Dataset Information

Functional performance and safety of bone-anchored prostheses in persons with a transfemoral or transtibial amputation: a prospective one-year follow-up cohort study.

ABSTRACT:

Objectives:

(1) To compare level of function, activity, health-related quality of life (HRQoL) and satisfaction in persons with a lower extremity amputation before surgery and 6- and 12-months after implantation of an osseointegration implant and (2) to report adverse events.

Design:

Prospective cohort study.

Setting:

University medical centre.

Subjects:

A total of 40 consecutive persons (median age: 56?years) who received a transfemoral (31) or transtibial (9) osseointegration implant, between April 2014 and March 2016.

Intervention:

Osseointegration implant surgery followed by a predefined rehabilitation programme.

Main measures:

Hip abductor strength, prosthetic use, back pain frequency, postoperative pain, mobility level (Timed-Up and Go (TUG) and wheelchair-boundedness), walking ability (6?minute walking test (6MWT) and walking distance in daily life), HRQoL, satisfaction regarding the prosthesis, and adverse events.

Results:

Strength, prosthetic use, walking distance, HRQoL, and satisfaction level increased significantly at 6- and 12-month follow-up compared to baseline ( P ? 0.002). The TUG showed no change at 6-month follow-up ( P = 0.420) but improved significantly at 12-month follow-up compared to baseline ( P = 0.005). Wheelchair-boundedness decreased from 12/40 participants at baseline to 0 at follow-ups. The 6MWT ( P ? 0.038) and back pain ( P ? 0.437) did not change over time. Stump pain was present in 28/39 and 22/40 of the participants at 6-and 12-month follow-up, respectively. The major adverse events were managed successfully and included three dual-cone breakages and four bone fractures. An uneventful course was completed by 19/31 transfemoral and 4/9 transtibial bone-anchored prostheses users.

Conclusion:

Bone-anchored prostheses lead to improved performance and appear to be safe, so they might be considered for persons with socket-related problems.

SUBMITTER: Leijendekkers RA

PROVIDER: S-EPMC6416705 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Publications

Functional performance and safety of bone-anchored prostheses in persons with a transfemoral or transtibial amputation: a prospective one-year follow-up cohort study.

Leijendekkers Ruud A RA van Hinte Gerben G Frölke Jan Paul JP van de Meent Hendrik H Atsma Femke F Nijhuis-van der Sanden Maria Wg MW Hoogeboom Thomas J TJ

Clinical rehabilitation 20181212 3

<h4>Objectives:</h4>(1) To compare level of function, activity, health-related quality of life (HRQoL) and satisfaction in persons with a lower extremity amputation before surgery and 6- and 12-months after implantation of an osseointegration implant and (2) to report adverse events.<h4>Design:</h4>Prospective cohort study.<h4>Setting:</h4>University medical centre.<h4>Subjects:</h4>A total of 40 consecutive persons (median age: 56 years) who received a transfemoral (31) or transtibial (9) osseo ...[more]

PMID: 30537856

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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.

Project description:BACKGROUND:We described safety and functional one-year follow-up outcomes of individuals with lower limb amputation treated with bone-anchored prostheses using titanium press-fit osseointegration implants. METHODS:All consecutive individuals treated between March 2015 and June 2018 with curved osseointegration femur implant (OFI-C) indicated for a long femoral remnant, gamma osseointegration femur implant (OFI-Y) indicated for a short femoral remnant, or osseointegration tibia implant (OTI) were eligible for this study. All adverse events were evaluated, infections were graded as follows: grade 1 and 2: low- and high-grade soft tissue infection, respectively, grade 3: deep bone infection, grade 4: septic implant failure. Functional outcome measures included prosthesis wearing time (PUS), health-related quality of life (GS), and the overall situation as an amputee (GS Q3); evaluated with the Questionnaire of persons with trans-femoral amputation (Q-TFA) before surgery and at one-year follow-up. RESULTS:Ninety of 91 individuals were included (mean age: 54±14 yrs, 26 females); treated with 53, 16 and 21 OFI-C, OFI-Y and OTI, respectively. Soft tissue infections (grade 1: 11 events, grade 2: 10 events) were treated successfully with antibiotics except in two (OFI-C and OFI-Y), who required additional surgery due to recurrent stoma irritation and peri-stoma abscess drainage. One individual with dysvascular amputation (OTI) developed septic implant loosening and occlusion of the femoral artery resulting in a transfemoral amputation. No aseptic loosening's occurred. One individual (OFI-Y) required stoma surgical refashioning due to soft tissue redundancy. At baseline mean ±SD and median (25th to 75th PCTL) Q-TFA PUS and GS were 52±39, 52(7-90) and 40±19, 42(25-50) and improved significantly to 88±18, 90 (90-100) and 71±15, 75 (67-83) at one-year follow-up. The GS Q3 improved over time. CONCLUSION:Titanium osseointegration implants can be safely used within a one-year follow-up period. The performance improved compared to the use of a socket-suspended prosthesis.

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:BackgroundPersons with lower limb amputation often experience decreased physical capacity, difficulty walking, and increased fall risk. To either prevent or recover from a loss of balance, one must effectively regulate their stepping movements. It is therefore critical to identify how well persons with amputation regulate stepping. Here, we used a multi-objective control framework based on Goal Equivalent Manifolds to identify how persons with transtibial amputation (TTA) regulate lateral stepping while walking without and with lateral perturbations.Research questionWhen walking in destabilizing environments, do otherwise healthy persons with TTA exhibit greater difficulty regulating lateral stepping due to impaired control? Or do they instead continue to use similar strategies to regulate lateral stepping despite their amputation?MethodsEight persons with unilateral TTA and thirteen able-bodied (AB) controls walked in a virtual environment under three conditions: no perturbations, laterally oscillating visual field, and laterally oscillating treadmill platform. We analyzed step-to-step time series of step widths and absolute lateral body positions. We computed means, standard deviations and Detrended Fluctuation Analysis scaling exponents for each time series and computed how much participants directly corrected step width and position deviations at each step. We compared our results to computational predictions to identify the underlying causes of our experimental findings.ResultsAll participants exhibited significantly increased variability, decreased scaling exponents, and tighter direct control when perturbed. Simulations from our stepping regulation models revealed that people responded to the increased variability produced by the imposed perturbations by tightening their control of both step width and lateral position. Participants with TTA exhibited only a few minor differences from AB in lateral stepping regulation, even when subjected to substantially destabilizing lateral perturbations.SignificanceSince control of stepping is intrinsically multi-objective, developing effective interventions to reduce fall risk in persons with amputation will likely require strategies that adopt multi-objective approaches.

Project description:ObjectiveThis study presents the walking abilities of participants fitted with transfemoral bone-anchored prostheses using a total of 14 gait parameters.DesignTwo-centre retrospective cross-sectional comparative study.SettingResearch facilities equipped with tridimensional motion capture systems.ParticipantsTwo control arms included eight able-bodied participants arm (54 ± 9 years, 1.75 ± 0.07 m, 76 ± 7 kg) and nine participants fitted with transfemoral socket-suspended prostheses arm (59 ± 9 years, 1.73 ± 0.07 m, 80 ± 16 kg). The intervention arm included nine participants fitted with transfemoral bone-anchored prostheses arm (51 ± 13 years, 1.78 ± 0.09 m, 87.3 ± 16.1 kg).InterventionFitting of transfemoral bone-anchored prostheses.Main measuresComparisons were performed for two spatio-temporal, three spatial and nine temporal gait parameters.ResultsThe cadence and speed of walking were 107 ± 6 steps/min and 1.23 ± 0.19 m/s for the able-bodied participants arm, 88 ± 7 steps/min and 0.87 ± 0.17 m/s for the socket-suspended prosthesis arm, and 96 ± 6 steps/min and 1.03 ± 0.17 m/s for bone-anchored prosthesis arm, respectively. Able-bodied participants and bone-anchored prosthesis arms were comparable in age, height, and body mass index as well as cadence and speed of walking, but the able-bodied participant arm showed a swing phase 31% shorter. Bone-anchored and socket-suspended prostheses arms were comparable for age, height, mass, and body mass index as well as cadence and speed of walking, but the bone-anchored prosthesis arm showed a step width and duration of double support in seconds 65% and 41% shorter, respectively.ConclusionsBone-anchored and socket-suspended prostheses restored equally well the gait parameters at a self-selected speed. This benchmark data provides new insights into the walking ability of individuals using transfemoral bionics bone-anchored prostheses.

Dataset Information

Functional performance and safety of bone-anchored prostheses in persons with a transfemoral or transtibial amputation: a prospective one-year follow-up cohort study.

Objectives:

Design:

Setting:

Subjects:

Intervention:

Main measures:

Results:

Conclusion:

Publications

Functional performance and safety of bone-anchored prostheses in persons with a transfemoral or transtibial amputation: a prospective one-year follow-up cohort study.

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