Aim of this study was to establish the first clinical results after implantation of ultrathin silver-polysiloxane-coated1 plates in the treatment of infected non-union of the femoral shaft. As part of the REFECT study, a prospective, non-interventional analysis was conducted encompassing all patients who received internal stabilization with a silver-coated1 plate from 01/2023 to 09/2024 as part of the treatment for infected non-union of the femur. Standardized clinical follow-ups including PROMs (WOMAC-Index, LEF-S, EQ-5D, VAS) and X-rays were performed 3, 6, 12 (and 24) months postoperatively. For comparison, a retrospective analysis of 76 patients with infected femoral non-union, who had received a stabilization with an uncoated plate in the past 10 years, was performed.Aim
Method
Gait analysis is an indispensable tool for scientific assessment and treatment of individuals whose ability to walk is impaired. The high cost of installation and operation are a major limitation for wide-spread use in clinical routine. Advances in Artificial Intelligence (AI) could significantly reduce the required instrumentation. A mobile phone could be all equipment necessary for 3D gait analysis. MediaPipe Pose provided by Google Research is such a Machine Learning approach for human body tracking from monocular RGB video frames that is detecting 3D-landmarks of the human body. Aim of this study was to analyze the accuracy of gait phase detection based on the joint landmarks identified by the AI system. Motion data from 10 healthy volunteers walking on a treadmill with a fixed speed of 4.5km/h (Callis, Sprintex, Germany) was sampled with a mobile phone (iPhone SE 2nd Generation, Apple). The video was processed with Mediapipe Pose (Version 0.9.1.0) using custom python software. Gait phases (Initial Contact - IC and Toe Off - TO) were detected from the angular velocities of the lower legs. For the determination of ground truth, the movement was simultaneously recorded with the AS-200 System (LaiTronic GmbH, Innsbruck, Austria). The number of detected strides, the error in IC detection and stance phase duration was calculated. In total, 1692 strides were detected from the reference system during the trials from which the AI-system identified 679 strides. The absolute mean error (AME) in IC detection was 39.3 ± 36.6 ms while the AME for stance duration was 187.6 ± 140 ms. Landmark detection is a challenging task for the AI-system as can clearly be seen be the rate of only 40% detected strides. As mentioned by Fadillioglu et al., error in TO-detection is higher than in IC-detection.
In a consecutive retrospective analysis of 190 patients treated with the Masquelet technique at the BG Klinikum Hamburg from January 2012 to January 2022, defect-specific features such as the extent and morphology of the defect were recorded, and their influence on the time to reach full weight-bearing of the affected limb was investigated. A total of 217 defects were treated in 190 patients using the Masquelet technique. 70% of all defects were located in the tibia, followed by 22% in the femur and only about 7% in the upper extremity. The average length of all defects was 58 mm (+/−31 mm), with the largest defect measuring 180 mm and the smallest measuring 20 mm. 89% of the patients achieved full weight-bearing at the end of therapy. The average time from initiation of therapy to reaching safe full weight-bearing was 589 days. There was a significant correlation between defect length and time to reach full weight-bearing (p = 0.0134). These results could serve as a basis for creating a score for prognostics and evaluation of bone healing after treatment with the Masquelet technique. Additionally, the results could help guide indications for secondary stabilization using internal fixation.
The objectives of this study are to evaluate the impact of the CoVID-19 pandemic on the development of relevant emerging digital healthcare trends and to explore which digital healthcare trend does the health industry need most to support HCPs. A web survey using 39 questions facilitating Five-Point Likert scales was performed from 1.8.2020 – 31.10.2020. Of 260 participants invited, 90 participants answered the questionnaire. The participants were located in the Hospital/HCP sector in 11.9%, in other healthcare sectors in 22.2%, in the pharmaceutical sector in 11.1%, in the medical device and equipment industry in 43.3%. The Five-Point Likert scales were in all cases fashioned as from 1 (strongly disagree) to 5 (strongly agree). As the top 3 most impacted digital health care trends strongly impacted by CoVID-19, respondents named: - remote management of patients by telemedicine, mean answer 4.44 - shared data governance under patient control, mean answer 3.80 - new virtual interaction between HCP´s and medical industry, mean answer 3.76 Respondents were asked which level of readiness of the healthcare system currently possess to cope with the current trend impacted by CoVID-19. - Digital and efficient healthcare logistics, mean answer 1.54 - Integrated health care, mean answer 1.73 - Use of big data and artificial intelligence, mean answer 2.03 Asked if collaborative research in the form of digital data platforms for research data sharing and increasing collaboration with multi-centric consortia would have a positive impact on the healthcare sector, the agreement was high with a value of mean 4.10 on the scale. We can conclude that the impact of COVID-19 appears to be a high agreement of necessary advances in digitalization in the health care sector and in the collaboration of HCPs with the health care industry. Health care professional are unsure, in how far the national health care sector is capable of transformation in healthcare logistics and integrated health care.
A promising application of Mesenchymal stem cells (MSCs) is the treatment of non-unions. Substituting bone grafts, MSCs are directly injected into the fracture gap. High cell viability seems to be a prerequisite for therapeutic success. Administration of the MSCs via injection creates shear stresses possibly damaging or destroying the cells. Aim of this study was to investigate the effect of the injection process on cell viability. MSCs were isolated and cultivated from femoral tissue of five subjects undergoing arthroplasty. Prior to injection, the cells were identified as MSCs. After dissolving to a concentration of 1 Million cells/ml, 1 ml of the suspension was injected through a cannula of 200 mm length and 2 mm diameter (14 G) with flow rates of 38 and 100 ml/min. The viability of the MSCs at different flow rates was evaluated by staining to detect the healthy cell fraction. It was analyzed statistically against a control group via the Kruskal-Wallis-test and for equivalence via the TOST procedure. Significance level was set to 5 %, equivalence margin to 20 %. The healthy cell fraction of the control group was 85.88 ± 2.98 %, 86.04 ± 2.53 % at 38 ml/min and 85.48 ± 1.64 % at 100 ml/min. There was no significant difference between the fraction of healthy cells (p = 0.99) for different volume flows, but a significant equivalence between the control group and the two volume flows (38 ml/min: p = 0.002, 100 ml/min: p = 0.001). When injecting MSC solutions, e.g. into a non-union, the viability of the injected cells does not deterioriate significant. The injecting technique is therefore feasible.
Vacuum orthoses are being applied in the care of patients with foot and lower leg conditions, as ankle fractures or sprains. The lower leg is protected and immobilized, which increases mobility. Due to the design, the orthoses lead to a difference in leg length, i.e. the side with the orthosis becomes longer, which changes the gait kinematics. To prevent or mitigate the unfavourable effects of altered gait kinematics, leg length-evening devices (shoe lifts) are offered that are worn under the shoe on the healthy side. Our aim was to evaluate the effect of such a device on the normality of gait kinematics. Gait analysis was conducted with 63 adult, healthy volunteers having signed an informed consent form that were asked to walk on a treadmill at a speed of 4.5km/h in three different conditions: barefoot - as reference for establishing the normality score baseline with a vacuum orthosis (VACOPed, OPED GmbH, Germany) and a sport shoe with a vacuum orthosis and a shoe lift (EVENup, OPED GmbH, Germany) Data was sampled using the gait analysis system MCU 200 (LaiTronic GmbH, Austria). The positions of the joint markers were exported from the software and evaluated for the joint angles during the gait cycle using custom software (implemented in DIAdem 2017, National Instruments). A normality score using a modification of the Gait Profile Score (GPS) was calculated in every 1%-interval of the gait cycle and evaluated with a Wilcoxon signed rank test. The GPS value was reduced by 0.33° (0.66°) (median and IQR) while wearing the shoe lift. The effect was statistically significant, and very large (W = 1535.00, p < .001; r (rank biserial) = 0.52, 95% CI [0.29, 0.70]). The significant reduction of the GPS value indicates a more normal gait kinematics while using the leg length-evening device on the contralateral shoe. This rather simple and inexpensive device thus might improve patient comfort and balance while using the vacuum orthoses.
The degeneration of the adjacent segment in lumbar spine with spondylodesis is well known, though the exact incidence and the mechanism is not clear. Several implants with semi rigid or dynamic behavior are available to reduce the biomechanical loads and to prevent an adjacent segment disease (ASD). Randomized controlled trials are not published. We investigated the biomechanical influence of dynamic and semi rigid implants on the adjacent segment in cadaver lumbar spine with monosegmental fusion (MF). 14 fresh cadaver lumbar spines were prepared; capsules and ligaments were kept intact. Pure rotanional moments of ±7.5 Nm were applied with a Zwick 1456 universal testing machine without preload in lateral bending and flexion/extension. The intradiscal pressure (IDP) and the range of motion (ROM) were measured in the segments L2/3 and L3/4 in following situations: in the native spine, monosegmental fusion L4/5 (MF), MF with dynamic rod to L3/4 (Dynabolt), MF with interspinous implant L3/4 (Coflex), and semi rigid fusion with PEEK rod (CD Horizon Legacy) L3-L5.Introduction
Materials and Methods
Bone shape variability within a specific population has been seldom investigated and used to optimize implant design. There is insufficient anatomical fitting of the existing prebend periarticular plates for the distal fibula. We developed a methodology for design of orthopaedic implants that fit a maximum percentage of the target population, both in terms of geometry and biomechanical stability. In co-operation with an implant manufacturer and different academic institutions, a virtual bone database has been developed that contains anatomical data of more than 1000 CT datasets with the implemented possibility to generate idealized implant fits for different anatomical sites. This program (Stryker Virtual Bone Database (VBD) is able to generate statistical anatomical shapes for different populations like age groups or ethnical groups. Based on this, an implant for the distal fibula has been developed (VariAx Distal Lateral Fibula Locking Plate) for distal fibula fracture treatment. Aim of this study was to develop and validate an implant that is optimized for the specific anatomical area. It should be precontoured and still fit to the majority of patients sustaining a distal fibular fracture. Another objective was to create a distally tapered design as there is less soft tissue cover in that anatomic area. ProE CAD system was used in combination with the Bone Database (VBDB) to evaluate the bone shape of the target population plate shape. Several bones (from CT scans) have been used in a first validation process in comparison with an implant already available on the market (SPS Fibula Plate). Additionally, the results have been verified with a bone fitting study which was conducted in collaboration with the Maurice E. Müller Institute (MEM) in Bern/Switzerland. In a second step, the finished implant design was validated against statistical bone shapes of populations of different ethical origin. The comparison of the new Plate's shape with real bone data confirmed that the neutral form does cope with the anatomic situation laterally which means that no systematic pre-bending of the plate is required. Comparing with a conventional implant, the new implant could have been implanted unbend in 6 of 7 cases of virtual matching with real patient datasets compared to none with the conventional implant. The validation of statistical datasets of different ethnical origin (Caucasian, Asian) showed no statistical difference of implant mismatch.Materials & Methods
Results
Implants with multidirectional locked screws have theoretical advantages in the treatment of periprosthetic fractures. In osteoporotic bone those locked plate systems with multidirectional applicable screws give a high stability. With the possibility of fixing screws in various angles, a rigid fixation in the presence of a prosthetic implant can be achieved. We concluded a retrospective study of a consecutive series of the outcome of Vancouver B1 and C femoral injuries using two specific locked implants (Straight and wave plate). From June 1996 to December 2004 we treated 58 patients with a periprosthetic fracture of the femur with a locked plate. The mean age at the index procedure was 72.4 years, 40 patients were female (69%). In 32 cases (55.2%) we saw a hip endoprosthesis, in 21 cases (36.2%) a knee endoprosthesis and in 5 cases both (8.6%). Outcome measures were intra- and postoperative complications, bony union, degree of mobility and social status, Barthel mobility index and “stand up and go” test. Union occurred in 56 cases (96.5%) after the index procedure. Twice the implant failed, we saw 4 general complications. The mean duration until full weight bearing status in these patients was 8.6 weeks. At follow up 46 patients (78%) had maintained the same social status as before the fracture. Regarding the mobility status 52 patients (89%) had regained their previous level, 4 patients walking without aid before now required a cane and two patients a walking frame. The mean Barthel Index was 85 points of possible 100 and improved from 35 points at point of beginning of the rehabilitation. The mean stand-up&
go time was measured as 22 seconds.
Cemented modular metal backed total hip prostheses have the theoretical advantage to allow different inlays to be used. Asymetric or snap inlays are some of the options. First attempts with this kind of implant failed due to PE quality. A novel implant has been specifically designed and constructed for the use of cement. In vitro testing has shown results equal to other cemented cups. Aim of this study is to investigate the first clinical results of this implant with special consideration to intraoperative complications, intraoperative change of inlays, postoperative complications and clinical results.
The implant under investigation was a cemented modular acetabular component (C-MIC, ESKA Implants, Germany). The inlays are manufactured of highly crosslinked polyethylene. The standard protocols regarding DVT prophylaxis and antibiosis for HHS and the Barthel index.
We can conclude that the C-MIC acetabular component is safe to use. Due to limitations of this study we are not able to state if THA is superior to hemiarthroplasty in geriatric patients.
Intracortical osteosarcoma is a comparatively rare and distinct tumor separated from conventional osteosarcoma and other osteosarcoma variants. At first, the lesion was described in two patients by Jaffe in 1960. To date, 17 cases have been described in the literature. In all cases, the tumor occured in the cortex of the shaft of the femur or tibia. En-bloc resection was performed as primary therapeutic approach in most cases, sometimes in combination with neoadjuvant or adjuvant chemotherapy. We, for the first time, describe a case of intracortical osteosarcoma of the midshaft of the right ulna which was found accidentaly in a patient taking part in a screening programm for heriditary breast cancer. The patient underwent en-bloc resection without additional chemotherpapy and shows no reccurence after 18-months follow up.
The operative therapy of intraarticular fractures of the calcaneus is nowadays established surgical standard. Aim is an accurate reduction with reconstruction of the Boehler’s angle, the length and the subtalar joint. 3D-fluoroscopy with the Siremobil Iso-C 3D? mobile C-arm radiography system is a valuable assistance for the accurate reconstruction of the anatomical structures. Remaining incongruities can be recognized and corrected intraoperatively. The achieved reduction can be safely fixed by the advantages of a locked implant In the period of 10/2002 until 10/2004 we operated 59 patients with intraarticular fractures of the calcaneus by means of anatomical reduction and locked plate (Calcaneus TiFix, Litos, Germany) under control of 3D-fluoroscopy. After routine CT diagnostics, fractures were classified according to Sanders: 18 fractures were type II, 33 fractures type III and 9 were classified type IV. Results: Surgical treatment of the fractures took place according on average after an interval of 8.5 days (7 to 11). A 3D-fluoroscopy was performed after reduction and temporary fixation of the fracture. There was no technical fault of the device. Median theatre time was 72 minutes (53–112 minutes) including 3-D-fluoroscopy. In 22 cases a remaining incongruity of >
1 mm could be seen on intraoperative 3-D-fluoroscopy. In these cases a reduction was performed again. The Boehler’s angle could be raised on average by 18° (11° to 22°), shortening of the hindfoot could be improved on average by 13 picture millimetres (9 to 17mm). Bone graft was not required in any case. At 6 months follow up, all patients had returned to work, or if unemployed, where judged fit to work by their GP. Three patients changed their position. 25 Patients were completely pain free at follow-up. In all cases the achieved reduction could be fixed by the implant until full weight bearing was reached. Conclusion: The use of 3D Fluoroscopy had a real impact in the treatment of calcaneal fractures. If this short term advantage influences the long term result has to be shown in further follow up.
Fully automated robots for the planning and implantation of total hip arthroplasty have completely withdrawn from the market. Reasons were technical problems during the reaming process that lead to postoperative neurological problems. This lead, especially in Germany, to numerous court cases and created a hostile environment regarding robotic orthopaedic surgery. The first steps in the development of a robotic assisted system for total hip arthroplasty are presented. This system will be able to plan and mill both femoral and acetabular implant seat. This project aims to combine the advantages of minimally invasive techniques and navigational systems with the accuracy that robotic assisted bone milling can provide. One of the main goals is the study of the technical problems of previous systems and to develop methods to prevent those. The project-name is RomEo (Robotic minimally invasive Endoprosthetics), the main project partners are the Helmut-Schmidt University/Hamburg and the Department of Trauma and Orthopaedics of the BG Trauma Hospital Hamburg. The paper focuses on:
The “workspace” created in minimally invasive hip surgery as determined in cadaver operations, including a 3D reconstruction Possible solutions of the problems of non-invasive patient fixation as determined in cadaver testing with different fixation methods Feasibility of 3D operation simulation using Voxelman data, access route data and implant CAD data