Clinical outcome of osseointegrated prostheses for lower extremity amputations

Eck, Carola F. van; McGough, Richard L.

doi:10.1097/bco.0000000000000248

Cited by 43 publications

(32 citation statements)

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“…The principle is well established in the prosthetic replacement of teeth [ 7 ] and in craniofacial reconstruction [ 14 ]. In lower limb replacement a few modular methods [ 9 , 23 , 43 ] were developed after the first orthopaedic implantation by Per Ingvar Brånemark and Björn Rydevik in 1990 [ 9 ]. The use of biomedical implants involves a risk of infection, particularly if the skin barrier is penetrated.…”

Section: Introductionmentioning

confidence: 99%

Osteomyelitis Risk in Patients With Transfemoral Amputations Treated With Osseointegration Prostheses

Tillander

Hagberg

Berlin

et al. 2017

Clinical Orthopaedics &Amp; Related Research

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BackgroundPercutaneous anchoring of femoral amputation prostheses using osseointegrating titanium implants has been in use for more than 25 years. The method offers considerable advantages in daily life compared with conventional socket prostheses, however long-term success might be jeopardized by implant-associated infection, especially osteomyelitis, but the long-term risk of this complication is unknown.Questions/Purposes(1) To quantify the risk of osteomyelitis, (2) to characterize the clinical effect of osteomyelitis (including risk of implant extraction and impairments to function), and (3) to determine whether common patient factors (age, sex, body weight, diabetes, and implant component replacements) are associated with osteomyelitis in patients with transfemoral amputations treated with osseointegrated titanium implants.MethodsWe retrospectively analyzed our first 96 patients receiving femoral implants (102 implants; mean implant time, 95 months) treated at our center between 1990 and 2010 for osteomyelitis. Six patients were lost to followup. The reason for amputation was tumor, trauma, or ischemia in 97 limbs and infection in five. All patients were referred from other orthopaedic centers owing to difficulty with use or to be fitted with socket prostheses. If found ineligible for this implant procedure no other treatment was offered at our center. Osteomyelitis was diagnosed by medical chart review of clinical signs, tissue culture results, and plain radiographic findings. Proportion of daily prosthetic use when osteomyelitis was diagnosed was semiquantitatively graded as 1 to 3. Survivorship free from implant- associated osteomyelitis and extraction attributable to osteomyelitis respectively was calculated using the Kaplan-Meier estimator. Indication for extraction was infection not responsive to conservative treatment with or without minor débridement or loosening of implant.ResultsImplant-associated osteomyelitis was diagnosed in 16 patients corresponding to a 10-year cumulative risk of 20% (95% CI 0.12–0.33). Ten implants were extracted owing to osteomyelitis, with a 10-year cumulative risk of 9% (95% CI 0.04–0.20). Prosthetic use was temporarily impaired in four of the six patients with infection who did not undergo implant extraction. With the numbers available, we did not identify any association between age, BMI, or diabetes with osteomyelitis; however, this study was underpowered on this endpoint.ConclusionThe increased risk of infection with time calls for numerous measures. First, patients should be made aware of the long-term risks, and the surgical team should have a heightened suspicion in patients with method-specific presentation of possible infection. Second, several research questions have been raised. Will the surgical procedure, rehabilitation, and general care standardization since the start of the program result in lower infection rates? Will improved diagnostics and early treatment resolve infection and prevent subsequent extraction? Although not supported in this study, it is im...

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Section: Introductionmentioning

confidence: 99%

Osteomyelitis Risk in Patients With Transfemoral Amputations Treated With Osseointegration Prostheses

Tillander

Hagberg

Berlin

et al. 2017

Clinical Orthopaedics &Amp; Related Research

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“…6 Downsides to direct skeletal attachment include a risk of superficial and deep infection through the skin opening, a risk of femoral fractures, implant extraction, high proximal revision, and potential bone resorption due to stress shielding. [13][14][15][16] Despite the variety of devices, it appears that many surgeons remain unhappy with the concept of a permanent percutaneous implant. Subcutaneous implants have been developed: in the 1960s Swanson et al 17 developed a mushroom-shaped silicone implant in an attempt to improve end bearing.…”

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confidence: 99%

Micromotion and Push‐Out Evaluation of an Additive Manufactured Implant for Above‐the‐Knee Amputees

Barnes

Clasper

Bull

et al. 2019

Journal Orthopaedic Research

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In comparison to through‐knee amputees the outcomes for above‐the‐knee amputees are relatively poor; based on this novel techniques have been developed. Most current percutaneous implant‐based solutions for transfemoral amputees make use of high stiffness intramedullary rods for skeletal fixation, which can have risks including infection, femoral fractures, and bone resorption due to stress shielding. This work details the cadaveric testing of a short, cortical bone stiffness‐matched subcutaneous implant, produced using additive manufacture, to determine bone implant micromotion and push‐out load. The results for the micromotions were all <20 μm and the mean push‐out load was 2,099 Newtons. In comparison to a solid control, the stiffness‐matched implant exhibited significantly higher micromotion distributions and no significant difference in terms of push‐out load. These results suggest that, for the stiffness‐matched implant at time zero, osseointegration would be facilitated and that the implant would be securely anchored. For these metrics, this provides justification for the use of a short‐stem implant for transfemoral amputees in this subcutaneous application. © 2019 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 37:2104–2111, 2019

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“…Evidences of sustainable clinical benefits of boneanchored prosthesis (BAP) using osseointegrated fixation over typical socket-suspended prostheses (SSP) are becoming more probing, particularly for young and active individuals with non-vascular transfemoral amputation. (1)(2)(3)(4) Clinical risks with BAP particularly infection and breakage of components are currently deemed acceptable although yet to be resolved satisfactorily. (5)(6)(7)(8) Significant improvement in health-related quality of life has driven a steady demand from wide range of individuals with lower limb amputation.…”

Section: Strong Demand For Bone-anchored Prosthesesmentioning

confidence: 99%

“…(5)(6)(7)(8) Significant improvement in health-related quality of life has driven a steady demand from wide range of individuals with lower limb amputation. (1)(2)(3)(4)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26) Indeed, surgical procedures are growing at an unprecedented pace worldwide. (18,27,28)…”

Section: Strong Demand For Bone-anchored Prosthesesmentioning

confidence: 99%

Development of a Government Continuous Quality Improvement Procedure for Assessing the Provision of Bone Anchored Limb Prosthesis: A Process Re-Design Descriptive Study

Frossard

Ferrada

Quincey

et al. 2018

Can. Prosthet. Orthot. J.

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BACKGROUND: Evidences of sustainable clinical benefits of bone-anchored prosthesis (BAP) using osseointegrated fixation over typical socket-suspended prostheses are becoming more probing. This influx of individuals to be fitted with BAP has pressed government organisations to adjust their policies. However, the appraisal of consumer’s experience for the provision of BAP founded by government organisation is yet to be developed. This descriptive study shares the experience gained by a government organisation, namely the Queensland Artificial Limb Service (QALS), while developing a specific BAP-inclusive continuous quality improvement (CQI) procedure. OBJECTIVE(S): The primary objective was to present the methods and outcomes of key steps required to plan and create this CQI procedure. The secondary objective was to highlight key barriers and facilitators of the transition from a socket-focused to the proposed BAP-inclusive CQI procedure. METHODOLOGY: The re-design process of the CQI procedure for 65 current QALS’s consumers with BAP involved a two-step process for the planning (e.g., case-mix, stakeholder) and creation (e.g., diagnosis, technical options, cost). FINDINGS: Prosthetists labour toward CQI procedure represented 1.3 hrs out of 22 hrs and AUD$213 out of AUD$3,300 or 6% of the whole procedure for the provision of BAP. The time spent by a prosthetist, consumer and QALS staff represented 24%, 24% and 53% of the time of the CQI procedure, respectively. The cost of prosthetist and QALS staff labour represented 70% and 30% of the CQI procedure, respectively. CONCLUSIONS: This descriptive study shares the workings and methodology that government organisations, such as QALS, can use to re-design a CQI procedure for comprehensive appraisal of the provision of prosthesis that could be inclusive of BAP and affordable while minimally time-consuming for prosthetists. The transition from a socket-focused to the proposed minimally disruptive BAP-inclusive CQI procedure was facilitated by prior knowledge of BAP treatment, early identification of the stakeholders and adaptation of current CQI procedure. Article PDF Link: https://jps.library.utoronto.ca/index.php/cpoj/article/view/31326/24425 LAYMAN’S ABSTRACT There is evidence supporting the long term clinical benefits of bone-anchored prosthesis (BAP) using an osseointegrated fixation over typical socket-suspended prostheses. The increasing number of individuals treated with osseointegrated fixation has pressed government organisations to adjust their policies for fair and equitable provision of prosthetic care. However, the appraisal of consumer’s experience for the provision of BAP by government organisation is yet to be developed. This descriptive study has fulfilled this need by sharing the experience gained by a QALS while developing a specific BAP-inclusive continuous quality improvement (CQI) procedure. This study revealed that government organisations can design a CQI procedure for comprehensive appraisal of the provision of prosthesis that could be inclusive of BAP and affordable while minimally time-consuming for prosthetists. The transition from a socket-focused to the proposed minimally disruptive BAP-inclusive CQI procedure was facilitated by prior knowledge of BAP treatment, early identification of the stakeholders and adaptation of current CQI procedure. How to Cite: Frossard L, Ferrada L, Quincey T, Burkett B, Berg D. Development of a government continuous quality improvement procedure for assessing the provision of bone anchored limb prosthesis: a process re-design descriptive study. Canadian Prosthetics & Orthotics Journal, Volume 1, Issue 2, No 4, 2018. DOI: https://doi.org/10.33137/cpoj.v1i2.31326

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Clinical outcome of osseointegrated prostheses for lower extremity amputations

Cited by 43 publications

References 28 publications

Osteomyelitis Risk in Patients With Transfemoral Amputations Treated With Osseointegration Prostheses

Osteomyelitis Risk in Patients With Transfemoral Amputations Treated With Osseointegration Prostheses

Micromotion and Push‐Out Evaluation of an Additive Manufactured Implant for Above‐the‐Knee Amputees

Development of a Government Continuous Quality Improvement Procedure for Assessing the Provision of Bone Anchored Limb Prosthesis: A Process Re-Design Descriptive Study

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