Mechanical and Finite Element Analysis of an Innovative Orthopedic Implant Designed to Increase the Weight Carrying Ability of the Femur and Reduce Frictional Forces on an Amputee's Stump.

This study was designed to test the hypothesis that: "A properly designed implant that harnesses the principle of the incompressibility of fluids can improve the weight carrying ability of an amputee's residual femur and reduce the frictional forces at the stump external socket interface." The hypothesis was tested both mechanically on an Amputee Simulation Device (ASD) and through Finite Element Analysis (FEA) modeling software. With the implant attached to the femur, the FEA and ASD demonstrated that the femur carried 90% and 93% respectively of the force of walking. Without the implant, the FEA model and ASD femur carried only 35% and 77%, respectively, of the force of walking. Statistical calculations reveal three (3) degrees of separation (99% probability of non-random significant difference) between with and without implant data points. FEA modeling demonstrates that the normal contact forces and shear forces are pushed the distal weight-bearing area of the amputee stump, relieving the lateral stump of frictional forces. The ASD mechanical and FEA modeling data validate each other with both systems supporting the hypotheses with confidence intervals of three degrees of separation between with implant and without implant models.

Performance, Reliability, Usability, and Safety of the ID-Cap System for Ingestion Event Monitoring in Healthy Volunteers: A Pilot Study.

Background: Nonadherence to prescribed medications is an important consideration in the clinical management of patients and in clinical research and drug development. The ID-Cap System is a novel technology that provides an objective measure of medication ingestion and enables real-time reporting of verified medication adherence data at the dose level. The ID-Cap System consists of an ingestible microsensor that is embedded in an oral dosage form and, once activated by stomach fluid, communicates digital messages to an external wearable reader to confirm ingestion. Objective: The objective of this exploratory study was to evaluate the performance, reliability, usability, and safety of the ID-Cap System for remote monitoring of 20 ingestion events over four weeks in 20 healthy volunteers. Design: This study was an open-label, single-arm, exploratory study of the ID-Cap System. The study design included the following three phases: 1) screening phase, 2) treatment phase consisting of 20 daily capsule ingestion events over a four-week period, and 3) follow-up phase consisting of a follow-up study visit that included an abdominal X-ray and a follow-up phone call. The initial use of the ID-Cap Reader and ingestion of the first study capsule were directly observed by the investigator during the first study visit. Subsequent study capsule ingestions were completed outside the research facility at the study participant's home or other location of his or her choice with ingestion assessed using the ID-Cap System. Setting: The study was conducted at a single clinical research site in Gainesville, Florida. Participants: Twenty healthy volunteers were enrolled in this four-week pilot study that was conducted between September and November 2014. Measurements: Study measurements included ID-Tag detection indicating capsule ingestion, utilization of the ID-Cap System consistent with instructions for use, adverse event reports, discontinuations of the System during the study, and safety assessments related to excretion of the ID-Tags through abdominal X-ray evaluations. Results: Positive detection accuracy was 100 percent for the 20 directly observed ingestions of study capsules that occurred during the initial study visits. Of the 384 ingestion events that were self-administered by the study participants without direct observation, 371 were accurately detected using the ID-Cap System. Overall adherence to the prescribed study capsules as measured by the ID-Cap System was 97.75 percent (391 detections/400 expected ingestion events). Significant intra-individual and inter-individual variability in the timing of self-administered doses was observed in this study. No adverse events were reported, and no study participants discontinued use of the ID-Cap System for any reason during the study. There was no evidence indicating retention of ID-Tags based on abdominal X-ray evaluations. Conclusion: The ID-Cap System enables accurate measurement of medication adherence for oral drug therapy at the dose level. This study supports the clinical validation of the technology and feasibility in using the system for the collection and real-time reporting of medication adherence in the clinical management of patients and in clinical research and drug development.

Vascularized plantar myocutaneous free flap transfer for amputee stump preparation: a proof of concept cadaver study.

Lower extremity amputee stump ulceration, irritation, and pain have been a deterrent to consistent long-term or continuous use of lower extremity prosthetics. This study is the first in a series that hypothesizes that these complications can be minimized through the insetting of a vascularized plantar free flap (VPFF) on the amputee stump. Using three hip disarticulated cadaver specimens, a VPFF was designed, dissected, and implanted on one transfemoral and two transtibial stumps. Using accepted vascular anastomosis techniques, the posterior tibial artery was anastomosed to the distal femoral or popliteal artery with corresponding anastomoses for venous drainage. In addition, the possibility of a limited to partial sensate flap may be created with a neurorrhaphy of the associated nerves. This potentially sensate area would provide plantar skin that aids the existing local sensate flap used to close the defect. It is hypothesized that this procedure offers significant rehabilitative and long-term benefits to battlefield or other acute causes for lower extremity amputation. The procedure can be accomplished in battlefield surgical setting as an immediate or delayed inset for some but not all traumatic amputations. Salvaging a partial or complete VPFF from a traumatized foot will obviously be predicated on the degree of trauma to the donor tissue.

An otolaryngologist's experience with in-flight commercial airline medical emergencies: three case reports and literature review.

Managing a medical emergency onboard a commercial airline is an uncommon but real possibility for those physicians who fly. Understanding your potential role, management options, medical supplies and help that is available to you is important.