Dataset Information

Biomechanical Characterisation of Bone-anchored Implant Systems for Amputation Limb Prostheses: A Systematic Review.

ABSTRACT: 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.

SUBMITTER: Thesleff A

PROVIDER: S-EPMC5809556 | biostudies-other | 2018 Mar

REPOSITORIES: biostudies-other

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Biomechanical Characterisation of Bone-anchored Implant Systems for Amputation Limb Prostheses: A Systematic Review.

Thesleff Alexander A Brånemark Rickard R Håkansson Bo B Ortiz-Catalan Max M

Annals of biomedical engineering 20180111 3

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 sys ...[more]

PMID: 29327257

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Project description: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.

Project description:IntroductionBone-anchored prostheses (BAP) are an advanced reconstructive surgical approach for individuals who had transfemoral amputation and are unable to use the conventional socket-suspension systems for their prostheses. Access to this technology has been limited in part due to the lag between the start of a new procedure and the availability of evidence that is required before making decisions about widespread provision. This systematic review presents as a single resource up-to-date information on aspects most relevant to decision makers, i.e., clinical efficacy, safety parameters, patient experiences, and health economic outcomes of this technology.MethodsA systematic search of the literature was conducted by an information specialist in PubMed, MEDLINE, Embase, CINAHL, Cochrane Library, the Core Collection of Web of Science, CADTH's Grey Matters, and Google Scholar up until May 31, 2023. Peer-reviewed original research articles on the outcomes of clinical effectiveness (health-related quality of life, mobility, and prosthesis usage), complications and adverse events, patient experiences, and health economic outcomes were included. The quality of the studies was assessed using the Oxford Centre for Evidence-Based Medicine Levels of Evidence and ROBINS-I, as appropriate.ResultsFifty studies met the inclusion criteria, of which 12 were excluded. Thirty-eight studies were finally included in this review, of which 21 reported on clinical outcomes and complications, 9 case series and 1 cohort study focused specifically on complications and adverse events, and 2 and 5 qualitative studies reported on patient experience and health economic assessments, respectively. The most common study design is a single-arm trial (pre-/post-intervention design) with varying lengths of follow-up.DiscussionThe clinical efficacy of this technology is evident in selected populations. Overall, patients reported increased health-related quality of life, mobility, and prosthesis usage post-intervention. The most common complication is a superficial or soft-tissue infection, and more serious complications are rare. Patient-reported experiences have generally been positive. Evidence indicates that bone-anchored implants for prosthesis fixation are cost-effective for those individuals who face significant challenges in using socket-suspension systems, although they may offer no additional advantage to those who are functioning well with their socket-suspended prostheses.

Dataset Information

Biomechanical Characterisation of Bone-anchored Implant Systems for Amputation Limb Prostheses: A Systematic Review.

Publications

Biomechanical Characterisation of Bone-anchored Implant Systems for Amputation Limb Prostheses: A Systematic Review.

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