. Robotic surgery and smart tools are new innovative technologies and it will remain to be seen if history will look on its development as a profound improvement in surgical technique or a bump on the road to something more important


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_13 | Pages 31 - 31
1 Nov 2015
Roche M
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Total knees today are performed with the use of standard trials that the surgeon utilises to define appropriate implant rotation, range of motion, and soft tissue balance. This “feel” based approach is very subjective, and lacks a quantifiable approach to interpret our intra-operative knee assessment. Sensor-based trials are embedded into the specific knee designed tibial trial, and wirelessly displays data related to the implant's position and ligament tension. The surgeon can now identify malrotation, soft tissue imbalance, and instability through a full ROM. The surgeon can see dynamic responses to ligament releases, alignment changes, and implant adjustments. As Insall taught us; a TKR is a soft tissue procedure, and a “balanced” knee will demonstrate improved outcomes and greater patient satisfaction. Smart Trials allow us to discuss how our intra-operative techniques affect our patient's outcomes. This surgery will utilise Smart Trials during a Cruciate Retaining TKR


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_14 | Pages 29 - 29
1 Dec 2015
Trigkilidas D Drabu R Keightley A Halliwell P
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Introduction. Lesser toe proximal interphalangeal joint arthrodesis is a common forefoot procedure for correction of claw toe deformities. The most common method of fixation is with k-wires. Although this is a very cost-effective method of fixation, well-known disadvantages include pin site infection, non union, wire migration and the inconvenience to the patients of percutaneous wires for up to six weeks. For these reasons, intramedullary devices for joint fixation without crossing the distal IP joint have been developed. Many different designs are currently available. The Smart Toe prosthesis which has appeared as a type I and II, is one such implant. In two recent studies using type I, the use of this implant is advocated. We wish to present our experience with the use of the Smart Toe II. Methods. In this retrospective study we present a radiological review of 46 consecutive cases in 25 patients who underwent lesser toe interphalangeal arthrodeses using the Smart Toe II implant between July 2010 and November 2014 by the senior author. There were 7 (28%) male and 18 (72%) female patients. Post operative radiographs, taken at a mean follow up of 6 months, were reviewed for non-union, migration and implant failure. Results. There were 9 (20%) implant fractures, 10 (22%) radiological non- unions and 5 (11%) implant migrations. 4 toes (9%) were sufficiently symptomatic to require revision. Conclusion. In contrast to two previous studies, our series showed a high rate of implant fracture and non-union, sometimes leading to the need for revision surgery. We recommend caution in use of the Smart Toe II and welcome further reports of results. If our experience is replicated, we suggest the device's use is withheld pending appropriate studies to identify and address the reasons for implant failure, especially if more of the radiological failures come to require revision


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_1 | Pages 45 - 45
1 Feb 2015
Murphy S
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Acetabular component malalignment remains the single greatest root cause for revision THA with malposition of at least ½ of all acetabular components placed using conventional methods. The use of local anatomical landmarks has repeatedly proven to be unreliable due to individual variation of these structures. As a result, the use of such landmarks without knowledge of their three-dimensional orientation may actually be a major cause of component malpositioning. Traditional navigation and robotics can potentially lead to improved component placement but these technologies have not gained widespread use due to the increase in time of use, complexity, and cost of these systems. The alternative of placing the cup in the supine position, even with the use of arthroscopy, has been proven to have an incidence of inaccuracy equal or greater than that in the lateral position. A smart mechanical instrument system was developed to quickly and easily achieve accurate cup alignment (HipXpert System, Surgical Planning Associates, Boston, MA). The system is based on a low dose, low cost CT study and a customised patient-specific surgery plan. The laterally-based system docks on a patient-specific basis with 3 legs: one through the incision behind the posterior rim, one percutaneously on the lateral side of the ASIS, and a third percutaneously on the surface of the ilium. A direction indicator on the top of the instrument points in the desired cup orientation. The anteriorly-based system also docks on a patient-specific basis with one leg on the anterior ischium and one leg on each ASIS, either to skin or to bone. The lateral system has been proven to be robust, with repeated studies showing accurate cup placement in 100% of cases and an independent study showing accurate cup placement in 98% of cases. The newer anterior system has the potential for even greater accuracy. Smart mechanical navigation of cup placement offers the optimum combination of accuracy, speed, and simplicity for solving the ubiquitous problem of acetabular component malorientation


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_28 | Pages 83 - 83
1 Aug 2013
Fuente MDL Jeromin S Boyer A Billet S Lavallée S Stiehl J Radermacher K
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Major aspects on long-term outcome in Total Knee Arthroplasty are the correct alignment of the implant with the mechanical load axis, the rotational alignment of the components as well as good soft tissue balancing. To reduce the variability of implant alignment and at the same time minimise the invasiveness different computer assisted systems have been introduced. To achieve accuracy as high as those of a robotic system but with a pure mechanically adjustable cutting block, the Exactech GPS system has been developed. The new concept comprises a seamlessly planning and navigation screen with an integrated optical tracking system for fast and accurate acquisition and verification of anatomical landmarks within the sterile field as well as a tiny cutting guide for accurate transfer of the planned bone resections. Using a conventional screwdriver the cutting block could be accurately aligned with the planned resection by controlling the current position of the cutting block on the navigation screen. To save time, to maximise the ease of use and to minimize the surgeon's mental workload during adjustment, a smart screwdriver (SSD) has been developed being able to automatically adjust the screws. The basic idea of the smart screwdriver is to have a system providing an automatic transfer of the planned data to the cutting guide similar to a robotic system, but with the actuators separated from the kinematic. The use of the SSD is as simple as follows: After planning of the intervention and rigid fixation of the cutting guide on the bone, the surgeon simply connects sequentially the screwdriver to all screws of the cutting guide. To further maximise the ease of use and to avoid a mix-up of different screws, an identification means has been integrated into the positioning screws as well as into the smart screwdriver. For an automated identification of the screws different technologies have been analysed as position tracking, optical recognition or wired/wireless electronics. A first prototype without screw identification has been used successfully on 4 cadaver knees. All guide positions could be adjusted automatically using the SSD. However, the absence of screw identification required that the surgeon follows indications given by the computer to turn screws sequentially. A second prototype of the smart screwdriver has successfully been built up and is able to identify the different positioning screws in less than 1s with high reliability. The identification is realised as inductive coupling of different small resonance circuits that are integrated into the screw heads and the screwdrivers tip. To adjust the cutting guide from neutral to the planned position, the screws have to be adjusted by 5 mm in average. The rotational speed of the current SSD implementation is 2 rounds per second, resulting in a mean time of about 3.5 s for each screw adjustment. The rotational accuracy of the screwdriver is ±5°. Taking into account a thread of the positioning screws of 0.7 mm, the theoretical translational error is about ±0.01 mm. Looking at the angular accuracy, the maximum distance of the screws of the current setup of the cutting block of 15 mm results in an angular error of less than ±0.05°


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLI | Pages 94 - 94
1 Sep 2012
Zafar MS Gadgil A
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Symptomatic flexion deformity of proximal interpahalangeal joint (PIPJ) is one of the most common foot deformities and usually treated with arthrodesis. In general, percutaneous K-wires are used to stabilize the joint after excision of cartilage. K-wires projecting out of the toe need special care and can occasionally be dislodged accidentally. Furthermore issues such as cellulitis, pin tract infections, rarely osteomyelitis and need for removal make alternative fixation methods desirable. Smart toe is an intra-osseous titanium memory implant, which is stored frozen. It expands on insertion and does not require removal. 18 consecutive K-wire PIPJ arthrodesis were compared with 18 Smart toe PIP fusions with a mean follow up of 6 months. Post operative forefoot scores and complications were documented. Patient satisfaction was higher and complications were lower with Smart toe fusions than with K-wire arthrodesis. Fusion of PIP joints with smart toe is an effective and safer alternative to using K-wires. Although more expensive, higher patient satisfaction and lower complication rate may offset the extra cost of the implant


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 354 - 354
1 Sep 2012
Zafar M Zafar M Gadgil A
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Background. Symptomatic flexion deformity of proximal interpahalangeal joint (PIPJ) is one of the most common foot deformities and usually treated with arthrodesis. In general, percutaneous K-wires are used to stabilize the joint after excision of cartilage. K-wires projecting out of the toe need special care and can occasionally be dislodged accidentally. Furthermore issues such as cellulitis, pin tract infections, rarely osteomyelitis and need for removal make alternative fixation methods desirable. Smart toe is an intra-osseous titanium memory implant, which is stored frozen. It expands on insertion and does not require removal. Methods. 30 consecutive K-wire PIPJ arthrodesis were compared with 30 Smart toe PIP fusions with a mean follow up of 6 months. Post operative forefoot scores and complications were documented. Results. Patient satisfaction was higher and complications were lower with Smart toe fusions than with K-wire arthrodesis. Conclusions. Fusion of PIP joints with smart toe is an effective and safer alternative to using K-wires. Although more expensive, higher patient satisfaction and lower complication rate may offset the extra cost of the implant


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_16 | Pages 16 - 16
1 Nov 2018
Rochev Y
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By definition, a smart biomaterial is a material, such as a ceramic, alloy, gel or polymer, that can convert energy from one form into another by responding to a change in a stimulus in its environment. These stimuli may involve temperature, pH, moisture, or electric and magnetic fields. In particular, thermoresponsive biomaterials have been successfully employed to host mammalian cells with a view to musculoskeletal tissue engineering. The presentation provides an overview of the use of thermosensitive polymers for the non-enzymatic stem cell harvesting, cell sheet engineering, three-dimensional scaffolds fabrications and organ-printing materials


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_4 | Pages 41 - 41
1 Mar 2021
Pontremoli C Berkmann JC Martin AXH Ellinghaus A Schmidt-Bleek O Laurano R Boffito M Turo CT Schmidt-Bleek K Duda GN Fiorilli S Brovarone CV
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Mesoporous bioactive glasses (MBGs) have been widely studied as bone regeneration systems, due to their bioactivity and ability to store and release therapeutic agents with specific biological functions. The incorporation of these nanomaterials into a thermosensitive hydrogel (TSH), in which a solution undergoes a sol-gel transition under physiological conditions, represents a promising approach to design multifunctional devices able to deliver selected molecules to pathological sites. In fact, this system can perfectly fit the defect cavity shape prior to the complete gelation, and acts as a carrier for therapeutic agents prolonged release in situ. This challenging concept is the underlying idea of the MOZART project, whose objective was to develop a library of MBGs containing different therapeutic ions and drugs, to be used as a new, smart platform technology for highly targeted therapies to enhance bone healing. The aim of this work is to investigate the bone regeneration potential of MBGs containing strontium ions (pro-osteogenic) and incorporated into thermosensitive poly(etherurethane)(PEU) based on Poloxamer407. In order to further increase the pro-osteogenic response, MBGs were also loaded with N-acetylcysteine (NAC). MBGs containing 2%mol of Sr. 2+. were prepared by an aerosol-assisted spray-drying method and NAC was loaded post-synthesis via an incipient wetness method. The PEU hydrogel (SHP407) was synthesized via a two-step procedure in nitrogen atmosphere. Particles were characterized (FE-SEM, N. 2. adsorption-desorption analysis, TGA, DSC, FT-IR and XRD) and then incorporated into the hydrogel. The hybrid systems rheological properties and stability in aqueous environment at 37°C, and its ability to co-release Sr. 2+. and NAC were analysed. After preliminary biological in vitro tests, a proof-of-concept rodent study was run to assess the ability of the resulting formulation as bone healing device. X-ray at 2 and 4-weeks post-surgery and µCT-analysis were used to evaluate the healing results in a rat osteotomy model of biologically impaired healing. Then, bones were processed for histological evaluation. Preliminary in vivo results demonstrated that incorporation of MBGs into a TSH is a promising strategy to design a multifunctional injectable formulation for in situ and sustained delivery of pro-osteogenic species enhancing bone regeneration