Background: Expedient prediction of adverse bone fracture healing (delayed-or non-union) is necessary to advise secondary treatments for improving healing outcome to minimize patient suffering. Radiographic imaging, the current standard diagnostic, remains largely ineffective at predicting nonunions during the early stages of fracture healing resulting in mean nonunion diagnosis times exceeding six months. Thus, there remains a clinical deficit necessitating improved diagnostic techniques. It was hypothesized that adverse fracture healing expresses impaired biological progression at the fracture site, thus resulting in reduced temporal progression of fracture site stiffness which may be quantified prior to the appearance of radiographic indicators of fracture healing (i.e., calcified tissue).Methods: A novel multi-location direct electromagnetic coupling antenna was developed to diagnose relative changes in the stiffness of fractures treated by metallic orthopaedic hardware. The efficacy of this diagnostic was evaluated during fracture healing simulated by progressive destabilization of cadaveric ovine metatarsals treated by locking plate fixation (n=8). An ovine in vivo comparative fracture study (n=8) was then utilized to better characterize the performance of the developed diagnostic in a clinically translatable setting.In vivo measurements using the developed diagnostic were compared to weekly radiographic images and postmortem biomechanical, histological, and micro computed tomography analyses.Results: For all cadaveric samples, the novel direct electromagnetic coupling antenna displayed significant differences at the fracture site (P<0.05) when measuring a fully fractured sample versus partially intact and fully intact fracture states. In subsequent in vivo fracture models, this technology detected significant differences (P<0.001) in fractures trending towards delayed healing during the first 30 days post-fracture.Conclusions: This technology, relative to traditional X-ray imaging, exhibits potential to greatly expedite clinical diagnosis of fracture nonunion, thus warranting additional technological development.

Current diagnostic modalities, such as radiographs or computed tomography, exhibit limited ability to predict the outcome of bone fracture healing. Failed fracture healing after orthopaedic surgical treatments are typically treated by secondary surgery; however, the negative correlation of time between primary and secondary surgeries with resultant health outcome and medical cost accumulation drives the need for improved diagnostic tools. This study describes the simultaneous use of multiple (n = 5) implantable flexible substrate wireless microelectromechanical (fsBioMEMS) sensors adhered to an intramedullary nail (IMN) to quantify the biomechanical environment along the length of fracture fixation hardware during simulated healing in ex vivo ovine tibiae. This study further describes the development of an antenna array for interrogation of five fsBioMEMS sensors simultaneously, and quantifies the ability of these sensors to transmit signal through overlaying soft tissues. The ex vivo data indicated significant differences associated with sensor location on the IMN (p < 0.01) and fracture state (p < 0.01). These data indicate that the fsBioMEMS sensor can serve as a tool to diagnose the current state of fracture healing, and further supports the use of the fsBioMEMS as a means to predict fracture healing due to the known existence of latency between changes in fracture site material properties and radiographic changes.

Objective To determine the influence of a novel surgical guide on the accuracy and technical difficulty of closing wedge osteotomies (CWO). Study design Ex vivo experimental study. Sample population Canine tibia models (n = 40). Methods A 20° cranial CWO (CCWO) was created without (standard procedure; STCCWO) or with the aid of a novel wedge osteotomy guide (WOCCWO). Procedures were performed by diplomate (n = 4) and resident (n = 6) surgeons, with each performing 2 STCCWO followed by 2 WOCCWO. To prevent bias, surgeons were unaware of the study purpose until after completing the STCCWO. The wedges were evaluated by comparing the deviation from the 20° target angle, divergence of the 2 osteotomies (osteotomy divergence angle [ODA]), and measurements of the wedge height at the caudomedial cortex (CMC) and caudolateral cortex (CLC). Technique difficulty was explored through a surgeon questionnaire. Results The WOCCWO resulted in smaller mean ODA (WOCCWO = 0.86°, SD ± 0.38°, P < .001), and smaller mean difference between CMC and CLC (WOCCWO = 0.29 mm, SD ± 0.19, P < .001) than for the STCCWO (4.22°, SD ± 2.16° and 1.39 mm, SD ± 0.65 respectively). Deviation from the target 20° wedge angle was greater after STCCWO (1.46°, SD ± 1.27°) than after WOCCWO (0.53°, SD ± 0.33°, P = .004). No difference was reported regarding the difficulty of the procedures, but resident surgeons stated that they were more likely to use the guide in a clinical setting compared with diplomates. Conclusion The wedge osteotomy guide improved the accuracy of CCWO compared with standard technique. Clinical significance The clinical significance of the differences detected in this study is unclear and warrants in vivo investigation.

Introduction The Jaipur Foot is a low-cost prosthetic limb developed by Dr. P.K. Sethi and implemented in clinics across India and the world. Although the device is well-suited for many geographic and socioeconomic areas, it suffers from an inconsistent lifespan. Methods The purpose of this study was to use finite element analysis to parametrically simulate the Jaipur Foot to determine potential improvements to the prosthesis’ design. The resulting model used varied material properties and internal boundary conditions through two stages of the gait cycle to predict the effects on the likelihood of device failure. Further analysis investigating the effect on device mechanics by the change in material properties due to vulcanization was also completed. Results Results suggested that the interface between microcellular rubber blocks is a concern for failure, which agrees with epidemiological studies of the prosthesis. Data further indicated changes in material property to result in substantial alterations to the stresses experienced within the prosthesis. Conclusions Future work could use this model for alternative designs of the Jaipur Foot.