Recent Progress in Animal Studies of the Skin- and Bone-integrated Pylon With Deep Porosity for Bone-Anchored Limb Prosthetics With and Without Neural Interface.

INTRODUCTION: The three major unresolved problems in bone-anchored limb prosthetics are stable, infection-free integration of skin with a percutaneous bone implant, robust skeletal fixation between the implant and host bone, and a secure interface of sensory nerves and muscles with a prosthesis for the intuitive bidirectional prosthetic control. Here we review results of our completed work and report on recent progress. MATERIALS AND METHODS: Eight female adult cats received skin- and bone-integrated pylon (SBIP) and eight male adult cats received SBIP-peripheral neural interface (PNI) pylon into the right distal tibia. The latter pylons provided PNI for connection between a powered sensing transtibial prosthesis and electrodes in residual soleus muscle and on residual distal tibial nerve. If signs of infection were absent 28-70 days after implantation, cats started wearing a passive prosthesis. We recorded and analyzed full-body mechanics of level and slope locomotion in five cats with passive prostheses and in one cat with a powered sensing prosthesis. We also performed histological analyses of tissue integration with the implants in nine cats.Four pigs received SBIPs into the left hindlimb and two pigs-into the left forelimb. We recorded vertical ground reaction forces before amputation and following osseointegration. We also conducted pullout postmortem tests on the implanted pylons. One pig received in dorsum the modified SBIPs with and without silver coating. RESULTS: Six cats from the SBIP groups had implant for 70 days. One cat developed infection and did not receive prosthesis. Five cats had pylon for 148 to 183 days, showed substantial loading of the prosthesis during locomotion (40.4% below presurgery control), and demonstrated deep ingrowth of skin and bone tissue into SBIP (over 60%). Seven of eight cats from the SBIP-PNI group demonstrated poor pylon integration without clinical signs of infection. One cat had prosthesis for 824 days (27 months). The use of the bidirectionally controlled prosthesis by this animal during level walking demonstrated increased vertical loading to nearly normal values, although the propulsion force was significantly reduced.From the study on pigs, it was found that symmetry in loading between the intact and prosthetic limbs during locomotion was 80 ± 5.5%. Skin-implant interface was infection-free, but developed a stoma, probably because of the high mobility of the skin and soft tissues in the pig's thigh. Dorsal implantation resulted in the infection-free deep ingrowth of skin into the SBIP implants. CONCLUSIONS: Cats with SBIP (n = 5) and SBIP-PNI (n = 1) pylons developed a sound interface with the residuum skin and bone and demonstrated substantial loading of prosthetic limb during locomotion. One animal with SBIP developed infection and seven cats with SBIP-PNI demonstrated poor bone integration without signs of infection. Future studies of the SBIP-PNI should focus on reliability of integration with the residuum. Ongoing study with pigs requires decreasing the extra mobility of skin and soft tissues until the skin seal is developed within the SBIP implant.

Kinetics of individual limbs during level and slope walking with a unilateral transtibial bone-anchored prosthesis in the cat.

Ongoing animal preclinical studies on transcutaneous bone-anchored prostheses have aimed to improve biomechanics of prosthetic locomotion in people with limb loss. It is much less common to translate successful developments in human biomechanics and prosthetic research to veterinary medicine to treat animals with limb loss. Current standard of care in veterinary medicine is amputation of the whole limb if a distal segment cannot be salvaged. Bone-anchored transcutaneous prostheses, developed for people with limb loss, could be beneficial for veterinary practice. The aim of this study was to examined if and how cats utilize the limb with a bone-anchored passive transtibial prosthesis during level and slope walking. Four cats were implanted with a porous titanium implant into the right distal tibia. Ground reaction forces and full-body kinematics were recorded during level and slope (±50%) walking before and 4-6 months after implantation and prosthesis attachment. The duty factor of the prosthetic limb exceeded zero in all cats and slope conditions (p < 0.05) and was in the range of 45.0-60.6%. Thus, cats utilized the prosthetic leg for locomotion instead of walking on three legs. Ground reaction forces, power and work of the prosthetic limb were reduced compared to intact locomotion, whereas those of the contralateral hind- and forelimbs increased (p < 0.05). This asymmetry was likely caused by insufficient energy generation for propulsion by the prosthetic leg, as no signs of pain or discomfort were observed in the animals. We concluded that cats could utilize a unilateral bone-anchored transtibial prosthesis for quadrupedal level and slope locomotion.