Novel intramedullary device for lengthening transfemoral residual limbs

BACKGROUND Lower limb loss is a highly disabling medical condition that can severely impact a person's quality of life. Recovery becomes especially challenging if an amputee has a short residual limb, which can complicate proper prosthetic fitting, causing discomfort, difficulties in suspension, and reduced mobility. Current limb lengthening techniques such as the Ilizarov apparatus and external fixators are cumbersome, uncomfortable, and have high complication rates. In this study, we investigated the effectiveness of a novel limb-lengthening device that uses intramedullary bone lengthening and requires only one percutaneous rod at the end of the limb during the distraction phase. Only the intramedullary nail remains after the distraction phase, and no external components are required during the consolidation phase. We hypothesize that this system would create a much easier experience for the patient. METHODS The system was first tested in a mock surgical implantation using plastic femur bones. The device was then tested in a series of cadaveric experiments using pelvis-to-knee specimens by a group of surgeons. Surgeons evaluated the surgical insertion technique, soft tissue considerations, hardware fixation strategies, and the effectiveness of the distraction mechanism. Revisions and improvements to the device and surgical procedure were made based on the results from the cadaveric experiments. RESULTS A questionnaire was given to two visiting surgeons following the final iteration of the device. The surgeons reported that the system effectively lengthened the limb, was sturdy, and could be installed efficiently. However, there remains a risk of infection and soft tissue imbalances, similar to that introduced by an external fixator device. Suggestions on how to improve the design of the device and mitigate infection through postoperative management and surgical standard of care will be considered for future clinical trials. CONCLUSIONS The described intramedullary residual limb-lengthening device has evolved from a prototype to a mature model tested in six cadaveric experiments to date. Further mechanical and functional testing is needed to finalize the device before testing in patients.