Long-term functional and clinical outcome of combined targeted muscle reinnervation and osseointegration for functional bionic reconstruction in transhumeral amputees: a case series.

Objective: To describe and evaluate the combination of osseointegration and nerve transfers in 3 transhumeral amputees.

Design: Case series.

Patients: Three male patients with a unilateral traumatic transhumeral amputation.

Cutting Edge Bionics in Highly Impaired Individuals: A Case of Challenges and Opportunities.

Highly impaired individuals stand to benefit greatly from cutting-edge bionic technology, however concurrent functional deficits may complicate the adaptation of such technology. Here, we present a case in which a visually impaired individual with bilateral burn injury amputation was provided with a novel transradial neuromusculoskeletal prosthesis comprising skeletal attachment via osseointegration and implanted electrodes in nerves and muscles for control and sensory feedback. Difficulties maintaining implant hygiene and donning and doffing the prosthesis arose due to his contralateral amputation, ipsilateral eye loss, and contralateral impaired vision necessitating continuous adaptations to the electromechanical interface.

A highly integrated bionic hand with neural control and feedback for use in daily life.

Restoration of sensorimotor function after amputation has remained challenging because of the lack of human-machine interfaces that provide reliable control, feedback, and attachment. Here, we present the clinical implementation of a transradial neuromusculoskeletal prosthesis-a bionic hand connected directly to the user's nervous and skeletal systems. In one person with unilateral below-elbow amputation, titanium implants were placed intramedullary in the radius and ulna bones, and electromuscular constructs were created surgically by transferring the severed nerves to free muscle grafts.

Improved control of a prosthetic limb by surgically creating electro-neuromuscular constructs with implanted electrodes.

Remnant muscles in the residual limb after amputation are the most common source of control signals for prosthetic hands, because myoelectric signals can be generated by the user at will. However, for individuals with amputation higher up the arm, such as an above-elbow (transhumeral) amputation, insufficient muscles remain to generate myoelectric signals to enable control of the lost arm and hand joints, thus making intuitive control of wrist and finger prosthetic joints unattainable. We show that severed nerves can be divided along their fascicles and redistributed to concurrently innervate different types of muscle targets, particularly native denervated muscles and nonvascularized free muscle grafts.

Patient-Specific Guides for Accurate and Precise Positioning of Osseointegrated Implants in Transfemoral Amputations: A Proof-of-Concept In Vitro Study.

: The treatment of transfemoral amputees using osseointegrated implants for prosthetic anchorage requires accurate implant positioning when using threaded bone-anchoring implants due to the curvature of the femur and the risk of cortical penetration in misaligned implants. This study investigated the accuracy and precision in implant positioning using additively manufactured case-specific positioning guides. : The geometry and density distribution of twenty anatomic specimens of human femora were assessed in quantitative computed tomography (QCT) scanning.

The effect of cortical thickness and thread profile dimensions on stress and strain in bone-anchored implants for amputation prostheses.

Skeletal attachment of limb prostheses ensures load transfer between the prosthetic leg and the skeleton. For individuals with lower limb amputation, these loads may be of substantial magnitude. To optimize the design of such systems, knowledge about the structural interplay between implant design features, dimensional changes, and material properties of the implant and the surrounding bone is needed.

Thermal Effects during Bone Preparation and Insertion of Osseointegrated Transfemoral Implants.

Background: The preparation of bone for the insertion of an osseointegrated transfemoral implant and the insertion process are performed at very low speeds in order to avoid thermal damages to bone tissue which may potentially jeopardize implant stability. The aim of this study was to quantify the temperature increase in the femur at different sites and insertion depths, relative to the final implant position during the stepwise implantation procedure.

Methods: The procedure for installation of the osseointegrated implant was performed on 24 femoral specimens.

Avian extremity reconstruction via osseointegrated leg-prosthesis for intuitive embodiment.

For large avians such as vultures, limb loss leads to loss of ambulation and eventually death from malnutrition. Prosthetic devices may replace the limb, however, conventional prosthetic sockets are not feasible in feathered limbs and the extreme stress and strain of unreflected daily use in animals. Osseointegration is a novel technique, where external prosthetic parts are connected directly to a bone anchor to provide a solid skeletal-attachment.

Successful salvage via re-osseointegration of a loosened implant in a patient with transtibial amputation.

Case Description: Osseointegration is a relatively new technique for prosthetic limb attachment that offers various improvements for patients with amputation and facilitates joint preservation. We present a case of implant loosening during rehabilitation in a patient with transtibial amputation that was successfully managed through a combination of measures, aiming to promote re-osseointegration of the implant.

Objectives: Not much is known about structured management of adverse events after osseointegration.

Advanced techniques in amputation surgery and prosthetic technology in the lower extremity.

Bone-anchored implants give patients with unmanageable stump problems hope for drastic improvements in function and quality of life and are therefore increasingly considered a viable solution for lower-limb amputees and their orthopaedic surgeons, despite high infection rates.Regarding diversity and increasing numbers of implants worldwide, efforts are to be supported to arrange an international bone-anchored implant register to transparently overview pros and cons.Due to few, but high-quality, articles about the beneficial effects of targeted muscle innervation (TMR) and regenerative peripheral nerve interface (RPNI), these surgical techniques ought to be directly transferred into clinical protocols, observations and routines.

Targeted Muscle Reinnervation and Osseointegration for Pain Relief and Prosthetic Arm Control in a Woman with Bilateral Proximal Upper Limb Amputation.

Background: Bilateral proximal upper limb loss is a dramatic life-changing event. Replacement of the lost function with prosthetic arms, including multiple mechatronic joints, has remained a challenge from the control, comfort, and pain management perspectives. Targeted muscle reinnervation (TMR) is a peripheral nerve surgical procedure proposed to improve the intuitive control of the prosthetic arm and for neuroma and phantom pain management.

Neural feedback strategies to improve grasping coordination in neuromusculoskeletal prostheses.

Conventional prosthetic arms suffer from poor controllability and lack of sensory feedback. Owing to the absence of tactile sensory information, prosthetic users must rely on incidental visual and auditory cues. In this study, we investigated the effect of providing tactile perception on motor coordination during routine grasping and grasping under uncertainty.

Self-Contained Neuromusculoskeletal Arm Prostheses.

We report the use of a bone-anchored, self-contained robotic arm with both sensory and motor components over 3 to 7 years in four patients after transhumeral amputation. The implant allowed for bidirectional communication between a prosthetic hand and electrodes implanted in the nerves and muscles of the upper arm and was anchored to the humerus through osseointegration, the process in which bone cells attach to an artificial surface without formation of fibrous tissue. Use of the device did not require formal training and depended on the intuitive intent of the user to activate movement and sensory feedback from the prosthesis.

Caprine Models of the Agonist-Antagonist Myoneural Interface Implemented at the Above- and Below-Knee Amputation Levels.

Background: Traditional approaches to amputation are not capable of reproducing the dynamic muscle relationships that are essential for proprioceptive sensation and joint control. In this study, the authors present two caprine models of the agonist-antagonist myoneural interface (AMI), a surgical approach designed to improve bidirectional neural control of a bionic limb. The key advancement of the AMI is the surgical coaptation of natively innervated agonist-antagonist muscle pairs within the residual limb.

Grip control and motor coordination with implanted and surface electrodes while grasping with an osseointegrated prosthetic hand.

Background: Replacement of a lost limb by an artificial substitute is not yet ideal. Resolution and coordination of motor control approximating that of a biological limb could dramatically improve the functionality of prosthetic devices, and thus reduce the gap towards a suitable limb replacement.

Methods: In this study, we investigated the control resolution and coordination exhibited by subjects with transhumeral amputation who were implanted with epimysial electrodes and an osseointegrated interface that provides bidirectional communication in addition to skeletal attachment (e-OPRA Implant System).

Loads on Transhumeral Amputees Using Osseointegrated Prostheses.

The treatment of the upper extremities is not as prevalent as that of the lower limbs, but it is nonetheless equally important. Today, there are no load data relating to upper extremity bone-anchored prosthesis users in the literature, but they are important in order to improve the rehabilitation protocol, design aspects and confidence of the user when it comes to loading the prosthesis in daily life. The aim of the present study was to investigate, in a population of eleven transhumeral amputees with osseointegrated implants, the load levels reached during specific prosthetic movements at maximum voluntary effort and during daily activities.

Thumb Amputations Treated With Osseointegrated Percutaneous Prostheses With Up to 25 Years of Follow-up.

Introduction: Implantation of an osseointegrated percutaneous prosthesis provides a reconstruction alternative for thumb amputation without sacrificing donor tissues.

Methods: Thirteen thumb amputees received osseointegrated prostheses (1990 to 2014). The treatments were started with custom-designed implants.

Osseointegrated Percutaneous Prosthetic System for the Treatment of Patients With Transfemoral Amputation: A Prospective Five-year Follow-up of Patient-reported Outcomes and Complications.

Introduction: Direct skeletal attachment of prostheses has previously been shown to improve patient-reported outcome (PRO) measures of individuals with transfemoral amputation (TFA) at 2-year follow-up. This prospective study reports the outcomes at 5-year follow-up.

Methods: A total of 51 patients (55 legs) with TFA were included in a prospective study.

Myoelectric signals and pattern recognition from implanted electrodes in two TMR subjects with an osseointegrated communication interface.

Permanent implantation of electrodes for prosthetic control is now possible using an osseointegrated implant as a long-term stable communication interface (e-OPRA). The number of myoelectric sites to host such electrodes can be increased by Targeted Muscle Reinnervation (TMR). Traditionally, patients need to wait several months before the TMR signals are strong enough to be recorded by electrodes placed over the skin.

Case Studies in Neuroscience: Sensations elicited and discrimination ability from nerve cuff stimulation in an amputee over time.

The present case study details sensations elicited by electrical stimulation of peripheral nerve axons using an implanted nerve cuff electrode, in a participant with a transhumeral amputation. The participant uses an osseointegrated electromechanical interface, which enables skeletal attachment of the prosthesis and long-term, stable, bidirectional communication between the implanted electrodes and prosthetic arm. We focused on evoking somatosensory percepts, where we tracked and quantified the evolution of perceived sensations in the missing hand, which were evoked from electrical stimulation of the nerve, for over 2 yr.

Biomechanical Characterisation of Bone-anchored Implant Systems for Amputation Limb Prostheses: A Systematic Review.

Bone-anchored limb prostheses allow for the direct transfer of external loads from the prosthesis to the skeleton, eliminating the need for a socket and the associated problems of poor fit, discomfort, and limited range of movement. A percutaneous implant system for direct skeletal attachment of an external limb must provide a long-term, mechanically stable interface to the bone, along with an infection barrier to the external environment. In addition, the mechanical integrity of the implant system and bone must be preserved despite constant stresses induced by the limb prosthesis.

Osteomyelitis Risk in Patients With Transfemoral Amputations Treated With Osseointegration Prostheses.

Background: Percutaneous anchoring of femoral amputation prostheses using osseointegrating titanium implants has been in use for more than 25 years. The method offers considerable advantages in daily life compared with conventional socket prostheses, however long-term success might be jeopardized by implant-associated infection, especially osteomyelitis, but the long-term risk of this complication is unknown.

Questions/purposes: (1) To quantify the risk of osteomyelitis, (2) to characterize the clinical effect of osteomyelitis (including risk of implant extraction and impairments to function), and (3) to determine whether common patient factors (age, sex, body weight, diabetes, and implant component replacements) are associated with osteomyelitis in patients with transfemoral amputations treated with osseointegrated titanium implants.