Abstract:This article reviews the development of multidisciplinary osseointegration treatment in the Netherlands since its start in 2009. People experiencing limitations due to their socket prosthesis after a leg amputation present to the Radboud University Nijmegen Medical Centre for an osseointegration implant or “bone-anchored” prosthesis. In this article we share our experience with the first 100 patients regarding referral pattern, selection criteria, available osseointegration systems, preoperative planning, surg… Show more
“…For a significant portion of patients with limb loss, the direct skeletal attachment of artificial limbs into the medullary canal of the residual bone offers a vastly superior alternative to the centuries‐old “socket‐suspension” method for prosthetic limb attachment . This technology—termed percutaneous osseointegrated (OI) prostheses (POPs)—has been used successfully in Europe for more than two decades, and the benefits of which are well recognized in multiple European and Australian clinical trials .…”
Percutaneous osseointegrated (OI) prostheses (POPs) are used to skeletally attach artificial limbs in amputees. While any permanent percutaneous interface is at risk of becoming infected by the resident microbiota colonizing the stoma, most of these patients remain infection-free. Avoidance of infection likely depends upon a mechanically and/or biologically stable skin-to-implant interface. The ultimate question remains, "why do some stomata become infected while others do not?" The answer might be found in the dynamic bacterial communities of the patient and within the stomal site itself. This study is an appendix to the first Food and Drug Administration approved prospective early feasibility study of OI prosthetic docking, in which, 10 transfemoral amputees were implanted with a unique POP device. In this analytical, longitudinal cohort study, each patient's skin and stomal microbiota were analyzed from the initial surgery to 1 year following the second-stage surgery. During each follow-up visit, three swab samples-stomal, device thigh skin and contralateral thigh skin-were obtained. DNA was extracted, and bacterial 16S ribosomal RNA (rRNA) genes were amplified and sequenced to profile microbial communities. The stomal microbiota were distinct from the microbiota on the adjacent thigh skin and the skin of the contralateral thigh, with a significantly increased abundance of Staphylococcus aureus within the stoma. Early on stomal microbiota were characterized by high diversity and high relative abundance of obligate anaerobes. Over time, the stomal microbiota shifted and stabilized in communities of lower diversity dominated by Streptococcus, Corynebacterium, and/or Staphylococcus spp.
“…For a significant portion of patients with limb loss, the direct skeletal attachment of artificial limbs into the medullary canal of the residual bone offers a vastly superior alternative to the centuries‐old “socket‐suspension” method for prosthetic limb attachment . This technology—termed percutaneous osseointegrated (OI) prostheses (POPs)—has been used successfully in Europe for more than two decades, and the benefits of which are well recognized in multiple European and Australian clinical trials .…”
Percutaneous osseointegrated (OI) prostheses (POPs) are used to skeletally attach artificial limbs in amputees. While any permanent percutaneous interface is at risk of becoming infected by the resident microbiota colonizing the stoma, most of these patients remain infection-free. Avoidance of infection likely depends upon a mechanically and/or biologically stable skin-to-implant interface. The ultimate question remains, "why do some stomata become infected while others do not?" The answer might be found in the dynamic bacterial communities of the patient and within the stomal site itself. This study is an appendix to the first Food and Drug Administration approved prospective early feasibility study of OI prosthetic docking, in which, 10 transfemoral amputees were implanted with a unique POP device. In this analytical, longitudinal cohort study, each patient's skin and stomal microbiota were analyzed from the initial surgery to 1 year following the second-stage surgery. During each follow-up visit, three swab samples-stomal, device thigh skin and contralateral thigh skin-were obtained. DNA was extracted, and bacterial 16S ribosomal RNA (rRNA) genes were amplified and sequenced to profile microbial communities. The stomal microbiota were distinct from the microbiota on the adjacent thigh skin and the skin of the contralateral thigh, with a significantly increased abundance of Staphylococcus aureus within the stoma. Early on stomal microbiota were characterized by high diversity and high relative abundance of obligate anaerobes. Over time, the stomal microbiota shifted and stabilized in communities of lower diversity dominated by Streptococcus, Corynebacterium, and/or Staphylococcus spp.
“…Reprinted from Unfallchirurg. 23 Figure 5 (a) Single-component POP implant used in sheep studies: (1) tapered smooth region, (2) fluted region, (3) porous coated region, (4) porous coated subdermal barrier, (5) Morse taper for connection to exo-prosthesis; (b) POP implant system assembly for humans: (1) implant stem, (2) stoma shield, (3) percutaneous post, (4) assembly bolt, (5) adapter, (6) adapter bolt; (c) Schematic view of the ITAP implant; (d) Radiograph of ITAP implant in a transhumeral amputee; (e) ITAP implant used in dog number 3 of the clinical study on dogs. Image A is reprinted from Clinical Orthopaedics and Related Research, 47 with permission from Springer.…”
Section: Resultsmentioning
confidence: 99%
“…2 d). 1 , 23 The implant also had a bone-stabilising bracket, which wrapped around the cortical bone distally (Figs. 3 a and 3 b).…”
Section: Resultsmentioning
confidence: 99%
“… 3 Mechanical failures of the intramedullary implant have been reported in all three countries. 5 , 23 , 49 …”
Section: Resultsmentioning
confidence: 99%
“…The OPL was introduced in Australia in 2013 6 and in the Netherlands in 2015. 23 The system is used for transfemoral or transtibial amputation levels. Standardised implants are used for transfemoral amputees with sufficient stump length (≥ 160 mm), while custom-made implants are available for transtibial amputees and transfemoral amputees with very short stumps (Fig.…”
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. Three different percutaneous implant systems for direct skeletal attachment of external limb prostheses are currently clinically available and a few others are under investigation in human subjects. These systems employ different strategies and have undergone design changes with a view to fulfilling the aforementioned requirements. This review summarises such strategies and design changes, providing an overview of the biomechanical characteristics of current percutaneous implant systems for direct skeletal attachment of amputation limb prostheses.
Bone resorption caused by stress shielding and insufficient bone‐implant contact continues to be problematic for orthopedic endoprostheses that utilize osseointegration (OI) for skeletal fixation. Morphologic analyses have helped combat this issue by defining anatomic parameters to optimize endoprosthesis loading by maximizing bone‐implant contact. These studies have not typically included diaphyseal medullary morphology, as this region is not pertinent to total joint replacement. To the contrary, percutaneous OI endoprostheses for prosthetic limb attachment are placed in the diaphysis of the long bone. This study examined the cortical and medullary morphology of 116 fresh‐frozen human cadaveric tibia using computed tomography. Anatomic landmarks were selected and custom MATLAB scripts were used to analyze the cross‐sectional cortical and medullary morphology normalized to biomechanical length (BML). BML measured the distance between the tibial plateau and the tibial plafond. Properties such as cortical thickness, medullary diameter, and circularity of the medullary canal were quantified. We tested the influence of sex and laterality on morphology, and examined variations along the length of the bone. Results showed that while both sex and laterality impacted the location of anatomic landmarks, only sex influenced cross‐sectional morphology. Overall, morphology significantly affected shape along the length of the bone for all examined properties except medullary circularity. This analysis found that distal to 35% BML, the canal is conducive to a circular implant, with medullary diameter ranging from 13 to 32 mm between 20 and 80% BML. A large size range is necessary for sufficient implant contact in order to accommodate residual limb length after amputation.
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