Comparison of functional outcome and patient satisfaction between patients with socket prosthesis and patients treated with transcutaneous osseointegrated prosthetic systems (TOPS) after transfemoral amputation

Örgel, Marcus; Schwarze, Frederik; Graulich, Tilman; Krettek, Christian; Weidemann, Friederike; Aschoff, Horst‐Heinrich; Winkelmann, Marcel; Ranker, Alexander

doi:10.1007/s00068-022-02018-6

Cited by 9 publications

(13 citation statements)

References 65 publications

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“…To asses the wettability of the surface specifications two uncoated and two TiN-coated plain TiAl6V4 samples were evaluated by contact angle measurement (OCA 15, Data-Physics, Filderstadt, Germany). Using water as liquid medium (density 0.998 g/cm 3 , viscosity 1 mPas, surface tension SFT 72.8 mN/m) three droplets per sample with a dosage volume of 5 µl and a dosage rate of 1 mL/s were applied according to the sessile drop method. Mean contact angle and standard deviation were calculated based on the resulting six measurement values per specification.…”

Section: Contact Angle Measurementmentioning

confidence: 99%

“…Transcutaneous osseointegrated prosthetic systems (TOPS) have gained increasing interest as alternative to a conventional socket prosthesis. [1][2][3] These systems consist of a bone-anchored, osseointegrated module, the "fixture", which is press-fit implanted in the medullary cavity, and a skin-penetrating module, the "abutment", which is attached to the fixture by an abutment screw. The basic concept is similar to the direct anchorage of dental implants in the jaw.…”

Section: Introductionmentioning

confidence: 99%

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Impact of topography and added TiN-coating on adult human dermal fibroblasts after seeding on titanium surface in-vitro

Hauschild,

Hardes,

Dudda

et al. 2024

J Biomater Appl

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Complications of transcutaneous osseointegrated prosthetic systems (TOPS) focus on the metal-cutaneous interface at the stoma. Besides pain due to scare tissue as well as undefined neuropathic disorders, there is high evidence that the stoma presents the main risk causing hypergranulation and ascending infection. To restore the cutaneous barrier function in this functional area, soft-tissue on- or in-growth providing a vital and mechanically stable bio-artificial conjunction is considered a promising approach. In this study we assessed viability and proliferation of adult human dermal fibroblasts (HDFa) on modifications of a standard prosthetic titanium surface. Un-coated (TiAl6V4) as well as a titanium-nitrite (TiN) coated additive manufactured porous three-dimensional surface structures (EPORE®) were seeded with HDFa and compared to plain TiAl6V4 and polystyrene surfaces as control. Cell viability and proliferation were assessed at 24 h and 7 days after seeding with a fluorescence-based live-dead assay. Adhesion and cell morphology were analyzed by scanning electron microscopy at the respective measurements. Both EPORE® surface specifications revealed a homogenous cell distribution with flat and spread cell morphology forming filopodia at both measurements. Proliferation and trend to confluence was seen on un-coated EPORE® surfaces with ongoing incubation but appeared substantially lower on the TiN-coated EPORE® specification. While cell viability on both EPORE® specifications was comparable to plain TiAL6V4 and polystyrene controls, cell proliferation and confluence were less pronounced when compared to controls. The EPORE® topography allows for fibroblast adhesion and viability in both standard TiAl6V4 and – to a minor degree - TiN-coated specifications as a proof of principle.

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Section: Contact Angle Measurementmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Impact of topography and added TiN-coating on adult human dermal fibroblasts after seeding on titanium surface in-vitro

Hauschild,

Hardes,

Dudda

et al. 2024

J Biomater Appl

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“…Despite subtle differences between the systems utilized for the intramedullary anchoring of the prosthetic stem, all data indicate that mobility and quality of life significantly increase while the frequency of stoma infections is remarkably low as long as the patient is able to follow simple postoperative care protocols 2-5,9,10,13-19 .…”

Section: Expected Outcomesmentioning

confidence: 99%

“…Transcutaneous osseointegrated prosthetic systems for replacement of an upper or lower limb might not be an option in patients who are unable, for any reason, to take adequate care of the stoma. Expected Outcomes: Despite subtle differences between the systems utilized for the intramedullary anchoring of the prosthetic stem, all data indicate that mobility and quality of life significantly increase while the frequency of stoma infections is remarkably low as long as the patient is able to follow simple postoperative care protocols [2][3][4][5]9,10,[13][14][15][16][17][18][19] . Important Tips: The impaction pressure of the implant depends on the diameter of the implant and the quality of the residual bone (i.e., the time interval between the amputation and the implantation of the prosthetic stem).…”

mentioning

confidence: 99%

Transcutaneous Osseointegrated Prosthesis Systems (TOPS) for Rehabilitation After Lower Limb Loss

Aschoff,

Örgel,

Sass

et al. 2024

JBJS Essential Surgical Techniques

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Background: The biology of osseointegration of any intramedullary implant depends on the design, the press-fit anchoring, and the loading history of the endoprosthesis. In particular, the material and surface of the endoprosthetic stem are designed to stimulate on- and in-growth of bone as the prerequisite for stable and long-lasting integration 1–8 . Relative movement between a metal stem and the bone wall may stimulate the formation of a connective-tissue interface, thereby increasing the risk of peri-implant infections and implant loss 9–12 . The maximum achievable press-fit (i.e., the force closure between the implant and bone wall) depends on the diameter and length of the residual bone and thus on the amputation level. Beyond this, the skin-penetrating connector creates specific medical and biological challenges, especially the risk of ascending intramedullary infections. On the one hand, bacterial colonization of the skin-penetrating area (i.e., the stoma) with a gram-positive taxon is obligatory and almost impossible to avoid 9,10 . On the other hand, a direct structural and functional connection between the osseous tissue and the implant, without intervening connective tissue, has been shown to be a key for infection-free osseointegration 11,12 . Description: We present a 2-step implantation process for the standard Endo-Fix Stem (ESKA Orthopaedic Handels) into the residual femur and describe the osseointegration of the prosthesis 13 . In addition, we demonstrate the single-step implantation of a custom-made short femoral implant and a custom-made humeral BADAL X implant (OTN Implants) in a patient who experienced a high-voltage injury with the loss of both arms and the left thigh. Apart from the standard preparation procedures (e.g., marking the lines for skin incisions, preparation of the distal part of the residual bone), special attention must be paid when performing the operative steps that are crucial for successful osseointegration and utilization of the prosthesis. These include shortening of the residual bone to the desired length, preparation of the intramedullary cavity for hosting of the prosthetic stem, precise trimming of the soft tissue, and wound closure. Finally, we discuss the similarities and differences between the Endo-Fix Stem and the BADAL X implant in terms of their properties, intramedullary positioning, and the mechanisms leading to successful osseointegration. Alternatives: Socket prostheses for transfemoral or transtibial amputees have been the gold standard for decades. However, such patients face many challenges to recover autonomous mobility, and an estimated 30% of all amputees report unsatisfactory rehabilitation and 10% cannot use a socket prosthesis at all. Rationale: Transcutaneous osseointegrated prosthetic systems especially benefit patients who are unable to tolerate socket suspension systems, such as those with short residual limbs and/or bilateral limb loss. The use of a firmly integrated endoprosthetic stem allows patients and surgeons to avoid many of the limitations associated with conventional socket prostheses, such as the need to continually fit and refit the socket to match an ever-changing stump 6,14–19 . Discussion between patients who are considering an osseointegrated prosthesis and those who have already received one (“peer patients”) has proven to be a powerful tool to prevent unrealistic expectations. Patients with a transhumeral amputation especially benefit from the stable connection between the residual limb and exoprosthesis. Motion of the affected and even the contralateral shoulder is no longer impaired, as straps and belts are dispensable. Furthermore, transmission of myoelectric signals from surrounding muscles to the prosthesis is fundamentally improved. However, comorbidities such as diabetes mellitus or peripheral arterial disease require careful counseling, even if these conditions were not responsible for the loss of the limb. Transcutaneous osseointegrated prosthetic systems for replacement of an upper or lower limb might not be an option in patients who are unable, for any reason, to take adequate care of the stoma. Expected Outcomes: Despite subtle differences between the systems utilized for the intramedullary anchoring of the prosthetic stem, all data indicate that mobility and quality of life significantly increase while the frequency of stoma infections is remarkably low as long as the patient is able to follow simple postoperative care protocols 2–5,9,10,13–19 . Important Tips: The impaction pressure of the implant depends on the diameter of the implant and the quality of the residual bone (i.e., the time interval between the amputation and the implantation of the prosthetic stem). The extent of reaming of the inner cortex of the residual bone must be adapted to these conditions. The standard Endo-Fix Stem and BADAL X implant are both slightly curved to adapt to the physiological shape of the femur. Thus, the surgeon must be sure to insert the implant in the right position and at the correct rotational alignment. When preparing a short femoral stump, carefully identify the exact transection level in order to obtain enough bone stock to anchor the implant in the correct intramedullary position for an additional locking screw into the femoral neck and head. Depending on the residual length of the humerus and the press-fit stability of the implant, the utilization of locking screws is optional, as a notch at the distal end of the implant guarantees primary rotational stability. Acronyms and Abbreviations: TOPS = transcutaneous osseointegrated prosthesis systemsEEP = endo-exo prosthesisMRSA = methicillin-resistant staphylococcus aureus a.p. = anteroposteriorK-wire = Kirschner wireCT = computed tomographyDCA = double conus adapterOFP = osseointegrated femur prosthesis

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“…Additionally, we focused on soft tissue complications, and no patientreported outcome measures were collected; thus, we were not able to give insight into patient satisfaction in relation to the occurrence of complications. Nevertheless, earlier research demonstrates that most bone-anchored prosthesis users are satisfied compared with previous socket-prosthesis use, even with the occurrence of adverse events [19,24]. Furthermore, a decrease in the incidence and severity of complications might increase patient satisfaction.…”

Section: Limitationsmentioning

confidence: 99%

Have Surgery and Implant Modifications Been Associated With Reduction in Soft Tissue Complications in Transfemoral Bone-anchored Prostheses?

Atallah¹,

Reetz²,

Kleuver³

et al. 2023

Clin Orthop Relat Res

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BackgroundThe most frequently occurring adverse events in individuals with a transfemoral amputation treated with a bone-anchored prosthesis are soft tissue infections and stoma-related complications. These soft tissue complications are believed to be influenced by surgical technique and implant design, but little is known about the effect of changes to treatment on these events.Questions/purposes(1) What is the result of surgical technique and implant modifications on the incidence of soft tissue infections and stoma-related complications in transfemoral bone-anchored prosthesis users, depending on whether they had a conventional stoma and a cobalt-chrome-molybdenum (CoCrMo) osseointegration implant (treatment period 2009 to 2013) or a shallower stoma and titanium osseointegration implant (2015 to 2018)? (2) What is the incidence of serious complications, such as bone or implant infection, aseptic loosening, intramedullary stem breakage, and periprosthetic fracture?MethodsBetween 2009 and 2013, we performed osseointegration implant surgery using a conventional surgical technique and a CoCrMo implant in 42 individuals who had a lower extremity amputation experiencing socket-related problems that resulted in limited prosthesis use. We considered all individuals treated with two-stage surgery with a standard press-fit transfemoral osseointegration implant as potentially eligible for inclusion. Based on this, 100% (42) were eligible, and 5% (two of 42) were excluded because they did not provide informed consent, leaving 95% (40 of 42) for analysis. Between 2015 and 2018, we treated 79 individuals with similar indications with osseointegration implant surgery, now also treating individuals with dysvascular amputations. We used an adapted surgical technique resulting in a shallower stoma combined with a titanium implant. Using the same eligibility criteria as for the first group, 51% (40 of 79) were eligible; 49% (39 of 79) were excluded because they were treated with transtibial amputation, a patient-specific implant, or single-stage surgery and 1% (one of 79) were lost before the 2-year follow-up interval, leaving 49% (39 of 79) for analysis. The period of 2013 to 2015 was a transitional period and was excluded from analysis in this study to keep groups reasonably comparable and to compare a historical approach with the present approach. Hence, we presented a comparative study of two study groups (defined by surgical technique and implant design) with standardized 2-year follow-up. The risk factors for adverse events were similar between groups, although individuals treated with the shallow stoma surgical technique and titanium implant potentially possessed an increased risk because of the inclusion of individuals with dysvascular amputation and the discontinuation of prolonged postoperative antibiotic prophylaxis. Outcomes studied were soft tissue infections and stoma-related complications (hypergranulation or keloid formation as well as stoma redundant tissue) and bone or implant infection, aseptic loosenin...

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Comparison of functional outcome and patient satisfaction between patients with socket prosthesis and patients treated with transcutaneous osseointegrated prosthetic systems (TOPS) after transfemoral amputation

Cited by 9 publications

References 65 publications

Impact of topography and added TiN-coating on adult human dermal fibroblasts after seeding on titanium surface in-vitro

Impact of topography and added TiN-coating on adult human dermal fibroblasts after seeding on titanium surface in-vitro

Transcutaneous Osseointegrated Prosthesis Systems (TOPS) for Rehabilitation After Lower Limb Loss

Have Surgery and Implant Modifications Been Associated With Reduction in Soft Tissue Complications in Transfemoral Bone-anchored Prostheses?

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