Complications of bone-anchored prostheses for individuals with an extremity amputation: A systematic review

Abstract

BackgroundThis study aimed to provide an overview of device-related complications occurring in individuals with an upper or lower extremity amputation treated with a screw, press-fit or other type of bone-anchored implant as well as interventions related to these complications.MethodA systematic literature search was conducted in the MEDLINE, Cochrane, EMBASE, CINAHL and Web of Science databases. The included studies reported on device-related complications and interventions occurring in individuals with bone-anchored prostheses. The outcomes evaluated were death, infection, bone/device breakage, implant loosening, soft tissue complications, systemic events, antibiotic and surgical treatment. Subgroup analyses were performed for the following groups: a) implant type (screw, press-fit and other types of implants) and b) level of amputation (transfemoral, transtibial and upper extremity amputation).ResultsOf 309 studies, 12 cohort studies were eligible for inclusion, all of which had methodological shortcomings and 12 studies were excluded due to complete overlap of patient data. Implant infection were rare in certain transfemoral implants (screw: 2–11%, press-fit: 0–3%, Compress: 0%) but common in transtibial implants (29%). The same was observed for implant loosening, in transfemoral (screw: 6%, press-fit: 0–3%, Compress: 0%), transtibial implants (29%) as well as for upper extremity implants (13–23%). Intramedullary device breakage were rare in transfemoral implants (screw: 0%, press-fit: 1%, Compress: unknown) but frequent in individuals with transradial implants (27%) and absent in transtibial implants. Soft tissue infections and complications were common and underreported in most articles.ConclusionsMajor complications (e.g. implant infection, implant loosening and intramedullary device breakage) are rare in transfemoral bone-anchored prosthesis and seem to occur less frequently in individuals with press-fit implants. Minor complications, such as soft tissue infections and complications, are common but are substantially influenced by the learning curve, implant design and surgical technique. Data for patients treated with a transtibial, upper extremity or Compress implant are underreported, precluding definitive conclusions. There is a need for either an international database to report on or a standard core set of complications as well as the need to follow classification systems that result in unequivocal data.

Automated Characterization of Anthropomorphicity of Prosthetic Feet Fitted to Bone-Anchored Transtibial Prosthesis

“…[18][19][20][21][22][23][24][25][26][27][28][29] Therefore, better understanding of the impact of ankle stiffness on osseointegrated fixation could possibly contribute to reduce early loosening of fixation, mechanical failure of percutaneous and medullar parts of fixation, periprosthetic issues and infections that are yet to be fully satisfactorily resolved. [23,24,[30][31][32][33][34][35] Altogether, stiffness characterization might also assist in the development of specific guidelines for design and prescription of feet and ankle units for transtibial prostheses, the sole loading elements under the control of prosthetists that is also subjected to cost-benefit analyses by funders. [36,37]…”

Safety, prosthesis wearing time and health-related quality of life of lower extremity bone-anchored prostheses using a press-fit titanium osseointegration implant: A prospective one-year follow-up cohort study

“…[1,6,14] A recent systematic review of the safety of BAP showed a slightly better femoral OI survival for press-fit implants compared to screw implants. [15] Several studies have shown favourable performance data when comparing BAP to SSP leading to increased level of function, activity, and healthrelated quality of life. [1,[4][5][6]16] Previous risk-benefit studies of BAP using a press-fit OI have predominantly included selected individuals with transfemoral amputation treated with the curved press-fit osseointegration femur implant (OFI-C), both with a chromium-cobalt-molybdenum and a titanium alloy.…”

“…[1,[4][5][6]16] Previous risk-benefit studies of BAP using a press-fit OI have predominantly included selected individuals with transfemoral amputation treated with the curved press-fit osseointegration femur implant (OFI-C), both with a chromium-cobalt-molybdenum and a titanium alloy. [15] Currently almost half of the candidates referred to our center for OI treatment have either short femoral remnants or a transtibial amputation. For individuals with transfemoral amputation with short femoral remnants and individuals with transtibial amputation, a gamma press-fit osseointegration femur implant (OFI-Y) and press-fit osseointegration tibia implant (OTI) is used, respectively.…”

Patient Perspectives on Osseointegration: A National Survey of Veterans with Upper Limb Amputation

“…Osseointegrated (OI) prostheses, which are attached to a residual limb by means of a fixture anchored in the bone, have a unique benefit‐risk profile among prosthetic alternatives. They may improve user comfort, function, and sensation but involve significant risks such as aseptic loosening (reported in 13%‐23% in upper extremity implants), periprosthetic fracture (reported in 0%‐18% of transfemoral implants, but 0% in upper extremity implants), intermedullary device breakage (reported in 27% of transradial implants), and infection (reported in 23%‐29%) . They have been marketed in Europe since the 1990s, in Australia since 2011, and in the United States under a Humanitarian Device Exemption since 2015.…”

“…Evidence has grown about the potential benefits and risks associated with OI prostheses, and the trade‐offs between OI and other prostheses make the choice to pursue an OI prosthesis a shared decision between patients and healthcare professionals. Information about the diversity of upper‐limb prosthesis user perspectives on these distinctive benefits and risks, prosthesis‐user subpopulations for whom OI is most acceptable, and the outcomes that matter most to patients could help inform clinical and regulatory decision‐making.…”