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Review Article

Technical Overview of Osseointegrated Transfemoral Prostheses: Orthopedic Surgery and Implant Design Centered OPEN ACCESS

[+] Author and Article Information
Andrii Maryniak

Center for Medical Education,
Poznan University of Medical Sciences,
Poznan 61-701, Poland
e-mail: andre.maryniak@mail.utoronto.ca

Brock Laschowski

Institute of Biomaterials and
Biomedical Engineering,
University of Toronto,
Toronto, ON M5S 3G9, Canada
e-mail: brock.laschowski@mail.utoronto.ca

Jan Andrysek

Bloorview Research Institute,
Holland Bloorview Kids Rehabilitation Hospital,
Toronto, ON M4G 1R8, Canada
e-mail: jandrysek@hollandbloorview.ca

1Corresponding author.

Manuscript received November 12, 2017; final manuscript received January 16, 2018; published online February 27, 2018. Assoc. Editor: Peter McNair.

ASME J of Medical Diagnostics 1(2), 020801 (Feb 27, 2018) (7 pages) Paper No: JESMDT-17-2051; doi: 10.1115/1.4039105 History: Received November 12, 2017; Revised January 16, 2018

Bone-anchored prostheses represent a promising solution to numerous medical complications associated with conventional socket-suspended prostheses. The following technical overview was constructed for engineers and orthopedic surgeons interested in osseointegrated implants for transfemoral prosthesis-residuum interfacing. Existing osseointegrated implants comprise different biomaterial compositions (i.e., titanium alloy versus cobalt-chromium-molybdenum alloy) and mechanical designs (i.e., screw-fixated versus press-fixated devices). Perioperative systems of osseointegration surgery include preoperative assessments (i.e., alongside inclusion and exclusion criteria), intraoperative procedures, and postoperative rehabilitation (i.e., static loading and dynamic gait rehabilitation). The intraoperative procedures involve transecting and reorganizing the residual musculature, embedding the implant into the femoral intramedullary cavity, and coupling the osseointegrated implant to an external prosthesis. Postoperative clinical evaluations have demonstrated significant biomechanical, psychological, and physiological improvements in patients using bone-anchored prostheses compared to conventional socket-suspended prostheses. Nevertheless, bacterial infections surrounding the skin-implant bio-interface, often resulting from Staphylococcus aureus or other coagulase-negative staphylococci, remain a relatively frequent medical complication, which can culminate in periprosthetic osteomyelitis and/or implant extraction. The technical overview concludes with discussing the recent Food and Drug Administration humanitarian use device designations, financial analyses between bone-anchored prostheses and socket-suspended prostheses, and applications of vibrotactile osseoperception for augmenting walking and balance feedback control.

FIGURES IN THIS ARTICLE
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According to recent investigations, limb amputations have affected 1 in 190 persons in the U.S., amounting to approximately 1.7 million cases [13]. The prevalence of lower limb amputations is projected to significantly increase owing to the emergent aging population and high rates of peripheral vascular diseases [4]. Though vascular diseases have accounted for the majority of amputations among geriatrics, amputations in younger persons have primarily been attributed to trauma and tumor resection [4,5]. Other sources of lower limb amputations have included infections and arterial embolisms [6].

Lower limb prostheses have traditionally interfaced with the residual limb through prosthetic sockets. Nonetheless, numerous socket-related complications have been documented, including soft tissue breakdown, residual limb pain, unreliable socket suspension, difficulty donning/doffing the prosthesis, biomechanical gait deviations, and overall decrease in quality of life [24,714]. Residual limb pain has mainly been attributed to the excessive mechanical loading of the distal soft tissue from the prosthetic socket [15]. Fluctuations in residuum volume and mass have been associated with inadequate socket suspension and discomfort [11,16]. Soft tissue complications resulting from conventional socket-suspended prostheses have included pressure ulcers, dermatitis, itching, acne vulgaris, lacerations, and fistula formations [17]. Though numerous attempts have been made to redesign prosthetic sockets to minimize the incidences of the aforementioned complications (e.g., using computer-aided design and manufacturing), only modest improvements have been reported [8,16].

Bone-anchored prostheses represent a promising solution to numerous socket-related complications. The notion of bone-anchored prostheses originated from Dr. Per-Ingvar Branemark in the 1950s, who discovered that titanium implants could develop strong molecular fusions with periprosthetic bone tissue in rabbits, therein becoming permanently bonded [9,14,18]. Branemark introduced the term “osseointegration” to describe this phenomenon. He defined osseointegration as “continuing structural and functional coexistence, possibly in a symbiotic manner, between differentiated, adequately remodeled, biologic tissues and strictly defined and controlled synthetic components, providing lasting, specific clinical functions without initiating rejection mechanisms” [18]. Revisions to this definition have since included: “when there is no progressive relative movement between the implant and the bone with which it has direct contact” [19].

Osseointegrated implants were originally implemented in dental medicine, followed by bone-anchored hearing devices, craniofacial prostheses, maxillofacial reconstruction, and finger and thumb prostheses [9,11,19]. In 1997, Dr. Rickard Branemark extended upon his father's groundbreaking research and constructed the first osseointegrated transfemoral prosthesis, which included a 12 cm screw-fixated intramedullary titanium implant, with an abutment and external prosthesis arranged in series [20]. Thereafter, one of the first clinical investigations involving bone-anchored transfemoral prostheses, termed the Osseointegrated Prostheses for the Rehabilitation of Amputees, commenced at the Sahlgrenska University Hospital (Sweden) in the late 1990s [9,14,21,22].

Compared to conventional socket-suspended prostheses, osseointegrated prostheses have been correlated with increased hip joint range of motion, improved somatosensory feedback, greater resilience to fluctuations in residuum volume and mass, decreased metabolic energy expenditure while ambulating, improved sitting comfort, and fewer outpatient appointments [2,810,13,14,16,18,21,2325]. The previous reviews of bone-anchored transfemoral prostheses have focused on discussing postoperative clinical evaluations, specifically biomechanical, psychological, and physiological outcome measures [2,17]. Building upon these investigations, the objective of the following technical overview was to provide engineers and orthopedic surgeons updated information regarding osseointegrated implant designs and surgical implementation methods for transfemoral prosthesis-residuum interfacing. Such information might additionally be pertinent to clinicians (e.g., physiotherapists, physiatrists, and prosthetists). Literature searches were conducted in prominent scientific and engineering databases, specifically IEEE Xplore, MEDLINE, PubMed, Scopus, and Web of Science. The technical overview focused on publications written in English, involving transfemoral amputee patients, and published in peer-reviewed journals and conferences. Though osseointegrated implants have diverse lower limb prosthetic device applications (e.g., transtibial and transmetatarsal prostheses [25,26], and joint arthroplasties), the current research focused specifically on transfemoral prostheses considering that such orthopedic applications are purportedly the most prevalent worldwide. Note that the term “bone-anchored” prostheses is synonymous with “osseointegrated” prostheses, both of which have been used in the previous literature.

There are three main osseointegration systems for transfemoral amputees, specifically the osseointegrated prosthesis for the rehabilitation of amputees (OPRA), the endo-exo femoral prosthesis (EEFP), and the intraosseous transcutaneous amputation prosthesis (ITAP) [5,17,27]. The current research focused on the OPRA and EEFP systems since limited information has been published regarding the ITAP system (UK). Each osseointegration system includes an intramedullary implant (Fig. 1), an abutment perforating the distal residuum (i.e., which functions as a coupling device), and an external transfemoral prosthesis [27]. Such prostheses could include advanced robotic devices. The OPRA and EEFP implants differ in both mechanical design and material composition. The OPRA implant utilizes screw-fixated design and titanium alloy, while the EEFP implants utilize press-fixated designs and either titanium alloy or cobalt-chromium-molybdenum alloy.

Generally speaking, most bone-anchored medical devices comprise titanium alloy. Titanium is a biocompatible, noncorrosive metal capable of withstanding high mechanical loads at the bone-implant bio-interface. The previous investigations have demonstrated the superiority of titanium over other metals, like stainless steel, with regard to osseointegration [28]. Implants with titanium composition have exhibited better anti-infectious properties compared to other biomaterials when embedded into bone and soft tissues [6]. Titanium implants molecularly interface with the periprosthetic bone tissue through hydrated peroxy matrices [18]. This phenomenon is distinctive of titanium as the peroxy matrices of other transition metals contain insufficient solubility and/or stability [18].

Osseointegrated Prosthesis for the Rehabilitation of Amputees Implant Designs.

The OPRA implant (Sweden) includes a threaded cylindrical stem comprising Ti-6Al-4V alpha-beta titanium alloy, with an abutment and external prosthesis organized in series [6,9,14,24,2931]. The 80 mm implant is embedded into the femoral intramedullary cavity using screw-fixation, while the transcutaneous abutment, which perforates the distal residuum, is threaded into the opposite end of the implant [6,9,24,3033] (Fig. 2). The threads provide added surface area, which increases the mechanical stability at the bone-implant bio-interface. Finite element analysis has been used to mathematically evaluate the bio-interface mechanical load patterns [24,30,34,35]. To minimize potential damage to the OPRA implant from overloading, a fail-safe mechanism divides the abutment and external prosthesis [11,27]. The fail-safe mechanism enables various components to rotate about one another, therein attenuating excessive mechanical loading [11,27]. The abutment's capacity to marginally bend under mechanical loading provides another protective means to prevent periprosthetic bone tissue damage [11,36].

Compared to press-fixation, screw-fixated designs are more mechanically effective, requiring a smaller bone-implant contact area for the same amount of resistance to separation [1,29]. This feature is particularly advantageous for patients with relatively short residual limbs [1,29]. Disadvantages of threaded implants include limited mechanical stability against torsional forces (i.e., which can be significant during certain ambulatory movements) and periprosthetic bone tissue resorption by osteoclasts resulting from stress concentrations around the implant threads [31,3739].

Endo-Exo Femoral Prosthesis Implant Designs.

The EEFP system (Germany) embodies both the integral leg prosthesis (ILP) and the more recent osseointegrated prosthetic limb (OPL) implant systems. These systems comprise an internal (endo) module and an external (exo) module. The endo module is hammered directly into the femoral intramedullary cavity [2,3,31]. Compared to the OPRA implant, the EEFP implants utilize press-fixation [24,29,31]. The OPL implant comprises titanium alloy, while the ILP implant consists of cobalt-chromium-molybdenum alloy, coated with titanium-niobium oxide [2,3,24,29,33,37,40]. These highly porous surfaces synthetically model cancellous bone tissue, forming a three-dimensional grid structure that promotes osseointegration [29,37,40]. The ILP implant can range between 140 and 180 mm in length.

Both EEFP systems contain a transcutaneous “dual adaptor,” with Morse-tapered ends, which connect the osseointegrated implant to an external transfemoral prosthesis [29,37,40]. The dual adaptor passes through a circular percutaneous incision in the distal residuum, known as the stoma [29,37,40]. The dual adaptor has a polished smooth surface (i.e., to minimize soft tissue friction) and is coated with titanium-niobium oxide, which possesses antibacterial properties [3,37,40]. To prevent periprosthetic and/or implant damage, the dual adaptor incorporates a fail-safe mechanism consisting of a pin that fails under significant torsional mechanical loads [15,37,41]. Patients with femur lengths less than 160 mm are eligible for customized implants that are stabilized via orthopedic locking screws [33,37].

The EEFP implants achieve structural fixation through osseous penetration and ingrowth [37,39]. The implants contain highly porous surfaces, which decrease the stem stiffness and are beneficial for bone maintenance from a biomechanical perspective [24,29,31,38,42]. Implants with low-stiffness porous surfaces improve upon the safety at the bone-implant bio-interface through minimizing shear stresses [24,38]. Compared to patients with screw-fixated implants, those with press-fixated implants have exhibited lower rates of superficial bacterial infections [39] and increased periprosthetic cortical thickness at 2 years postsurgery [42]. These differences in the periprosthetic bone tissue remodeling have been attributed to the differences in implant surface porosity [42]. Increased periprosthetic cortical thickness can likewise minimize the incidences of bone fractures [42].

Preoperative Assessments.

Preoperative assessments for osseointegration surgery include collecting patient history, performing physical examinations, discussing psychosocial motivations behind the intervention, and reviewing medical images [11,33]. The dimensions and quality of the residual femur are measured radiographically (e.g., using computed tomography or dual energy X-ray absorptiometry) [9,21,33]. Preoperative gait analyses are performed to obtain baseline standards for postoperative comparison [11]. Patients might complete the questionnaire for persons with a transfemoral amputation for added baseline standards [13]. Discussions with the patients regarding their expectations and understanding of intraoperative and postoperative medical complications are essential [11]. Prescribed limitations to ambulation and physical activity are likewise addressed to prevent osseointegration implant failure [9,11].

Inclusion and Exclusion Criteria.

Patients with relatively short residual limbs are excluded from certain osseointegrated implants considering that small bone-implant bio-interfaces offer decreased mechanical stability [39,43,44]. Minimally required femur dimensions have not been established. Those with concomitant osteoporosis are excluded owing to inadequate bone tissue quality [39]. Patients with amputations from peripheral vascular diseases, and those who have not previously failed with socket-suspended prostheses, are not eligible for certain transfemoral osseointegrated implants [2,3,11,13,33]. Nonetheless, recent research from Australia has successfully executed osseointegration in transtibial amputee patients with peripheral vascular diseases [26]. Failure with socket-suspended prostheses involves “recurrent skin infections and ulceration in the socket contact area, soft tissue scarring, and/or socket retention problems due to excessive perspiration” [11]. Additional exclusion criteria include patients who have undergone chemotherapy or other immunosuppressive agents, chronic tobacco users, and overweight patients [15].

For the OPRA system specifically, patients must meet the following criteria: previous failure with socket-suspended prostheses; below 70 years of age; adequate skeletal maturation; bodyweight less than 100 kg; and preoperative clearance for surgery. A relatively short residuum might preclude patients from operation [9,11,22,27]. The OPRA system includes many preoperative and postoperative assessments (i.e., until 2 years postsurgery), including radiography, registration of medical complications, hip joint range of motion, metabolic energy expenditure while ambulating, and health related quality of life measurements [9,22]. Unfortunately, comparable details regarding the inclusion and exclusion criteria of the EEFP systems have not been documented in scientific literature.

Intraoperative Procedures.

The OPRA and EEFP systems generally follow similar intraoperative procedures, consisting of two surgeries separated by recovery periods of varying durations. Nonetheless, comparable to the ITAP system [31], the latest “Osseointegration Group of Australia Accelerated Protocol-2” (OGAAP-2) involving the OPL system comprises only one surgery, wherein both orthopedic surgeries are performed uninterruptedly [45,46]. Infection prevention is important considering the invasiveness of osseointegration surgery and the possibility of periprosthetic osteomyelitis. Bacterial infections could produce severe medical complications culminating in implant extraction [21]. Perioperative intravenous antibiotic prophylaxis is standard [47]. In Australia, there is a preference for prophylactic intravenous vancomycin and cephazolin at induction of anesthesia, which are continued for 48 h postsurgery [37,40]. In the Netherlands, cephazolin is administered at induction and continued intravenously for 98 h postsurgery [13,37]. Wound dressings are changed daily throughout the first 2 weeks following each surgery [40].

The main objectives of the first surgery include transecting and reorganizing the thigh musculature; and embedding the implant into the femoral intramedullary cavity [5,6,11,14,19,21,29,44] (Fig. 3). Transecting the neighboring skeletal muscles (e.g., rectus femoris, biceps femoris, and adductor magnus) exposes the distal 5–10 cm of the femoral shaft [5]. After the transected muscles have been sutured elsewhere, the residuum is debulked of subcutaneous and adipose tissues [5,21,44]; reaming of the femoral intramedullary cavity follows [33,37,48]. Sample implants are used to determine the appropriate length and diameter of the implant [48]. Fluoroscopy is used to guide the implant positioning. The implant is either screw-fixated or press-fixated. Mechanical stability of the implant is attained using a slight insertion curvature or orthopedic locking screws. The soft tissue is subsequently restructured, and the fascial and dermal layers are closed [7,33,37].

Between the first and second surgery, patients typically ambulate with assistive devices like crutches to avoid complete implant weight-bearing [37,40]. Depending on the elected system, the length of recovery between surgeries varies. The OPRA system requires approximately 6 months of recovery for adequate osseointegration, while the EEFP systems require only 6–8 weeks [9,11,14,22,33,37,43,49]. Orthopedic surgeons have attributed the high surface porosity of the EEFP implants to the quicker and more mechanically stable fixation of the osseointegrated implant [33]. The main objectives of the second surgery include fashioning the stoma and attaching an external transfemoral prosthesis (e.g., robotic device) [5,13,21,29,33,37,40,44,49]. A surgical scalpel is used to the create the stoma. The osseointegrated implant is connected to a transcutaneous coupling device which passes through the stoma and attaches to the external prosthesis [78,11,33,37]. Unlike the EEFP systems, the OPRA system bonds the femoral shaft and dermal layers using surgical grafting [1,6,17]. Debulking the subcutaneous and adipose tissues neighboring the graft promotes bone-skin adherence [1,7].

Postoperative Rehabilitation.

Irrespective of the selected osseointegration system, the primary objective of postoperative rehabilitation is to achieve complete implant weight-bearing [8]. Throughout rehabilitation, the osseointegrated implant undergoes incremental static loading. This strategy is founded on the principle that timely application of mechanical loads promotes periprosthetic bone tissue remodeling and prepares the implant to withstand the physical demands of everyday living [30,50]. Static loading can likewise function to strengthen the atrophied musculature of the residual limb [30,50]. Alternatively, overloading the implant too early could increase the possibility of osseointegration failure [50]. There presumably exists an optimal relationship between timing and mechanical loading, though such an optimization remains undetermined [30,51]. Dynamic gait rehabilitation with assistive devices is subsequently introduced, which progresses to complete implant weight-bearing overtime. Independent ambulation should be achieved without residual limb pain. The length of postoperative rehabilitation depends on the elected osseointegration system.

Osseointegrated Prosthesis for the Rehabilitation of Amputees Postoperative Rehabilitation.

The OPRA system requires 18 months of postoperative rehabilitation after which patients should be capable of independent ambulation and complete implant weight-bearing [9,14,33,52]. To prevent hip joint contractures, patients begin range of motion training within 2 weeks postsurgery [9]. Patients abstain from complete implant weight-bearing during the first 4–6 weeks postsurgery [9], followed by 4–6 weeks of partial implant weight-bearing using training prostheses [11,30]. These prostheses permit static load training, which is performed twice daily [9,11,14,21,30,50]. Training begins with approximately 20 kg static loads, with 10 kg incremental increases each week thereafter until total bodyweight is accomplished [9,14,21,30,50]. Patients are subsequently outfitted with standard transfemoral prostheses and undergo dynamic gait rehabilitation using assistive devices for approximately 3 months [9,21]. Postoperative rehabilitation culminates when patients achieve independent ambulation without residual limb pain. Analyses of 100 patients undergoing the OPRA rehabilitation program recorded an average of 46 outpatient appointments during the first year and eight appointments during the second year [9,11].

Endo-Exo Femoral Prosthesis Postoperative Rehabilitation.

Although the OPRA rehabilitation program has been well documented, less has been published regarding the EEFP system. The main difference between the two systems involves the duration of postoperative rehabilitation [2]. Compared to the OPRA system, the EEFP systems facilitate earlier static loading, which can be increased more rapidly, thereby producing an overall shorter rehabilitation program [24,40]. Patients begin static loading with training prostheses after only 2 weeks postsurgery [13,40]. Static loads equivalent to 50% and 100% total bodyweight are applied during the third and fourth week, respectively [13,40]. Patients are outfitted with standard transfemoral prostheses after 1 month postsurgery. Dynamic gait rehabilitation with assistive devices is subsequently introduced, which progresses to complete implant weight-bearing. The EEFP rehabilitation programs last approximately 6–8 weeks [13,40].

Advantages.

Compared to conventional socket-suspended prostheses, patients using bone-anchored prostheses have demonstrated significant biomechanical and physiological improvements, including increased gait velocities [44], longer percentages of stance-phase weight-bearing [44], further walking distances during 2 min and 6 min walking tests (e.g., between 37 m and 84 m and 27% farther) [3,11,13,21,43,47,48], approximately 44% faster “timed up and go” performance times [13,21,47], and more similar walking biomechanics to able-bodied individuals at 1 year postsurgery [2]. Patients have also demonstrated greater hip joint abductor strength [3] and increased hip joint range of motion [2,8,12], while reporting improved sitting comfort [2,8] and reduced back pain at 2 years postsurgery [12]. Physiological advantages have included approximately 18% less oxygen consumption while ambulating (i.e., 1093 mL/min versus 1330 mL/min) [13] and overall reductions in metabolic energy expenditure at self-selected gait velocities [2,23,44].

Regarding psychological factors, patients using bone-anchored prostheses have reported improved scores on the questionnaire for persons with a transfemoral amputation at 2 years postsurgery (e.g., between 29 and 52 points and 68% higher) [3,13,14,22,43,47], better health related quality of life scores [2,3,13,14,23,53], and overall improved body image [53]. Patients have demonstrated increased weekly prosthetic usage (e.g., 56 h/week versus 101 h/week) [2,13,23], reported approximately 95% satisfaction rates [21], and identified more with “healthy persons” and less with being “disabled” [11,53]. Several patients have acknowledged feeling “like the person they were prior to amputation” [23]. To learn more about these biomechanical, psychological, and physiological outcome measures, the authors recommend reading the previously published reviews, which primarily focused on discussing postoperative clinical evaluations [2,17].

Limitations.

There are several notable limitations specific to bone-anchored prostheses. The previous investigations have noted superficial infections (i.e., 28–55%), deep infections (i.e., 2–41%), implant loosening (i.e., 2–6%), periprosthetic fractures (i.e., 0–9%), revision surgeries (i.e., 8–67%), and implant extraction (i.e., 3–20%) [17]. Nevertheless, the occurrence of bacterial infections surrounding the skin-implant bio-interface remains the most concern [14,21,27,28,30,54]. Staphylococcus aureus and other coagulase-negative staphylococci are the most prevalent bacterial species isolated, accounting for approximately 91% of implant-related infections [37,54]. The previous research reported that approximately 50% of osseointegration patients were colonized with virulent strains of Staphylococcus aureus [6]. In cases of periprosthetic osteomyelitis, Staphylococcus aureus was twice as prevalent as coagulase-negative staphylococci strains [54]. Early bacterial infections (i.e., occurring < 3 months) are generally indicative of intraoperative contamination, while late infections (i.e., occurring > 24 months) are associated with hematogenous seeding of bacteria [6]. Infections in osseointegration patients have been typically diagnosed using radiographic imaging, nuclear imaging, ultrasound, or computed tomography [37]. Treatment can include oral antibiotics, parenteral antibiotics, and/or surgical debridement [37,47].

Superficial infections have been more prevalent than deep infections among osseointegration patients [6,7,13,37,45]. Most of these infections were classified as low grade (e.g., cellulitis with signs of inflammation), which usually resolved spontaneously or with oral antibiotics [6,37]. Different rates of superficial infections have been documented up to 55% at 2 years postsurgery [7]. Though advancements in implant design and perioperative management have significantly reduced the prevalence of deep infections [6,7,37,45,54], complications like periprosthetic osteomyelitis, septic implant loosening, and/or implant extraction remain pertinent [54,55]. According to a recent investigation involving 96 patients with bone-anchored prostheses, 17% presented with periprosthetic osteomyelitis [54]. The authors indicated that the cumulative probability of implant-associated osteomyelitis increased over time [54]. Earlier applications of osseointegrated prostheses reported approximately 18% infection-related implant extractions within 1 year postsurgery [11]. Recent investigations have documented < 10% implant extractions through 10 years postsurgery [2,37,54,55]. Other notable reasons for revision surgery and/or implant extraction have included periprosthetic fractures and malfunctioning of intramedullary components [2,37,38,45].

Financial Analyses.

Limited research has compared the financial expenses between bone-anchored prostheses and socket-suspended prostheses [16,56,57]. Assessing the prospective economic advantages of osseointegration is challenging considering the expenses for intraoperative procedures, postoperative rehabilitation, and prosthetic maintenances are interconnected and potentially covered through multiple entities (e.g., publicly funded healthcare, workers' compensation, health insurance, and/or the patients themselves) [56]. To the best of the author's knowledge, the previous investigations have not attested to the specific expenses associated with the osseointegration surgery. The previous research has demonstrated that, irrespective of the accompanying external prosthesis (i.e., low-, medium-, and high-budget), osseointegrated devices were more financially economical over 6 years than prosthetic sockets for patients with K4 functional classifications [56]. For patients with classifications below K4, only the low-budget external prostheses were financially beneficial with osseointegrated devices relative to prosthetic sockets [56]. Furthermore, the manpower and prosthetic attachment expenses were significantly lower (i.e., 17% and 89%, respectively) for osseointegrated devices independent of the elected external prosthesis [56]. Other investigations have determined that the total average annual expenses of bone-anchored prostheses were comparable to conventional socket-suspended prostheses, wherein the higher material and manufacturing overhead of osseointegrated devices were counterbalanced by fewer outpatient appointments (i.e., 3.1 versus 7.2 appointments/year) and lower expenditures for new prosthetic hardware and maintenance services (i.e., €3149 versus €3672) [16].

Recent findings have demonstrated that, while the average total provision expenses of bone-anchored prostheses exceeded those of socket-suspended prostheses (i.e., 21±41% greater), bone anchored prostheses were 19% more cost-saving and 88% more cost-effective compared to socket-suspended alternatives [57]. These analyses were supported through increased quality-adjusted life years (i.e., 17±5% greater) and improved incremental cost-effectiveness ratios (i.e., $17,000 AUD per quality-adjusted life year) following fitting with bone-anchored prostheses [57]. Accordingly, the aforementioned analyses could assist international funding organizations construct financial assistance programs for patients selecting bone-anchored prostheses over conventional socket-suspended prostheses [56].

Osseoperception.

An interesting topic for future consideration is the concept of osseoperception. Osseoperception is the “sensation arising from mechanical stimulation of the bone-anchored prosthesis, transduced by various mechanoreceptors, together with changes in central neural processing” [14,17,18,25,58]. The physical interface between osseointegrated implants and femoral bone provides new opportunities for somatosensory information exchange between the external prosthesis and the human neuromusculoskeletal system [2,3]. Proprioception can be improved through activation of mechanoreceptors otherwise unrecruited using conventional prosthetic sockets, thereby increasing sensory feedback [5]. Previous investigations have demonstrated the superiority of bone-anchored prostheses, over socket-suspended prostheses, for detecting external mechanical stimuli [9,11,18,36]. For instance, vibratory stimuli underneath the prosthetic foot were better perceived in osseointegration patients compared to control groups and preoperative baseline measurements [58]. Such augmented tactile perception was best exemplified at higher vibration frequencies, specifically 250 Hz [58]. Improved foot-ground contact vibrotactile sensing could theoretically enhance walking and balance feedback control, subsequently minimizing the incidences of accidental injuries [5,9].

The primary objective of the present technical overview was to provide engineers and orthopedic surgeons, who are interested in bone-anchored medical devices, noteworthy information regarding osseointegrated implant designs and surgical implementation methods for transfemoral prosthesis-residuum interfacing. Though extensively utilized in dental medicine, maxillofacial reconstruction, hearing devices, and craniofacial prostheses [9,11,19], osseointegration is progressively becoming the standard of care for transfemoral amputee patients [45]. Compared to conventional socket-suspended prostheses, patients using bone-anchored prostheses have demonstrated significant biomechanical, psychological, and physiological improvements [2,3,813,2125,37,4348]. Furthermore, bone-anchored prostheses have exhibited economical benefits for both transfemoral amputee patients and publically funded healthcare providers [16,56,57]. Opportunities for innovation like integrating osseointegration systems with robotics, combining supplementary reconstructive orthopedic interventions [39,43], and optimizing intraoperative procedures to minimize rehabilitation time [46], support osseointegration surgery becoming the standard of care for patients with lower limb amputations [45]. Nevertheless, bacterial infections surrounding the skin-implant bio-interface remain a relatively frequent medical complication, which can culminate in periprosthetic osteomyelitis and/or implant extraction [54,55].

The incorporation of osseointegrated implants into transfemoral prostheses is relatively modern (i.e., average publication year = 2012±5). The leading orthopedic surgeons performing osseointegration on patients with transfemoral amputations include Dr. Rickard Branemark (Sweden) [610,14,15,18,19, 22,23,25,30,32,36,50,51,54,55,5862], Dr. Horst Heinrich Aschoff (Germany) [21,49], Dr. Jan Paul Frolke (The Netherlands) [2,4,13,33,37,42], and Dr. Munjed Al Muderis (Australia) [26,37,39,40,43,46,47]. Other notable scientists investigating bone-anchored prostheses include Dr. Laurent Frossard (Australia) [10,15,25,30,36,38,43,50,51,56,57,5962] and Dr. Kerstin Hagberg (Sweden) [610,15,16,22,23,25,36,50,51,53,54,58,60, 62]. The Centre of Orthopaedic Osseointegration at the Sahlgrenska University Hospital (Sweden), managed by Dr. Rickard Branemark (Fig. 4), has allegedly performed the most osseointegration surgeries, encompassing approximately 150 patients [9,16]. Through personal correspondences with Dr. Horst Heinrich Aschoff, Dr. Laurent Frossard, Dr. Kerstin Hagberg, and Dr. Munjed Al Muderis, the authors estimate that approximately 600 patients worldwide have been treated with osseointegrated transfemoral prostheses. In July 2015, the U.S. Food and Drug Administration granted the OPRA implant system a “Humanitarian Use Device” designation through their Humanitarian Device Exemption policy [40,57]. This designation permits osseointegration clinical trials with transfemoral amputees, though includes rather stringent inclusion and exclusion criteria for patient selection [40]. The first documented osseointegration surgery in the U.S. was performed at the University of California San Francisco in April 2016.

Bone-anchored prostheses represent a promising solution to numerous medical complications associated with conventional socket-suspended prostheses. Upon the time of publication, postoperative clinical evaluations have demonstrated significant biomechanical, psychological, and physiological improvements; financial analyses have exhibited economic benefits for osseointegration patients and healthcare providers; and applications of vibrotactile osseoperception have presented innovative opportunities for augmenting walking and balance feedback control. These developments support the emerging implementation of bone-anchored prostheses over conventional socket-suspended prostheses among transfemoral amputee patients, therein partially motivating the recent Food and Drug Administration humanitarian use device designations for orthopedic reconstructive interventions. Further advancements in implant biomaterials and mechanical designs, intraoperative procedures, and postoperative rehabilitation are warranted to maximize the advantages and minimize the potential limitations associated with utilizing osseointegrated implants for transfemoral prosthesis-residuum interfacing.

The authors thank Dr. Horst Heinrich Aschoff (Germany), Dr. Laurent Frossard (Australia), Dr. Kerstin Hagberg (Sweden), Dr. Munjed Al Muderis (Australia), Dr. Lluis Guirao Cano (Spain), and Jonas Bergman (Sweden) for their assistance. This research was funded through the Natural Sciences and Engineering Research Council of Canada (NSERC) and the Holland Bloorview Kids Rehabilitation Hospital.

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Leijendekkers, R. A. , Van Hinte, G. , Frolke, J. P. , Van De Meent, H. , Nijhuis-Van Der Sanden, M. W. G. , and Staal, J. B. , 2017, “ Comparison of Bone-Anchored Prostheses and Socket Prostheses for Patients With a Lower Extremity Amputation: A Systematic Review,” Disability Rehabil., 39(11), pp. 1045–1058. [CrossRef]
Leijendekkers, R. A. , Van Hinte, G. , Nijhuis-Van Der Sanden, M. W. G. , and Staal, J. B. , 2017, “ Gait Rehabilitation for a Patient With an Osseointegrated Prosthesis Following Transfemoral Amputation,” Physiother. Theory Pract., 33(2), pp. 147–161. [CrossRef] [PubMed]
Leijendekkers, R. A. , Staal, J. B. , Van Hinte, G. , Frolke, J. P. , Van De Meent, H. , Atsma, F. , Nijhuis-Van Der Sanden, M. W. G. , and Hoogeboom, T. J. , 2016, “ Long-Term Outcomes Following Lower Extremity Press-Fit Bone-Anchored Prosthesis Surgery: A 5-Year Longitudinal Study Protocol,” BMC Musculoskeletal Disord., 17(1), p. 484.
Pantall, A. , Durham, S. , and Ewins, D. , 2011, “ Surface Electromyographic Activity of Five Residual Limb Muscles Recorded During Isometric Contraction in Transfemoral Amputees With Osseointegrated Prostheses,” Clin. Biomech., 26(7), pp. 760–765. [CrossRef]
Tillander, J. , Hagberg, K. , Hagberg, L. , and Branemark, R. , 2010, “ Osseointegrated Titanium Implants for Limb Prostheses Attachments: Infectious Complications,” Clin. Orthop. Relat. Res., 468(10), pp. 2781–2788. [CrossRef] [PubMed]
Branemark, R. , Berlin, O. , Hagberg, K. , Bergh, P. , Gunterberg, B. , and Rydevik, B. , 2014, “ A Novel Osseointegrated Percutaneous Prosthetic System for the Treatment of Patients With Transfemoral Amputation: A Prospective Study of 51 Patients,” Bone Jt. J., 96-B(1), pp. 106–113. [CrossRef]
Hagberg, K. , Haggstrom, E. , Uden, M. , and Branemark, R. , 2005, “ Socket Versus Bone-Anchored Trans-Femoral Prostheses: Hip Range of Motion and Sitting Comfort,” Prosthetics Orthotics Int., 29(2), pp. 153–163. [CrossRef]
Hagberg, K. , and Branemark, R. , 2009, “ One Hundred Patients Treated With Osseointegrated Transfemoral Amputation Prostheses—Rehabilitation Perspective,” J. Rehabil. Res. Develop., 46, pp. 331–344. [CrossRef]
Lee, W. C. C. , Frossard, L. A. , Hagberg, K. , Haggstrom, E. , Gow, D. L. , Gray, S. , and Branemark, R. , 2008, “ Magnitude and Variability of Loading on the Osseointegrated Implant of Transfemoral Amputees During Walking,” Med. Eng. Phys., 30(7), pp. 825–833. [CrossRef] [PubMed]
Sullivan, J. , Uden, M. , Robinson, K. P. , and Sooriakumaran, S. , 2003, “ Rehabilitation of the Trans-Femoral Amputee With an Osseointegrated Prosthesis: The United Kingdom Experience,” Prosthetics Orthotics Int., 27(2), pp. 114–120. [CrossRef]
Tranberg, R. , Zugner, R. , and Karrholm, J. , 2011, “ Improvements in Hip- and Pelvic Motion for Patients With Osseointegrated Trans-Femoral Prostheses,” Gait Posture, 33(2), pp. 165–168. [CrossRef] [PubMed]
Van De Meent, H. , Hopman, M. T. , and Frolke, J. P. , 2013, “ Walking Ability and Quality of Life in Subjects With Transfemoral Amputation: A Comparison of Osseointegration With Socket Prostheses,” Arch. Phys. Med. Rehabil., 94(11), pp. 2174–2178. [CrossRef] [PubMed]
Li, Y. , and Branemark, R. , 2017, “ Osseointegrated Prostheses for Rehabilitation Following Amputation: The Pioneering Swedish Model,” Unfallchirurg, 120(4), pp. 285–292. [CrossRef] [PubMed]
Lee, W. C. C. , Frossard, L. A. , Hagberg, K. , Haggstrom, E. , Branemark, R. , Evans, J. H. , and Pearcy, M. J. , 2007, “ Kinetics of Transfemoral Amputees With Osseointegrated Fixation Performing Common Activities of Daily Living,” Clin. Biomech., 22(6), pp. 665–673. [CrossRef]
Haggstrom, E. , Hansson, E. , and Hagberg, K. , 2012, “ Comparison of Prosthetic Costs and Service Between Osseointegrated and Conventional Suspended Transfemoral Prostheses,” Prosthetics Orthotics Int., 37(2), pp. 152–160. [CrossRef]
Van Eck, C. F. , and McGough, R. L. , 2015, “ Clinical Outcome of Osseointegrated Prostheses for Lower Extremity Amputations: A Systematic Review of the Literature,” Curr. Orthop. Pract., 26(4), pp. 349–357. [CrossRef]
Branemark, R. , Branemark, P. I. , Rydevik, B. , and Myers, R. R. , 2001, “ Osseointegration in Skeletal Reconstruction and Rehabilitation: A Review,” J. Rehabil. Res. Develop., 38(2), pp. 175–181.
Nebergall, A. , Bragdon, C. , Antonellis, A. , Karrholm, J. , Branemark, R. , Berlin, O. , and Malchau, H. , 2012, “ Stable Fixation of an Osseointegrated Implant System for Above-the-Knee Amputees: Titel RSA and Radiographic Evaluation of Migration and Bone Remodeling in 55 Cases,” Acta Orthop., 83(2), pp. 121–128. [CrossRef] [PubMed]
Eriksson, E. , and Branemark, P. I. , 1994, “ Osseointegration From the Perspective of the Plastic Surgeon,” Plast. Reconstr. Surg., 93(3), pp. 626–637. [CrossRef] [PubMed]
Aschoff, H. H. , Kennon, R. E. , Keggi, J. M. , and Rubin, L. E. , 2010, “ Transcutaneous, Distal Femoral, Intramedullary Attachment for Above-the-Knee Prostheses: An Endo-Exo Device,” J. Bone Jt. Surg., 92(Suppl. 2), pp. 180–186. [CrossRef]
Hagberg, K. , Branemark, R. , Gunterberg, B. , and Rydevik, B. , 2008, “ Osseointegrated Trans-Femoral Amputation Prostheses: Prospective Results of General and Condition-Specific Quality of Life in 18 Patients at 2-Year Follow-Up,” Prosthetics Orthotics Int., 32(1), pp. 29–41. [CrossRef]
Hagberg, K. , Hansson, E. , and Branemark, R. , 2014, “ Outcome of Percutaneous Osseointegrated Prostheses for Patients With Unilateral Transfemoral Amputation at Two-Year Follow-Up,” Arch. Phys. Med. Rehabil., 95(11), pp. 2120–2127. [CrossRef] [PubMed]
Tomaszewski, P. K. , Verdonschot, N. , Bulstra, S. K. , and Verkerke, G. J. , 2010, “ A Comparative Finite-Element Analysis of Bone Failure and Load Transfer of Osseointegrated Prostheses Fixations,” Ann. Biomed. Eng., 38(7), pp. 2418–2427. [CrossRef] [PubMed]
Frossard, L. , Hagberg, K. , Haggstrom, E. , Gow, D. L. , Branemark, R. , and Pearcy, M. , 2010, “ Functional Outcome of Transfemoral Amputees Fitted With an Osseointegrated Fixation: Temporal Gait Characteristics,” J. Prosthetics Orthotics, 22(1), pp. 11–20. [CrossRef]
Atallah, R. , Li, J. J. , Lu, W. , Leijendekkers, R. , Frölke, J. P. , and Al Muderis, M. , 2017, “ Osseointegrated Transtibial Implants in Patients With Peripheral Vascular Disease: A Multicenter Case Series of 5 Patients With 1-Year Follow-Up,” J. Bone Jt. Surg., 99(18), pp. 1516–1523. [CrossRef]
Schwarze, M. , Hurschler, C. , Seehaus, F. , Correa, T. , and Welke, B. , 2014, “ Influence of Transfemoral Amputation Length on Resulting Loads at the Osseointegrated Prosthesis Fixation During Walking and Falling,” Clin. Biomech., 29(3), pp. 272–276. [CrossRef]
Albrektsson, T. , Branemark, P. I. , Hansson, H. A. , and Lindstrom, J. , 1981, “ Osseointegrated Titanium Implants: Requirements for Ensuring a Long-Lasting, Direct Bone-to-Implant Anchorage in Man,” Acta Orthop. Scand., 52(2), pp. 155–170. [CrossRef] [PubMed]
Pitkin, M. , 2013, “ Design Features of Implants for Direct Skeletal Attachment of Limb Prostheses,” J. Biomed. Mater. Res., Part A, 101(11), pp. 3339–3348.
Lee, W. C. C. , Doocey, J. M. , Branemark, R. , Adam, C. J. , Evans, J. H. , Pearcy, M. J. , and Frossard, L. A. , 2008, “ FE Stress Analysis of the Interface Between the Bone and an Osseointegrated Implant for Amputees—Implications to Refine the Rehabilitation Program,” Clin. Biomech., 23(10), pp. 1243–1250. [CrossRef]
Tomaszewski, P. K. , Verdonschot, N. , Bulstra, S. K. , Rietman, J. S. , and Verkerke, G. J. , 2012, “ Simulated Bone Remodeling Around Two Types of Osseointegrated Implants for Direct Fixation of Upper-Leg Prostheses,” J. Mech. Behav. Biomed. Mater., 15, pp. 167–175. [CrossRef] [PubMed]
Thompson, M. L. , Backman, D. , Branemark, R. , and Mechefske, C. K. , 2011, “ Evaluating the Bending Response of Two Osseointegrated Transfemoral Implant Systems Using 3D Digital Image Correlation,” ASME J. Biomech. Eng., 133(5), p. 051006.
Frolke, J. P. M. , Leijendekkers, R. A. , and Van De Meent, H. , 2017, “ Osseointegrated Prosthesis for Patients With an Amputation: Multidisciplinary Team Approach in The Netherlands,” Unfallchirurg, 120, pp. 293–299. [CrossRef] [PubMed]
Xu, W. , and Robinson, K. , 2008, “ X-Ray Image Review of the Bone Remodeling Around an Osseointegrated Trans-Femoral Implant and a Finite Element Simulation Case Study,” Ann. Biomed. Eng., 36(3), pp. 435–443. [CrossRef] [PubMed]
Zhang, M. , Don, X. , and Fa, Y. , 2006, “ Stress Analysis of Osseointegrated Transfemoral Prosthesis: A Finite Element Model,” Annual International Conference of the Engineering in Medicine and Biology Society (EMBS), Shanghai, China, Jan. 17–18, pp. 4060–4063.
Frossard, L. A. , Stevenson, N. , Smeathers, J. , Haggstrom, E. , Hagberg, K. , Sullivan, J. , Ewins, D. , Gow, D. L. , Gray, S. , and Branemark, R. , 2008, “ Monitoring of the Load Regime Applied on the Osseointegrated Fixation of a Trans-Femoral Amputee: A Tool for Evidence-Based Practice,” Prosthetics Orthotics Int., 32(1), pp. 68–78. [CrossRef]
Al Muderis, M. , Khemka, A. , Lord, S. J. , Van De Meent, H. , and Frolke, J. P. , 2016, “ Safety of Osseointegrated Implants for Transfemoral Amputees: A Two-Center Prospective Cohort Study,” J. Bone Jt. Surg., 98(11), pp. 900–909. [CrossRef]
Helgason, B. , Palssona, H. , Runarssona, T. P. , Frossard, L. A. , and Viceconti, M. , 2009, “ Risk of Failure During Gait for Direct Skeletal Attachment of a Femoral Prosthesis: A Finite Element Study,” Med. Eng. Phys., 31(5), pp. 595–600. [CrossRef] [PubMed]
Khemka, A. , FarajAllah, C. I. , Lord, S. J. , Bosley, B. , and Al Muderis, M. , 2016, “ Osseointegrated Total Hip Replacement Connected to a Lower Limb Prosthesis: A Proof-of-Concept Study With Three Cases,” J. Orthop. Surg. Res., 11, p. 13.
Al Muderis, M. , Tetsworth, K. , Khemka, A. , Wilmot, S. , Bosley, B. , Lord, S. J. , and Glatt, V. , 2016, “ The Osseointegration Group of Australia Accelerated Protocol (OGAAP-1) for Two-Stage Osseointegrated Reconstruction of Amputated Limbs,” Bone Jt. J., 98-B(7), pp. 952–960. [CrossRef]
Welke, B. , Schwarze, M. , Hurschler, C. , Calliess, T. , and Seehaus, F. , 2013, “ Multi-Body Simulation of Various Falling Scenarios for Determining Resulting Loads at the Prosthesis Interface of Transfemoral Amputees With Osseointegrated Fixation,” J. Orthop. Res., 31(7), pp. 1123–1129. [CrossRef] [PubMed]
Haket, L. M. , Frolke, J. P. M. , Verdonschot, N. , Tomaszewski, P. K. , and Van De Meent, H. , 2017, “ Periprosthetic Cortical Bone Remodeling in Patients With an Osseointegrated Leg Prosthesis,” J. Orthop. Res., 35(6), pp. 1237–1241. [CrossRef] [PubMed]
Khemka, A. , Frossard, L. A. , Lord, S. J. , Bosley, B. , and Al Muderis, M. , 2015, “ Osseointegrated Total Knee Replacement Connected to a Lower Limb Prosthesis: 4 Cases,” Acta Orthop., 86(6), pp. 740–744. [CrossRef] [PubMed]
Pantall, A. , and Ewins, D. , 2013, “ Muscle Activity During Stance Phase of Walking: Comparison of Males With Transfemoral Amputation With Osseointegrated Fixations to Nondisabled Male Volunteers,” J. Rehabil. Res. Develop., 50(4), pp. 499–514. [CrossRef]
Hebert, J. S. , Rehani, M. , and Stiegelmar, R. , 2017, “ Osseointegration for Lower-Limb Amputation: A Systematic Review of Clinical Outcomes,” J. Bone Jt. Surg., 5(10), p. e10.
Al Muderis, M. , Lu, W. , Tetsworth, K. , Bosley, B. , and Li, J. J. , 2017, “ 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,” BMJ Open, 7(3), p. e013508.
Al Muderis, M. , Lu, W. , and Li, J. J. , 2017, “ Osseointegrated Prosthetic Limb for the Treatment of Lower Limb Amputations: Experience and Outcomes,” Unfallchirurg, 120(4), pp. 306–311. [CrossRef] [PubMed]
Guirao, L. , Samitier, C. B. , Costea, M. , Camos, J. M. , Majo, M. , and Pleguezuelos, E. , 2017, “ Improvement in Walking Abilities in Transfemoral Amputees With a Distal Weight Bearing Implant,” Prosthetics Orthotics Int., 41(1), pp. 26–32. [CrossRef]
Schalk, S. A. , Jonkergouw, N. , Van Der Meer, F. , Swaan, W. M. , Aschoff, H. H. , and Van Der Wurff, P. , 2015, “ The Evaluation of Daily Life Activities After Application of an Osseointegrated Prosthesis Fixation in a Bilateral Transfemoral Amputee: A Case Study,” Medicine, 94(36), p. e1416.
Frossard, L. , Gow, D. L. , Hagberg, K. , Cairns, N. , Contoyannis, B. , Gray, S. , Branemark, R. , and Pearcy, M. , 2010, “ Apparatus for Monitoring Load Bearing Rehabilitation Exercises of a Transfemoral Amputee Fitted With an Osseointegrated Fixation: A Proof-of-Concept Study,” Gait Posture, 31(2), pp. 223–228. [CrossRef] [PubMed]
Vertriest, S. , Coorevits, P. , Hagberg, K. , Branemark, R. , Haggstrom, E. , Vanderstraeten, G. , and Frossard, L. , 2015, “ Static Load Bearing Exercises of Individuals With Transfemoral Amputation Fitted With an Osseointegrated Implant: Reliability of Kinetic Data,” IEEE Trans. Neural Syst. Rehabil. Eng., 23(3), p. 423–430.
Cairns, N. J. , Adam, C. J. , Pearcy, M. J. , and Smeathers, J. , 2011, “ Evaluation of Modal Analysis Techniques Using Physical Models to Detect Osseointegration of Implants in Transfemoral Amputees,” Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), Boston, MA, Aug. 30–Sept. 3, pp. 1600–1603.
Lundberg, M. , Hagberg, K. , and Bullington, J. , 2011, “ My Prosthesis as a Part of Me: A Qualitative Analysis of Living With an Osseointegrated Prosthetic Limb,” Prosthetics Orthotics Int., 35(2), pp. 207–214. [CrossRef]
Tillander, J. , Hagberg, K. , Berlin, O. , Hagberg, L. , and Branemark, R. , 2017, “ Osteomyelitis Risk in Patients With Transfemoral Amputations Treated With Osseointegration Prostheses,” Clin. Orthop. Relat. Res., 475(12), pp. 3100–3108.
Lenneras, M. , Tsikandylakis, G. , Trobos, M. , Omar, O. , Vazirisani, F. , Palmquist, A. , Berlin, O. , Branemark, R. , and Thomsen, P. , 2017, “ The Clinical, Radiological, Microbiological, and Molecular Profile of the Skin-Penetration Site of Transfemoral Amputees Treated With Bone-Anchored Prostheses,” J. Biomed. Mater. Res., Part A, 105, pp. 578–589. [CrossRef]
Frossard, L. , Berg, D. , Merlo, G. , Quincey, T. , and Burkett, B. , 2017, “ Cost Comparison of Socket-Suspended and Bone-Anchored Transfemoral Prostheses,” J. Prosthetics Orthotics, 29(4), pp. 150–160. [CrossRef]
Frossard, L. A. , Merlo, G. , Burkett, B. , Quincey, T. , and Berg, D. , 2017, “ Cost-Effectiveness of Bone-Anchored Prostheses Using Osseointegrated Fixation: Myth or Reality?,” Prosthetics Orthotics Int., epub.
Haggstrom, E. , Hagberg, K. , Rydevik, B. , and Branemark, R. , 2013, “ Vibrotactile Evaluation: Osseointegrated Versus Socket-Suspended Transfemoral Prostheses,” J. Rehabil. Res. Develop., 50, pp. 1423–1434. [CrossRef]
Dumas, R. , Branemark, R. , and Frossard, L. , 2017, “ Gait Analysis of Transfemoral Amputees: Errors in Inverse Dynamics Are Substantial and Depend on Prosthetic Design,” IEEE Trans. Neural Syst. Rehabil. Eng., 25(6), pp. 679–685. [CrossRef] [PubMed]
Frossard, L. , Hagberg, K. , Haggstrom, E. , and Branemark, R. , 2009, “ Load-Relief of Walking Aids on Osseointegrated Fixation: Instrument for Evidence-Based Practice,” IEEE Trans. Neural Syst. Rehabil. Eng., 17(1), pp. 9–14. [CrossRef] [PubMed]
Frossard, L. , Tranberg, R. , Haggstrom, E. , Pearcy, M. , and Branemark, R. , 2010, “ Load on Osseointegrated Fixation of a Transfemoral Amputee During a Fall: Loading, Descent, Impact and Recovery Analysis,” Prosthetics Orthotics Int., 34(1), pp. 85–97. [CrossRef]
Vertriest, S. , Coorevits, P. , Hagberg, K. , Branemark, R. , Haggstrom, E. E. , Vanderstraeten, G. , and Frossard, L. A. , 2016, “ Static Load Bearing Exercises of Individuals With Transfemoral Amputation Fitted With an Osseointegrated Implant: Loading Compliance,” Prosthetics Orthotics Int., 41(4), pp. 393–401.
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References

Pitkin, M. , 2009, “ On the Way to Total Integration of Prosthetic Pylon With Residuum,” J. Rehabil. Res. Develop., 46, pp. 345–360. [CrossRef]
Leijendekkers, R. A. , Van Hinte, G. , Frolke, J. P. , Van De Meent, H. , Nijhuis-Van Der Sanden, M. W. G. , and Staal, J. B. , 2017, “ Comparison of Bone-Anchored Prostheses and Socket Prostheses for Patients With a Lower Extremity Amputation: A Systematic Review,” Disability Rehabil., 39(11), pp. 1045–1058. [CrossRef]
Leijendekkers, R. A. , Van Hinte, G. , Nijhuis-Van Der Sanden, M. W. G. , and Staal, J. B. , 2017, “ Gait Rehabilitation for a Patient With an Osseointegrated Prosthesis Following Transfemoral Amputation,” Physiother. Theory Pract., 33(2), pp. 147–161. [CrossRef] [PubMed]
Leijendekkers, R. A. , Staal, J. B. , Van Hinte, G. , Frolke, J. P. , Van De Meent, H. , Atsma, F. , Nijhuis-Van Der Sanden, M. W. G. , and Hoogeboom, T. J. , 2016, “ Long-Term Outcomes Following Lower Extremity Press-Fit Bone-Anchored Prosthesis Surgery: A 5-Year Longitudinal Study Protocol,” BMC Musculoskeletal Disord., 17(1), p. 484.
Pantall, A. , Durham, S. , and Ewins, D. , 2011, “ Surface Electromyographic Activity of Five Residual Limb Muscles Recorded During Isometric Contraction in Transfemoral Amputees With Osseointegrated Prostheses,” Clin. Biomech., 26(7), pp. 760–765. [CrossRef]
Tillander, J. , Hagberg, K. , Hagberg, L. , and Branemark, R. , 2010, “ Osseointegrated Titanium Implants for Limb Prostheses Attachments: Infectious Complications,” Clin. Orthop. Relat. Res., 468(10), pp. 2781–2788. [CrossRef] [PubMed]
Branemark, R. , Berlin, O. , Hagberg, K. , Bergh, P. , Gunterberg, B. , and Rydevik, B. , 2014, “ A Novel Osseointegrated Percutaneous Prosthetic System for the Treatment of Patients With Transfemoral Amputation: A Prospective Study of 51 Patients,” Bone Jt. J., 96-B(1), pp. 106–113. [CrossRef]
Hagberg, K. , Haggstrom, E. , Uden, M. , and Branemark, R. , 2005, “ Socket Versus Bone-Anchored Trans-Femoral Prostheses: Hip Range of Motion and Sitting Comfort,” Prosthetics Orthotics Int., 29(2), pp. 153–163. [CrossRef]
Hagberg, K. , and Branemark, R. , 2009, “ One Hundred Patients Treated With Osseointegrated Transfemoral Amputation Prostheses—Rehabilitation Perspective,” J. Rehabil. Res. Develop., 46, pp. 331–344. [CrossRef]
Lee, W. C. C. , Frossard, L. A. , Hagberg, K. , Haggstrom, E. , Gow, D. L. , Gray, S. , and Branemark, R. , 2008, “ Magnitude and Variability of Loading on the Osseointegrated Implant of Transfemoral Amputees During Walking,” Med. Eng. Phys., 30(7), pp. 825–833. [CrossRef] [PubMed]
Sullivan, J. , Uden, M. , Robinson, K. P. , and Sooriakumaran, S. , 2003, “ Rehabilitation of the Trans-Femoral Amputee With an Osseointegrated Prosthesis: The United Kingdom Experience,” Prosthetics Orthotics Int., 27(2), pp. 114–120. [CrossRef]
Tranberg, R. , Zugner, R. , and Karrholm, J. , 2011, “ Improvements in Hip- and Pelvic Motion for Patients With Osseointegrated Trans-Femoral Prostheses,” Gait Posture, 33(2), pp. 165–168. [CrossRef] [PubMed]
Van De Meent, H. , Hopman, M. T. , and Frolke, J. P. , 2013, “ Walking Ability and Quality of Life in Subjects With Transfemoral Amputation: A Comparison of Osseointegration With Socket Prostheses,” Arch. Phys. Med. Rehabil., 94(11), pp. 2174–2178. [CrossRef] [PubMed]
Li, Y. , and Branemark, R. , 2017, “ Osseointegrated Prostheses for Rehabilitation Following Amputation: The Pioneering Swedish Model,” Unfallchirurg, 120(4), pp. 285–292. [CrossRef] [PubMed]
Lee, W. C. C. , Frossard, L. A. , Hagberg, K. , Haggstrom, E. , Branemark, R. , Evans, J. H. , and Pearcy, M. J. , 2007, “ Kinetics of Transfemoral Amputees With Osseointegrated Fixation Performing Common Activities of Daily Living,” Clin. Biomech., 22(6), pp. 665–673. [CrossRef]
Haggstrom, E. , Hansson, E. , and Hagberg, K. , 2012, “ Comparison of Prosthetic Costs and Service Between Osseointegrated and Conventional Suspended Transfemoral Prostheses,” Prosthetics Orthotics Int., 37(2), pp. 152–160. [CrossRef]
Van Eck, C. F. , and McGough, R. L. , 2015, “ Clinical Outcome of Osseointegrated Prostheses for Lower Extremity Amputations: A Systematic Review of the Literature,” Curr. Orthop. Pract., 26(4), pp. 349–357. [CrossRef]
Branemark, R. , Branemark, P. I. , Rydevik, B. , and Myers, R. R. , 2001, “ Osseointegration in Skeletal Reconstruction and Rehabilitation: A Review,” J. Rehabil. Res. Develop., 38(2), pp. 175–181.
Nebergall, A. , Bragdon, C. , Antonellis, A. , Karrholm, J. , Branemark, R. , Berlin, O. , and Malchau, H. , 2012, “ Stable Fixation of an Osseointegrated Implant System for Above-the-Knee Amputees: Titel RSA and Radiographic Evaluation of Migration and Bone Remodeling in 55 Cases,” Acta Orthop., 83(2), pp. 121–128. [CrossRef] [PubMed]
Eriksson, E. , and Branemark, P. I. , 1994, “ Osseointegration From the Perspective of the Plastic Surgeon,” Plast. Reconstr. Surg., 93(3), pp. 626–637. [CrossRef] [PubMed]
Aschoff, H. H. , Kennon, R. E. , Keggi, J. M. , and Rubin, L. E. , 2010, “ Transcutaneous, Distal Femoral, Intramedullary Attachment for Above-the-Knee Prostheses: An Endo-Exo Device,” J. Bone Jt. Surg., 92(Suppl. 2), pp. 180–186. [CrossRef]
Hagberg, K. , Branemark, R. , Gunterberg, B. , and Rydevik, B. , 2008, “ Osseointegrated Trans-Femoral Amputation Prostheses: Prospective Results of General and Condition-Specific Quality of Life in 18 Patients at 2-Year Follow-Up,” Prosthetics Orthotics Int., 32(1), pp. 29–41. [CrossRef]
Hagberg, K. , Hansson, E. , and Branemark, R. , 2014, “ Outcome of Percutaneous Osseointegrated Prostheses for Patients With Unilateral Transfemoral Amputation at Two-Year Follow-Up,” Arch. Phys. Med. Rehabil., 95(11), pp. 2120–2127. [CrossRef] [PubMed]
Tomaszewski, P. K. , Verdonschot, N. , Bulstra, S. K. , and Verkerke, G. J. , 2010, “ A Comparative Finite-Element Analysis of Bone Failure and Load Transfer of Osseointegrated Prostheses Fixations,” Ann. Biomed. Eng., 38(7), pp. 2418–2427. [CrossRef] [PubMed]
Frossard, L. , Hagberg, K. , Haggstrom, E. , Gow, D. L. , Branemark, R. , and Pearcy, M. , 2010, “ Functional Outcome of Transfemoral Amputees Fitted With an Osseointegrated Fixation: Temporal Gait Characteristics,” J. Prosthetics Orthotics, 22(1), pp. 11–20. [CrossRef]
Atallah, R. , Li, J. J. , Lu, W. , Leijendekkers, R. , Frölke, J. P. , and Al Muderis, M. , 2017, “ Osseointegrated Transtibial Implants in Patients With Peripheral Vascular Disease: A Multicenter Case Series of 5 Patients With 1-Year Follow-Up,” J. Bone Jt. Surg., 99(18), pp. 1516–1523. [CrossRef]
Schwarze, M. , Hurschler, C. , Seehaus, F. , Correa, T. , and Welke, B. , 2014, “ Influence of Transfemoral Amputation Length on Resulting Loads at the Osseointegrated Prosthesis Fixation During Walking and Falling,” Clin. Biomech., 29(3), pp. 272–276. [CrossRef]
Albrektsson, T. , Branemark, P. I. , Hansson, H. A. , and Lindstrom, J. , 1981, “ Osseointegrated Titanium Implants: Requirements for Ensuring a Long-Lasting, Direct Bone-to-Implant Anchorage in Man,” Acta Orthop. Scand., 52(2), pp. 155–170. [CrossRef] [PubMed]
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Figures

Grahic Jump Location
Fig. 1

Example of a press-fixated osseointegrated transfemoral implant. Photograph courtesy of Dr. Lluis Guirao Cano, MD., Ph.D. (Hospital de Mataró, Consorci Sanitari del Maresme, Spain).

Grahic Jump Location
Fig. 2

Schematic of the OPRA osseointegration implant system. Photograph courtesy of Jonas Bergman (CEO of Integrum, Sweden).

Grahic Jump Location
Fig. 3

Surgically embedding an osseointegrated implant into the patient's femoral intramedullary cavity. Photograph courtesy of Dr. Lluis Guirao Cano, MD., Ph.D. (Hospital de Mataró, Consorci Sanitari del Maresme, Spain).

Grahic Jump Location
Fig. 4

Transfemoral amputee patient with the OPRA osseointegration implant system standing beside Dr. Rickard Branemark. Photograph courtesy of Jonas Bergman (CEO of Integrum, Sweden).

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