Osseointegration for Amputees: Past, Present and Future: Basic Science, Innovations in Surgical Technique, Implant Design and Rehabilitation Strategies

Loss of a leg or arm is a tremendous disability. Immediate and obvious impairments are decreased mobility or diminished functional capacity. Not quite as obvious are the difficulties associated with activities of daily living, quality of life impairments, sometimes loss of independence or employment, and the mental health issues which often accompany limb loss. The interface between native tissue and the prosthetic limb presents the greatest challenge to amputee rehabilitation. Computer-controlled robotic limbs have been widely available since the 1990s. However, the weight of prosthetic limbs, coupled with the difficulty of where to locate the components, requires substantial loads to be transferred through the humanimplant interface. This interface has always been a skin-squeezing mechanism which results in repetitive soft-tissue loading and trauma, in both compression and shear, which inevitably causes multiple problems (pain, skin breakdown and infection, hyperhidrosis, allergic reaction to the material) leading to periodic or prolonged prosthesis disuse. So unfortunately, despite all the effort and expense invested in the prosthetic limb itself, patients often were unable to benefit. Percutaneous EndoProsthetic Osseointegration for Limbs (PEPOL) is a revolutionary technique that involves anchoring a metal implant directly to a patient’s skeleton, then permanently passed through the patient’s skin, and attached to a prosthetic limb. By doing this, the weight of the prosthesis is borne by the patient’s skeleton and is directly powered by muscles, leading to a lighter and more native experience. The skin is no longer compressed and traumatised, eliminating the aforementioned issues. Since learning about this technology in the mid-2000s and performing my first independent procedure in 2009, I have investigated and pioneered the world’s leading surgical techniques and rehabilitative methods for PEPOL. Treating nearly 1000 amputees via the Osseointegration Group of Australia and the MQ Health Limb Reconstruction Centre at Macquarie University has allowed research to be performed on this technology, documented, and discussed in the 2 Body of Work. Patients almost always improve their objective and assessed mobility performance (Overall 38.6% distance improvement on the 6MWT), they wear their prosthetic limb more (Overall 38.1% increase in the Q-TFA Prosthetic Use Score), and they are subjectively more satisfied with their condition as an amputee (Overall 41.1% increase in the Q-TFA Global Score) . While these benefits are consistent, my research has also identified the fortunately limited problems with infection and soft tissue management (29% of all patients required re-operations due to direct or indirect complications). PEPOL clearly provides excellent improvement for the vast majority of patients, and the continued investigation of this technology should lead to even greater improvements in progressing from what is already successful, make it more readily available, and ameliorate its existing challenges

Minimally invasive medial patellofemoral ligament reconstruction for patellar instability using an artificial ligament: A two year follow-up

Introduction: Recurrence of acute patellar dislocation affects approximately 30% of individuals, and up to 75% of those with grade IV instability. The medial patellofemoral ligament (MPFL) is considered to be critical for patella stabilisation. MPFL reconstruction with allografts has been proposed to reduce risk of recurrence, but there is limited evidence about the safety and effectiveness of techniques using synthetic allografts. Method: We present a retrospective case series of 29 individuals who underwent a MPFL reconstruction between 2009 and 2012, using an artificial ligament for patellar instability by a single surgeon. Clinical, radiological and functional outcomes were measured at a minimum of 24 months. Results: 31 knees (29 individuals) were followed up for a median of 43 (range: 24 – 68) months. Using the Crosby and Insall grading system, 21 (68%) were graded as excellent, 9 (29%) were good, 1 (3%) as fair and none as worse at 24 months. The mean improvement in Lysholm knee score for knee instability was 68 points (standard deviation 10). Ligamentous laxity was seen in 17 (55 %) of individuals. In this subset, 12 were graded as excellent, 4 as good and 1 as fair. The mean improvement in patellar height was 11 % at 3 months follow-up. All knees had a stable graft fixation with one re-dislocation following trauma. Conclusions: We propose a minimally invasive technique to reconstruct the MPFL using an artificial ligament allowing early mobilization without bracing. This study indicates the procedure is safe, with a low risk of re-dislocation in all grades of instability

Osseointegrated total knee replacement connected to a lower limb prosthesis: 4 cases

Background and purpose Osseointegrated implants are an alternative for prosthetic attachment in individuals with amputation who are unable to wear a socket. However, the load transmitted through the osseointegrated fixation to the residual tibia and knee joint can be unbearable for those with transtibial amputation and knee arthritis. We report on the feasibility of combining total knee replacement (TKR) with an osseointegrated implant for prosthetic attachment. Patients and methods We retrospectively reviewed all 4 cases (aged 38–77 years) of transtibial amputations managed with osseointegration and TKR in 2012–2014. The below-the-knee prosthesis was connected to the tibial base plate of a TKR, enabling the tibial residuum and knee joint to act as weight-sharing structures. A 2-stage procedure involved connecting a standard hinged TKR to custom-made implants and creation of a skin-implant interface. Clinical outcomes were assessed at baseline and after 1–3 years of follow-up using standard measures of health-related quality of life, ambulation, and activity level including the questionnaire for transfemoral amputees (Q-TFA) and the 6-minute walk test. Results There were no major complications, and there was 1 case of superficial infection. All patients showed improved clinical outcomes, with a Q-TFA improvement range of 29–52 and a 6-minute walk test improvement range of 37–84 meters. Interpretation It is possible to combine TKR with osseointegrated implants

Single-stage osseointegrated reconstruction and rehabilitation of lower limb amputees: the Osseointegration Group of Australia Accelerated Protocol-2 (OGAAP-2) for a prospective cohort study

Introduction: Lower limb amputations have detrimental influences on the quality of life, function and body image of the affected patients. Following amputation, prolonged rehabilitation is required for patients to be fitted with traditional socket prostheses, and many patients experience symptomatic socket–residuum interface problems which lead to reduced prosthetic use and quality of life. Osseointegration has recently emerged as a novel approach for the reconstruction of amputated limbs, which overcomes many of the socket-related problems by directly attaching the prosthesis to the skeletal residuum. To date, the vast majority of osseointegration procedures worldwide have been performed in 2 stages, which require at least 4 months and up to 18 months for the completion of reconstruction and rehabilitation from the time of the initial surgery. The current prospective cohort study evaluates the safety and efficacy of a single-stage osseointegration procedure performed under the Osseointegration Group of Australia Accelerated Protocol-2 (OGAAP-2), which dramatically reduces the time of recovery to ∼3–6 weeks. Methods and analysis: The inclusion criteria for osseointegrated reconstruction under the OGAAP-2 procedure are age over 18 years, unilateral transfemoral amputation and experiencing problems or difficulties in using socket prostheses. All patients receive osseointegrated implants which are press-fitted into the residual bone. Functional and quality-of-life outcome measures are recorded preoperatively and at defined postoperative follow-up intervals up to 2 years. Postoperative adverse events are also recorded. The preoperative and postoperative values are compared for each outcome measure, and the benefits and harms of the single-stage OGAAP-2 procedure will be compared with the results obtained using a previously employed 2-stage procedure. Ethics and dissemination: This study has received ethics approval from the University of Notre Dame, Sydney, Australia (014153S). The study outcomes will be disseminated by publications in peer-reviewed academic journals and presentations at relevant clinical and orthopaedic conferences

Hard-wired epimysial recordings from normal and reinnervated muscle using a bone-anchored device

Background: A combined approach for prosthetic attachment and control using a transcutaneous bone-anchored device and implanted muscle electrodes can improve function for upper-limb amputees. The bone-anchor provides a transcutaneous feed-through for muscle signal recording. This approach can be combined with targeted muscle reinnervation (TMR) to further improve myoelectric control. Methods: A bone-anchored device was implanted trans-tibially in n = 8 sheep with a bipolar recording electrode secured epimysially to the peroneus tertius muscle. TMR was carried out in a single animal: the peroneus tertius was deinnervated and the distal portion of the transected nerve to the peroneus muscle was coapted to a transected nerve branch previously supplying the tibialis anterior muscle. For 12 weeks (TMR) or 19 weeks (standard procedure), epimysial muscle signals were recorded while animals walked at 2 km·h−1. Results: After 19 weeks implantation following standard procedure, epimysial recording signal-to-noise ratio (SNR) was 18.7 dB (± 6.4 dB, 95% CI) with typical recordings falling in the range 10–25 dB. Recoveries in gait and muscle signals were coincident 6 weeks post-TMR; initial muscle activity was identifiable 3 weeks post-TMR though with low signal amplitude and signal-to-noise ratio compared with normal muscle recordings. Conclusions: Following recovery, muscle signals were recorded reliably over 19 weeks following implantation. In this study, targeted reinnervation was successful in parallel with bone-anchor implantation, with recovery identified 6 weeks after surger

Periprosthetic osseointegration fractures are infrequent and management is familiar

Aims Osseointegrated prosthetic limbs allow better mobility than socket-mounted prosthetics for lower limb amputees. Fractures, however, can occur in the residual limb, but they have rarely been reported. Approximately 2% to 3% of amputees with socket-mounted prostheses may fracture within five years. This is the first study which directly addresses the risks and management of periprosthetic osseointegration fractures in amputees. Methods A retrospective review identified 518 osseointegration procedures which were undertaken in 458 patients between 2010 and 2018 for whom complete medical records were available. Potential risk factors including time since amputation, age at osseointegration, bone density, weight, uni/bilateral implantation and sex were evaluated with multiple logistic regression. The mechanism of injury, technique and implant that was used for fixation of the fracture, pre-osseointegration and post fracture mobility (assessed using the K-level) and the time that the prosthesis was worn for in hours/day were also assessed. Results There were 22 periprosthetic fractures; they occurred exclusively in the femur: Two in the femoral neck, 14 intertrochanteric and six subtrochanteric, representing 4.2% of 518 osseointegration operations and 6.3% of 347 femoral implants. The vast majority (19/22, 86.4%) occurred within 2 cm of the proximal tip of the implant and after a fall. No fractures occurred spontaneously. Fixation most commonly involved dynamic hip screws (10) and reconstruction plates (9). No osseointegration implants required removal, the K-level was not reduced after fixation of the fracture in any patient, and all retained a K-level of = 2. All fractures united, 21 out of 22 patients (95.5%) wear their osseointegration-mounted prosthetic limb longer daily than when using a socket, with 18 out of 22 (81.8%) reporting using it for = 16 hours daily. Regression analysis identified a 3.89-fold increased risk of fracture for females (p = 0.007) and a 1.02-fold increased risk of fracture per kg above a mean of 80.4 kg (p = 0.046). No increased risk was identified for bilateral implants (p = 0.083), time from amputation to osseointegration (p = 0.974), age at osseointegration (p = 0.331), or bone density (g/cm2, p = 0.560; T-score, p = 0.247; Z-score, p = 0.312). Conclusion The risks and sequelae of periprosthetic fracture after press-fit osseointegration for amputation should not deter patients or clinicians from considering this procedure. Females and heavier patients are likely to have an increased risk of fracture. Age, years since amputation, and bone density do not appear influential

Near-infrared fluorescent probe traces bisphosphonate delivery and retention in vivo

Bisphosphonate use has expanded beyond traditional applications to include treatment of a variety of low-bone-mass conditions. Complications associated with long-term bisphosphonate treatment have been noted, generating a critical need for information describing the local bisphosphonate-cell interactions responsible for these observations. This study demonstrates that a fluorescent bisphosphonate analogue, far-red fluorescent pamidronate (FRFP), is an accurate biomarker of bisphosphonate deposition and retention in vivo and can be used to monitor site-specific local drug concentration. In vitro, FRFP is competitively inhibited from the surface of homogenized rat cortical bone by traditional bisphosphonates. In vivo, FRFP delivery to the skeleton is rapid, with fluorescence linearly correlated with bone surface area. Limb fluorescence increases linearly with injected dose of FRFP; injected FRFP does not interfere with binding of standard bisphosphonates at the doses used in this study. Long-term FRFP retention studies demonstrated that FRFP fluorescence decreases in conditions of normal bone turnover, whereas fluorescence was retained in conditions of reduced bone turnover, demonstrating preservation of local FRFP concentration. In the mandible, FRFP localized to the alveolar bone and bone surrounding the periodontal ligament and molar roots, consistent with findings of osteonecrosis of the jaw. These findings support a role for FRFP as an effective in vivo marker for bisphosphonate site-specific deposition, turnover, and long-term retention in the skeleton. © 2010 American Society for Bone and Mineral ResearchPeer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/77952/1/66_ftp.pd