Pull-Out Strength of Orthodontic Miniscrews in the Temporal Bone.

BACKGROUND: Minimally invasive cochlear implant surgery by using a microstereotactic frame demands solid connection to the bone. We aimed to determine the stability of commercially available orthodontic miniscrews to evaluate their feasibility for frame's fixation. In addition, which substitute material most closely resembles the mechanical properties of the human temporal bone was evaluated. METHODS: Pull-out tests were carried out with five different types of orthodontic miniscrews in human temporal bone specimens. Furthermore, short fiber filled epoxy (SFFE), solid rigid polyurethane (SRPU50), bovine femur, and porcine iliac bone were evaluated as substitute materials. In total, 57 tests in human specimens and 180 tests in the substitute materials were performed. RESULTS: In human temporal bone, average pull-out forces ranged from 220 N to 285 N between screws. Joint stiffness in human temporal bone ranged between 14 N/mm and 358 N/mm. Statistically significant differences between the tested screws were measured in terms of stiffness and elastic energy. One screw type failed insertion due to tip breakage. No significant differences occurred between screws in maximum pull-out force. The average pull-out values of SFFE were 14.1 N higher compared to human specimen. CONCLUSION: Orthodontic miniscrews provided rigid fixation when partially inserted in human temporal bone, as evidenced by pull-out forces and joint stiffness. Average values exceeded requirements despite variations between screws. Differences in stiffness and elastic energy indicate screw-specific interface mechanics. With proper insertion, orthodontic miniscrews appear suitable for microstereotactic frame anchoring during minimally invasive cochlear implant surgery. However, testing under more complex loading is needed to better predict clinical performance. For further pull-out tests, the most suitable substitute material is SFFE.

Comparison of conventional socket attachment and bone-anchored prosthesis for persons living with transfemoral amputation - mobility and quality of life.

BACKGROUND: For patients with transfemoral amputation experiencing issues with their sockets, bone-anchored prosthesis systems are an alternative and sometimes the only way to be mobile and independent. The present cross-sectional study aimed to investigate the gait performance and quality of life of a group of patients treated with bone-anchored systems compared to those of participants treated with a conventional socket-suspended prosthesis. METHODS: A total of 17 participants with a socket-suspended and 20 with a bone-anchored prosthesis were included. Gait patterns were examined for symmetry, and performance was assessed using the six-minute walk test and the timed "Up & Go" test. Magnetic resonance imaging was performed to detect signs of osteoarthritis in both hips. Mobility in everyday life and quality of life were assessed using questionnaires. FINDINGS: There were no differences between the groups regarding the quality of life, daily mobility, and gait performance. The step width was significantly higher for the patients using socket-suspended prosthesis. The socket-suspended group showed a significant asymmetry regarding the step length. In the socket-suspended group, the prosthetic leg showed significantly higher cartilage abrasion than the contralateral leg did. INTERPRETATION: Large differences in the measured outcomes in both groups illustrate the very different capabilities of the individual participants, which is apparently not primarily determined by the type of treatment. For patients who are satisfied with the socket treatment and perform well, bone-anchored prosthesis systems may not necessarily improve their functional capabilities and perceived quality of life.

Fracture Healing in Elderly Mice and the Effect of an Additional Severe Blood Loss: A Radiographic and Biomechanical Murine Study.

Femoral fractures and severe bleeding frequently occur in old patients showing a delayed healing. As there are no studies investigating the combined effect of high age and severe blood loss on fracture healing, this was examined radiographically and biomechanically in this study. Therefore, young and old male mice were randomly assigned to three operation groups. In the fracture group (Fx), external fixator and osteotomy were applied to the femur. The combined trauma group (THFx) additionally received a pressure-controlled hemorrhage. Sham animals were only implanted with arterial catheter and external fixator. Sacrifice was performed after three weeks and bone healing was evaluated radiologically via µCT, as well as biomechanically using a three-point bending test. A decreased share of callus/total bone volume was observed in old mice with blood loss compared to old Fx. Hemorrhagic shock also reduced the trabecular number in old mice compared to Fx and young THFx. Moreover, a lower elastic limit in old Sham mice without fracture was revealed. Fracture combined with a high loss of blood further reduced the elastic limit in old mice compared to isolated Fx in old animals. In conclusion, this study showed that severe blood loss has a higher negative effect in old mice compared to young ones.

Accuracy measurement of different marker based motion analysis systems for biomechanical applications: A round robin study.

INTRODUCTION: Multiple camera systems are widely used for 3D-motion analysis. Due to increasing accuracies these camera systems gained interest in biomechanical research areas, where high precision measurements are desirable. In the current study different measurement systems were compared regarding their measurement accuracy. MATERIALS AND METHODS: Translational and rotational accuracy measurements as well as the zero offset measurements of seven different measurement systems were performed using two reference devices and two different evaluation algorithms. All measurements were performed in the same room with constant temperature at the same laboratory. Equal positions were measured with the systems according to a standardized protocol. Measurement errors were determined and compared. RESULTS: The highest measurement errors were seen for a measurement system using active ultrasonic markers, followed by another active marker measurement system (infrared) having measurement errors up to several hundred micrometers. The highest accuracies were achieved by three stereo camera systems, using passive 2D marker points having errors typically below 20 µm. CONCLUSIONS: This study can help to better assess the results obtained with different measurement systems. With the focus on the measurement accuracy, only one aspect in the selection of a system was considered. Depending on the requirements of the user, other factors like measurement frequency, the maximum analyzable volume, the marker type or the costs are important factors as well.

Knee disarticulation following oncologic total knee arthroplasty: A 5-year follow-up case report.

BACKGROUND: The present case report describes the 5-year follow-up results of an atypical knee disarticulation of a man previously treated with an oncologic total knee arthroplasty due to an Ewing sarcoma. METHODS: The patient presented an aseptic loosened tibial component of a tumor prosthesis system and requested final amputation, as he had previously suffered from five revision surgeries. To encourage the most functional outcome regarding an exoskeletal prosthesis, we decided to disarticulate the knee joint while retaining the currently fixed femoral component to create a full end-bearing stump. FINDINGS: The patient could be mobilized as a functional knee disarticulated amputee. Seven months after amputation, he showed a slightly less symmetrical gait compared to the preoperative status (preoperative mean Symmetry Index: 0.984 for kinematics and 0.940 for kinetics, 7-month postoperative Symmetry Index: 0.858 and 0.915). At the 5-year follow-up, the femoral component is still stably fixated and shows no loosening signs. In addition, the Symmetry Index increased to 0.908 and 0.949. INTERPRETATION: Even after 5 years, the presented amputation appears to be consistent with "conventional" knee disarticulation. The femoral component still withstands the altered loads and the patient shows a further improved gait pattern.

3D-surface scan based validated new measurement technique of femoral joint line reconstruction in total knee arthroplasty.

PURPOSE: This study aimed to validate a new joint line measurement technique in total knee arthroplasty for separated assessment of the medial and lateral femoral joint line alteration with 3D-surface scan technology. Separate assessment of the medial and lateral joint line alteration may improve TKA alignment assessment regarding to joint line restoration in kinematic alignment and use of robotic-assisted TKA surgery. METHODS: The medial and lateral joint line difference after TKA implantation on an artificial bone model was analyzed and compared with a 3D-scan and full femoral radiographs pre- and postoperatively. Radiographic analysis included the perpendicular distance between the most distal point of the medial and lateral condyle and the reproduced preoperative lateral distal femoral angle (LDFA). For evaluation of validity and reliability, radiographs were captured initially with true anteroposterior view and subsequently with combined flexion and rotation malpositioning. Reliability of the introduced measurement technique in between three observers was tested with intraclass correlation coefficient (ICC). RESULTS: Radiographic measurement showed a mean difference of 0.9 mm on the medial side and 0.6 mm on the lateral side when compared to the 3D-surface scan measurement. The reliability of measurement accuracy was ≤ 1 mm in x-rays with < 10° flexion error regardless to malrotation in these images. The ICC test showed very good reliability for the medial joint line evaluation and good reliability for lateral joint line evaluation (ICC 0.92, ICC 0.86 respectively). CONCLUSION: The new introduced joint line measurement method showed a sufficient reliability, accuracy and precision. It provides separated information about medial and lateral joint line alteration in TKA surgery in absolute values. LEVEL OF EVIDENCE: V - Experimental Study.

Biomechanical Assessment of Three Osteosynthesis Constructs by Periprosthetic Humerus Fractures.

BACKGROUND: Biomechanical stability assessment of 3 different constructs for proximal fixation of a locking compression plate (LCP) in treating a Worland type C periprosthetic fracture after total shoulder arthroplasty. METHODS: 27 Worland type C fractures after shoulder arthroplasty in synthetic humeri were treated with 14-hole LCP that is proximally fixed using the following: (1) 1 × 1.5 mm cerclage wires and 2x unicortical-locking screws, (2) 3 × 1.5 mm cerclage wires, or (3) 2x bicortical-locking attachment plates. Torsional stiffness was assessed by applying an internal rotation moment of 5 Nm and then after unloading the specimen, an external rotation moment of 5 Nm at the same rate was applied. Axial stiffness was assessed by applying a 50 N preload, and then applying a cyclic load of 250 N, then increasing the load by 50 N each time, until a maximum axial load of 2500 N was reached or specimen failure occurred. RESULTS: With regard to internal as well as external rotational stiffness, group 1 showed a mean stiffness of 0.37 Nm/deg and 0.57 Nm/deg, respectively, group 2 had a mean stiffness of 0.51 Nm/deg and 0.39 Nm/deg, respectively, while group 3 had a mean stiffness of 1.34 Nm/deg and 1.31 Nm/deg, respectively. Concerning axial stiffness, group 1 showed an average stiffness of 451.0 N/mm, group 2 had a mean stiffness of 737.5 N/mm, whereas group 3 had a mean stiffness of 715.8 N/mm. CONCLUSION: Group 3 displayed a significantly higher torsional stiffness while a comparable axial stiffness to group 2.

TGF-ß3 Loaded Electrospun Polycaprolacton Fibre Scaffolds for Rotator Cuff Tear Repair: An in Vivo Study in Rats.

Biological factors such as TGF-ß3 are possible supporters of the healing process in chronic rotator cuff tears. In the present study, electrospun chitosan coated polycaprolacton (CS-g-PCL) fibre scaffolds were loaded with TGF-ß3 and their effect on tendon healing was compared biomechanically and histologically to unloaded fibre scaffolds in a chronic tendon defect rat model. The biomechanical analysis revealed that tendon-bone constructs with unloaded scaffolds had significantly lower values for maximum force compared to native tendons. Tendon-bone constructs with TGF-ß3-loaded fibre scaffolds showed only slightly lower values. In histological evaluation minor differences could be observed. Both groups showed advanced fibre scaffold degradation driven partly by foreign body giant cell accumulation and high cellular numbers in the reconstructed area. Normal levels of neutrophils indicate that present mast cells mediated rather phagocytosis than inflammation. Fibrosis as sign of foreign body encapsulation and scar formation was only minorly present. In conclusion, TGF-ß3-loading of electrospun PCL fibre scaffolds resulted in more robust constructs without causing significant advantages on a cellular level. A deeper investigation with special focus on macrophages and foreign body giant cells interactions is one of the major foci in further investigations.

Possibilities and limitations of electrospun chitosan-coated polycaprolactone grafts for rotator cuff tear repair.

Acute and chronic rotator cuff tears remain challenging for therapy. A wide range of therapeutic approaches were developed but re-tears and postoperative complications occur regularly. Especially in elderly people, the natural regeneration processes are decelerated, and graft materials are often necessary to stabilize the tendon-to-bone attachment and to improve the healing process. We here investigated in a small animal model a newly developed electrospun polycaprolactone fiber implant coated with a chitosan-polycaprolactone graft copolymer and compared these implants biomechanically and histologically with either a commercially available porous polyurethane implant (Biomerix 3D Scaffold) or suture-fixed tendons. Fifty-one rats were divided into three groups of 17 animals each. In the first surgery, the left infraspinatus tendons of all rats were detached, and the animals recovered for 4 weeks. In the second surgery, the tendons were fixed with suture material only (suture-fixed group; n = 17), whereas in the two experimental groups, the tendons were fixed with suture material and the polyurethane implant (Biomerix scaffold group; n = 17) or the modified electrospun polycaprolactone fiber implant (CS-g-PCL scaffold group; n=17), respectively. The unaffected right infraspinatus tendons were used as native controls. After a recovery of 8 weeks, all animals were clinically inconspicuous. In 12 animals of each group, repaired entheses were biomechanically tested for force at failure, stiffness, and modulus of elasticity, and in five animals, repaired entheses were analyzed histologically. Biomechanically, all parameters did not differ statistically significant between both implant groups, and the entheses failed typically at the surgical site. However, with respect to the force at failure, the median values of the two implant groups were smaller than the median value of the suture-fixed group. Histologically, the modified polycaprolactone fiber implant showed no acute inflammation processes, a good infiltration with cells, ingrowth of blood vessels and tendinous tissue, and a normal fibrous ensheathment. Further improvement of the implant material could be achieved by additional implementation of drug delivery systems. Therewith, the used CS-g-PCL fiber mat is a promising basic material to reach the goal of a clinically usable graft for rotator cuff tear repair.

Force, impulse and energy during falling with and without knee protection: an in-vitro study.

The mechanics of protective knee padding mitigating injury from a high-force fall have not been investigated in real-life scenarios to date. This study compares the effect of wearing knee pads to unprotected impact on a hard surface. We hypothesized that knee pads reduce the force and energy transmitted to the bony structures of the knee cap compared with unprotected conditions. Eight human knee cadaver specimens were embedded and fixed with a flexion angle of 100 degrees in a custom-made drop testing device (75 kg including the knee). The usage of a knee pad led to an average peak force attenuation on impact of 15% (no pad: 5932 N SD: 2472 N; pad: 4210 N SD: 2199 N; p < 0.001). Contact time on the plate was higher with a knee pad (no pad: 0.015 s SD: 0.009 s; pad: 0.028 s SD: 0.014 s; p < 0.001). Therefore, the observed impulse was also increased (no pad: 62.2 Ns SD: 17.8 Ns; pad: 74.6 Ns SD: 18.6 Ns; p < 0.001). This effect diminished as drop height was increased. Energy dissipation, defined as the difference between kinetic energy pre-impact and peak potential energy post-impact, was higher without a knee pad (no pad: 10.5 J SD: 6.2 J; pad: 4.2 J SD: 5.0 J; p < 0.001). The results from this study illustrate the magnitude of influence that knee pads have on peak forces, transmitted impulse, and energy transfer from a high-force impact in real-life scenarios. Contrary to expectations, the knee pad did not act as a mechanical damper. The mechanical behavior more closely resembled a spring that temporarily stores energy and consequentially reduces peak forces upon impact. Based on this study, future developments in padding might benefit from focusing on the aspect of energy storage and temporarily delayed energy dissipation.

The prevalence of osteoarthritis: Higher risk after transfemoral amputation?-A database analysis with 1,569 amputees and matched controls.

BACKGROUND: Several studies have shown that patients with a unilateral amputation have an increased risk of developing osteoarthritis (OA) in the knee of their sound leg. OBJECTIVE: The first objective was to investigate whether amputees are more frequently affected by gon-, cox- or polyarthritis as well as back pain or spinal disorders. We hypothesized that mobile and active transfemoral amputees more often experience OA and spinal disorders than non-amputees. The second objective was to compare the mean age of the patients with OA. PATIENTS: Patients with a unilateral transfemoral amputation (n = 1,569) and five abled-body control groups (each n = 1,569) matched in terms of age and gender resulting in total of 9,414 participants. METHODS: Groups were analyzed regarding the prevalence of six selected diagnoses regarding musculoskeletal disorders. RESULTS: A significantly decreased prevalence of OA and specific disorders of the spine in transfemoral amputees compared to a control group was found. The amputees with OA are significantly younger than patients with OA in the control group. CONCLUSION: The results from the presented study contradict previously published literature. Apparently circumstances of life play an important role, like physical work and strenuous activities which are likely to be underrepresented in the amputee group. The results of the study need to be used cautiously due to the major limitation of the study which is the lack of detail in individual patients caused by the methodology.

The determination of the validity of an application-based knee-training device.

The goals of knee rehabilitation are to improve range of motion and muscle status. The aim of the study was to investigate accuracy and reproducibility of a newly designed knee-training device (KT) under standardized laboratory conditions.Two application-based software programs, one to measure maximum force and the other intended to improve users' coordination were developed to be used on a tablet during exercises, wirelessly connected to KT placed under the popliteal fossa.KT was loaded for 20 intervals of 15 seconds (s) ranging between 0-350 Newton (N) each. The interval of times was chosen to be enough to take right measurement for accurate results. In addition, a 300-s continuous measurement was undertaken. The pressure readings were developed through a servo-hydraulic system and used as reference values. KT results were compared with the reference values to assess its accuracy. In addition, KT was tested on a force-measuring platform in a close to reality measurement.Based on Bland-Altman plots, the mean difference between KT and material testing machine was -0.63 N (0.4%), between KT and force-measuring platform was -0.11 N (0.7%), which proves the accuracy of its result.Laboratory experiments confirm that KT delivers precise and reproducible values, which provide base for clinical trials.

Biomechanical properties following open wedge high tibial osteotomy: Plate fixator combined with dynamic locking screws versus standard locking screws.

BACKGROUND: Open wedge high tibial osteotomy is widespread in treating osteoarthritis of the knee. Bone healing of the gap and the necessity of bone substitutes are under discussion. Increasing movement of the osteotomy gap can improve bone healing, while excessive movement should be avoided. It was hypothesised that the use of dynamic locking screws, compared to standard locking screws, will increase interfragmental motion while construct stability persists. METHODS: In 20 tibia sawbones open wedge high tibial osteotomy was performed using standard locking screws or dynamic locking screws. An incremental cyclic (2 Hz) compression to termination protocol was applied using a material testing machine (MTS MiniBionix 858). Relative motion of the osteotomy and construct stability were measured using an optical tracking system (PONTOS 5M system). Levels of significance were set to 0.05. FINDINGS: 19 Sawbones were statistically evaluated. Interfragmental motion increased significantly with dynamic locking screws compared to standard locking screws (P < 0.001). Lateral hinge fractured after a mean of 29,489 (dynamic locking screws) vs. 48,111 (standard locking screws) load cycles at a median load level 3 (50-1120 N) in dynamic locking screws group and at a median load level 5 (50-1440 N) (P = 0.002) in standard locking screws group. INTERPRETATION: Using dynamic locking screws in open wedge high tibial osteotomy increases interfragmental motion within the range of optimal bone healing. A decrease in construct stability has to be considered compared to standard locking screws.

In vitro investigation of two connector types for continuous rod construct to extend lumbar spinal instrumentation.

PURPOSE: Instrumentation of the lumbar spine is a common procedure for treating pathologic conditions. Studies have revealed the risks of pathologies in the adjacent segments, with the incidence rate being up to 36.1%. Revision procedures are often required, including extension of the instrumentation by the use of connectors to adjacent levels. The aim of this study was to determine the stiffness of side-to-side and end-to-end connectors for comparison with the use of continuous rods. METHODS: Ten human lumbar spine specimens (L1-S1) were tested about the three axes under pure moment loading of ± 7.5 Nm. Nine conditions were used to investigate the functions of the extensions for different instrumentation lengths (L3-S1 and L2-S1) and different connector levels (L3/4 and L2/3). The intersegmental range of motion (iROM) and intersegmental neutral zone as well as total range of motion (tROM) and total neutral zone (tNZ) were analyzed. RESULTS: The application of the spinal system significantly decreased the tROMs (- 44 to - 83%) and iROMs in levels L2/3 (- 56 to - 94%) and L3/4 (- 68 to - 99%) in all the tested directions, and the tNZ under flexion/extension (- 63 to - 71%) and axial rotation (- 34 to - 72%). These decreases were independent of the employed configuration (p < 0.05). The only significant changes in the iROM were observed under lateral bending between the continuous rod and the side-to-side connector at level L3/4 (p = 0.006). CONCLUSION: From a biomechanical viewpoint, the tested connectors are comparable to continuous rods in terms of ROM and NZ. These slides can be retrieved under Electronic Supplementary Material.

Severe Hemorrhagic Shock Leads to a Delayed Fracture Healing and Decreased Bone Callus Strength in a Mouse Model.

BACKGROUND: Multiple trauma is frequently associated with hemorrhagic shock and fractures of the extremities. Clinically, the rate of impaired fracture healing (delayed healing and nonunion) seems to be increased in patients with multiple injuries compared with patients with isolated fractures. As the underlying pathogenesis remains poorly understood, we aimed to analyze the biomechanical properties during fracture healing in a murine model. QUESTIONS: The aim of this study was to determine whether fracture healing after severe hemorrhagic shock results in (1) delayed bridging as determined by macroscopic and radiographic assessment, (2) altered conditions of callus components as determined by µCT, and (3) decreased maximum bending moment measured by a three-point-bending test compared with ordinary fracture healing. METHODS: Male C57BL/6NCrl mice were randomly assigned to five groups and four different times (five to 10 mice per group and time). Only the right femur from each mouse was used for analysis: the trauma hemorrhage (TH) group received a pressure-controlled hemorrhagic shock via catheter; the osteotomy (Fx) group underwent osteotomy and implantation of an external fixator on the right femur; the combined trauma (THFx) group received hemorrhagic shock and an external fixator with osteotomy; the sham group underwent implantation of a catheter and external fixator but had no blood loss or osteotomy, and the control group underwent no interventions. After 2, 3, 4, or 6 weeks, five to 10 animals of each group were sacrificed. Bones were analyzed macroscopically and via radiographs, µCT, and three-point-bending test. Statistical significance was set at a probability less than 0.05. Comparisons were performed using the Mann-Whitney U or the Kruskal-Wallis test. RESULTS: In the Fx group, the osteotomy gap was stable and bridged after 2 weeks in contrast to some bones in the THFx group where stable bridging did not occur. No difference was observed between the groups. µCT analysis showed reduced density of bone including callus (THFx: 1.17 g/cm3; interquartile range [IQR], 0.04 g/cm3; Fx: 1.22 g/cm3; IQR, 0.04 g/cm3; p = 0.002; difference of medians [DM], -0.048; 95% CI, -0.073 to -0.029) and increased share of callus per volume of bone mass (%) after 2 weeks in the THFx group compared with the Fx group (THFx: 44.16%; IQR, 8.66%; Fx: 36.73%; IQR, 4.39%; p = 0.015; DM, 7.634; 95% CI, 2.018-10.577). The three-point-bending test established a decreased maximum bending moment in the THFx group compared with the Fx group 2 weeks after surgery (THFx: 7.10 Nmm; IQR, 11.25 Nmm; Fx: 11.25 Nmm; IQR, 5.70 Nmm; p = 0.026; DM, -5.043; 95% CI, -10.867 to -0.74). No differences were observed between the THFx and Fx groups after more than 2 weeks. CONCLUSION: In this in vivo mouse fracture model, we conclude that hemorrhagic shock retards fracture healing during the early phase of the facture healing process. CLINICAL RELEVANCE: A severe hemorrhagic shock in patients could result in initial delayed fracture healing and needs special attention. We plan to conduct a prospective, observational clinical research study to analyze if delayed fracture healing occurs in patients after severe blood loss.

Effect of single intralesional treatment of surgically induced equine superficial digital flexor tendon core lesions with adipose-derived mesenchymal stromal cells: a controlled experimental trial.

BACKGROUND: Adipose tissue is a promising source of mesenchymal stromal cells (MSCs) for the treatment of tendon disease. The goal of this study was to assess the effect of a single intralesional implantation of adipose tissue-derived mesenchymal stromal cells (AT-MSCs) on artificial lesions in equine superficial digital flexor tendons (SDFTs). METHODS: During this randomized, controlled, blinded experimental study, either autologous cultured AT-MSCs suspended in autologous inactivated serum (AT-MSC-serum) or autologous inactivated serum (serum) were injected intralesionally 2 weeks after surgical creation of centrally located SDFT lesions in both forelimbs of nine horses. Healing was assessed clinically and with ultrasound (standard B-mode and ultrasound tissue characterization) at regular intervals over 24 weeks. After euthanasia of the horses the SDFTs were examined histologically, biochemically and by means of biomechanical testing. RESULTS: AT-MSC implantation did not substantially influence clinical and ultrasonographic parameters. Histology, biochemical and biomechanical characteristics of the repair tissue did not differ significantly between treatment modalities after 24 weeks. Compared with macroscopically normal tendon tissue, the content of the mature collagen crosslink hydroxylysylpyridinoline did not differ after AT-MSC-serum treatment (p = 0.074) while it was significantly lower (p = 0.027) in lesions treated with serum alone. Stress at failure (p = 0.048) and the modulus of elasticity (p = 0.001) were significantly lower after AT-MSC-serum treatment than in normal tendon tissue. CONCLUSIONS: The effect of a single intralesional injection of cultured AT-MSCs suspended in autologous inactivated serum was not superior to treatment of surgically created SDFT lesions with autologous inactivated serum alone in a surgical model of tendinopathy over an observation period of 22 weeks. AT-MSC treatment might have a positive influence on collagen crosslinking of remodelling scar tissue. Controlled long-term studies including naturally occurring tendinopathies are necessary to verify the effects of AT-MSCs on tendon disease.

Dynamic Time Warping compared to established methods for validation of musculoskeletal models.

By means of Multi-Body musculoskeletal simulation, important variables such as internal joint forces and moments can be estimated which cannot be measured directly. Validation can ensued by qualitative or by quantitative methods. Especially when comparing time-dependent signals, many methods do not perform well and validation is often limited to qualitative approaches. The aim of the present study was to investigate the capabilities of the Dynamic Time Warping (DTW) algorithm for comparing time series, which can quantify phase as well as amplitude errors. We contrast the sensitivity of DTW with other established metrics: the Pearson correlation coefficient, cross-correlation, the metric according to Geers, RMSE and normalized RMSE. This study is based on two data sets, where one data set represents direct validation and the other represents indirect validation. Direct validation was performed in the context of clinical gait-analysis on trans-femoral amputees fitted with a 6 component force-moment sensor. Measured forces and moments from amputees' socket-prosthesis are compared to simulated forces and moments. Indirect validation was performed in the context of surface EMG measurements on a cohort of healthy subjects with measurements taken of seven muscles of the leg, which were compared to simulated muscle activations. Regarding direct validation, a positive linear relation between results of RMSE and nRMSE to DTW can be seen. For indirect validation, a negative linear relation exists between Pearson correlation and cross-correlation. We propose the DTW algorithm for use in both direct and indirect quantitative validation as it correlates well with methods that are most suitable for one of the tasks. However, in DV it should be used together with methods resulting in a dimensional error value, in order to be able to interpret results more comprehensible.

In vitro investigation of a new dynamic cervical implant: comparison to spinal fusion and total disc replacement.

PURPOSE AND METHODS: For the treatment of degenerative disc diseases of the cervical spine, anterior cervical discectomy and fusion (ACDF) still represents the standard procedure. However, long term clinical studies have shown a higher incidence of pathologies in the adjacent segments. As an alternative to spinal fusion, cervical total disc replacement (cTDR) or dynamically implants were increasingly used. This in vitro study analyzed the kinematics and intradiscal pressures in seven multi-segmental human cervical spine using hybrid multidirectional test method. The aim of our study was to compare the intact condition with a single-level dynamic stabilization with DCI(®), with cTDR (activC(®)) and with simulated ACDF (CeSPACE(®) cage and CASPAR plate). RESULTS: No significant changes in the kinematics and pressures were observed in all segments after arthroplasty. The DCI(®) significantly decreased the motion of the treated segment in flexion/extension and lateral bending with some remaining residual mobility. Thereby the motion of the upper segment was increased significantly in flexion/extension. No significant changes of the intradiscal pressures were observed. With simulated fusion the motion of the indexed level was significantly decreased in flexion/extension and axial rotation with the greatest changes in the adjacent levels and the highest pressures. CONCLUSION: Based on our biomechanical study the DCI(®) can pose an alternative to fusion, which has a lesser effect on adjacent levels. This might reduce the risk of long-term degeneration in those levels. In particular, the facet joint arthritis and kyphotic deformity, as a contraindication to the arthroplasty, could be a clinical application of the dynamic implant.

In vivo evaluation of a magnesium-based degradable intramedullary nailing system in a sheep model.

The biocompatibility and the degradation behavior of the LAE442 magnesium-based intramedullary interlocked nailing system (IM-NS) was assessed in vivo in a comparative study (stainless austenitic steel 1.4441LA) for the first time. IM-NS was implanted into the right tibia (24-week investigation period; nails/screws diameter: 9 mm/3.5 mm, length: 130 mm/15-40 mm) of 10 adult sheep (LAE442, stainless steel, n=5 each group). Clinical and radiographic examinations, in vivo computed tomography (CT), ex vivo micro-computed tomography (µCT), mechanical and histological examinations and element analyses of alloying elements in inner organs were performed. The mechanical examinations (four-point bending) revealed a significant decrease of LAE442 implant stiffness, force at 0.2% offset yield point and maximum force. Periosteal (new bone formation) and endosteal (bone decline) located bone alterations occurred in both groups (LAE442 alloy more pronounced). Moderate gas formation was observed within the LAE442 alloy group. The CT-measured implant volume decreased slightly (not significant). Histologically a predominantly direct bone-to-implant interface existed within the LAE442 alloy group. Formation of a fibrous tissue capsule around the nail occurred in the steel group. Minor inflammatory infiltration was observed in the LAE442 alloy group. Significantly increased quantities of rare earth elements were detected in the LAE442 alloy group. µCT examination showed the beginning of corrosion in dependence of the surrounding tissue. After 24 weeks the local biocompatibility of LAE442 can be considered as suitable for a degradable implant material. STATEMENT OF SIGNIFICANCE: An application oriented interlocked intramedullary nailing system in a comparative study (degradable magnesium-based LAE442 alloy vs. steel alloy) was examined in a sheep model for the first time. We focused in particular on the examination of implant degradation by means of (µ-)CT, mechanical properties (four-point bending), clinical compatibility, local bone reactions (X-ray and histology) and possible systemic toxicity (histology and element analyses of inner organs). A significant decrease of magnesium (LAE442 alloy) implant stiffness and maximum force occurred. Moderate not clinically relevant gas accumulation was determined. A predominantly direct bone-to-implant contact existed within the magnesium (LAE442 alloy) group compared to an indirect contact in the steel group. Rare earth element accumulation could be observed in inner organs but H&E staining was inconspicuous.